REITER FINAL.DOC

4/30/2009 10:22:01 PM

Experimentation on Prisoners: Persistent
Dilemmas in Rights and Regulations
Keramet Reiter†

INTRODUCTION
Between 1965 and 1966, Dr. Albert M. Kligman exposed approximately
seventy-five prisoners at Holmesburg prison in Pennsylvania to high doses of
dioxin, the main poisonous ingredient in Agent Orange.1 Dow Chemical paid
Dr. Kligman $10,000 to conduct the experiments on the toxicity effects of this
Vietnam War-era chemical warfare agent. Dr. Kligman exposed prisoners to a
dosage 468 times greater than that in the Dow Chemical protocol for the
experiments.2 Records from the experiments have been destroyed, and the
Environmental Protection Agency’s 1981 investigation into the matter failed to
identify the exact participants, rendering the long-term effects of the exposure
untraceable.3 Nonetheless, prisoners who participated in dermatological
experiments under Dr. Kligman’s hand in 1965 and 1966 report that they still
experience scars, blisters, cysts, and ongoing rashes.4 Indeed, at least two
prisoners filed lawsuits against Dow Chemical in the 1980s for the exposure
they suffered in the 1960s; both settled their claims for undisclosed sums.5 Dr.
Kligman is perhaps better known for developing the skin treatment Retin-A, at

Copyright © 2009 California Law Review, Inc. California Law Review, Inc. (CLR) is a
California nonprofit corporation. CLR and the authors are solely responsible for the content of
their publications.
†
J.D., University of California, Berkeley, School of Law (Boalt Hall), expected 2009;
Ph.D. in Jurisprudence and Social Policy, University of California, Berkeley, expected 2012;
M.A., John Jay College of Criminal Justice, City University of New York 2006; B.A., Harvard
University 2003. With gratitude to Professor Franklin E. Zimring, who encouraged and challenged
me in equal measure through this endeavor, as well as to the thoughtful members of the California
Law Review, especially Willoughby Anderson. And thanks to my partner, Thomas Blair, who
both read several drafts and helped me to interpret complex medical procedures.
1. See Allen M. Hornblum, Acres of Skin, 163-83 (1998) (chronicling the story of Dr.
Kligman’s dioxin experiments at Holmesburg prison).
2. Id. at 169.
3. William Robbins, Dioxin Tests Conducted in 60’s on 70 Philadelphia Inmates, Now
Unknown, N.Y. Times, July 17, 1983, at A16.
4. Hornblum, supra note 1, at 181.
5. Id.

501

REITER FINAL.DOC

502

4/30/2009 10:22:01 PM

CALIFORNIA LAW REVIEW

[Vol. 97:501

least partially on the basis of experiments he conducted on prisoners at
Holmesburg prison.6 The story of Dr. Kligman’s experiments was fully
explored in 1998 in a book entitled Acres of Skin; the title is based on a
quotation from Dr. Kligman himself, who recalled visiting Holmesburg prison
for the first time and seeing “acres of skin” on which he could experiment.7
In response to experiments conducted in prisons across the United States,
under the supervision of doctors such as Dr. Kligman and sponsored by drug
companies such as Dow Chemical, the United States Department of Health,
Education, and Welfare released a report in 1976 condemning the use of
prisoners in human subjects research.8 This report (1976 DHEW Report)
inspired the federal government to pass strict regulations limiting prisoner
experimentation to narrow categories of non-intrusive, low-risk, individually
beneficial research.9 Congress passed these regulations, codified at Title 45 of
the Code of Federal Regulations, in 1978, a scant two years after the release of
the DHEW Report.10 Following the 1976 DHEW Report’s release and the
codification of its recommendations into Title 45, Upjohn and Parke Davis, two
of the largest drug companies in the United States, closed their Phase I drugtesting facilities in Michigan state prisons.11 Simultaneously, state prison
systems forced doctors like Dr. Kligman to stop their research programs in the
prisons.12
But medical experimentation on prisoners was far from over. Forty years
after Dr. Kligman conducted his dioxin experiments, and thirty years after the
implementation of strict federal regulations virtually banning the use of
prisoners in medical experiments, prisoner subjects continue to be used in
medical experiments. For instance, between 2006 and 2008, a drug company
called Hythian contracted with jurisdictions in at least five different states
including Indiana, Washington, Texas, Louisiana, and Georgia to enroll
criminal defendants in an experimental drug addiction treatment program.13 As
part of this program, state judges “divert” drug court participants, who have
been found in possession of drugs, into an experimental treatment program

6. Id. at 211-31 (documenting how “Retin-A’s Birthplace was at Holmesburg Prison”).
7. Id. at 37.
8. Protection of Human Subjects, 42 Fed. Reg. 3076-91 (DHEW Jan. 14, 1977) (to be
codified at 45 C.F.R. pt. 46), available at http://www.hhs.gov/ohrp/documents/19770114.pdf
[hereinafter 1976 DHEW Report].
9. 45 C.F.R. § 46.306(a)(2)(i)-(iv) (2007) (describing the four categories of research in
which prisoners might permissibly be included: (1) research about the effects of incarceration, (2)
research about prisons as institutions, (3) research about conditions particularly affecting
prisoners, and (4) research about practices expected to improve the health of individual subjects).
10. See 45 C.F.R §§ 46.301-.306 (2007).
11. See infra notes 61-76 and surrounding text.
12. Hornblum, supra note 1, at 187.
13. See Gregory Dober, Junk Bonds to Junk Science? Drug Treatment Program
Questioned, Prison Legal News, March 2008, available at http://breakallchains.blogspot.com/
2008/04/junk-bonds-to-junk-science-drug.html.

REITER FINAL.DOC

2009]

4/30/2009 10:22:01 PM

EXPERIMENTATION ON PRISONERS

503

called Prometa. Hythian runs the Prometa program at a cost of $15,000 per
participant. The program involves thirty days of treatment with three different
drugs, none of which has been approved for use in addiction treatment by the
Food and Drug Administration (FDA).14 At least one Collin County, Texas,
participant in the Prometa program died; the court recorded the death as a
suicide.15 Unlike Dr. Kligman’s experiments, the Prometa program has not yet
inspired an investigative journalism project. No participants have been publicly
interviewed, and no federal agency has investigated the effects of the program.
Taken together, the stories of Dr. Kligman’s dioxin experiments and
Hythian’s drug-addiction treatment trials, occurring over the span of forty
years, reveal a number of critical facts about the use of prisoners for medical
experimentation in the United States. First, a wide variety of research has
been—and continues to be—conducted on prisoner subjects in the United
States; universities, the federal government, and private drug companies alike
have sponsored such research.16 Second, this research takes place behind prison
walls, inside non-traditional confinement facilities like drug addiction treatment
centers, governed by private contracts, and often beyond the reach of public
regulation. And, finally, this research evades restrictions.
Each of these facts—the continued participation of prisoners in
experimental protocols despite federal regulations forbidding such
participation, the lack of transparency in this research and the associated
difficulty of oversight, and the particular resistance of private drug company
researchers to regulation—motivated the recommendations in a recent federal
report entitled Ethical Considerations for Research Involving Prisoners (2006
IOM Report). In 2006, the Department of Health and Human Services (DHHS),
which is responsible for enforcing the federal human subjects research
regulations implemented in the 1970s, commissioned the Institute of Medicine
(IOM) to reevaluate the federal standards governing medical experimentation
on prisoners.17
The 2006 IOM Report calls for significant changes in the ethical standards

14. See Lawrence M. Weinstein et al., Scientific Basis of the Prometa Treatment
Program 1 (2007), available at http://www.prometainfo.com/site/special/ A8x1513x8x1.pdf.
15. Dober, supra note 13.
16. As the Prometa drug-treatment studies described above suggest, private drug
companies continue signing contracts to use criminal defendants and prisoners as subjects in
experimental addiction treatment drug trials. As recently as 2007, determination letters from the
Department of Health and Human Services cited violations of the federal regulations prohibiting
experimentation in prisons. These letters suggest that medical experiments in prisons have taken
place at least since 2000 and may have been ongoing for the past thirty years. See infra note 151
and surrounding text.
17. The Institute of Medicine, “chartered in 1970 as a component of the National Academy
of Sciences,” is a nonprofit organization that works to “ensure scientifically informed analysis and
independent guidance” and “to serve as adviser to the nation to improve health.” Inst. of Med. of
the Nat’l Acads., About, http://www.iom.edu/CMS/AboutIOM.aspx (last visited Oct. 14, 2008).

REITER FINAL.DOC

504

4/30/2009 10:22:01 PM

CALIFORNIA LAW REVIEW

[Vol. 97:501

governing medical experiments on prisoners.18 Of the many recommendations
in the 265-page report, two are critical. First, the Report recommends
streamlining and expanding oversight of prisoner experimentation.19 Second,
the Report recommends replacing the current categorical limitations on
prisoner experimentation codified at Title 45 with case-by-case risk-benefit
analyses of individual experiments.20 This Comment argues that the first
category of recommendations—increasing oversight of experimentation on
prisoner subjects—is absolutely necessary. However, the second category of
recommendations—implementing cost-benefit analyses—should not be
implemented.
According to a staff member at the Office for Human Research
Protections (the division of the DHHS that regulates federally-funded human
subjects research), Congress might consider and adopt the new standards
suggested by the IOM at any time.21 However, the process requires legislative
initiative and a public comment period, so any change will likely be slow. In
the interim, the DHHS can and should take steps to implement some aspects of
the 2006 Report, while encouraging further research on the more controversial
recommendations. For instance, Report recommendations calling for more
rigorous oversight, expanding definitions of who is a prisoner, and encouraging
enhanced transparency around human subjects research on prisoners should be
implemented immediately.22 Specifically, the DHHS should alter its
recommendations to incorporate as broad a definition of prisoner as possible
and should initiate “a publicly available, national registry of research involving
prisoners.”23 Additionally, Congress should legislate expanded regulatory
authority for the DHHS and other federal agencies.
On the other hand, those regulations that suggest replacing the categorical
limitations on prisoner experimentation with case-by-case risk-benefit analyses
of individual experimental protocols should not be implemented. Before
Congress considers any such regulatory change, additional research in two
areas should be conducted. First, further research is needed to determine the
prevalence and scope of current prisoner subjects experimentation. (Of course,
implementing the 2006 IOM Report recommendations for increased oversight
18. Inst. of Med. of the Nat’l Acads., Ethical Considerations for Research
Involving Prisoners (2007) [hereinafter 2006 IOM Report].
19. Id. at 6-7.
20. Id. at 8-10.
21. An Office for Human Research Protections staff member said that changes to the
regulations will “literally require[] a Congressional Act.” In the interim, the office has “written
some new guidance documents to help clarify the office’s position,” and “will continue to work
through to get new regulations written.” Telephone Interview with Lynda Lahl, Education/Quality
Improvement staff, Office for Human Research Protections, in Rockville, Md. (April 24, 2008).
22. For instance, recommendations 2.1, 3.1, and 6.7, noted in the Summary of the Report,
in a section describing those recommendations that “Ensure Universal, Consistent Ethical
Protections,” should be implemented immediately. 2006 IOM Report, supra note 18, at 6-7.
23. Id. at 7.

REITER FINAL.DOC

2009]

4/30/2009 10:22:01 PM

EXPERIMENTATION ON PRISONERS

505

mechanisms would be a first step toward achieving this preliminary research
goal.) Second, further research is needed to explore the relationship between
current U.S. prison conditions and prisoners’ abilities to provide informed
consent, participate in experimentation, and challenge inhumane practices.
Detrimental prison conditions, from overcrowding to constitutionally
inadequate healthcare, to provide just two examples, may both compromise
prisoners’ abilities to protect themselves from medical experiments gone-wrong
and also compromise the enforcement of current and potential regulations.24 A
supplemental IOM report, a Congressional mandate, or further DHHS
initiatives could facilitate pursuit of this twofold research agenda.
The public response to the 2006 IOM Report has been limited. A few
national newspapers ran short editorials responding to the Report’s
recommendations immediately after its release.25 Only three scholarly articles
have addressed the recommendations in the Report: one of these articles
provides a simple summary of the regulations authored by the Chair of the
2006 Report Committee; another article focuses on the ethics of consent; a third
uses hypothetical case studies to argue in support of the Report’s
recommendations.26 In sum, scholarly analysis of the Report’s
recommendations, to date, as well as public debate over the pros and cons of
the recommendations, has been limited. This Comment represents the first
critical analysis of the recent recommendations on prisoner experimentation,
situated in the particular context of the history of continuous medical
experimentation in U.S. prisons in the twentieth and twenty-first centuries,
including new investigative research on current practices. Furthermore, this
Comment draws on analyses of international law and domestic court cases to
suggest that both current U.S. regulations and the changes proposed in the 2006
24. The detrimental prison conditions in U.S. prisons currently are described in Part I.B.2
on “Human Sardines,” below.
25. A small flurry of articles challenging the Report recommendations and threatening a
return to the horrors inflicted by Nazi doctors in concentration camps and by United States Public
Health Service doctors during the Tuskegee syphilis experiments greeted the release of the 2006
IOM Report. See, e.g., Allen M. Hornblum & Osagie K. Obasogie, “Medical Exploitation:
Inmates Must Not Become Guinea Pigs Again,” Phila. Inquirer, Sept. 13, 2007; Ian Urbina,
“Panel Suggests Using Inmates In Drug Trials,” N.Y. Times, Aug. 13, 2006, at 1; see also Osagie
K. Obasogie, “Prisoners and Clinical Trials: Cruel and Unusual Ethics?” Genetic Crossroads,
June 29, 2007, available at http://geneticsandsociety.org/article.php?id=3203.
26. See Lawrence O. Gostin (Chair of the Committee on Ethical Considerations for
Revisions to DHHS Regulations for Protection of Prisoners Involved in Research), Biomedical
Research Involving Prisoners: Ethical Values and Legal Regulation, 297 JAMA 737 (2007)
(summarizing the recommendations in the 2006 IOM Report); Andrea Lynn Osganian, Note,
Limitations on Biomedical and Behavioral Research Involving Prisoners: An Argument
Supporting the Institute of Medicine’s Recommendations to Revise Regulations, 34 New Eng. J.
on Crim. & Civ. Confinement 429 (2008) (addressing the hypothetical effects on prisoners and
society of implementing the regulations); Rachel Wener, Comment, Not Situated to Exercise Free
Power of Choice: Human Subject Research in Prison Settings, 26 Temp. J. Sci. Tech. & Envtl.
L. 365 (2007) (analyzing how the 2006 IOM Report recommendations interact with common law
understandings of consent).

REITER FINAL.DOC

506

4/30/2009 10:22:01 PM

CALIFORNIA LAW REVIEW

[Vol. 97:501

IOM Report provide inadequate legal protections for prisoner subjects of
experimentation.
Part I reviews the history of medical experimentation in U.S. prisons to
date, both before and after the first set of federal regulations on prisoner
experimentation took effect in 1976. This history reveals both the risks of
allowing medical experimentation without implementation of rigid safeguards
and the limitations of existing safeguards. Indeed, investigative research reveals
that medical experimentation currently occurs in prisons across the United
States in spite of federal regulations attempting to curtail such practices. Part II
compares the 1976 DHEW Report to the 2006 IOM Report, exploring each
Report’s different recommendations and analyzing the potential effects of these
differences. Part III catalogues the applicable standards—international and
domestic, legal and medical—that currently govern medical experimentation on
prisoners. This analysis reveals current protections for U.S. prisoners of
experimentation to be inadequate, both in comparison to international standards
and in the face of strict federal limitations on the rights of prisoners to
challenge conditions of confinement and healthcare inadequacies. Part IV
suggests how the federal government should regulate research in prisons in the
future.
In the Conclusion, this Comment returns to its central analysis of the 2006
IOM Report. Congress and the DHHS should implement regulatory changes
that streamline and expand oversight of experiments that involve prisoner
subjects. However, neither Congress nor the DHHS should implement a riskbenefit analysis to evaluate research proposals on prisoners. Implementing a
risk-benefit analysis standard of review requires two preconditions. First,
minimum human rights standards must exist in U.S. prisons and be
incorporated into standards of review. Otherwise, a risk-benefit approach
cannot feasibly and accurately determine the risks or the benefits of any
individual prisoner’s participation in medical experimentation. Second, any
risk-benefit analysis must focus solely on the risks and benefits to the
individual prisoner participant, and not on any potential benefit to general
scientific knowledge or society-at-large. Until these two conditions are met,
regulatory agencies should seek to curtail severely, rather than to expand,
human subjects research on prisoners. In sum, while many of the suggestions in
the 2006 IOM Report make sense in isolation, as a whole they add up to an
idealistic and infeasible vision of the controls that regulators might exert over
future research conducted on prisoners.
I
CONTEXT: WHY CHANGE REGULATIONS GOVERNING PRISONER
EXPERIMENTATION?
While “human subjects research” is a modern term, human beings have
been used in experiments throughout the world since at least the ancient

REITER FINAL.DOC

2009]

4/30/2009 10:22:01 PM

EXPERIMENTATION ON PRISONERS

507

times.27 In the United States, biomedical research “unrelated to the health or
well-being” of prisoners took place at least as early as 1934, when a program at
Leavenworth Prison in Kansas evaluated the effects of narcotic analgesics on
prisoners.28 In fact, the popularity of human subjects experimentation,
especially on prisoners, has waned only in the last thirty years.
A series of public revelations about the human rights abuses perpetuated
in the name of science on prisoners and other vulnerable populations
precipitated the decline in popularity of human subjects experimentation. First,
the Nuremberg Trials in the late 1940s revealed the brutality of Nazi
concentration camp medical experiments. Closer to home, the U.S.
government’s experiments on prisoners and similarly vulnerable populations
came under scrutiny. For instance, revelations about the Heller Experiments,
which the U.S. government funded between 1963 and 1973, to examine the
effects of radiation on the testes of Oregon prisoners, shocked the nation.29
Similarly, revelations that, from 1932 through 1972, U.S. government officials
supervised the Tuskegee syphilis experiments, which evaluated the long-term
effects of untreated syphilis in African American men, drew public ire.30
The history of experimentation in prisons and on other vulnerable
populations reveals the extreme risks of using these kinds of vulnerable
subjects in either state-sanctioned or private medical experiments, especially
without clear and enforceable regulations. In 1978, Congress acted on the
public outrage over such abuses, passing an act for the “Protection of Human
Subjects.”31 This act, codified at Title 45, regulates all categories of human
27. Ancient Persian and Roman authorities used prisoners as research subjects. Similarly,
eighteenth-century European physicians used prisoners in infectious disease studies, deliberately
infecting them with everything from cancer to typhoid. Sharona Hoffman, Beneficial and Unusual
Punishment: An Argument in Support of Prisoner Participation in Clinical Trials, 33 Ind. L. Rev.
475, 482 (2000) (citing 4 Encyclopedia of Bioethics 2056 (Warren T. Reich ed., rev. ed.
1995)). In the nineteenth-century United States, doctors, with the permission of slave owners,
subjected enslaved people in Alabama and Georgia to medical experimentation. See Barbara L.
Bernier, Class, Race, and Poverty: Medical Technologies and Socio-Political Choices, 11 Harv.
BlackLetter L.J. 115, 118-20 (1994). For instance, one doctor experimented on slave women
suffering from vesico-vaginal fistulas by conducting multiple surgeries without anesthetics to find
the most effective “treatment.” Similarly, a Georgia doctor experimented with the effects and
remedies of sunstroke by placing a slave into an “open-pit” oven. Id. at 118-20 (citing Diana E.
Axelsen, Women as Victims of Medical Experimentation: J Marion Sims’ Surgery on Slave
Women, 1845-59, 2 Sage 10 (1985); Todd L. Savitt, Medicine and Slavery: The Diseases
and Health Care of Blacks in Antebellum Virginia 280 (1978)).
28. 1976 DHEW Report, supra note 8, at 3081.
29. See Bibeau v. Pac. Nw. Research Found., 980 F. Supp. 349, 351-52 (D. Or. 1997).
30. See James H. Jones, Bad Blood: The Tuskegee Syphilis Experiment (2d ed.
1993). Note that although the Tuskegee subjects were not prisoners, they did constitute a
vulnerable population: poor, illiterate, African-American sharecroppers in the South prior to the
civil rights movement. The Tuskegee study, like many medical experiments involving prisoner
subjects, suffered from a lack of transparency, an absence of a therapeutic aim, and a significant
knowledge and power imbalance between the subjects and the experimenters, all of which created
serious questions regarding consent.
31. See 45 C.F.R. §§ 46.101-.409 (2007).

REITER FINAL.DOC

508

4/30/2009 10:22:01 PM

CALIFORNIA LAW REVIEW

[Vol. 97:501

subjects research, including research on three specific categories of vulnerable
populations: children, pregnant women, and prisoners.32
The contrast between the widespread use of prisoners in medical
experiments prior to 1978 and the terms of the regulations strictly limiting the
use of prisoners in medical experiments after 1978 suggests an ethical
dilemma: should prisoners be permitted to participate in medical
experimentation, and under what conditions? In the 1950s, society and the
prisoners themselves expressed gratitude for the benefits of prisoner
participation in medical experimentation. Indeed, in the 1940s and 1950s,
doctors and prison officials considered such participation in experiments a
“privilege” for prisoners; the American Medical Association actually
discouraged participation of less worthy prisoners, defined as prisoners
convicted of “particularly serious crimes.”33
During the Nuremberg Trials in the late 1940s, however, Nazi doctors
defended themselves against charges of atrocities committed in the name of
medical science with evidence of the medical experimentation taking place in
American prisons.34 At that point, not surprisingly, prisoner experimentation
came under fire worldwide.35 But proponents still justified medical
experimentation on prisoners as a socially beneficial practice through the early
1970s.36 Meanwhile, though, critics spoke out against this “social benefit” idea,
suggesting that such justifications were actually an unethical manipulation of
the prisoner’s desire to contribute to the social good, particularly where the
experiments provided no conceivable benefit to the prisoner participant.37

32. See id. §§ 46.401-.409 (“Additional Protections for Children Involved as Subjects in
Research”); id. §§ 46.201-.207 (“Additional Protections for Pregnant Women, Human Fetuses and
Neonates Involved in Research”); id. §§ 46.301-.306 (“Additional Protections Pertaining to
Biomedical and Behavioral Research Involving Prisoners as Subjects”).
33. 1976 DHEW Report, supra note 8, at 3081; see also Hornblum, supra note 1, at 78-79
(documenting wartime prison medical experiments).
34. An article in the Austin American-Statesman noted that the Nazi doctors were referring
specifically to two American medical experiments conducted in the first decades of the twentieth
century: the infection of prisoners in the Philippines with a “defective cholera vaccine” that
resulted in thirteen deaths in 1906, and testicular transplants—implanting the testicular glands of
“boars, rams and goats”—inflicted on at least 500 prisoners at California’s San Quentin State
Prison between 1919 and 1922. Mike Ward & Bill Bishop, Becoming Guinea Pigs to Avoid Poor
Prison Care: Ill Inmates Urge Each Other to Join Experiments, Austin Am.-Statesman, Dec.
17, 2001, at A1.
35. Hornblum, supra note 1, at 75.
36. See infra notes 82-83 and surrounding text.
37. In particular, Jessica Mitford fueled this perspective by writing about behavioral
modification and medical experiments gone wrong in her 1973 book, Kind and Usual Punishment.
See 1976 DHEW Report, supra note 8, at 3077-78 (referencing the influence of Jessica Mitford,
Kind and Usual Punishment (Vintage Books 1974) (1973) [hereinafter Mitford, Kind and
Usual Punishment]). Jessica Mitford was a well-known investigative journalist who published a
number of exposés about American institutions. The first, about the American funeral industry,
was called The American Way of Death and was first published in 1963. See Jessica Mitford,
The American Way of Death (1963).

REITER FINAL.DOC

2009]

4/30/2009 10:22:01 PM

EXPERIMENTATION ON PRISONERS

509

The 2006 IOM Report recommendations suggest that current opinion once
again favors at least some experimentation on prisoners as potentially
beneficial. The remainder of Part I reviews the history of the pendulum swing
in opinion between all-benefit and all-detriment perspectives on prisoner
experimentation. Part A below reviews the pre-1976 history of experimentation
on prisoners. Rampant pre-1976 abuses of vulnerable population participants in
medical research convinced courts, researchers, some prisoners, and federal
policy makers alike that medical experimentation on prisoners, particularly
unregulated experimentation, was almost universally detrimental. Hence,
Congress sought to eliminate the vast majority of this experimentation through
the passage of the strict human subjects regulations codified at Title 45. Part B
below reviews the limited information available about experimentation on
prisoners between 1976 and 2008, describes what little is known about the
benefits and detriments of this experimentation, and evaluates the post-1976
implementation and effectiveness of the Title 45 regulations governing
experimentation on prisoners. Part B also provides an overview of relevant
prison conditions in 2008.
A. Human Subjects Research in Prisons Prior to 1976
The 1970s transition in social norms from embracing to condemning
experimentation on prisoners helps to frame the 1976 DHEW Report and its
recommendations. Moreover, the abusive conditions that prisoner subjects of
medical experimentation experienced up until the late 1970s serve as a forceful
reminder of the risks of inadequate limitations on such experimentation.
A number of factors coalesced to inspire the 1976 DHEW Report and its
subsequent congressional ratification and codification into a federal statute,
which severely curtailed biomedical experimentation in prison.38 First, prison
medical experimentation expanded in sheer quantity across the United States.
Second, media outcry and public awareness of the kinds of medical tests
performed, as well as of the associated dangers, grew. Third, as prisoners
brought lawsuits challenging the terms of experimentation and seeking
damages for experiments gone wrong, courts and prison administrators also
became acutely aware of the dangers and the liabilities of medical testing. Prior
to the 1976 DHEW Report and the codification of regulations in Title 45,39
public regulation of human experimentation in any form had been minimal, or
based on non-binding recommendations like the Nuremberg Code.40

38. 2006 IOM Report, supra note 18, at 95 (noting that biomedical research in prison is
“rare,” particularly non-therapeutic biomedical research, which only two state Departments of
Corrections permitted as of 2006).
39. This statute is codified at 45 C.F.R. § 46.306.
40. See infra note 257 and surrounding text.

REITER FINAL.DOC

510

4/30/2009 10:22:01 PM

CALIFORNIA LAW REVIEW

[Vol. 97:501

1. Human Guinea Pigs
Three broad categories of experiments took place in prisons in the 1970s:
behavior modification research conducted by prison officials; biomedical
research, often supported or directed by federal agencies; and pharmaceutical
research, largely funded and controlled by private drug companies.41
Ultimately, the 1978 federal statute regulating experimentation on prisoners
prohibited all non-therapeutic biomedical and drug research on prisoners but
permitted biomedical and behavioral research specifically seeking to improve
the health of the research subject.42 However, even the regulations permitting
behavioral research suggest that any research must involve “no more than
minimal risk and no more than inconvenience to the subjects.”43 These
limitations allude to the experiments that led to the worst abuses—research
with no directed, therapeutic purpose and research which, even if ostensibly
therapeutic, involved excessive risks and inconvenience.
Although behavioral modification research is, by definition, designed to
be therapeutic, many pre-1976 behavioral research experiments were not only
risky and inconvenient, but also abusive.44 Because behavioral modification is
theoretically therapeutic and integral to the rehabilitative punishment model
dominant in the 1970s, behavioral modification “experiments” can be difficult
to distinguish from punishment and from everyday prison policies.45 The
difficulty of detecting and defining behavioral modification experiments makes
this category of experiments ripe for abuse.
A few examples of behavioral modification experiments, from the 1950s
through the 1970s, will illustrate the need for regulation of this kind of
experimentation. For example, in 1972, Missouri prison officials initiated the
Special Treatment and Rehabilitation Training (START) program, which
functioned for approximately eighteen months. In START, prison officials
placed prisoners in solitary confinement with no programming and with only a

41. The 1976 DHEW Report documents the variety and prevalence of human subjects
research taking place in prisons in the United States in the early 1970s. See 1976 DHEW Report,
supra note 8, at 3081-83. Jessica Mitford also addresses this topic. See Mitford, Kind and
Usual Punishment, supra note 37, at 151-84. The court cases challenging some of these
experiments provide further documentation of the kinds and numbers of experiments taking place
in prisons across the United States in the 1970s. See infra notes 87-89 and surrounding text.
42. 45 C.F.R. § 46.306(a)(2)(i)-(iv).
43. Id. § 46.306(a)(2)(i), (ii). The regulations specifically define minimal risk as “the
probability and magnitude of physical or psychological harm that is normally encountered in the
daily lives, or in the routine medical, dental, or psychological examination of healthy persons.” Id.
§ 46.303(d).
44. See, e.g., Garry Martin & Joseph Pear, Behavior Modification: What It Is and
How to Do It (8th ed. 2005) (discussing and defining the benefits of behavior modification as a
therapeutic technique); see also discussion of the START program in Missouri and electric shock
programs in California in this section for examples of abusive behavioral modification
“therapies.”
45. 1976 DHEW Report, supra note 8, at 3081, 3087.

REITER FINAL.DOC

2009]

4/30/2009 10:22:01 PM

EXPERIMENTATION ON PRISONERS

511

Bible as reading material; as the prisoners met certain behavioral benchmarks,
they received additional reading material or access to programming. The
program abruptly shut down after the American Civil Liberties Union
successfully challenged its overly punitive conditions.46 Even more
egregiously, in a program at San Quentin in the 1950s, a psychiatrist employed
“electric shock, insulin shock, fever treatment, hydrotherapy, Amytal and
Pentothal interviews, spinals, and cisternals,” all as “therapeutic practices.”47
The very existence of such practices suggests that prison officials and
physicians did not need evidence of therapeutic success to run extreme
behavioral modification programs. Other extreme “treatments,” inflicted as late
as the 1970s, included “castration for sexual offenders and psychosurgery for
uncontrollable violence.”48 This history reminds us that even the most
innocuous category of medical experimentation on prisoners, behavioral
research—which current federal regulations still permit—had a sinister quality
in at least some pre-1976 experiments.49
46. See Clonce v. Richardson, 379 F. Supp. 338, 345 (W.D. Mo. 1974).
47. Mitford, Kind and Usual Punishment, supra note 37, at 111. Note that cisternals
are punctures of the upper spine, in the neck area, conducted in order to retrieve spinal fluid; they
are an alternative to a spinal, or a spinal tap, in which a doctor punctures the lower spine to obtain
fluid. Luiz Antonio Pezzi Portela et al., Laceration of the Posterior Inferior Cerebellar Artery by
Suboccipital Puncture of the Cisterna Magna, 62 Arq Neuropsiquiatr 882-84 (2004). Cisternals
are rarely if ever conducted today, because the “dura matter” in the area of a brain where a
cisternal needle punctures can buckle inward, drawing the needle into the central nervous system,
where needles have been known to puncture an artery, a vein, or the medulla, causing permanent
damage and even sudden death. Id. at 883-84. A 1964 paper described a number of deaths
resulting from cisternals, and the procedure has been little used since then. Id. at 883, 884 n.3.
48. 1976 DHEW Report, supra note 8, at 3081. The 1976 DHEW Report also documents
some less abusive behavioral modification experiments taking place in the Federal Bureau of
Prisons and under the supervision of the National Institute of Mental Health (NIMH). NIMH, for
instance, conducted studies of behavioral issues particularly affecting prisoners, such as the effects
of institutionalization and the psychological and social sources of individual violence. Id. at 3082.
49. Because “behavioral modification” is such a flexible term, often indistinguishable from
everyday prison policies for punishment, calculating just how many abusive behavioral
modification experiments have taken place, in the manner of the START program or the San
Quentin program of electric shock and other invasive “therapies,” is nearly impossible. Such a
determination would depend on the definition of a program as a “behavior modification” program,
a definition often at the discretion of prison officials themselves. Indeed, many prison practices
today recall the “behavioral modification” experiments that Mitford and others condemned in the
1970s. For instance, state prison systems across the United States maintain “supermaximum”
security facilities, where prisoners are locked in solitary confinement, without reading material,
for indefinite periods. See, e.g., Craig Haney, Mental Health Issues in Long-term Solitary and
“Supermax” Confinement, 49 Crime & Delinquency, 124, 124–156 (2003) (describing
supermaximum security facilities and chronicling what is known about the as-yet undetermined
long-term health effects of such practices); see also Terry A. Kupers, Prison Madness: The
Mental Health Crisis Behind Bars and What We Must Do About It, at ix-xiv (1999)
(same). Such programs are eerily reminiscent of the START program. Likewise, some states even
today allow castration for sexual offenders. See, e.g., Candace Rondeaux, Can Castration Be a
Solution for Sex Offenders? Man Who Mutilated Himself in Jail Thinks So, but Debate on Its
Effectiveness Continues in Va., Elsewhere, Wash. Post, July 5, 2006, at B1 (noting that eight
states allow chemical castration of sex offenders; Texas allows surgical castration). These

REITER FINAL.DOC

512

4/30/2009 10:22:01 PM

CALIFORNIA LAW REVIEW

[Vol. 97:501

The more gruesome pre-1976 experiments did not involve behaviormodification programs but were conducted instead for purely non-therapeutic
purposes. These non-therapeutic experiments included a range of biomedical
interventions, from inducing scurvy in prisoners to infecting prisoners with
measles or malaria to irradiating prisoners. For instance, at Iowa State
Penitentiary, starting in the late 1940s, one doctor induced scurvy in five
prisoners by feeding them ascorbic-acid-free liquid solutions through a stomach
tube for months at a time. The doctor, affiliated with the University of Iowa,
published a scholarly article about his research findings in 1971; the article
included research documenting the effects of scurvy in these prisoner-patients:
shortness of breath, dental cavities, hair loss, skin hemorrhaging, and
permanent nerve damage.50 In another project at Petersburg Prison in Virginia,
in the late 1960s and 1970s, National Institutes of Health affiliates
systematically exposed prisoner subjects to measles and documented the
effects.51 And, in a federally-sanctioned project run from 1969 to 1975, the
Public Health Service, on behalf of the National Aeronautics and Space
Administration (NASA), forced prisoners in San Francisco to spend six months
or more in bed, wearing compression suits, while being injected with
radioactive isotopes.52 Similarly, as mentioned in the introduction, the
researchers running the decade-long Heller Experiments tested the effects of
radiation on the testes of Oregon prisoners.53 And the University of Maryland
conducted experiments at the Maryland House of Corrections between 1971
and 1975, infecting prisoners with either malaria or a species of bacteria
causing severe diarrhea.54
Sanctioned by universities and federal agencies alike, these nontherapeutic biomedical experiments took place across the United States until
the late 1970s. These experiments do not represent isolated instances of human
subjects experimentation gone wrong but rather widespread abusive practices
with abusive results in the years leading up to the 1976 DHEW Report. Indeed,
the DHEW Report Commission found, as the examples above suggest, that
many government agencies were involved in a wide variety of biomedical

programs are not regulated as “behavioral modification” experiments, but instead remain in place
as “administrative procedures” implemented within the discretion of prison officials and
policymakers.
50. Mitford, Kind and Usual Punishment, supra note 37, at 159-63 (describing a study
reported by Robert Hodges: Robert Hodges et al., Clinical Manifestations of Abscorbic Acid
Deficiency in Man, 24 Am. J. Clinical Nutrition 432 (1971), available at
http://www.ajcn.org/cgi/reprint/24/4/432).
51. Hornblum, supra note 1, at 108-09.
52. Id.
53. Bibeau v. Pac. Nw. Research Found., 980 F. Supp. 349, 351-52 (D. Or. 1997)
(describing the Heller Experiments in the context of participants’ challenge to the validity of the
informed consent they provided).
54. Bailey v. Lally, 481 F. Supp. 203 (D. Md. 1979).

REITER FINAL.DOC

2009]

4/30/2009 10:22:01 PM

EXPERIMENTATION ON PRISONERS

513

experiments in prisons in the 1970s.55 Between 1970 and 1976, five of six
Public Health Service agencies “conducted or supported” biomedical research
in prisons, including drug detection methods analysis, studies of the properties
and effects of addictive drugs such as morphine and methadone, and studies of
alcoholism and violence.56 In this same period, the Centers for Disease Control
ran three prisoner studies testing vaccines and studying skin sensitization to
parasitic skin diseases, and the FDA conducted eight studies on prisoners,
including “oral administration of a standard dose of a commercially available
antibiotic” and skin sensitivity tests.57 Similarly, the Health Services
Administration conducted thirteen studies on prisoners concerning “metabolic
responses to prolonged bed rest.”58 The Research Division of the Federal
Bureau of Prisons likewise conducted thirty-three studies on prisoners.59 In
sum, as of 1976, twenty-one states specifically permitted biomedical research,
and seven states had ongoing biomedical experiments on prisoners.60
In addition to these non-therapeutic biomedical experiments, prisoners
also participated in a wide variety of Phase I drug tests in the 1970s. Like many
of the biomedical experiments described above, Phase I drug tests are
inherently non-therapeutic; they require healthy volunteers, who, by design, are
not expected to benefit from the treatment in question.61 In 1976, the largest
drug companies depended on prisoners for anywhere from 2 percent to 100
percent of their Phase I drug testing research.62 Although only one company
surveyed used prisoners for 100 percent of its Phase I drug testing, the median
company used prisoners for 50 percent of its Phase I drug testing.63
For instance, Upjohn and Parke Davis, two of the largest drug companies
in the United States in the 1970s, had “exclusive rights” to access prisoners at
Jackson State Prison in Michigan for Phase I drug tests.64 Specifically, Upjohn
and Parke Davis paid to build the facilities in which prisoners were housed and
tested; the drug companies then transferred the title to the facilities to the State
of Michigan in exchange for corporate tax breaks.65 The facilities not only used
prisoners as the subjects of drug trials but were also largely run by prison
55. 1976 DHEW Report, supra note 8, at 3082-83.
56. Id. at 3082.
57. Id.
58. Id.
59. Id. The Report notes that some of these experiments were not biomedical, but
behavioral.
60. Id.
61. “Phase 1 trials try to determine dosing, document how a drug is metabolized and
excreted, and identify acute side effects. Usually, a small number of healthy volunteers (between
20 and 80) are used in Phase 1 trials.” Carol Rados, Inside Clinical Trials: Testing Medical
Products in People, FDA Consumer Mag., Sept.-Oct. 2003, available at
http://www.fda.gov/FDAC/features/2003/503_trial.html.
62. 1976 DHEW Report, supra note 8, at 3082-83.
63. Id.
64. Mitford, Kind and Usual Punishment, supra note 37, at 171.
65. Id.

REITER FINAL.DOC

514

4/30/2009 10:22:01 PM

CALIFORNIA LAW REVIEW

[Vol. 97:501

laborers, who served as technicians and nurses.66 The drug companies paid
these laborers between thirty cents and $1.25 per day for their services.67
Prisoners who participated as subjects of drug trials usually received around $1
per day, or $30 per month, for participation.68 In other words, a prisoner could
make considerably more than the lowest-paid prison laborer simply by
participating in a drug trial.69 Likewise, using prisoners as the subjects of Phase
I drug tests constituted tremendous savings for drug companies like Upjohn and
Parke Davis.70
Even those running the experiments on behalf of the drug companies
benefited financially. For instance, as noted in the introduction, Dr. Kligman
received $10,000 in direct payments from Dow Chemical for his work testing
dioxin on prisoners in Pennsylvania in 1965 and 1966.71 Similarly, two doctors
who ran a number of experiments on Oklahoma prisoners in the mid-to-late
1960s on behalf of various pharmaceutical companies, including Upjohn and
Merck, received $300,000 annually for their work.72
In total, of fifty-one drug companies responding to a Pharmaceutical
Manufacturers Association (PMA) survey in 1976, fourteen companies used
more than thirty-five hundred prisoners to conduct Phase I drug tests of
seventy-one different substances. Although only fourteen companies used
prisoners for Phase I drug tests, the money spent by these companies on the
drug tests comprised “three-fourths of the [PMA] members’ annual

66. Id.
67. Id. Interestingly, the average wage for prison labor in 2008, nearly forty years later, is
approximately the same as the wages Upjohn and Parke Davis were paying their prisoner subjects
and laborers. See Bob Egelko, Lawyer Slams Prison Wages: Tony Serra Files Suit on Behalf of
Federal Inmates for Low Rate of Pay for Labor by the Incarcerated, S.F. Chron., Mar. 22, 2007,
at B1, available at http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2007/03/22/ BAGILOP
M0K1.DTL (noting that J. Tony Serra, a prominent California defense attorney who served time
in federal prison for boycotting federal taxes, had brought suit against the federal prison industries
program to challenge their low wages—which range from five cents to $1.65 an hour).
68. Mitford, Kind and Usual Punishment, supra note 37, at 157.
69. In some human subjects experiments, prisoners received even greater amounts of
compensation. For instance, in the Heller Experiments, discussed above at note 53 and
surrounding text, the prisoner subjects received $5 per month for participation, $10 for every
biopsy, and $100 at the conclusion of the study. Gregory Dober, Cheaper than Chimpanzees:
Expanding the Use of Prisoners in Medical Experiments, Prison Legal News, Mar. 2008, at 5,
available at http://www.prisonlegalnews.org/19630_displayArticle.aspx. Relative to prison wages
that were as low as $9 per month, such payments certainly constituted a windfall for a prisoner, if
he could withstand the effects of the experimentation.
70. Free-world subjects receive a huge variety of payments for participation in drug trials; a
2008 New Yorker article suggested that payments for participation vary depending on how
invasive a study is. Carl Elliott, Guinea-Pigging, New Yorker, Jan. 7, 2008, at 36. For instance,
within two studies the New Yorker profiled, one participant received $7,500 for an invasive fiveweek study of gastro-intestinal tracts, and another received $3,300 dollars for a less-invasive,
shorter “drug delivery study.” Id. at 36, 40.
71. Hornblum, supra note 1, at 169.
72. Dober, supra note 69, at 5; Hornblum, supra note 1, at 97-98.

REITER FINAL.DOC

2009]

4/30/2009 10:22:01 PM

EXPERIMENTATION ON PRISONERS

515

expenditures for research and development.”73 In 1976, the total population of
federal and state prisoners in the United States was just over 200,000.74 In other
words, around 2 percent of the total prison population participated in Phase I
drug testing.
According to both the 1976 DHEW Report and Jessica Mitford, changes
to the FDA regulations that govern drug testing drove the expanding use of
prisoners in commercial drug tests.75 In 1962, the FDA amended its regulations
to require that drugs be tested on human subjects prior to approval for
marketing.76 Given the difficulty of finding such subjects, the new regulations
had the presumably unintended effect of creating incentives for drug companies
to turn to prisoners—a conveniently captive and cheap subject base—for use in
drug trials. As noted above, drug companies received tax breaks for building
testing facilities, if the facilities housed or employed prisoners. Drug companies
then filled these facilities with prisoner subjects who were readily available in
large numbers, would not fail to return for follow-up tests as they were literally
captive, and could be compensated very cheaply. And, finally, drug companies
staffed these facilities with prison laborers who were even cheaper to
compensate than the prisoner subjects.
The federal regulations inspired by the 1976 DHEW Report and
implemented in Title 45 explicitly forbid such non-therapeutic prisoner
experimentation.77 Despite the federal regulations limiting prisoner
participation in drug trials, the FDA still requires drug companies to find
human subject participants for all phases of drug trials, and drug companies
continue to have great difficulty attracting and retaining experimental
subjects.78 Indeed, a recent New Yorker article noted the difficulties drug
companies face, and the perverse incentives companies have to target
vulnerable populations in need of money as subjects of potentially dangerous
drug trials.79 While little information on continued Phase I drug testing in
prisons exists, lucrative incentives to find and retain human subjects for all
phases of drug trials persist in 2008.80

73. 1976 DHEW Report, supra note 8, at 3082-83.
74. See Figure 3.1 and surrounding text in Franklin E. Zimring, The Great American
Crime Decline 46 (2007).
75. 1976 DHEW Report, supra note 8, at 3081 (citing the 1962 Kefauver-Harris
Amendments to the Food and Drug Act, which expanded the requirements for testing drugs prior
to marketing); Mitford, Kind and Usual Punishment, supra note 37, at 153 (noting that the
FDA requires that new drugs be tested on humans prior to marketing).
76. 1976 DHEW Report, supra note 8, at 3081.
77. 45 C.F.R. § 46.306(a)(2)(i)-(iv).
78. See, e.g., Elliott, Guinea-Pigging, supra note 70, at 36-41.
79. Id.
80. The impacts of these incentives are explored further in Part B, below.

REITER FINAL.DOC

516

4/30/2009 10:22:01 PM

CALIFORNIA LAW REVIEW

[Vol. 97:501

2. Oversight: Media, Courts, and Regulations
As medical experimentation in prisons exploded between the 1950s and
the 1970s, media investigations and condemnations of such experiments also
increased. In 1971, influential investigative journalist Jessica Mitford published
Kind and Usual Punishment, cited by the authors of the 1976 DHEW Report.81
The book includes a chapter entitled “Cheaper than Chimpanzees,” which
chronicles the investments made by drug companies in prisoner
experimentation, as well as the range of biomedical experimentation on
prisoners resulting in medical journal publications in the 1950s and 1960s.82 In
fact, medical journals continued to publish the results of biomedical
experiments conducted on prisoners through the early 1970s.83 The continued
publication of such research results in peer-reviewed journals indicates that the
medical community at least tacitly condoned the use of prisoners for
biomedical experimentation well into the 1970s.
Nonetheless, local and national media increasingly criticized the practice.
For instance, in a series of exposés, the Montgomery, Alabama, Advertiser
documented the extensive drug experiments conducted by one physician on
behalf of thirty-seven major drug companies in Alabama, Arkansas, and
Oklahoma.84 The New York Times reported on the same physician’s projects in
1969.85 Furthermore, editorials calling for new federal regulations and
documenting the findings of the 1976 DHEW Report appeared in national
newspapers, including the Washington Post and the New York Times.86
81. See, e.g., John Bruce Moore, Book Note, 65 J. Crim. L. & Criminology 423 (1974)
(reviewing Jessica Mitford, Kind and Usual Punishment (1973)); 1976 DHEW Report,
supra note 8, at 3078.
82. Mitford, Kind and Usual Punishment, supra note 37, at 151-84.
83. Id. at 161 (noting that the results of a study in which doctors induced scurvy in
prisoners at Iowa State Penitentiary were published in a 1971 issue of the American Journal of
Clinical Nutrition); see also Bailey v. Lally, 481 F. Supp. 203, 217 (D. Md. 1979) (noting that
studies conducted on prisoners in the Maryland House of Corrections by the University of
Maryland were still being published in elite medical journals such as the New England Journal of
Medicine and The Journal of Infectious Diseases, even as federal restrictions on such prisoner
experiments expanded).
84. Mitford, Kind and Usual Punishment, supra note 37, at 155.
85. Hornblum, supra note 1, at 97-98 (citing Walter Rugaber, Prison Drug and Plasma
Projects Leave Fatal Trail, N.Y. Times, July 29, 1969, at 1). According to Hornblum, before the
late 1960s and early 1970s, there had been favorable reports in national newspapers regarding
experiments on prisoner subjects that led to breakthroughs in hepatitis and malaria treatments. Id.
at 101 (citing, e.g., Walter Sullivan, Scientist Reports Isolation 2 Strains of Hepatitis, N.Y. Times,
June 29, 1961; Marjorie Hunter, Drug is Reported to Avert Malaria, N.Y. Times, Nov. 2, 1962, at
33).
86. In particular, both the New York Times and the Washington Post printed many stories
and editorials detailing the recommendations in the 1976 DHEW Report and supporting changes
to the law. See, e.g., Ill Dept of Correction Orders End to All Malaria Experiments, N.Y. Times,
April 28, 1974, at 50; Medical Research in Prisons, Wash. Post, Mar. 12, 1978, at C6
(supporting bill to end experimentation, referencing Maryland experiments); Harold M. Schmeck,
1st Natl Minority Conf on Human Experimentation Drafts Recommendations, N.Y. Times, Jan. 9,
1976, at 29; Jonathan Steele, U.S. to Keep Testing Drugs on Prisoners, Wash. Post, Aug. 27,

REITER FINAL.DOC

2009]

4/30/2009 10:22:01 PM

EXPERIMENTATION ON PRISONERS

517

The courts, too, reflected the ongoing controversy over the experiments
taking place in U.S. prisons.87 In Clay v. Martin, the Second Circuit stated that
the plaintiff complained of “callous disregard for the safety of human subjects
in medical experimentation,” and noted that human subjects experimentation
was “a problem which has drawn increasing public and governmental
attention.”88 Similarly, in Bailey v. Lally, the Maryland District Court
chronicled the regulatory and legal attention that biomedical testing in prisons
had received in the 1970s, including increasingly rigid restrictions on
experimentation.89 As awareness of the existence and effects of medical
experiments on prisoners grew among courts, government officials, and the
general public, standards of humane testing and scientific rigor changed.
Although medical research on prisoner subjects continued into the 1970s,
restrictions on medical research in prisons steadily increased throughout the
decade. Congress initiated some of these restrictions. In 1974, responding to
public outcry over the Tuskegee syphilis study, a U.S. Senate subcommittee led
by Senator Edward Kennedy from Massachusetts held hearings on prisoner
experimentation.90 Later in 1974, Congressman Parren Mitchell from Maryland
introduced a bill seeking to end medical experimentation on prisoners in the
federal prison system.91 Also in 1974, Congress passed the National Research
Act, which established the National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research.92 Congress charged this
Commission with reviewing the ethical principles for medical research on
human subjects and developing appropriate research guidelines.93 This
Commission eventually produced the 1976 DHEW Report.
Federal agencies also played a role in limiting medical experimentation
practices. Although the 1974 Congressional bill to end medical experimentation
in the federal prison system failed, Norman A. Carlson, the director of the
federal prison system, initiated plans in 1976 to discontinue biomedical
research in federal prisons.94 According to the 1976 DHEW Report, only one
state had passed legislation banning biomedical research in prisons, but six
more had departmental policies prohibiting such research.95 Between 1971 and
1978, the Department of Health, Education, and Welfare issued five different
1977, at A6.
87. See, e.g., Clay v. Martin, 509 F.2d 109 (2d. Cir. 1975); Bailey, 481 F. Supp. 203.
88. 509 F.2d at 112. The Clay court further noted that prisoner cases challenging the terms
of medical experimentation raised a particularly complex legal issue about whether or not the
plaintiff had given informed consent. Id. at 114.
89. 481 F. Supp. at 214-15.
90. Hornblum, supra note 1, at 110.
91. Id.
92. Clay, 509 F.2d at 112-13 (citing National Research Act, Pub. L. No. 93-348, §
202(a)(1)(A), 88 Stat. 342, (1974)).
93. Id. at 112.
94. 1976 DHEW Report, supra note 8, at 3082 n.2; Hornblum, supra note 1, at 113.
95. 1976 DHEW Report, supra note 8, at 3082. The Report does not identify the states.

REITER FINAL.DOC

518

4/30/2009 10:22:01 PM

CALIFORNIA LAW REVIEW

[Vol. 97:501

notices about proposed limitations on federally funded human subjects
research.96 These regulatory changes reflected what one historian has
characterized as “overwhelming” opposition to prison medical testing by the
mid-1970s.97
The convening of the commission that wrote the 1976 DHEW Report
(DHEW Commission), as well as the Report’s resulting recommendations,
represented the culmination of public, political, legal, and regulatory foment
over prison medical testing. The DHEW Commission included eleven people:
three medical doctors, four medical professors, two law professors, one
attorney, and the President of the National Council of Negro Women. These
eleven members were drawn from research institutions across the country. In
making its recommendations, the Commission sought input from prisoners,
prison officials, and government agency representatives.
The 1976 DHEW Report ultimately recommended strict regulation of
medical testing in U.S. prisons.98 The recommendations were quickly codified
into law as part of the Code of Federal Regulations on Protection of Human
Subjects, at Title 45, Part 46, Subpart C, which was adopted by Congress in
November of 1978.99 Title 45 closely parallels the recommendations made in
the 1976 DHEW Report.100 Such quick Congressional action reflected the
public awareness of—and outcry against—experimentation on prisoners.
The following year, the National Committee for the Protection of Human
Subjects Research released The Belmont Report.101 The stated goal of the report
was “to summarize the basic ethical principles identified by the Commission in
the course of its deliberations.”102 Although short, at ten pages in length, The
Belmont Report has become the benchmark for human subjects research,
detailing the ethical principles that must guide such research with requirements
for informed consent, risk-benefit assessments, and subject selection.103 The
Belmont Report represents a continuation of the trend toward rigid restrictions
on human experimentation, particularly when that experimentation takes place
in prisons. In subsequent years, the FDA and the American Correctional

96. Bailey v. Lally, 481 F. Supp. 203, 214-15 (D. Md. 1979) (noting that after the first
restrictions in 1971: “Further HEW notices of proposed rulemaking were published in 1974, [39
Fed. Reg. 18,914 (May 30, 1974)], [39 Fed. Reg. 30,648 (Aug. 23, 1974)], and in 1978, [43 Fed.
Reg. 1049 (Jan. 5, 1978)], followed by published rules on November 16, 1978, [43 Fed. Reg.
53,652], restricting research on prisoners (45 C.F.R. §§ 46.301-46.306)”).
97. Hornblum, supra note 1, at 113-14.
98. See Part II infra (discussing the specifics of the regulations).
99. See 45 C.F.R §§ 46.301-.306.
100. See 1976 DHEW Report, supra note 8, at 3080-81; 45 C.F.R §§ 46.301-.306.
101. Nat’l Comm’n for the Prot. of Human Subjects of Biomedical and
Behavioral Research, The Belmont Report: Ethical Principles and Guidelines for the
Protection
of
Human
Subjects
Research
(1979),
available
at
http://medschool.umaryland.edu/geei/BelmontReport.pdf.
102. Id. (quote in summary).
103. Id.

REITER FINAL.DOC

2009]

4/30/2009 10:22:01 PM

EXPERIMENTATION ON PRISONERS

519

Association, an independent prison-accrediting body, have followed
recommendations in the DHEW Report and The Belmont Report and have
adopted regulations similar to those codified at Title 45.104
Specifically, in 1978, the FDA itself moved to forbid the use of prisoners
for drug tests. However, the FDA regulations on prisoner experimentation are
in a state of semi-permanent confusion and have been since the FDA first
adopted them.105 In theory, FDA regulations forbidding prisoner participation
in drug trials would cover a broader range of human subjects than the Title 45
regulations. For instance, Title 45 regulations cover only those facilities
receiving federal funding. Therefore, a private contractor running a state prison
could conceivably contract with a private university, or with a private drug
company, to run drug trials. Such a contract would be beyond the regulatory
authority of the Department of Health and Human Services under Title 45. The
FDA regulations in Title 21, on the other hand, govern all companies seeking
federal approval to market their drugs publicly, so the regulations cover private
actors through the mechanism of federal regulation.106 Therefore, FDA
standards forbidding the use of prisoners in any drug trials could compensate
for the regulatory gap left by Title 45. Unfortunately, the FDA, like most
federal agencies, has not “chosen to follow the more rigid regulations for
protection of prisoners in medical studies” recommended in the 1976 DHEW
Report and codified at Title 45.107
So, although Title 45 implemented rigid restrictions on the use of prisoner
subjects in biomedical research, the reach of Title 45 is limited to research
receiving federal funding. Therefore, Title 45 leaves open a number of
regulatory gaps, which individual agencies must each close through voluntary
regulatory changes. Although the FDA attempted to close one such regulatory
gap by implementing regulations on the use of prisoner subjects in drug trials
conducted for purposes of federal regulatory approval, these regulations have
never been formally adopted. Nonetheless, the parts of Title 21 dealing with
prisoner subjects remain “reserved” today, resulting in a de facto ban on the use
of prisoners for drug testing at any phase.108

104. See generally 21 C.F.R. pts. 50, 56 (describing standards specifically applicable to
drug testing that parallel the human subjects research standards described in Title 45).
105. As soon as the FDA adopted the regulations forbidding prisoner participation in drug
trials, a group of prisoners sued the agency for attempting to curtail their rights to participate in
human subjects research. The FDA then suspended those specific regulations restricting the use of
prisoners in drug trials. 2006 IOM Report, supra note 18, at 88.
106. See 21 C.F.R. § 50.1 (describing the scope of the FDA’s regulatory authority vis-à-vis
human subjects regulations).
107. Dober, supra note 69, at 3 (noting that the National Institutes of Health, the Central
Intelligence Agency, and the Social Security Administration are the only federal agencies that
have officially adopted the rigorous standards for experimentation on prisoners in Title 45).
108. 2006 IOM Report, supra note 18, at 88.

REITER FINAL.DOC

520

4/30/2009 10:22:01 PM

CALIFORNIA LAW REVIEW

[Vol. 97:501

B. Human Subjects Research in Prison Between 1976 and 2008
By 1978, the Title 45 provisions for strict regulation of all medical
experimentation in prison constituted binding law. Under Title 45, only four
narrow categories of federally-funded research may include prisoner subjects:
(1) research about the effects of incarceration; (2) research about prisons as
institutions; (3) research about conditions particularly affecting prisoners; and
(4) research about practices expected to improve the health of individual
subjects.109 Title 45 requires that independent review bodies both conduct strict
evaluations of all human subjects research and ensure fulfillment of minimum
conditions of consent and comfort.110
In sum, the provisions forbid non-therapeutic biomedical and drug testing
on prisoners. By many accounts, medical experimentation in prisons decreased
dramatically as a result of the 1976 regulations. In addition to these federal
regulations limiting experimentation on prisoners to narrow categories of
research, independent governmental agencies like the FDA, as well as state
correctional authorities, took steps to enact regulations in the late 1970s to limit
biomedical experimentation and drug research in prisons.111
In lawsuits challenging experimentation on prisoners, courts assumed that
the experiments had ceased in the second half of the 1970s.112 Indeed, a
LexisNexis search for prisoner or former prisoner plaintiffs’ suits challenging
experimentation practices, procedures, or after-effects, found only eleven cases
that either mentioned experimentation on prisoners, or characterized treatments
or practices as experimental.113 Of course, this list of eleven cases is by no
109. 45 C.F.R. §46.306(a)(2)(i)-(iv).
110. See id.
111. See supra notes 104-107 (discussing FDA and other agency regulations).
112. See, e.g., Clay v. Martin, 509 F.2d 109, 111 (2d Cir. 1975) (noting that experiments
were conducted in the early 1970s); Bailey v. Lally, 481 F. Supp. 203, 205 (D. Md. 1979) (noting
that experiments were conducted from 1958 to 1976); Bibeau v. Pac. Nw. Research Found., 980 F.
Supp. 349, 351-52 (D. Or. 1997) (noting that the experiments were conducted from 1963 to 1973).
113. The search terms used were “prisoner,” “experiment,” “research,” and “ethics”; no
date restriction was applied. While hundreds of cases were reviewed, only eleven actually dealt
with allegations of experimentation on prisoners. See Stanley v. Swinson, No. 93-16078, 1995
U.S. App. LEXIS 2262, at *10 (9th Cir. Dec. 15, 1994) (describing allegations that the use of
regular blood tests for HIV constituted an unregulated medical “experiment” in a federal prison in
California in the 1990s); Clay, 509 F.2d at 112 (describing drug addiction treatment at the
Addiction Research Center, located in a federal prison in Lexington, Kentucky, in 1970; prisoner
alleged that the experimental treatment caused a heart attack); Knecht v. Gillman, 488 F.2d 1136,
1137, 1140 (8th Cir. 1973) (describing the use of an injected drug, which caused prisoners to
vomit for between fifteen minutes to one hour, as punishment for breaking prison rules in an Iowa
state prison in the early 1970s; although the court did not describe the injection practice as
experimental per se, the court did describe the drug administered as “unproven . . . for this
[behavior modification] purpose,” indicating its use was essentially experimental); Mackey v.
Procunier, 477 F.2d 877, 877 (9th Cir. 1973) (describing experimental administration of a drug
that stopped plaintiff’s breathing during shock treatments at a California state prison in 1967);
Brown v. Martinez, 2007 U.S. Dist. LEXIS 55350, at *2 (M.D. Pa. July 31, 2007) (describing
allegations that food-deprivation and sleep-deprivation constituted behavioral modification

REITER FINAL.DOC

2009]

4/30/2009 10:22:01 PM

EXPERIMENTATION ON PRISONERS

521

means exhaustive. First, many suits filed by prisoners alleging experimental
practices are settled out of court.114 Second, determining exactly what
constitutes an experimental practice is difficult. For instance, in Knecht v.
Gillman, the court did not describe the vomit-inducing drug at issue in the case
as experimental, though the court did note that the drug was “unproven” for the
kind of behavioral modification use being challenged.115 Knecht is included in
the list of eleven cases referenced above, as an example of an experimental
medical practice described by a court, though the practice is arguably just a bad
correctional policy. Indeed, courts often disagree with prisoner plaintiffs about
whether an alleged experimental practice is therapeutic, consensual, or simply a
legitimate correctional policy.116
Of the eleven cases described above that did explicitly mention
experimentation on prisoners, nine of the challenged experiments took place
before the codification of the DHEW Report recommendations in Title 45 in
1978.117 The two suits that did challenge post-1978 “experiments” were
unpublished and involved claims related to prison practices that arguably were
not medical experiments at all.118 For instance, in Stanley v. Swinson, prisoners
challenged mandatory HIV blood-tests as unconstitutional medical

“experiments” conducted at a Pennsylvania state prison in the 2000s); In re Cincinnati Radiation
Litig., 874 F. Supp. 796, 800-02 (S.D. Ohio 1995) (describing the experimental administration of
“massive doses” of radiation to prisoners with terminal cancer in Ohio between 1960 and 1972);
Bibeau, 980 F. Supp. at 352 (describing the experimental radiation of testes that took place in an
Oregon state prison between 1965 and 1969); Cain v. United States, 643 F. Supp. 175 (S.D.N.Y.
1986) (describing allegations that doctors deliberately infected prisoners with syphilis during
experiments conducted in a New York state prison in the 1950s); Bailey, 481 F. Supp. at 205
(describing a variety of infectious disease tests run by the University of Maryland medical school
within the Maryland House of Correction between 1958 and 1976); Roach v. Kligman, 412 F.
Supp. 521, 523 (E.D. Pa. 1976) (describing permanent liver damage resulting from participation in
dermatological experiments in a Pennsylvania state prison in 1973); Clonce v. Richardson, 379 F.
Supp. 338, 349 (W.D. Mo. 1974) (describing an experimental behavioral modification program
implemented in a federal prison in Missouri between 1972 and 1974).
114. See, e.g., Hornblum, supra note 1, at 181 (describing undisclosed settlement amounts
between Dow Chemical Company, the city of Philadelphia, and the University of Pennsylvania
and prisoners who suffered Dr. Kligman’s dermatological experiments, during which Kligman
exposed the prisoners to dioxin in the 1960s and 1970s).
115. 488 F.2d at 1140.
116. See, e.g., Tripp v. Carter, No. 99 C 3304, 1999 U.S. Dist. LEXIS 16487, at *2 (N.D.
Ill. Oct. 12, 1999) (describing prisoners allegations that the prison’s use of saccharin constituted a
medical experiment and dismissing the claim); McNeil v. United States, No. 92 C 0339, 1992 U.S.
Dist. LEXIS 7665, at *3 (N.D. Ill. May 29, 1992) (describing infectious disease research that
allegedly caused a hepatitis C infection in an Illinois prison in the early 1990s and dismissing the
claim). The tally of the eleven cases describing challenges to experiments on prisoners does not
include unsubstantiated claims like those in Tripp and McNeil.
117. See Clay, 509 F.2d at 112; Knecht, 488 F.2d at 1137, 1140; Mackey, 477 F.2d at 877;
In re Cincinnati Radiation Litig., 874 F. Supp. at 800-02; Bibeau, 980 F. Supp. at 352; Cain, 643
F. Supp. 175; Bailey, 481 F.Supp. at 205; Roach, 412 F. Supp. at 523; Clonce, 379 F. Supp. at
349.
118. See Stanley, 1995 U.S. App. LEXIS 2262, at *10; Brown, 2007 U.S. Dist. LEXIS
55350, at *2.

REITER FINAL.DOC

522

4/30/2009 10:22:01 PM

CALIFORNIA LAW REVIEW

[Vol. 97:501

experimentation.119 And in Brown v. Martinez, prisoners challenged
deprivation conditions in secure housing units as unconstitutional behavioral
modification experiments.120 One historian of prison medical testing has said
that prisoner experimentation was “effectively over” as of 1980.121 Indeed, the
absence of any published prisoner challenges alleging unconstitutional
treatment or injury from medical experimentation might seem to confirm this
assumption.122 Of course, as suggested above, there are many reasons why
prisoner suits challenging medical experimentation in prison might not appear
in a simple search of case law.
Indeed, despite the absence of published case law on point, medical
experimentation on prisoners is far from over. Investigative research reveals
that public universities, as well as drug companies, continue to use prisoners
and other individuals under correctional supervision as subjects in a variety of
medical experiments.123 For instance, the Hythian drug company’s Prometa
addiction-treatment program, discussed in the introduction, constitutes an
experimental drug trial on criminal defendants.124 Recall that the program
involves thirty days of treatment with three different drugs, none of which has
been approved for use in addiction treatment by the FDA.125 In other words,
people found in possession of illegal drugs in Texas, or in Washington, or in
Georgia, might be assigned to an experimental drug-treatment program closely
resembling the drug testing that took place in Michigan and Oklahoma prisons
before the DHEW Report.
1. Enforcing Regulations
The Hythian contract relates to one implicit motivation behind the 2006
IOM Report: fear that private companies are conducting experimentation in
nontraditional correctional settings, beyond the scope of the regulatory powers
of federal agencies. Currently, the Office for Human Research Protections
(OHRP), a division of the DHHS, is responsible for monitoring compliance
with and enforcing the regulations governing human subjects research as

119. 1995 U.S. App. LEXIS 2262, at *10.
120. 2007 U.S. Dist. LEXIS 55350, at *2.
121. Hornblum, supra note 1, at 114.
122. A national coalition of prisoners’ rights lawyers knew of no other recent or pending
challenges to medical experiments in prison settings. Posting of Keramet Reiter,
keramet@post.harvard.edu, to prisonersrights@mail.lawhelp.org (Oct. 4, 2008) (on file with
author); e-mail from Alex Friedman, Associate Editor, Prison Legal News, to author (Oct. 4,
2008, 08:10 PST) (on file with author); e-mail from Paul Wright, Editor, Prison Legal News, to
author (Oct. 12, 2008, 22:10 PST) (on file with author).
123. See, e.g., Silja J.A. Talvi, The Prison As Laboratory: Experimental Medical Research
on Inmates is on the Rise, In These Times, Jan. 23, 2002, available at
http://www.inthesetimes.com/issue/26/03/feature4.shtml; Dober, supra note 13; Dober, supra note
69.
124. Dober, supra note 13.
125. See Weinstein et al., supra note 14, at 1.

REITER FINAL.DOC

2009]

4/30/2009 10:22:01 PM

EXPERIMENTATION ON PRISONERS

523

codified at Title 45.126 However, for reasons discussed below, experimentation
conducted by private companies can easily fall outside of the scope of the
OHRP’s authority.
Any research that is federally conducted or federally supported is within
the regulatory authority of the OHRP.127 In addition, an institution, such as a
state prison system, can voluntarily choose to adopt the DHHS policies codified
at Title 45; in such cases, research conducted by those institutions is within the
regulatory authority of the OHRP.128 Therefore, federal agencies, universities
that receive federal funding or that have adopted DHHS regulations, and state
prison systems that have adopted DHHS regulations all fall within the
regulatory authority of the OHRP. However, in states that have passed human
subjects protection statutes that are stricter than the federal regulations, the
stricter state statute determines the scope of human subjects research, even for
purposes of OHRP regulation.129
Despite the various ways the OHRP might be able to regulate human
subjects research in non-federal institutions, the OHRP’s oversight powers are
limited. Specifically, the OHRP regulations dealing with prisoners (those
codified at Title 45, Part 46, Subpart C) do not cover participants in drugaddiction treatment programs, or participants in any program run by a private
contractor.130 The 2006 IOM Report specifically notes that the definition of
“prisoner” within the federal regulations is narrow.131 Of course the fact that
the OHRP can only regulate federally-funded research means that private drug
companies receiving no federal funding are also beyond the regulatory
authority of the OHRP.132
However, medical experimentation on prisoners is not only taking place
outside of the regulatory authority of the OHRP, as was the case for the
Hythian drug trial. Indeed, public and private universities, as well as state
prison systems, have incorporated prisoners into medical experiments in the

126. See 2006 IOM Report, supra note 18, at 4-6 (suggesting that the definition of prisoner
be expanded to include anyone under the supervision of the criminal justice system).
127. See 45 C.F.R. § 46.301(a).
128. Office for Human Research Prots. (OHRP), Dep’t of Health & Human Servs.,
OHRP’s Compliance Oversight Procedures for Evaluating Institutions 2 (2005),
available at http://www.hhs.gov/ohrp/compliance/ohrpcomp.pdf.
129. See, e.g., Tracy Weber, 1997 Drug Test on Teenage Inmates Probed, L.A. Times,
Aug. 16, 1999, at A1 (noting that California has its own statute governing human subjects
experimentation, and this statute is more strict, i.e. allows less research, than the federal statute);
see also 45 C.F.R. § 46.301(b) (noting that the federal regulations do not supersede more
restrictive state laws governing prisoner participation in medical research).
130. See 45 C.F.R. § 46.301(a).
131. 2006 IOM Report, supra note 18, at 4. According to Title 45, “prisoners” include
anyone who is “involuntarily confined or detained,” which would include individuals in prisons
and jails, but might not include those in nontraditional correctional settings such as drug-treatment
facilities or work-release programs. 45 C.F.R. § 46.303(c).
132. 45 C.F.R. §§ 46.101(a), 46.301(a)-(c).

REITER FINAL.DOC

524

4/30/2009 10:22:01 PM

CALIFORNIA LAW REVIEW

[Vol. 97:501

past decade.133 For instance, in 1997, Dr. Steiner, a psychiatrist at Stanford
University, conducted an experimental drug trial on sixty-one juvenile
prisoners within the California Youth Authority (CYA).134 Dr. Steiner
administered Depakote, a drug approved by the FDA as a treatment for
epileptic seizures, to the youth subjects, in order to test the drug’s effectiveness
as a treatment for a completely different problem: aggressive and violent
behavioral tendencies.135 An Institutional Review Board at Stanford approved
the study, even though it involved a questionable consent practice—allowing
the CYA to consent on behalf of youths whose parents did not respond to
mailed consent forms within thirty days.136 Also, the CYA apparently neglected
to grant official approval for the study; an unidentified lower-level
administrator gave Dr. Steiner permission to conduct the study.137
Both Stanford and the CYA, as institutions that accept federal funding, are
subject to the federal regulations governing research on prisoners. The Los
Angeles Times interviewed Dr. Thomas Pugliese, then-director of the OHRP,
about the research protocol for the Depakote study, and Dr. Pugliese expressed
concerns about the research protocol. Specifically, he objected to the use of
placebos in the study. Because placebos have experimental but not therapeutic
value, their use violates the federal requirement that medical experiments on
prisoners directly benefit the individual prisoner subject.138 The Inspector
General for the State of California also investigated the study for violations of
human subjects protection restrictions.139
Across the country, in Florida, at the same time Dr. Steiner was
conducting the Depakote study, private pharmaceutical companies funded
University of Miami researchers to conduct drug trials on HIV-infected
prisoners.140 The St. Petersburg Times published a feature story on the drug
trials in 2000 and noted a number of potential ethical problems. First, some
prisoners did not understand parts of the study; for instance, a reporter noted
that one prisoner was taking at least some placebos, without even
understanding the meaning of “placebo.”141 Of course, this is doubly
problematic, because federal regulations generally discourage the use of
placebos in prisoner populations, as former OHRP Director Pugliese suggested
in response to the Depakote study in California, and because any subject must

133. See Dober, supra note 69, at 6-7, 10.
134. Weber, supra note 129.
135. Id.
136. Dober, supra note 69, at 6.
137. Weber, supra note 129.
138. Id. As noted above, the applicable California state restrictions on prisoner
experimentation supercede the less restrictive federal regulations.
139. Id.
140. Sydney P. Freedberg, Questions Raised over AIDS Research on Inmates, St.
Petersburg Times, Mar. 19, 2000, at 1A.
141. Id.

REITER FINAL.DOC

2009]

4/30/2009 10:22:01 PM

EXPERIMENTATION ON PRISONERS

525

at least understand what kind of treatment he is receiving or not receiving in
order to provide informed consent to participate in an experiment. Second,
while the HIV-positive prisoners received no monetary compensation for
participation in the study, they did receive better housing (with air
conditioning), new clothing (including more comfortable tennis shoes), and
better treatment from university researchers and professional healthcare
providers than they had received in the traditional prison setting.142 In other
words, prisoner participants in the University of Miami program faced the
choice not just of participating in an experimental drug trial, but of escaping
sub-standard housing conditions, without adequate healthcare or air
conditioning—a potentially health-compromising condition in Florida. Where
unhealthy or inhumane prison conditions influence a prisoner’s choice to
participate in an experimental protocol, consent is compromised. Finally, drug
companies potentially influenced both researchers and correctional officials
through compensation packages. Specifically, the researchers at the University
of Miami running the study received funding from private drug companies like
Glaxo and Merck.143 In addition, the director of health services in Florida
prisons received honoraria from the drug companies funding the studies.144
In order to conduct these studies, the state had to lift its ban on human
subjects research in prisons. The state also sought and received approval from
the ethics arm of the National Institutes of Health, a government agency that
was also involved in funding the Florida HIV drug trials. Nonetheless, the
OHRP intervened and cited the University of Miami HIV-treatment drug trial
for violating the human subjects protections in Title 45 that govern research on
prisoners.145 As the University of Miami HIV-treatment experiment suggests,
experimentation on prisoners occurs not only outside of the regulatory power of
the OHRP, but also within the OHRP’s regulatory power.
The OHRP evaluates compliance with the DHHS regulations codified in
Title 45, including the regulations limiting experimentation on prisoners to
narrow categories of targeted, therapeutic research. The OHRP conducts both
for-cause compliance oversight based on “substantive written allegations” from
research subjects, researchers, or research publications, as well as not-for-cause
compliance oversight based on a variety of factors, including the volume of
research at the targeted institution or agency and previous concerns with
compliance.146
142. Id.
143. Id.
144. Id.
145. Letter from Sanford Leikin, Compliance Oversight Coordinator, to Norman Altman,
Vice Provost for Research, Univ. of Miami, Ira Clark, President, Pub. Health Trust, and Gus
Godoy, Research Adm’r, V.A. Med. Ctr. (July 31, 2000), available at http://www.hhs.gov/ohrp/
detrm_letrs/jul00l.pdf (criticizing research protocols for experiments involving prisoners
conducted by the University of Miami).
146. OHRP, supra note 128, at 2, 4. Judging by OHRP noncompliance letters, non-

REITER FINAL.DOC

526

4/30/2009 10:22:01 PM

CALIFORNIA LAW REVIEW

[Vol. 97:501

After learning of a violation, or an alleged violation, the OHRP conducts a
review and “issues findings of noncompliance” in determination letters sent to
the violating institution or agency.147 An OHRP finding of non-compliance can
result in a range of outcomes—from recommendations for improvements to
withdrawal of DHHS funding, removal of investigators or agency heads, and
halting of research projects.148 Determination letters from 2000 through 2008
are publicly available on the OHRP website, with reference to some unresolved
issues redacted.149
A careful review of the publicly-available OHRP non-compliance
determination letters spanning the years 2000 through 2008 suggests that
experimentation on prisoners regularly occurs. Apparently, drug trials like the
Hythian addiction drug trials, the Stanford Depakote trial, and the University of
Miami HIV-treatment drug trial occur despite strict federal regulations, which
have now been in place for forty years, and which were intended to limit
severely such experimentation, if not to eliminate it entirely.150 The number of
OHRP determination letters per year ranges from thirty-seven to over one
hundred; in total, there are 778 letters available online. Every year, anywhere
from three to more than one dozen of the non-compliance determination letters
mention protocols or studies involving research on prisoners or prisoner
participants.
The OHRP determination letters indicate that prisoner experimentation
has taken place in the past decade, sanctioned by universities across the United
States, including the University of California, the University of Texas, the

compliance issues come to the attention of the OHRP through two common means: complaint
letters written by researchers or research participants, or notices of suspension or termination of
research from individual institutional review boards. See, e.g., Letter from Carol J. Weil, Div. of
Compliance Oversight, Dep’t of Health & Human Servs., to Susan Kelly, President, Charles R.
Drew Univ. of Med. & Sci. (Feb. 11, 2008), available at http://www.hhs.gov/ohrp/detrm_letrs/
YR08/feb08c.pdf (noting researcher initiated the complaint); Letter from Lisa A. Rooney,
Compliance Oversight Coordinator, Dep’t of Health & Human Servs., to Robert M. Mahley,
President, The J. David Gladstone Insts., Sue Carlisle, Assoc. Dean, Univ. of Cal., S.F., Eugene
Washington, Executive Vice Chancellor, Univ. of Cal., S.F. (Dec. 17, 2007), available at
http://www.hhs.gov/ohrp/detrm_letrs/YR07/dec07a.pdf (noting research subject initiated the
complaint); Letter from Lisa A. Rooney, Compliance Oversight Coordinator, Dep’t of Health &
Human Servs., to Kyle De Fur, President, Saint John’s Health Sys. (Nov. 28, 2007), available at
http://www.hhs.gov/ohrp/detrm_letrs/YR07/nov07d.pdf (noting OHRP knew research had been
suspended).
147. Office for Human Research Prots., Compliance Oversight, http://www.hhs.gov/ohrp/
compliance/ (last visited Oct. 29, 2008).
148. OHRP, supra note 128, at 5-7.
149. Office for Human Research Prots., OHRP Fact Sheet, http://www.hhs.gov/ohrp/
about/ohrpfactsheet.htm (last visited Oct. 29, 2008); see also Office for Human Research Prots.,
2008 Determination Letters, http://www.hhs.gov/ohrp/compliance/letters/index.html (last visited
Oct. 29, 2008) [hereinafter Office for Human Research Prots., 2008 Determination Letters]. Unredacted letters, letters sent prior to the year 2000, and full reports on noncompliance findings are
available only in response to Freedom of Information Act requests. Id.
150. See 45 C.F.R. § 46.301-06.

REITER FINAL.DOC

2009]

4/30/2009 10:22:01 PM

EXPERIMENTATION ON PRISONERS

527

University of Miami, and the University of Florida.151 The titles of the
experimental protocols reviewed in certain OHRP letters—such as “Evaluation
of HIV/AIDS Case Reporting of Prisoners in Florida” or “Role of Attachment
in Early Onset of Conduct Problems”—indicate that some experiments using
prisoner subjects have involved sensitive and private medical information,
while others have involved behavioral research.152 In other words, the
experiments might involve more than minimal risks to prisoner subjects, in
violation of Title 45 regulations. Often, however, the OHRP omits details of the
experiments that might confirm or disprove this suspicion. Indeed, many of the
OHRP determination letters that reference research protocols involving
prisoners are heavily redacted, and they tend to refer to statutes that have been
violated, rather than providing factual details about specific violations.
Even those letters that simply describe procedural violations reveal that
institutional review board (IRB) procedures are frequently flawed and fail to
provide adequate protections to prisoner subjects of experimentation. For
instance, IRBs have approved the use of exculpatory language on consent
forms, failed to provide heightened evaluations and specific justifications for
the use of prisoner subjects in experiments, and denied prisoner representatives
roles on decision-making panels. To name a specific example, in 2000, the
OHRP criticized the University of Texas for using the following exculpatory
language on its consent forms: “Neither UTMB nor [the investigator] can
assume financial responsibility or liability for the expenses of such
treatment.”153 Not only do the federal regulations strictly forbid such
exculpatory language on consent forms, but regulations specifically require that
prisoner volunteers not be subjected to any risks beyond those non-prisoner
volunteers would face.154 In addition, IRBs have failed on multiple occasions to
conduct appropriate risk-benefit analyses to ensure that all prisoners

151. See generally Office for Human Research Prots., 2008 Determination Letters, supra
note 149; see also Letter from Michael A. Carome, Chief, Compliance Oversight Branch, Div. of
Human Subject Prots., to Dorothea Wilson, Vice President for Research, Univ. of Tex. Med.
Branch at Galveston (Sept. 14, 2000), available at http://www.hhs.gov/ohrp/detrm_letrs/
sep00b.pdf; Letter from Sanford Leikin to Norman Altman, Ira Clark, and Gus Godoy, supra note
145.
152. Letter from Karena Cooper, Compliance Oversight Coordinator, Div. of Compliance
Oversight, OHRP, to John Agwunobi, Sec’y of Health, Fla. Dep’t of Health (Oct. 13, 2004),
available at http://www.hhs.gov/ohrp/detrm_letrs/YR04/oct04a.pdf; Letter from Karena Cooper,
Compliance Oversight Coordinator, Div. of Compliance Oversight, OHRP, to John Agwunobi,
Sec’y of Health, Fla. Dep’t of Health (Aug. 13, 2004), available at
http://www.hhs.gov/ohrp/detrm_letrs/YR04/aug04n.pdf; Letter from Karena Cooper, Compliance
Oversight Coordinator, Div. of Compliance Oversight, OHRP, to Mark A. Emmert, President,
Univ. of Wash. (Sept. 9, 2005), available at http://www.hhs.gov/ohrp/detrm_letrs/
YR05/Sep05.pdf.
153. Letter from Michael A. Carome to Dorothea Wilson, supra note 151, at 6.
154. 45 C.F.R. § 46.116 (describing general requirements for informed consent and
explaining that exculpatory language is forbidden), § 46.305(a)(3) (describing limitations on risks
to which prisoner volunteers can be subjected).

REITER FINAL.DOC

528

4/30/2009 10:22:01 PM

CALIFORNIA LAW REVIEW

[Vol. 97:501

participating in experimentation are doing so solely for their own benefit.155 For
instance, a number of the determination letters criticize research protocols and
IRB reviews that fail to evaluate whether, when a previously un-incarcerated
subject of experimentation enters prison, “it is in the best interests of the
subject to remain in the research study while incarcerated.”156
The University of Miami IRB, which approved HIV-treatment drug trials
for prisoner populations, also failed to provide a number of requisite
protections to prisoner subjects in the drug trials. First the University failed to
include a prisoner representative as a full voting member on the IRB that
approved the drug trial. Second, the University failed to document findings that
justified prisoner participation in research protocols. Finally, the University
failed to prove that the pilot study actually had “a reasonable probability of
improving the health or well-being of the subjects.”157 The OHRP’s concerns
were significant enough that it ordered the immediate suspension of all the
DHHS-supported research projects at the University of Miami for which
violations had been noted.158
In general, the OHRP seems to scrutinize any mention of prisoners in
research protocols, often criticizing IRBs that fail to articulate, on the record,
whether a particular experiment falls within one of the four permissible
categories of prisoner experimentation.159 Title 45 prohibits research on

155. See Office of the Inspector Gen., Dep’t of Health & Human Servs.,
Institutional Review Boards: A Time For Reform, at ii-iii (1998), available at
http://www.oig.hhs.gov/oei/reports/oei-01-97-00193.pdf (noting that institutional review boards
are overworked, face conflicts of interest, and are insufficiently regulated); Div. of Compliance
Oversight, Office for Human Research Prots., OHRP Compliance Oversight Activities:
Significant Findings and Concerns of Noncompliance 3-6 (2005), available at
http://www.hhs.gov/ohrp/compliance/findings.pdf (describing the range of concerns the OHRP
frequently identifies in evaluating IRB compliance, or non-compliance, with Title 45).
156. See, e.g., Letter from Kristina C. Borror, Dir., Div. of Compliance Oversight, to
Chiyome L. Fukino, Dir. of Health, Haw. State Dep’t of Health, and James R. Gaines, Vice
President for Research, Univ. of Haw. 5 (June 25, 2007), available at
http://www.hhs.gov/ohrp/detrm_letrs/YR07/jun07b.pdf (regarding a study titled “Effects of
Upcountry Maui Water Additives on Health”).
157. Letter from Sanford Leikin to Norman Altman, Ira Clark, and Gus Godoy, supra note
145, at 2, 5.
158. Id.
159. See, e.g., Letter from Kristina C. Borror, Dir., Div. of Compliance Oversight, OHRP,
to Richard Sheridan, J.D., Gen. Counsel, Scripps Health (Apr. 10, 2006), available at
http://www.hhs.gov/ohrp/detrm_letrs/YR06/apr06a.pdf; Letter from Patrick J. McNeilly,
Compliance Oversight Coordinator, Div. of Compliance Oversight, OHRP, to Charles F. Zukoski,
Vice Chancellor for Research, Univ. of Ill. at Urbana-Champaign 5 (Oct. 12, 2006), available at
http://www.hhs.gov/ohrp/detrm_letrs/YR06/oct06b.pdf; Letter from Robert J. Meyer, Compliance
Oversight Coordinator, Div. of Compliance Oversight, OHRP, to C. Bradley Moore, Vice
President for Research, Nw. Univ. (Aug. 30, 2005), available at http://www.hhs.gov/
ohrp/detrm_letrs/YR05/aug05f.pdf; Letter from Robert J. Meyer, Compliance Oversight
Coordinator, Div. of Compliance Oversight, OHRP, to Lewis J. Smith, Acting Vice President for
Research, Nw. Univ. (June 29, 2005), available at http://www.hhs.gov/ohrp/detrm_letrs/YR05/
jun05a.pdf.

REITER FINAL.DOC

2009]

4/30/2009 10:22:01 PM

EXPERIMENTATION ON PRISONERS

529

prisoners unless the research falls into one of four narrow categories.160
Therefore, researchers who fail to articulate what exception justifies their
research have apparently ignored the general rule against using prisoners as
subjects of medical experiments. Indeed, the OHRP itself has expressed
concern with researchers’ lack of compliance with the Title 45 regulations
governing research on prisoners; the OHRP maintains a web page specifically
dedicated to explaining the protocols governing research involving prisoners.161
Such failures undermine the assumption in the 2006 IOM Report that IRBs can
feasibly be expected to conduct case-by-case risk-benefit analyses for every
research protocol involving prisoner subjects.
Although the specific details of experiments involving prisoners cannot be
gleaned from many of the OHRP letters, some letters clearly refer to
experimental protocols that have been reported in public media outlets or
otherwise investigated.162 These public investigations reveal further details
about how prisoners were used in the medical experiments the OHRP has cited
for violations of the regulations protecting prisoner research subjects. For
instance, the OHRP cited the University of Miami HIV-treatment drug trial for
a number of violations; as noted earlier in this section, news reports on this trial
from the St. Petersburg Times and other local news sources provide more
details about the drug trial than do the OHRP letters. The OHRP expressed
similar concerns about drug trials conducted in Texas state prisons by the
University of Texas Medical Branch (UTMB). Like the drug trials conducted in
Florida prisons by the University of Miami, local and national news sources
investigated the Texas drug trials and reported on their findings.163 According
to an investigative series on healthcare in the Texas state prison system,
published in the Austin American-Statesman in 2001, UTMB ran multiple drug
trials that incorporated prisoner participants. In 2001, there were “at least nine

160. See 45 C.F.R. § 46.306.
161. The webpage is called “OHRP Prisoner Frequently Asked Questions”—a clear
acknowledgement that medical experimentation takes place in prisons and that the OHRP attempts
to monitor this research. See OHRP, U.S. Dep’t of Health & Human Servs., OHRP Prisoner
Frequently Asked Questions, http://www.hhs.gov/ohrp/prisonerfaq.html (last visited Nov. 2,
2008).
162. See Ward & Bishop, supra note 34 (describing University of Texas Medical Branch
(UTMB) experiments on prisoners; the OHRP cited UTMB for violations of the Title 45
regulations governing research on prisoners in a September 2000 letter: Letter from Michael A.
Carome, Chief, Compliance Oversight Branch, Div. of Human Subject Prots., to Dorothea Wilson,
Vice President for Research, Univ. of Tex. Med. Branch at Galveston (Sept. 14, 2000), available
at http://www.hhs.gov/ohrp/detrm_letrs/sep00b.pdf); Dober, supra note 69, at 11 (noting that the
OHRP sent a determination letter to the University of Texas Medical Branch in 2000); see also
Freedberg, supra note 140 (describing University of Miami experiments on prisoners; the OHRP
cited the University of Miami for violations of Title 45 regulations governing research on
prisoners in a July 2000 letter: Letter from Sanford Leikin to Norman Altman, Ira Clark, and Gus
Godoy, supra note 145).
163. See, e.g., Ward & Bishop, supra note 34; Julia Lutsky, Texas and Florida Prisoners
Used in Medical Experiments, Prison Legal News, Apr. 2001, at 6.

REITER FINAL.DOC

530

4/30/2009 10:22:01 PM

CALIFORNIA LAW REVIEW

[Vol. 97:501

drug trials” with approved prisoner participants, and there were at least ninetynine prisoners participating in these drug trials.164 The Austin AmericanStatesman article noted that UTMB “doesn’t keep a count” of exactly how
many prisoners participate in drug trials.165 More disturbingly, based on their
interviews with multiple prisoners, the reporters summarized the prisoners’
motivations for participating in the drug trials: “[t]he only way to receive what
prisoners consider decent medical care was to join a biomedical research trial in
Galveston.”166 Most of the prisoner participants were HIV-positive, and many
of the trials focused on HIV treatment, which the Austin-American Statesman
implies the prisoners had no alternative means of accessing without
participating in experimental drug trials.
Because the federal government helped fund these drug trials, the OHRP
had authority to investigate whether the researchers were complying with
federal human subjects regulations.167 As noted earlier in this section, the
OHRP found numerous violations of the federal regulations in their
investigation, from UTMB’s use of exculpatory language on its consent forms
to its failure to document its justifications for using prisoners as the subjects of
medical experiments.168 As with the University of Miami, the OHRP ordered
the immediate suspension of prisoner participation in all UTMB research
projects receiving federal funding.169
One thing is clear from the fact that 778 OHRP non-compliance
determination letters are available online: lack of compliance with the basic
protocols governing human subjects research, in and out of prison, has been
both frequent and widespread since at least 2000. In fact, a number of the
violations cited in the determination letters, though not related to research on
prisoners, have disturbing implications for the feasibility of implementing
adequate protections in the prison context. For instance, some frequently cited
compliance violations include: failure to establish adequate privacy standards
for research subjects,170 failure to ensure standards for informed consent that
guarantee disclosure of “risks and discomforts associated with”
experimentation,171 overly permissive use of exculpatory statements in

164. Ward & Bishop, supra note 34.
165. Id.
166. Id.
167. Id.
168. Letter from Michael A. Carome to Dorothea Wilson, supra note 151, at 10-11.
169. Id.
170. See, e.g., Letter from Carol J. Weil, Compliance Oversight Coordinator, OHRP, to
Winfred M. Phillips, Vice President, Univ. of Fla., and Thomas Sutton, Acting Director, Malcom
Randall VA Med. Ctr. (May 2, 2007), available at http://www.hhs.gov/ohrp/detrm_letrs/YR07/
may07a.pdf.
171. See, e.g., Letter from Kristina C. Borror, Dir. Div. of Compliance Oversight, to David
McLaughlin, Provost, N.Y.U. 1 (Mar. 5, 2008), available at http://www.hhs.gov/ohrp/
detrm_letrs/YR08/mar08b.pdf.

REITER FINAL.DOC

2009]

4/30/2009 10:22:01 PM

EXPERIMENTATION ON PRISONERS

531

informed consent documents,172 and IRB memberships that are incomplete
(such as when no prisoner representative serves on the board) or compromised
(as when a board member has invested in a drug company whose research
protocols the board is reviewing).173 If violations of the current regulations,
which have been in place for thirty years, occur this frequently, then relaxing
the guidelines for research on particularly vulnerable populations, like
prisoners—with their diminished abilities to assert their rights, to consent, or to
seek alternative medical care—appears dangerous indeed.
While the OHRP determination letters provide a window into the
experimentation taking place in prisons, these letters certainly do not capture
the full extent or frequency of prisoner participation in medical
experimentation. As noted above, the OHRP does not have the authority to
regulate private research taking place in non-traditional correctional settings. If
the term “prisoner” were interpreted to include individuals in such settings,
including closely-monitored probation programs, or work-release programs, or
drug-treatment facilities, even more experimentation would likely be found to
be occurring.174 Nonetheless, the four case studies cited above of recent drug
trials—the Hythian drug-addiction trial in Texas, the Stanford psychiatric and
anger-management drug trial in California, the University of Miami HIVtreatment drug trial in Florida, and the University of Texas HIV-treatment trials
in Texas—reveal the variety of medical experiments in which prisoners have
participated in the past decade, the difficulties of regulating these experiments,
and the ethical problems that arise even within regulated experiments.
Ironically, these cases, along with the OHRP determination letters from the
2000s, suggest that the changes made to the federal regulations in the 1970s did
not end experimentation in prisons, but did succeed in removing this
experimentation from the public eye.
2. Human Sardines and Other Problems with Prison Conditions Today
Investigative journalism and a review of OHRP determination letters from
the past eight years indicate that prisoners continue to be used in drug trials and
as the subjects of biomedical research, despite the federal regulations
172. See, e.g., Letter from Patrick J. McNeilly, Compliance Oversight Coordinator, Div. of
Compliance Oversight, OHRP, to Stein Sture, Interim Vice Chancellor for Research & Interim
Dean of the Graduate School, Univ. of Colo. at Boulder 2 (July 6, 2006), available at
http://www.hhs.gov/ohrp/detrm_letrs/YR06/jul06a.pdf.
173. See, e.g., Letter from Lisa A. Rooney, Compliance Oversight Coordinator, OHRP, to
Albert L. Walker, President, Bluefield State Coll. (Feb. 21, 2008), available at
http://www.hhs.gov/ohrp/detrm_letrs/YR08/feb08d.pdf.
174. Indeed, one OHRP determination letter specifically noted that a program “for
previously incarcerated homeless women with substance abuse disorders” was exempt from the
special prisoner-related human subjects protections. Letter from Carol J. Weil, Div. of
Compliance Oversight, OHRP, to Gary R. Butchen, Executive Dir., Bridge Back Recovery
Homes, Inc. 1, 4 (Oct. 15, 2007), available at http://www.hhs.gov/ohrp/detrm_letrs/YR07/
oct07a.pdf.

REITER FINAL.DOC

532

4/30/2009 10:22:01 PM

CALIFORNIA LAW REVIEW

[Vol. 97:501

implemented in 1978. While the use of prisoners in drug trials and as the
subjects of biomedical research might not have decreased as much as 1970s
reformers would have hoped or expected, other conditions of the prison system
have changed more than those reformers could have ever imagined.
First, the prison population has increased more than ten-fold since
1978.175 This increase in population has led to overcrowding throughout federal
and state prisons in the United States.176 This overcrowding, in turn, causes a
variety of problems, from instability and violence within the prison population,
to extended delays in receiving medical care.177 The increased population has
been attributed to changes in sentencing policy, both in the duration of
sentences meted out and in the sheer numbers of people sentenced to prison for
decreasingly violent crimes.178
The related characteristics of overcrowding and increasingly long
sentences are major contributors to a second and growing problem in U.S.
prisons: inadequate healthcare. In fact, “inadequate” is an understatement: the
175. See Figure 3.1 and surrounding text in Zimring, supra note 74, at 46 (graphing the
steep increase in incarceration numbers since 1960); Bureau of Justice Statistics, U.S. Dep’t of
Justice, Prison Statistics, http://www.ojp.usdoj.gov/bjs/prisons.htm#publications (last visited Oct.
14, 2008) (counting 2,299,116 people in prison and jail in the United States at mid-year 2007—the
most recent statistics available); see also Bureau of Justice Statistics, U.S. Dep’t of Justice,
Correctional Populations: 1980-2006, http://www.ojp.usdoj.gov/bjs/glance/tables/corr2tab.htm
(identifying 1980 prison population at 319,598, and 2006 prison population at 1,492,973).
176. See, e.g., Plata v. Schwarzenegger, No. C01-1351 TEH, 2007 U.S. Dist. LEXIS
56031, at *6 (N.D. Cal. July 23, 2007) (describing overcrowding in California prisons and
associated healthcare inadequacies); Balla v. Idaho Bd. of Corr., No. CV81-1165-S-EJL, 2005
U.S. Dist. LEXIS 38804, at *4 (D. Idaho Dec. 9, 2005) (describing “current and ongoing
constitutional violations” based on overcrowding, and refusing to terminate a 1987 injunction
instituting a population cap to limit overcrowding); Gomez v. Singletary, 733 So. 2d 499, 501-04,
507 (Fla. 1998) (describing the history of increasing prison overcrowding in Florida: between
1983 and 1993, overcrowding “exceeded all of the prior thresholds” for maximum capacities; in
1995, the Florida legislature set the “‘lawful capacity’ of the prison system” at 150 percent of
design capacity); County of Gloucester v. State, 623 A.2d 763, 764 (N.J. 1993) (referencing “the
severe and continuing problem of prison overcrowding” and evaluating whether an ongoing
emergency existed based on this overcrowding); see also William J. Sabol et al., Prisoners in
2006, Bureau Just. Stats. Bull., Dec. 2007, at 5, available at http://www.ojp.usdoj.gov/bjs/
pub/pdf/p06.pdf (noting that “Federal prison system was operating at 37% above its rated capacity
at the end of 2006”); Andy Furillo, Jails Fill up, Inmates Pour out in Capital Region,
Sacramento Bee, Sept. 7, 2008, at A1 (noting that California jails released “86,064 convicted
inmates from jail before they had completed their sentences” in 2007); J. Clark Kelso, State Must
Invest in Prison Health-Care Facilities, S.F. Chron., Aug. 28, 2008, at B9 (describing
overcrowding in the California state prisons “with 172,000 inmates in 33 facilities, the state’s
correctional system is operating at double capacity”).
177. See, e.g., Plata, 2007 U.S. Dist. LEXIS 56031, at *6 (describing the possible
connection between unconstitutional healthcare and prison overcrowding); Ward & Bishop, supra
note 34 (describing the findings of a National Commission on Correctional Health Care
investigation that documented “pill lines as long as 1,000 inmates,” which often kept Texas
prisoners from getting to the window in time to get their time-sensitive medications, such as HIV
anti-retrovirals).
178. See William J. Sabol et al., supra note 176, at 3-4 (describing prison population
increase as based at least partially on more admissions than releases).

REITER FINAL.DOC

2009]

4/30/2009 10:22:01 PM

EXPERIMENTATION ON PRISONERS

533

healthcare in many U.S. prisons borders on inhumane.179 Relatedly, U.S.
prisoners are markedly less healthy than the average U.S. citizen. They are
more likely to be HIV positive.180 Likewise, they are more likely to have other
infectious and often fatal diseases like tuberculosis and hepatitis C.181
Moreover, the strains of disease that prisoners have are likely to be drug
resistant, in part at least because prisoners tend to have inconsistent access to
medication in and out of prison.182 U.S. prisoners are not only less physically
healthy than the general population; they are also less mentally healthy.183
Additionally, they suffer from other inflictions of poverty, including very low
education levels.184 Prisoners also tend to have limited access to resources, and
what jobs are available in the prisons tend to pay negligible sums.185
In addition to structural changes in prisons, such as overcrowding, and
detrimental demographic factors, such as high disease exposure and low
literacy rates, legal impediments have increasingly limited individual prisoners’
abilities to bring lawsuits against prison officials and other institutional actors.
Specifically, in 1996, the Prison Litigation Reform Act (PLRA) was passed
with the intention of severely limiting prisoner lawsuits, particularly around
conditions of confinement.186 The Act has largely accomplished its goals.187
Each of these problems with prisons in the United States in 2008 has
179. See, e.g., Plata v. Schwarzenegger, No. C01-1351 THE, 2007 U.S. Dist. LEXIS 43673
at *4 (N.D. Cal. June 4, 2007) (ongoing lawsuit on behalf of prisoners in the state of California
who have suffered from unconstitutionally bad healthcare; the court noted that “one inmate
needlessly dies every six to seven days due to constitutional deficiencies”); Mike Ward & Bill
Bishop, ‘Deadly Inadequacies’ Plague Inmate Wards: Gaps in Evaluating Care Let Some
Mistakes Go Unnoticed, Austin Am.-Statesman, Dec. 16, 2001, at A1 (describing gruesome and
abusive healthcare practices in Texas state prison system such as allowing prisoners to die in their
own feces or forcing terminally ill prisoners to crawl onto and out of a transport bus).
180. Theodore M. Hammett, Mary Patricia Harmon & William Rhodes, The Burden of
Infectious Disease Among Inmates of and Releasees from U.S. Correctional Facilities, 1997, 92
Am. J. Pub. Health 1789 (2002) (noting that U.S. prisoners are HIV positive at five times the
infection rate of the general population).
181. Ward & Bishop, supra note 34.
182. Id.
183. See Sasha Abramsky & Jamie Fellner, Ill-Equipped: U.S. Prisons and
Offenders with Mental Illness 25 (2003), available at http://www.hrw.org/reports/2003/
usa1003/ (suggesting that up to 40 percent of the U.S. prison population either suffers from
significant psychiatric dysfunction or will require some kind of psychiatric intervention during
their incarceration).
184. According to the Prison Policy Initiative, 19 percent of the U.S. prison population is
completely illiterate, and 40 percent are “functionally illiterate,” which means someone would be
“unable to write a letter explaining a billing error.” Peter Wagner, The Prison Index: Taking
the Pulse of the Crime Control Industry (2003), available at http://www.prisonpolicy.org/
prisonindex/rootsofcrime.html.
185. See supra note 67 (discussing current pay rates for prison laborers).
186. See infra note 202.
187. See SAVE Coalition, Prison Litigation Reform Act (PLRA): Myths and Facts,
http://www.savecoalition.org/myths.html (last visited Oct. 14, 2008) (noting that between 1981
and 1995, the rate of prisoner filings of civil rights cases decreased from twenty-nine per thousand
prisoners to twenty-five per thousand prisoners (while the prison population itself doubled)).

REITER FINAL.DOC

534

4/30/2009 10:22:01 PM

CALIFORNIA LAW REVIEW

[Vol. 97:501

affected and will continue to affect any individual prisoner’s ability to
participate freely and voluntarily in experimental medical research. First,
prisoners are both more likely to be in need of medical care and less likely to
have adequate care than the general population. Hence, prisoners might choose
to participate in medical experiments because such participation is the only
access they have to any form of medical care. Second, because of their high
illiteracy rates and low education levels, prisoners are likely to have difficulty
understanding complicated consent forms and might even be confused about
basic experimental protocols. Third, prisoners who do participate in medical
experimentation might have a compromised ability to enforce their rights in a
court of law, either because they have no access to legal resources outside of
the limited, outdated, hardcopy law books available inside prison libraries, or
because they are barred from filing any claim at all under the PLRA.
3. New Oversight Mechanisms: the 2006 IOM Report
Whereas the 1976 DHEW Report Commission convened as regulations
around human subjects research were first being formulated, the 2006 IOM
Report Committee was the product of more than thirty years of such regulation
and included representatives from a variety of regulatory agencies. The 2006
IOM Report Committee included many more people than the 1976 DHEW
Commission: in addition to thirteen core committee members, the 2006 IOM
Report Committee included one “expert adviser,” three consultants, six IOM
staff members, and seventeen independent report reviewers.188 The core
committee members were drawn from the humanities, law, and medical
programs of elite universities, as well as from nonprofit agencies, policy
organizations, and law firms.189
Overall, these members represent a range of legal and academic
perspectives and areas of expertise, from ethics to prison conditions to medical
care. Some were pre-existing members of the Institute of Medicine, such as
Lawrence O. Gostin, the Chair of the 2006 IOM Report Committee. Many of
the members, such as Jeffrey L. Metzner, who has evaluated correctional
mental health problems across the United States, and Michael S. Hamden, the
former director of the nonprofit Prisoner Legal Services in North Carolina,
brought first-hand experience of the prison system to the Committee and appear
to be free of substantial conflicts of interest.

188. 2006 IOM Report, supra note 18, at v-viii.
189. Id. at v. The specific backgrounds and qualifications of the Committee members
appear in Appendix E to the 2006 IOM Report. Id. at 239-52. While a few critics have accused
both the Committee and the Institute of Medicine of having financial interests in the
pharmaceutical and biotech industry, see, e.g., Alliance for Human Research Prot., IOM Panel
Recommends Using Prison Inmates as Guinea Pigs in Drug Trials_NYT, Aug. 13, 2006, available
at
http://www.ahrp.org/cms/index2.php?option=com_content&do_pdf=1&id=308,
these
accusations seem to be unfounded, based on the qualifications of the Committee members.

REITER FINAL.DOC

2009]

4/30/2009 10:22:01 PM

EXPERIMENTATION ON PRISONERS

535

Although this Comment criticizes the recommendations in the 2006 IOM
Report, the motivations of the federal agency that commissioned the Report,
and the motivations of the Report’s authors, were unquestionably ethical.
Indeed, the Report’s authors appear to have been motivated by an honest desire
to review and update regulations that had not been reconsidered since their
implementation thirty years prior. Moreover, the Report’s authors explicitly
stated their awareness that the current regulations are being enforced in a vastly
different research environment, in terms of scale, financing, and vulnerable
population demographics. For example, the recommendations in the Report that
focus on expanding the definition of prisoner and maintaining better databases
of ongoing research reaffirm the good intentions of the Report’s authors, who
should be commended for recognizing the limits of federal oversight.190
Indeed, the 2006 IOM Report authors identify the changing conditions
and demographics of U.S. prisons noted in Part I.B.2. above as one impetus for
the report. Specifically, the Report mentions the growing prison population,
increasingly composed of minorities and women, many of whom suffer from
mental illness, infectious diseases, and inadequate healthcare.191 In the preface
to the Report, the authors acknowledge a second impetus for the report: the
“considerable amount of confusion and disagreement in the research
community regarding the interpretation and application of Subpart C of 45
C.F.R. Part 46,” which addresses experimentation on prisoners in a prison
setting.192
While changing demographics and confusion over current regulations
provide the explicit impetus for the Report, there are implicit motivations as
well. First, the ongoing use of prisoner subjects in a variety of biomedical
experiments, especially in drug trials, may have influenced the decision to
commission an investigation into revising the current regulations. Second, not
only confusion about federal regulations, but also the clear violations of federal
regulations, which the OHRP has cited in the limited category of research
projects subject to OHRP authority, may also have played a role in inspiring the
Report. Indeed, it was the OHRP itself that commissioned the 2006 IOM
Report.193 Interestingly, however, the Report makes no mention of either
specific examples of the ongoing use of prisoners in medical experiments, or of
the OHRP non-compliance letters sent out over the past eight years.
Whereas the 1976 DHEW Report thoroughly catalogued the kinds of
experimentation taking place in prisons in the 1970s and pointed to specific
human rights violations, the 2006 IOM Report speaks only in generalities about

190. 2006 IOM Report, supra note 18, at 7.
191. Id. at 24-25; see also, supra, Part I.B.2 entitled “Human Sardines and Other Problems
with Prison Conditions Today.”
192. 2006 IOM Report, supra note 18, at 24.
193. Id.

REITER FINAL.DOC

536

4/30/2009 10:22:01 PM

CALIFORNIA LAW REVIEW

[Vol. 97:501

the kind of research that might be occurring in prisons today.194 The IOM
Committee’s failure to acknowledge the history of prisoner experimentation,
either before 1976 or in more recent years, led it to make one central,
significantly misguided proposal for reforming research involving prisoner
subjects: instituting a risk-benefit framework.195
The Report fails to discuss how such a standard might be enforced, or
whether it might exacerbate violations already taking place under the existing,
more straightforward categorical standards that are, nonetheless, frequently
breached. Indeed, the Report fails to evaluate whether the existing regulations
have succeeded in limiting experimentation on prisoners. Understanding how
the 1976 recommendations shaped prisoner experimentation in the subsequent
thirty years should be an integral part of making recommendations to further
oversee and control experimentation on prisoners.
In sum, while the Report acknowledges changed conditions in U.S.
Prisons, it does not adequately account for the current conditions of U.S.
prisons, incentives for researchers to incorporate prisoner subjects, or the
limitations of even an expanded regulatory authority. Without taking these
factors into account, recommendations like the one for a risk-benefit
framework are not only unrealistic, but are potentially dangerous to individual
prisoner subjects.
II
CHANGE: WHAT ARE THE RECOMMENDED REGULATORY REFORMS?
Both the 1976 DHEW Report and the 2006 IOM Report reflect the
historical context in which each was generated. The revelations in the media
and the courts regarding the frequency and abusiveness of prison medical
experiments in the 1970s were recent and shocking at the time the DHEW
Report was written. The DHEW Report broke new ground, setting up the first
federal regulatory framework for human subjects research and protections of
vulnerable populations. Thirty years later, the 2006 IOM Report seeks to refine
that framework, and to reexamine regulations against prisoner experimentation
in the context of a larger, more unwieldy criminal justice system. While this
new project is admirable and necessary, the resulting recommendations are
imperfect. The 2006 IOM Report suffers for its lack of engagement with the
kind of details the 1976 DHEW Report contained—about current prison
conditions, about current medical experiments in prisons, and about the
feasibility of enforcing human subjects protections.
This Part briefly analyzes and compares the kinds of data each report

194. As noted above, the 2006 IOM Report does not even refer to any of the human
subjects violations catalogued in the OHRP non-compliance determination letters discussed
above. See infra Part I.B.1.
195. 2006 IOM Report, supra note 18, at 8.

REITER FINAL.DOC

2009]

4/30/2009 10:22:01 PM

EXPERIMENTATION ON PRISONERS

537

considers and incorporates. Then, in Part A, the 1976 DHEW Report
recommendations are reviewed. In Part B, the 2006 IOM Report
recommendations are reviewed. Specifically, the 2006 recommendations
include two categories: those that seek to expand some human subjects research
protections for prisoners, and those that seek to shift the framework for
analyzing human subjects research on prisoners from categorical limitations to
individual risk-benefit analyses.
The 1976 DHEW Report considers the pros and cons of biomedical
testing in particular prisons as well as the institutional and medical systems
within which its recommendations will need to function. The Report
acknowledges that two principles— “respect for persons” and “justice”—might
justify either of two opposite positions: forbidding prisoner participation in
experiments in order to protect them from exploitation and abuse, or,
alternatively, allowing prisoner participation in experiments in order to protect
their right to choose to volunteer and their equal access to the benefits of
research.196 However, the DHEW Commission concludes that within the
institutional and medical settings of U.S. prisons, “persons seem regularly to
engage in activities which, were they stronger or in better circumstances, they
would avoid,” and so “respect dictates that they be protected against those
forces that appear to compel their choices.”197
The 1976 DHEW Report provides rich details about the activities most
free citizens would likely try to avoid, but which forces in U.S. prisons seem to
compel prisoner subjects to participate in. For instance, in its description of the
California Medical Facility at Vacaville (still in operation today), the DHEW
Commission describes not only the kinds of biomedical testing being conducted
at the prison, but also the more general conditions of prison life at the facility.
The Report documents the availability of job opportunities, educational
opportunities, legal advice, and prisoners’ level of contact with the outside
world through partially-censored mail and pay phones.198 The Report also
emphasizes the relationship between prison conditions and informed consent.
In doing so, it notes that sub-par conditions—including limited access to job
opportunities and the outside world, parole practices and demands, and the
degree to which every aspect of prisoners’ lives is controlled—compromise
prisoners’ ability to provide informed consent. In addition, the 1976 DHEW
Report reviews a survey commissioned for the Report about international
practices of drug testing and notes that the United States is unique in its use of
prisoners for drug testing, but also unique in its requirement that Phase I
research be conducted on healthy volunteers (as opposed to on sick patients
who might benefit from the drug trial).199
196.
197.
198.
199.

1976 DHEW Report, supra note 8, at 3078.
Id.
Id. at 3084.
Id. at 3090.

REITER FINAL.DOC

538

4/30/2009 10:22:01 PM

CALIFORNIA LAW REVIEW

[Vol. 97:501

The DHEW Commission could hardly have imagined the changes that
would take place in the U.S. prison system in the years following the release of
its report. The prison population in the United States more than quintupled, and
the combined prison and jail populations increased ten-fold.200 Twenty years
after the 1976 DHEW Report, the repeal of Pell Grant funding virtually
eliminated prisoners’ access to education in prisons.201 At around the same time
Pell Grants were repealed, passage of the Prison Litigation Reform Act
severely limited the ability of prisoners to challenge any condition of
confinement.202 Meanwhile, prisons expanded into rural areas of the United
States where civilian populations have severely limited access to healthcare,
and prisoners have even less access.203 In addition, both the levels of crowding
and disease in U.S. prisons increased dramatically, along with problems in
providing healthcare to the increasing and increasingly sick population.204
Finally, both indeterminate sentences and parole came to a near or total end in
many states across the nation, obviating at least one concern of the 1976
DHEW Report’s authors: indeterminate sentencing.205 Inasmuch as prison
officials had control over any individual’s sentence, those officials could
exercise coercive influence, trading promises of a shorter sentence for consent
to experimental participation.
From its very title, and throughout its 265 pages, the 2006 IOM Report
shifts the framework of analysis from particular prison and research
communities to broader regulatory frameworks. Rather than being a
straightforward report about the status of Research Involving Prisoners, the
2006 IOM Report is about Ethical Considerations in research involving
prisoners. The 2006 IOM Report focuses not on the nature of past or current
research in prisons, but on the ethical frameworks within which such research
should take place. The 2006 IOM Report does devote thirty pages to “changing
demographics” and “health issues” in prisons.206 However, unlike the careful
documentation of prison conditions in specific institutions visited by the
200. See supra note 175 (citing a number of graphs and statistics documenting the increase
in prison and jail populations in the United States in the last thirty years).
201. Pell Grant funding, which allowed prisoners to enroll in college courses, ended in
1994 with the passage of the Violent Crime Control Act. See, e.g., Richard Tewksbury, David
John Erickson & Jon Marc Taylor, Opportunities Lost: The Consequences of Eliminating Pell
Grant Eligibility for Correctional Education Students, 31 J. Offender Rehabilitation 43
(2000); Joshua Page, Eliminating the Enemy: The Import of Denying Prisoners Access to Higher
Education in Clinton’s America, 6 Punishment & Soc’y 357 (2004).
202. See generally John Boston, The Prison Litigation Reform Act (2004), available
at http://www.wnylc.net/pb/docs/plra2cir04.pdf.
203. See, e.g., Ruth Wilson Gilmore, Golden Gulag: Prisons, Surplus, Crisis, and
Opposition in Globalizing California (2007) (addressing the economic choices involved in
locating prisons in rural areas and the impacts of these choices).
204. See supra Part I.B.2 on “Human Sardines.”
205. See generally Joan Petersilia, When Prisoners Come Home: Parole and
Prisoner Reentry (2003).
206. 2006 IOM Report, supra note 18, at 29-59.

REITER FINAL.DOC

2009]

4/30/2009 10:22:01 PM

EXPERIMENTATION ON PRISONERS

539

Commission that wrote the 1976 DHEW Report, the 2006 IOM Report focuses
on aggregate data about the number of people in prison and their general
demographic characteristics, like gender, age, and education.207 Similarly, the
2006 IOM Report provides aggregate statistics about mental and physical
health of the prison population.208
In the same chapter of the 2006 IOM Report, the Committee reviews the
kinds of research permitted and taking place in state prisons across the United
States. Again, these are aggregated data, based on in-depth surveys in six states
and more cursory surveys in the remaining forty-four states.209 The Committee
admitted “it faced a dearth of information as to the recent and current landscape
of research involving prisoners as participants.”210 Nonetheless, the aggregated
form of the data in the 2006 IOM Report is notably different from the
combination of aggregate and specific data provided in the 1976 DHEW
Report. In particular, the 2006 IOM Report provides less specific information
about conditions in prisons and experiments taking place in prisons. Moreover,
while the 2006 IOM Report authors acknowledge concern about the dangers of
unregulated experiments, they express more hope for regulatory possibilities
than the 1976 DHEW Report authors, even though they provide little empirical
evidence to justify their hopeful perspectives.
The remainder of the 2006 IOM Report focuses on describing the ethical
foundations of the current regulations regarding research on prisoners,211 the
ethical foundations of the 1976 DHEW Report,212 and the key definitions that
should change based on a comparison between these two ethical
perspectives.213 The final chapter specifies the categories of safeguards that
should exist and applies these categories to specific examples of potential
research projects.214 Nowhere does the 2006 IOM Report discuss international
drug testing and biomedical experimentation practices, so there is no
comparative benchmark with the practices of other countries.215
In sum, while the 2006 IOM Report is almost four times as long as the
1976 DHEW Report, the 2006 Report, in terms of content and rigor, is skeletal
by comparison. The 2006 IOM Report contains much less discussion of either
the history or status of human subjects experimentation in prison, and the 2006
Committee also seems less concerned with determining and analyzing current
prison conditions. Further, the Report is generally less engaged with the

207. See, e.g., id. at 31-41, Tables 2.1-2.8, mostly reproducing data publicly available
through the Bureau of Justice Statistics.
208. See id. at 42-58.
209. Id. at 59.
210. Id.
211. Id. at 73-100.
212. Id. at 113-36.
213. Id. at 101-12.
214. Id. at 137-74.
215. See infra Section III.A. (discussing comparative international standards).

REITER FINAL.DOC

540

4/30/2009 10:22:01 PM

CALIFORNIA LAW REVIEW

[Vol. 97:501

Committee’s own process in reaching recommendations and more concerned
with general changes in ethical standards and how these might affect the law
around human subjects experimentation.
A. 1976 Recommendations
The recommendations section of the 1976 DHEW Report comprises only
seven pages and includes five simple and straightforward recommendations.
The first two recommendations concern two kinds of studies on prisoners and
in prisons that the Commission approved. First, the Commission approved
studies involving only questions about prisons and prisoners themselves. For
instance, the Commission approved of research questions about prisons as
institutions, incarceration as a process, and prisoner as a status—as long as the
studies both “present[ed] minimal or no risk and no more than mere
inconvenience” to the prisoner participant and also met the proposed general
experimentation requirements in subsequent recommendations.216 Second, the
Commission approved studies of practices intended to and likely to benefit
prisoners themselves—again, as long as the practices met the proposed general
experimentation requirements in subsequent recommendations.217
The third, fourth, and fifth recommendations set limits on biomedical
experimentation in prisons; these limits are so strict as to amount to a
presumption against any such experimentation taking place at all.218 The third
recommendation suggests that experimentation on prisoners take place only
after a “national ethical review body” certifies that the research provides a
“compelling” justification for using prisoners, “satisfies conditions of equity,”
and meets voluntariness standards, including stringent minimum conditions of
confinement.219 In the comments following this third recommendation, the
Commission enumerated seventeen specific confinement conditions that should
be met for a prison to satisfy conditions of equity and voluntariness
standards.220 These seventeen conditions included: an absence of overcrowding,
the availability of single-occupancy cells, operable toilets, access to functioning
showers, “good quality medical facilities . . . adequately staffed and equipped,”
sufficient mental health care, educational programming, and assurances of
personal safety.221 (Note how many of these conditions were highlighted as
ongoing problems in the Part I.B.2 above on “Human Sardines.”) Without these
preconditions, the Commission argued, prisoners cannot provide actual
informed consent to participate in biomedical research. The enumeration of the
seventeen quite specific minimum conditions of confinement suggests that the
216.
217.
218.
219.
220.
221.

1976 DHEW Report, supra note 8, at 3080.
Id.
Id. at 3080-81.
Id. at 3080.
Id. at 3080-81.
Id. at 3080.

REITER FINAL.DOC

2009]

4/30/2009 10:22:01 PM

EXPERIMENTATION ON PRISONERS

541

Commission either found such standards absent in their evaluation of prison
conditions or was concerned that the standards would be absent in the future.
Furthermore, the specificity of the minimum conditions requirements suggests
that such standards might be difficult to achieve. Indeed, in the Report’s
introduction, the Commission states that it “did not find in prisons the
conditions requisite for a sufficiently high degree of voluntariness and
openness.”222
The final two recommendations, the fourth and fifth, describe procedures
for reviewing and approving prisoner participation in experimentation. The
fourth recommendation requires that both institutional agency directors and
independent institutional review boards, which should be required to include
prisoner or prisoner advocate members, approve any research in prisons.223 The
final recommendation limits the duration of any then-existing, non-complying,
non-certified medical research projects to one year from the date of publication
of the recommendations.224
Congress codified these five succinct recommendations into a federal law
designed to eliminate nearly all human experimentation in U.S. prisons:
Subpart C of the “Protection of Human Subjects” regulations in the Code of
Federal Regulations.225 Although Congress did not codify the DHEW Report
recommendations verbatim, it did incorporate the Report’s presumption against
biomedical research. Specifically, the federal law allows for only four
categories of research on prisoners: studies about incarceration and criminal
behavior, studies about prisons and prisoners, “research on conditions
particularly affecting prisoners,” and “research on practices . . . which have the
intent and reasonable probability of improving the health or well-being of the
subject.”226 The first two categories of behavioral studies must present “no
more than minimal risk and no more than mere inconvenience to the
subjects.”227 In sum, the law restricts behavioral and biomedical research
“conducted or supported” by the DHHS.228 Non-therapeutic biomedical
research, such as that conducted by drug companies, is absolutely excluded
from the permissible categories of research on prisoners. In addition, Title 45,
Part 46 provides the standards for institutional review boards governing
research on prisoners.229

222.
223.
224.
225.
226.
227.
228.
229.

Id. at 3079.
Id. at 3081.
Id.
45 C.F.R. §§ 46.301–.306.
45 C.F.R. § 46.306(a)(2)(i)–(iv).
Id.
Id.
45 C.F.R. §§ 46.107-.115, 46.304.

REITER FINAL.DOC

542

4/30/2009 10:22:01 PM

CALIFORNIA LAW REVIEW

[Vol. 97:501

B. 2006 Recommendations
The 2006 IOM Report’s recommendations appear in small, dense print in
its twenty-page summary section, in much more detail than the succinct
recommendations that appear in seven double-spaced pages in the 1976 DHEW
Report.230 The 2006 Report recommendations suggest transforming the existing
code of federal regulations governing experiments on prisoners, from a system
of categorical approval and disapproval of research into a more flexible system
of case-by-case analysis of permissible research.
Like the 1976 DHEW Report, the 2006 IOM Report identifies five key
categories of reform. However, rather than making straightforward
recommendations about exactly what kind of research is and is not acceptable,
as the 1976 DHEW Report does, the 2006 IOM Report makes a series of
recommendations that are organized around five “objectives”:
The committee’s recommendations are directed to five distinct
objectives: (1) expand the definition of “prisoner,” (2) ensure
universal, consistent ethical protection, (3) shift from a category-based
to a risk-benefit approach to research review, (4) update the ethical
framework to include collaborative responsibility, and (5) enhance
systematic oversight of research with prisoners.231
At first glance, these objectives seem to call for expanded protections for
prisoners involved in research. In fact, in the four-page online summary of the
2006 IOM Report, the Committee notes the “four-fold” increase in the U.S.
population under correctional supervision over the past thirty years.232 The
Committee also acknowledges that access to adequate healthcare can be a
problem in a correctional population of this size and suggests that “these factors
point to a population that is more vulnerable and requires stronger protections
than those inspired by the national commission in the 1970s.”233
Implicit in this focus on expanding protections, however, is an
acknowledgement of the continued existence of some forms of experimentation
in prison. Thus, the recommendations seek to regulate experimentation rather
than simply curtailing or limiting it. On the one hand, reviewing the categorical
limitations implemented in the 1970s and refining the regulatory standards
230. The 2006 IOM Report is available for purchase from the National Academies Press at
a cost of $41.40, or for free online at: http://www.nap.edu/catalog.php?record_id=11692#toc.
231. Inst. of Med. of the Nat’l Acads., Report Brief: Ethical Considerations for
Research Involving Prisoners 2 (2006) [hereinafter 2006 IOM Report Brief].
232. See Figure 3.1 and surrounding text in Zimring, supra note 74, at 46 (graphing what
looks to be an eight-fold increase in incarceration numbers since 1960); see also Bureau of Justice
Statistics,
U.S.
Dep’t
of
Justice,
Correctional
Populations:
1980-2006,
http://www.ojp.usdoj.gov/bjs/glance/tables/corr2tab.htm (identifying 1980 prison population at
319,598, and 2006 prison population at 1,492,973, suggesting a 4.7-fold increase in only twenty
years).
233. 2006 IOM Report Brief, supra note 231, at 1. The 2006 IOM Report includes not just
the prison population in this number, but the total population of people in prisons and jails and on
probation and parole.

REITER FINAL.DOC

2009]

4/30/2009 10:22:01 PM

EXPERIMENTATION ON PRISONERS

543

makes sense. On the other hand, making any refinements without evaluating
whether those 1970s regulations have accomplished their goals, or whether
adequate safeguards protect prisoners participating in experiments today, is
difficult to justify.
A more careful analysis of the recommendations the Committee makes
within each of the five objectives identified will illuminate the Report’s
potential impact on federal regulations of human subjects research in prison.
The five objectives fit into two categories: expanding protections for prisoner
research subjects and shifting from a categorical to a risk-benefit evaluation of
potential research studies.
1. Expanding Protections
To implement the objectives seeking to expand protections, the
Committee recommends expanding the vulnerable subjects regulations to
protect any person in a setting in which his or her “liberty is restricted.”234
Current Title 45 regulations apply only to people in prisons and in jails, but the
Committee’s recommendations would incorporate the millions of people in the
United States who are on probation, on parole, or in nontraditional correctional
settings such as drug treatment facilities.235 The Commission also recommends
expanding the scope of oversight authority of the OHRP and similar offices.236
In addition, the Report suggests the maintenance of a public database of
research involving prisoners, as well as new requirements for both transparency
and accountability in this research.237 These recommendations respond to
Committee findings both that procedures for overseeing and regulating research
in prison were inconsistent from state to state, and also that reporting of this
research was inconsistent and difficult to find.238 Finally, the Report also insists
upon more consistent and rigorous review of proposed studies, with
involvement from prisoners and correctional staff.239 In sum, the refinements
the 2006 IOM Report Committee suggest are expansive: create a national
database, drastically expand the number of “prisoner” subjects covered by the
regulations through altered definitions, and broaden the scope of agency
regulation to include non-government-funded projects.
Given the current, ongoing problems with human subjects research—
problems the existing, narrowly-defined oversight system identifies annually,
as detailed in the Part I discussion of the OHRP’s non-compliance
determination letters—expanding this system and enforcing new regulations on

234. 2006 IOM Report, supra note 18, at 4–5.
235. 45 C.F.R. § 46.303(c) (defining “prisoner”).
236. 2006 IOM Report, supra note 18, at 6–7; see also 45 C.F.R. § 46.306(b) (delineating
the limited applicability of the regulations).
237. 2006 IOM Report, supra note 18, at 7.
238. Id. at 59.
239. Id. at 10.

REITER FINAL.DOC

544

4/30/2009 10:22:01 PM

CALIFORNIA LAW REVIEW

[Vol. 97:501

an even grander scale presents at best a considerable challenge and at worst an
impossible task. Nonetheless, expanding the oversight system is a laudable
goal, and one that Congress, the OHRP, and other oversight agencies should
work together to accomplish. Once expanded oversight systems are in place,
the systems should be carefully evaluated to determine their effectiveness. Only
once expanded oversight has been designed, implemented, and evaluated for its
success in achieving its goals, should broader prisoner participation in research
even be considered. In other words, a simple proposal to expand oversight of
human subjects research on prisoners should not serve as a justification for
simultaneously expanding prisoner participation in such research. Any
expansion of participation should be contingent on documented successes in
expansion of oversight.
2. Shifting Frameworks
The second category of objectives the 2006 IOM Report recommends
involves shifting the framework for analyzing potential research trials that
propose to involve prisoner subjects. Specifically, this Committee objective
calls for overhauling the categorical prohibitions against non-beneficial
biomedical research (as codified in the federal regulations) and replacing them
with a “risk-benefit approach,” which would force researchers to “identify the
particular ethical issues that each protocol raises in the specific context of the
correctional setting.”240 The 2006 Committee was careful to note that a riskbenefit framework might still maintain blanket prohibitions against cosmetic
products testing and Phase I and II FDA-sanctioned drug testing trials, because
such biomedical experiments would not directly benefit prisoners, and they
pose more than minimal risks.241 However, the 2006 IOM Report suggests that
Phase III drug testing likely would meet the ethical standards of the risk-benefit
framework.
According to the Report, the key determinants of a favorable risk-benefit
ratio are not whether the proposed experiment has therapeutic goals, but
whether any test being run has already produced “some evidence of safety and
efficacy” and whether “the ratio of prisoner to nonprisoner subjects does not
exceed 50 percent.”242 In some situations, if a research trial particularly targets
a condition specific to a prison population, these two conditions might even be
waived.243 In sum, with the addition of a few significant refinements to
safeguards for vulnerable populations, the Committee believes that
experimentation on prisoners, even including non-therapeutic research, could
be safe and humane.
Although the 2006 IOM Report sets a tone of protective reform, the actual
240.
241.
242.
243.

Id. at 8.
Id.
Id. at 9.
Id.

REITER FINAL.DOC

2009]

4/30/2009 10:22:01 PM

EXPERIMENTATION ON PRISONERS

545

recommendations suggest at numerous points that research on prisoners should
be expanded. The 2006 Committee freely acknowledges that it does not wish to
ban all human subjects research in prison. In the preface to the Report, the
Committee notes that recommending “a virtual ban on human subject research
involving prisoners” would be a simple, but lazy, solution.244 After all, the
Committee notes, research has benefits, including improving “correctional
settings” and addressing health problems faced particularly by correctional
populations, such as infectious diseases, addiction, and mental health
problems.245 Recommendations such as compiling databases seem targeted at
regulating and reviewing, rather than necessarily limiting, biomedical research.
Moreover, the Report explicitly suggests the possibility of using prisoners in
Phase III drug trials and in other biomedical research targeting conditions likely
to be found in incarcerated populations.
In fact, the Committee suggests a hope that its recommendations will
facilitate prisoner participation in cutting-edge drug trials and treatments for
diseases particularly affecting prisoner populations. There are two problems
with this hope. First, the current federal regulations already permit just these
kinds of therapeutic research projects in correctional settings. Title 45 explicitly
suggests that experimental hepatitis treatments should be permitted in prisons,
because prisoners are particularly likely to have hepatitis.246 The 2006 IOM
Report recommends establishing oversight and creating databases to determine
whether any such therapeutic research projects take place in prisons and
encourages such projects to take place more often. According to the authors of
the 2006 IOM Report, the limited oversight of prisoner experimentation
currently in place made it impossible for the Committee to determine whether
prisoners are actually participating in experimental treatment trials for diseases
they face with particular frequency.247
There is a second problem with the hope for more beneficial research.
Although some therapeutic studies targeting prisoners with HIV have recently
taken place in Texas and Florida, overcrowded, inhumane, and unhealthy
prison conditions compromise the voluntary nature of prisoner participation in
these studies. The 2006 IOM Report Committee argues that certain conditions
particularly or “almost exclusively” affect incarcerated populations, and, by
extension, these conditions might justify allowing increased prisoner
participation in medical experiments.248 The Report provides the examples of
the high incidence of experiences of repetitive sexual assaults in prisoner
populations, suggesting that such a health problem characteristic of the prisoner
population might justify prisoner participation in a biomedical research study of
244.
245.
246.
247.
248.

Id. at x.
Id.
45 C.F.R. § 46.306(a)(2)(iii).
2006 IOM Report, supra note 18, at 59.
Id. at 9-10.

REITER FINAL.DOC

546

4/30/2009 10:22:01 PM

CALIFORNIA LAW REVIEW

[Vol. 97:501

unknown benefit.249 Indeed, the UTMB and University of Miami studies
conducted on HIV-positive Texas and Florida prisoners, respectively, as
discussed in Part I.B., might constitute just the kind of prisoner-targeted study
that the 2006 IOM Report Committee had in mind. After all, prisoner
populations have significantly higher prevalence rates of HIV infection than the
general population.250 And without the possibility of participating in HIV drug
trials, prisoners in Texas or Florida might not have access to adequate HIV
treatments in overcrowded prisons with limited healthcare facilities.
Suddenly those insufficiently regulated studies in Texas and Florida,
which the OHRP cited for violations of the federal human subjects regulations,
seem like studies where the benefits to an underserved population might far
outweigh the risks. Indeed, such studies might be presumptively justifiable
under a risk-benefit analysis, rather than presumptively excluded, without
further, careful justifications, as they are under the current categorical analysis
codified in the federal regulations. This risk-benefit scale tips even further
toward the benefit side if the HIV drugs used in the study have already been
proven to have at least some potential efficacy. But this is exactly the problem
with the risk-benefit framework: under this framework, the very conditions in
the U.S. prison system, such as overcrowding and limited healthcare, which
make prisoners a particularly vulnerable population, weigh in favor of allowing
prisoners to participate in drug trials. In fact, prisoners themselves argue that
they should be allowed to participate in such trials.251 But this Faustian bargain
of “choosing” between sub-standard prison conditions and becoming a guinea
pig is hardly a choice at all. Moreover, falsely positing the situation as a choice
simply allows universities and private drug companies to invest in and control
state prisons that should themselves take responsibility for providing adequate
living conditions and healthcare to all prisoners, not simply those infected with
HIV who happen to be “lucky” enough to join an external drug trial.
The 2006 IOM Committee failed to explain how a risk-benefit approach
would take into account the basic conditions of confinement problems facing
U.S. prisons. How would a risk-benefit framework protect prisoners from being
forced into therapeutic research as the only means of attaining healthcare? Or,
more disturbingly, how could a risk-benefit framework protect prisoners from
being forced into non-therapeutic research, where they believe they are
receiving treatment but they actually are only receiving a non-therapeutic
placebo, often without even understanding the meaning of the term “placebo”?
A vitally important point here is that while a risk-benefit ratio “strongly
favorable” to prisoners is indisputably a necessary condition for any biomedical
experimentation in prison, it should not be a sufficient condition.
249. Id.
250. See supra note 180.
251. See, e.g., Ward & Bishop, supra note 34 (describing prisoners urging each other to
join drug trials).

REITER FINAL.DOC

2009]

4/30/2009 10:22:01 PM

EXPERIMENTATION ON PRISONERS

547

As the 1976 DHEW Report noted, regulatory authorities must document
basic conditions of confinement within the prison system before permitting any
experimentation—even targeted, therapeutic research—in prisons. Moreover,
adequate regulatory safeguards over such analyses must also be in place.
However, the breadth of the regulatory safeguard changes suggested in the
2006 IOM Report, along with the numerous violations of current regulations
cited in the public media and the OHRP determination letters, as described in
Part I.B., indicate that such safeguards are not in place.
In sum, the recommendations in the 2006 IOM Report for greater
oversight of prisoner experimentation are critical to protecting prisoner subjects
of any experiment or trial, even therapeutic behavioral research. However,
these recommendations are not adequate to justify any expansion of the use of
prisoners in experimental research, particularly for non-therapeutic purposes.
As recommended by the 1976 DHEW Report, any new federal legislation
should ensure that basic conditions of humane confinement and adequate
oversight are satisfied before any expansion of prisoner participation in
biomedical research should be considered. Moreover, any individualized riskbenefit analysis must focus solely on the risks and benefits to the individual
prisoner participant, and research should not be deemed beneficial simply
because a prisoner has no alternative means of receiving adequate treatment or
healthcare. Until adequate oversight is well-established, and prison conditions
ensure all prisoners receive basic healthcare, even without agreeing to
participate in drug trials, the 2006 IOM Report recommendation to implement a
risk-benefit framework for evaluating proposed biomedical research on
prisoners will remain both premature and idealistic.
III
REGULATION: WHAT ETHICAL STANDARDS GOVERN HUMAN MEDICAL
EXPERIMENTATION?
One goal unites the many ethical standards—both legal and medical—that
govern experimentation on human subjects: an aim to correct the power
imbalance between doctor and patient, researcher and subject. The physician or
researcher must have sufficient leeway to use his knowledge and resources to
treat patients to the best of his professional ability; the patient or subject must
have both the right to weigh the risks and benefits of various treatments and the
ability to make a reasoned, consensual decision about the kind of care to which
he submits. The law, be it international or domestic, tends to assume that the
patient or subject holds less power than the doctor or researcher, and that
safeguards must be institutionalized in order to protect the patient-subject. This
assumption seems both reasonable and necessary in light of the history of
medical experimentation reviewed in Part I.
Safeguards protecting patient-subjects from power imbalances include
consent requirements, ethical review requirements, and requirements that the

REITER FINAL.DOC

548

4/30/2009 10:22:01 PM

CALIFORNIA LAW REVIEW

[Vol. 97:501

experiment be beneficial, usually both to the patient and to medical practice
more generally. The institutional frame of the prison setting not only magnifies
the doctor-patient, researcher-subject power imbalance, but also highlights all
three concerns about consent, ethics, and benefits—concerns that have shaped
the existing safeguards for human subjects experimentation. A careful review
of the domestic and international standards, which apply to human subjects
research in general and to prisoner experimentation specifically, will help to
contextualize any proposed changes to federal standards as recommended by
the 2006 IOM Report.
A. International Standards
The 1976 DHEW Report contains a chapter entitled “Alternatives and
Foreign Practices” in which the DHEW Commission reviews medical
experimentation practices in the United States outside of prisons, as well as
foreign medical experimentation standards generally.252 The 1976 DHEW
Report cites a survey of foreign practice, which documented that most foreign
countries permitted pharmacology experiments to be conducted on human
subjects such as student, civil servant, or paramedical volunteers, but not on
prisoners.253 The DHEW Report notes that while there is no evidence of foreign
countries using prisoners for Phase I drug tests, many countries documented the
use of prisoners for “nontherapeutic research.”254 However, the example of
foreign, non-therapeutic research noted in the Report is relatively non-invasive:
a survey of the prevalence of the XYY chromosome.255
Unlike the 1976 DHEW Report, the 2006 IOM Report contains little
analysis of international norms regarding medical experimentation on humans
in general or prisoners in particular. Nor does the 2006 IOM Report discuss
empirical trends in medical testing on humans outside of the United States.
Both reports do mention the Nuremberg Code, the first set of international
standards for human subjects research, developed during the Nazi war crimes
trials.256 However, the 2006 IOM report provides few details about the
development in the twentieth century of international norms around medical
experimentation on humans generally and prisoners specifically.
The Nuremberg Code, while a proxy for presumptive international
standards of human medical experimentation, is non-binding and actually
appears only in the U.S. Nuremberg Military Tribunal decision convicting the
Nazi doctors who conducted grotesque medical experiments on concentration

252. 1976 DHEW Report, supra note 8, at 3088-90.
253. Id. at 3089. Merck Sharp & Dohme Research Laboratories, a private pharmaceutical
company, provided the survey.
254. Id. at 3090.
255. Id.
256. Id. at 3076; 2006 IOM Report, supra note 18, at 114, 194.

REITER FINAL.DOC

2009]

4/30/2009 10:22:01 PM

EXPERIMENTATION ON PRISONERS

549

camp prisoners.257 In fact, international standards are now more clearly
developed than their first articulation in the Nuremberg Code.258 An
examination of these international standards provides an important context for
thinking about how to frame American human experimentation standards,
especially as those standards pertain to prisoners. First, some of these
international standards are binding on the United States as a treaty signatory.
Second, assessing how other countries have handled human medical
experimentation is critical to analyzing “evolving standards of decency,” a
concept drawn from Eighth Amendment jurisprudence evaluating what
constitutes cruel and unusual punishment.259 Courts have applied this Eighth
Amendment “evolving standards of decency” analysis to evaluate prisoner
claims challenging the sufficiency of medical treatment received; the standard
is therefore relevant to analyzing both basic conditions of confinement and
human subjects research protocols.260
In United States v. Brandt, the Nuremberg Medical Trial in which Nazi
doctors were tried for war crimes committed in the name of medical science,
the Nazi doctors presented a defense based on a claim that the standards
governing human subjects research were ambiguous, and so there could be no
charge of a violation of an unknowable standard. In response to this claim, the
Nuremberg judges wrote the Nuremberg Code into their final judgment.261 The
Nuremberg Code contains ten points. The Code prioritized the requirement of
voluntary consent by making it the first of ten points. The remaining nine
257. Jonathan D. Moreno, Reassessing the Influence of the Nuremberg Code on American
Medical Ethics, 13 J. Contemp. Health L. & Pol’y 347, 348 (1997). Although the Code is
nonbinding, it has been mentioned in U.S. case law with great deference. See, e.g., United States
v. Stanley, 483 U.S. 669, 710 (1987) (O’Connor, J., concurring in part and dissenting in part); In
re Cincinnati Radiation Litig., 874 F. Supp. 796, 821 (S.D. Ohio 1995). The Nuremberg Code was
also mentioned by the Department of Defense and the National Institutes of Health in the adoption
of strict consent standards for human experimentation in the United States in the 1950s. In re
Cincinnati Radiation Litig., 874 F. Supp. at 821.
258. See, e.g., World Med. Ass’n, Declaration of Helsinki, available at
http://www.wma.net/e/policy/b3.htm [hereinafter Declaration of Helsinki]; World Health
Organization & the Council of Int’l Organization of Med. Scis., International
Ethical Guidelines for Biomedical Research Involving Human Subjects (rev. 2002),
http://www.cioms.ch/frame_guidelines_nov_2002.htm
[hereinafter
CIOMS
Guidelines];
International Covenant on Civil and Political Rights, G.A. Res. 2200A (XXI), 21 U.N. GAOR
Supp. (No. 16) at 52, U.N. Doc. A/6316 (Dec. 16, 1966), 999 U.N.T.S. 171 (entered into force
Mar. 23, 1976, in accordance with Article 49), available at http://www.unhchr.ch/html/menu3/b/
a_ccpr.htm [hereinafter ICCPR].
259. See Roper v. Simmons, 543 U.S. 551, 551, 575 (2005) (referencing international
norms around execution of juveniles “as instructive for . . . interpretation of the Eighth
Amendment’s prohibition of ‘cruel and unusual punishments’”) (citing Trop v. Dulles, 356 U.S.
86, 102-03 (1958)).
260. See, e.g., Roach v. Kligman, 412 F. Supp. 521, 525 (E.D. Pa. 1976) (“When a claim
against prison officials is based on improper medical treatment, it must depict conduct that is so
cruel and unusual as to present a colorable Eighth Amendment claim.”) (citing Gittlemacker v.
Prasse, 428 F.2d 1 (3d Cir. 1970)).
261. Moreno, supra note 257, at 348.

REITER FINAL.DOC

550

4/30/2009 10:22:01 PM

CALIFORNIA LAW REVIEW

[Vol. 97:501

points revolve around protecting human subjects of experimentation from
suffering pain, permanent injury, or death, and require constant attention to the
“humanitarian importance” of the experiments.262
A number of commentators have argued that the non-binding code had no
immediate influence on Western doctors, who viewed the regulations as
directed toward Nazi soldiers, rather than toward themselves.263 Nonetheless,
international law scholars argue that the Code established the preeminence of
consent as the core principle that must guide any human subjects
experimentation. For instance, one scholar notes that the Nuremberg Code
“first was seen as obviously applying to imprisoned and oppressed persons,
then to all healthy subjects, then to those who were sick but would not benefit
from an experiment, and then finally to those who were sick but stood a chance
of benefiting from research participation.”264 In other words, although not
binding on any individual nation, the Code has had far-reaching effects on the
development of the ethics of medical experimentation, in the United States and
throughout the world.265
Indeed, the Nuremberg Code’s ten points have been adopted in numerous
international guidelines and laws. Most notably, in 1964, the World Medical
Association drafted and ratified the Declaration of Helsinki, which incorporated
many of the principles from the Nuremberg Code. Since then, the Declaration
has been revised five times, in 1975, 1983, 1989, 1996, and 2000.266 The
revisions have included the addition of independent review committees as a
requirement of ethical research and changed regulations governing the use of
placebos in drug trials. Although the Declaration is not binding, it is intended to
function as “a statement of ethical principles to provide guidance to physicians
and other participants in medical research involving human subjects” around
the world.267
This Declaration has a “more flexible view of subject consent” than the
Nuremberg Code.268 The importance of informed consent, in writing, is
262. The Nuremberg Code, http://www.hhs.gov/ohrp/references/nurcode.htm (last visited
Nov. 2, 2008). For further information and documentation about the Nuremberg Trials, see
Harvard Law School Library, Nuremberg Trials Project: A Digital Document Collection,
available at http://nuremberg.law.harvard.edu/php/docs_swi.php?DI=1&text=overview.
263. See David J. Rothman, Strangers at the Bedside: A History of How Law and
Bioethics Transformed Medical Decision Making 62-63 (2d ed. 2003); Jay Katz, The
Consent Principle of the Nuremberg Code: Its Significance Then and Now, in The Nazi Doctors
and the Nuremberg Code 227, 231 (George J. Annas & Michael A. Grodin eds., 1992).
264. Moreno, supra note 257, at 359.
265. See id.; see also Henry Beecher, Ethics and Clinical Research, 274 New Eng. J. Med.
1354 (1966); Claire Alida Milner, Comment, Gulf War Guinea Pigs: Is Informed Consent
Optional During War?, 13 J. Contemp. Health L. & Pol’y 199, 211-18 (1996) (cited in
Moreno, supra note 257, at 350 nn.17 & 21, 357 n.62).
266. Declaration of Helsinki, supra note 258. Citations in the text are to the most recent
(2000) version of the Declaration.
267. Id. ¶ 1.
268. Moreno, supra note 257, at 357.

REITER FINAL.DOC

2009]

4/30/2009 10:22:01 PM

EXPERIMENTATION ON PRISONERS

551

relegated to paragraphs 20 and 22 in the Helsinki Declaration, rather than being
the first and most prominent command, as it is in the Nuremberg Code.269
Furthermore, the Helsinki Declaration provides for exceptions to the informed
consent rule, where a researcher deems it “impossible or impractical to obtain
[consent],” or where consent “would pose a threat to the validity of the
research,” as long as an ethics committee approves of the waiver of consent.270
Although the Declaration recommends that no subject should consent under
duress, and special precautions should be taken for legally incompetent
research subjects,271 neither prisons nor prisoners are explicitly mentioned
anywhere in the document. Thus, the Helsinki Declaration’s stance on the
importance of consent falls short of the Nuremberg Code’s stance on consent.
By contrast, the International Ethical Guidelines for Biomedical Research
Involving Human Subjects (hereinafter CIOMS Guidelines), published in 1982
by the World Health Organization and the Council of International
Organization of Medical Societies (CIOMS), explicitly mentions prisoners in
the commentary to Guidelines 9, 12, and 13.272 Guideline 9 states that where
research involves “individuals incapable of giving informed consent,” the
research must either be of “direct benefit” to the subject, or have a risk that is
“no more likely and not greater than the risk attached to routine medical or
psychological examination,” unless approved by an ethical review committee,
based on a specifically articulated medical rationale.273 The commentary to the
guideline notes that prisoners are among the category of individuals who have a
“limited capacity to give informed consent.”274
Guideline 12 concerns the “equitable distribution of burdens and benefits
in the selection of groups of subjects in research,” and includes commentary
noting that some groups, such as prisoners, have been overused in some kinds
of tests, like Phase I drug testing.275 The commentary to this Guideline further
states that while “the burdens of research should not fall disproportionately on
socio-economically disadvantaged groups,” or institutionalized groups, “neither
should such groups be categorically excluded from research protocols.”276
Finally, Guideline 13 recommends special protections for “vulnerable
populations” and notes that prisoners might be considered a vulnerable
population.277
These CIOMS Guidelines are critical for understanding international
standards around informed consent. First, the Guidelines categorize prisoners
269.
270.
271.
272.
273.
274.
275.
276.
277.

World Med. Ass’n, supra note 258.
Id. ¶ 25.
Id. ¶¶ 23, 24.
CIOMS Guidelines, supra note 258.
Id. (Guideline 9).
Id. (Commentary on Guideline 9).
Id. (Guideline 12 and Commentary).
Id. (Guideline 12 Commentary).
Id. (Guideline 13 and Commentary).

REITER FINAL.DOC

552

4/30/2009 10:22:01 PM

CALIFORNIA LAW REVIEW

[Vol. 97:501

as having a compromised ability to participate in informed consent procedures.
Second, the Guidelines insist that any human subjects research, particularly on
prisoners, must be beneficial to the subjects, and neither overly inclusive nor
overly exclusive of disadvantaged populations. Third, the Guidelines advocate
for subject protections, implicitly demanding some sort of ethical review
procedure for research.
In addition to the standards promoted by the World Medical Association
and the World Health Organization, the International Covenant on Civil and
Political Rights (ICCPR), which the United Nations adopted in 1966, and to
which the United States is a signatory, addresses medical experimentation and
consent.278 Article 7 states: “No one shall be subjected to torture or to cruel,
inhuman or degrading treatment or punishment. In particular, no one shall be
subjected without his free consent to medical or scientific experimentation.”279
As CIOMS says in its Ethical Guidelines: “It is through this statement that
society expresses the fundamental human value that is held to govern all
research involving human subjects—the protection of the rights and welfare of
all human subjects of scientific experimentation.”280 The ICCPR is a binding
Covenant.
Similarly, a number of European countries have recently adopted binding
regulations to control biomedical experimentation on human subjects. In 1997,
the Council of Europe ratified the Convention on Human Rights and
Biomedicine (CHRB)—“the first legally binding international treaty to govern
human experimentation.”281 As of 2005, seventeen European countries had
ratified the Convention.282 The Convention mentions consent as a requirement
for participation in experimentation, but prisoners are not explicitly
mentioned.283
In sum, the international legal and medical communities have articulated
specific guidelines for human medical experimentation. These guidelines
include a requirement for consent procedures, definitions of the conditions that
compromise a person’s ability to consent, and requirements for ethical review

278. ICCPR, supra note 258. The United States ratified the ICCPR on September 8, 1992.
Office of the High Commissioner for Human Rights, Status of Ratifications of the Principal
International Human Rights Treaties, June 9, 2004, available at http://www.unhchr.ch/pdf/
report.pdf.
279. ICCPR, supra note 258, Article 7.
280. CIOMS Guidelines, supra note 258, “International Instruments and Guidelines.”
281. Benjamin Mason Meier, International Protection of Persons Undergoing Medical
Experimentation: Protecting the Right of Informed Consent, 20 Berkeley J. Int’l L. 513, 528
(2002).
282. Markus Schott, Medical Research on Humans: Regulation in Switzerland, the
European Union, and the United States, 60 Food & Drug L.J. 45, 49 (2005).
283. Council of Europe, Convention for the Protection of Human Rights and Dignity of the
Human Being with regard to the Application of Biology and Medicine: Convention on Human
Rights and Biomedicine, Apr. 7, 1997, available at http://conventions.coe.int/treaty/en/
treaties/html/164.htm.

REITER FINAL.DOC

2009]

4/30/2009 10:22:01 PM

EXPERIMENTATION ON PRISONERS

553

of experimental protocols and review of the allocation of benefits and burdens
in experimentation. Arguably, the range and detail of these international legal
standards is both broader and more thorough than the proposals in the 2006
IOM Report.
B. Domestic Legal Standards
The federal standards controlling medical research on human subjects in
general are codified in a number of sections of the Code of Federal
Regulations. “Additional Protections Pertaining to Biomedical and Behavioral
Research Involving Prisoners as Subjects,” the section codifying the
recommendations in the 1976 DHEW Report, has already been discussed in
great detail above.284 Other sections of the Code of Federal Regulations,
particularly within Title 45, regulate the standards for consent, for institutional
review board approval, and for analyzing the benefits of human subjects
research.285 Additionally, Title 21 of the Code of Federal Regulations, which
governs the FDA, also describes standards specifically applicable to drug
testing on humans that are similar to the human subjects research standards
described in Title 45.286 In addition to these federal regulations, federal and
state courts also apply constitutional standards to evaluations of human medical
experimentation and healthcare in prison. These constitutional standards
include the Fifth, Eighth, and Fourteenth Amendments.287
The “Protection of Human Subjects” sections of Title 45 of the Code of
Federal Regulations apply only to federally funded research.288 Similarly, the
“Protection of Human Subjects” sections of Title 21 apply to “clinical
investigations regulated by the Food and Drug Administration.”289 Federally
funded research includes research not only within government agencies, such
as the military or prisons, but also research conducted by public educational

284. 45 C.F.R. § 46.301-.306.
285. See 45 C.F.R. pt. 46.
286. See
generally
21
C.F.R.
pts.
50,
56
(2008),
available
at
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm. Specifically, 21 C.F.R.
§ 50.20 addresses informed consent; 21 C.F.R. pt. 56 addresses institutional review boards.
287. See, e.g., Samuel Jan Brakel, Considering Behavioral and Biomedical Research on
Detainees in the Mental Health Unit of an Urban Mega-Jail, 22 New Eng. J. on Crim. & Civ.
Confinement 1 (1996). The Eighth Amendment prohibits cruel and unusual punishment and so
could be invoked against abusive experimentation in prison. See, e.g., Roach, 412 F. Supp. at 528.
Likewise, the Fifth and Fourteenth Amendment “due process” and “equal protection”
requirements could protect prisoners from being forced into participating in experimentation, or
could justify prisoner participation at rates comparable to the rates of free citizen participation in
experimentation. Brakel, at 25, n.86.
288. 45 C.F.R. § 46.101(a) (indicating that the protection policy “applies to all research
involving human subjects conducted, supported or otherwise subject to regulation by any federal
department or agency which takes appropriate administrative action to make the policy applicable
to such research”).
289. 21 C.F.R. § 50.1(a) (2007).

REITER FINAL.DOC

554

4/30/2009 10:22:01 PM

CALIFORNIA LAW REVIEW

[Vol. 97:501

institutions.290 A brief survey of the letters sent by the Department of Health
and Human Services to non-compliant institutions sheds light on the broad
array of human subjects research—from HIV treatment trials run by
universities to epidemiological studies conducted by state departments of
public health—that receives some federal funding and is therefore subject to
the regulations.291 There are some other exceptions to the application of the
Title 45 regulations: the regulations do not apply to educational testing,
consumer products testing, or completely non-intrusive testing such as
“collection or study of existing data, documents, [or] records.”292 In other
words, Title 45 is broad in both content and application. It covers biomedical as
well as behavioral research, as recommended in both the Belmont Report,
which established basic ethical principles for human subjects research in
general, and the 1976 DHEW Report, which particularly targeted research
involving prisoners.
Two sections of Title 45 specifically address informed consent.293 Any
human subjects research under federal regulation requires informed consent,
and the elements of informed consent are explicitly defined: a subject must
have the “opportunity to consider” participation; as much freedom as possible
from “coercion or undue influence”; and an explanation of the proposed
research, including risks, benefits, and alternatives, in language he or she
understands.294 Additionally, informed consent may not include any waiver of
legal rights on the part of the subject or waiver of liability on the part of the
researcher.295 These rules set firm boundaries requiring researchers to be frank
with the subjects of their experiments. While a rule against coercion, a
requirement that explanations be clear, and a prohibition on waiving legal
rights and obligations might each seem simple, they can all be difficult both to
implement and to regulate.
The dozens of determination letters that the OHRP sends annually to
researchers regarding their adherence to Title 45 regulations, as discussed in
Part I, above, is just one indication of the frequency with which Title 45
regulations are breached or ignored.296 Rules that are difficult to implement and
regulate in the free world often face more implementation obstacles—and,
conversely, less oversight—in a prison setting. The federal regulations
290. See also supra notes 128-129 and surrounding text (discussing additional categories of
regulatory authority to which Title 45 applies).
291. See supra Part I.
292. 45 C.F.R. § 46.101(b)(4), (1)-(6).
293. 45 C.F.R. §§ 46.116-.117.
294. Id. § 46.116.
295. Id.
296. A survey of the compliance letters archived on the OHRP website, from 2000 to 2008
suggests that more than a dozen determination letters are sent monthly to document research in
violation of some section of the Title 45 human subjects research regulations. See U.S. Dep’t of
Health & Human Servs., Office for Human Research Prots., 2000 Determination Letters,
http://www.hhs.gov/ohrp/compliance/letters/2000.html (last visited Oct. 17, 2008).

REITER FINAL.DOC

2009]

4/30/2009 10:22:01 PM

EXPERIMENTATION ON PRISONERS

555

explicitly acknowledge this difficulty, noting that prisoners are among the
subjects “likely to be vulnerable to coercion or undue influence.”297 Similarly,
the prohibition against waivers of legal rights and obligations is inherently
difficult to enforce in a prison setting, where the subjects have already lost
many of their legal rights, from freedom of movement to civic participation.
Additionally, a prisoner’s ability to enforce those rights he or she does have is
severely curtailed, both by a lack of access to resources and by laws which
actively seek to limit the prisoner’s access to the courts.298
The informed consent rules depend on the existence of active and engaged
institutional review boards (IRBs) to mediate ethical gray areas and police legal
boundaries. IRBs are independent advisory bodies that oversee human subjects
research; any institution sponsoring such research is usually required to have an
established IRB. Title 45 directly addresses IRBs in nine separate subsections.299 First, the federal regulations in Title 45 define IRB membership,
requiring at least five members, including members with scientific and nonscientific backgrounds, and members affiliated and not affiliated with the
institution in which the IRB functions.300 In both Title 45 and Title 21, which
governs the FDA, the sections defining IRB membership suggest that IRBs
reviewing research involving “a vulnerable category of subjects, such as . . .
prisoners” should at least consider “inclusion of one or more individuals who
are knowledgeable about and experienced in working with those subjects.”301
The human subjects regulations of Title 45 go on to delineate appropriate
IRB procedures and to specify the IRB’s role in enforcing other regulations
within Title 45. Specific criteria for IRB reviews include three key
requirements: minimization of risks to subjects, evaluating risks in relation to
benefits to subjects and to scientific knowledge in general, and equitable
selection of subjects.302 Under the section addressing the equitable selection of
subjects, prisoners are particularly identified as a category of subjects creating
“special problems of research,” which deserve an increased level of scrutiny.303
The FDA regulations for IRBs, codified at Title 21, identify parallel
requirements for drug testing, again including prisoners within the category of
“vulnerable populations” requiring heightened review.304
Both the informed consent rules and the IRB rules in Title 45 mention the
importance of articulating, analyzing, and justifying the risks and benefits of
any research project that uses humans as subjects. In other words, weighing the
risks and benefits of any human subjects experiment has been a critical step in
297.
298.
299.
300.
301.
302.
303.
304.

45 C.F.R. § 46.111(b).
See Boston, supra note 202.
45 C.F.R. §§ 46.107-.116.
45 C.F.R. § 46.107.
Id. § 46.107(a); 21 C.F.R. § 56.107.
45 C.F.R. § 46.111(a)(1)-(3).
45 C.F.R. § 46.111(a)(3).
21 C.F.R. § 56.111(a)(3).

REITER FINAL.DOC

556

4/30/2009 10:22:01 PM

CALIFORNIA LAW REVIEW

[Vol. 97:501

validating or approving human subjects research on prisoners since the 1970s.
The emphasis on this risk-benefit approach in the 2006 IOM Report, then, is
not novel. However, using this risk-benefit approach to the exclusion of other
methods of evaluation or in place of categorical regulations might eliminate
critical safeguards against experimental abuses.
The federal regulations codified at Titles 21 and 45 are prospective,
designed to prevent the kinds of problems with human experimentation
documented in the 1976 DHEW Report and in exposés like Jessica Mitford’s
Kind and Usual Punishment.305 On the other hand, the case law governing
human subjects experimentation is retrospective, articulating standards that
should have been in place, or identifying sufficient standards that were already
in place.306 The case law, then, is more focused on questions of consent and
standards of treatment, and less focused on IRB regulations and balancing tests,
than the federal regulations. Indeed, in some instances courts seem to be more
in tune with international regulations and the focus in international ethical
standards, stemming from the Nuremberg Codes, on consent.
In reviewing human medical experimentation challenges, courts have held
that informed and voluntary consent is absolutely critical to any research
protocol, particularly those involving prisoners. Without informed and
voluntary consent, experimentation on prisoners (and other vulnerable
populations) will not withstand constitutional scrutiny. Rather, such
experimentation will be subject to equal protection, due process, and cruel and
unusual punishment challenges. In articulating the importance of informed and
voluntary consent, the Supreme Court has directly referenced the Nuremberg
Code. Dissenting in a 1987 Supreme Court case regarding biomedical
experiments conducted by the U.S. military in the 1950s to test the effects of
LSD, Justice Sandra Day O’Connor referenced the Code as a morally binding
standard of consent for medical experimentation, enforceable through
constitutional guarantees of due process.307 In a district court case in 1995, in
which plaintiffs challenged the Human Radiation Experiments conducted by
the Department of Defense from 1960 to 1972, the court stated that the
Nuremberg Code represents a moral imperative, “part of the law of
305. See Mitford, Kind and Usual Punishment, supra note 37.
306. See, e.g., Mackey v. Procunier, 477 F.2d 877, 878 (9th Cir. 1973) (holding that if a
prisoner did not consent to experimental treatment, an Eighth Amendment question of cruel and
unusual punishment would be at issue). But cf. Bailey v. Lally, 481 F. Supp. 203, 225 (D. Md.
1979) (holding that consent forms and IRB procedures were adequate to protect subjects of
biomedical experimentation).
307. United States v. Stanley, 483 U.S. 669, 710 (1987) (O’Connor, J., concurring in part
and dissenting in part) (“The standards that the Nuremberg Military Tribunals developed to judge
the behavior of the defendants stated that the ‘voluntary consent of the human subject is absolutely
essential . . . to satisfy moral, ethical and legal concepts.’ If this principle is violated the very least
that society can do is to see that the victims are compensated, as best they can be, by the
perpetrators. I am prepared to say that our Constitution’s promise of due process of law guarantees
this much.” (citations omitted)).

REITER FINAL.DOC

2009]

4/30/2009 10:22:01 PM

EXPERIMENTATION ON PRISONERS

557

humanity.”308 These two references in case law to the Nuremberg Code, which
emphasizes the fundamental importance of consent in experimentation in its
first principle, suggest that American courts consider informed and voluntary
consent in evaluating the constitutionality of human subjects
experimentation.309
However, courts are divided on whether the circumstance of being in
prison compromises a prisoner’s ability to consent. As one author observes, the
application of constitutional standards seems to support medical
experimentation on prisoners at some points, and at other points seems to
discourage such experimentation:
[Constitutional principles] can be used as readily to argue that the
potential harm of research may not be visited on a disadvantaged and
“situationally coerced” population such as prisoners, as to support the
position that precluding prisoners from participating violates their right
to be treated with the same respect and deference to their autonomy
accorded other citizens.310
For instance, in Mackey v. Procunier, the appellate court reversed the trial
court’s dismissal and remanded for consideration of the merits of the claim that
although the prisoner consented to shock treatments, he did not consent to the
administration of an experimental drug, which caused him difficulty in
breathing.311 On the other hand, in Bailey v. Lally, a challenge to an experiment
in which prisoners were exposed to and infected with a variety of illnesses,
from diarrhea-inducing bacteria to malaria-carrying mosquitoes, the court
found no undue coercion, found good faith on the part of prison officials and
experimenters, and found no proof of any violation of the plaintiff’s
constitutional rights.312 Similarly, in Roach v. Kligman, a prisoner sought
damages in compensation for permanent liver damage he suffered from
biomedical experiments in which he participated in exchange for a small
payment.313 When Roach first fell ill in prison, prison doctors gave him
penicillin, without inquiring whether he was participating in a medical
experiment; Roach claimed the penicillin aggravated his illness and that

308. In re Cincinnati Radiation Litig., 874 F. Supp. 796, 821 (S.D. Ohio 1995) (“The
Nuremberg Code is part of the law of humanity. It may be applied in both civil and criminal cases
by the federal courts in the United States” (citing Stanley, 483 U.S. 699)).
309. Of course, in recent years, the authority of international laws and treaties has become
a point of contention in federal jurisprudence, and the Supreme Court has split over whether
international law should even be a point of reference in American legal decisions. See Roper v.
Simmons, 543 U.S. 551, 605 (O’Connor, J., dissenting) (describing the marginality of
international law as a factor in the decision about the juvenile death penalty); id. at 622 (Scalia, J.,
dissenting) (rejecting international law entirely as irrelevant to Eighth Amendment jurisprudence).
310. Brakel, supra note 287, at 24.
311. Mackey, 477 F.2d at 877.
312. Bailey v. Lally, 481 F. Supp. 203, 225, 206 n.7, 207 n.9 (D. Md. 1979).
313. Roach v. Kligman, 412 F. Supp. 521, 524 (E.D. Pa. 1976).

REITER FINAL.DOC

558

4/30/2009 10:22:01 PM

CALIFORNIA LAW REVIEW

[Vol. 97:501

conditions in his cell were “inadequate and unconstitutional.”314 The court held
that the prisoner was not coerced to enter the experiment, the medical care was
at most negligent, and the conditions in which Roach was held did not
constitute cruel and unusual punishment.315 Thus, while some courts have
recognized that the Nuremberg Code is a moral imperative, and that consent is
critical to human experimentation, there is little consensus as to what
constitutes valid consent.
In fact, Bailey and Roach epitomize the difficulties prisoners have in
bringing suits that challenge the conditions of confinement in general, and the
detrimental effects of medical experimentation in particular. Even in the 1970s,
when concern regarding the problems with biomedical experimentation on
prisoners was at its peak, few courts even heard prisoners’ claims against
experimenters and prison officials, let alone found in favor of prisoners. Today,
prisoners continue to face a number of procedural hurdles in even getting their
challenges to medical care and experimental participation heard before a
tribunal, as discussed below. And if they are successful at establishing a prima
facie case, prisoners face an even higher bar to making an ultimately successful
claim, in terms of the standard of proof the law requires a prisoner to meet in
order to win a challenge against the government or a prison official.316
Initially, prisoners face many procedural hurdles in bringing any challenge
to medical care or experimental participation. First, there is a federal
requirement (applicable to state prisoners as well) that prisoners exhaust their
administrative remedies—through filing a grievance within the institution
where they are confined, and, if they are unsuccessful, appealing this grievance
to the highest level possible in the institutional chain of command—before a
lawsuit can be filed.317 For instance, in McNeil v. United States, McNeil’s claim
against the U.S. Public Health Service for infecting him with hepatitis C
through biomedical experimentation was dismissed, because McNeil had failed
to exhaust his administrative remedies under the Federal Tort Claims Act.318
Prisoners face additional hurdles; for instance, statutes of limitations may
expire before the prisoners can realize the full extent of the damages they have
suffered from medical experimentation. This is, of course, a particular problem
for a population that is confined in an institutional setting. The low literacy and

314. Id.
315. Id. at 523, 529.
316. Usually a prison official or government actor is a named defendant in these kinds of
prisoner challenges, because the institution had some role in approving, facilitating, or following
up on the experimentation in which the prisoner participated, even if the actual experimenter was
from a private company or an educational institution. See, e.g., Bailey v. Lally, 481 F. Supp. 203
(D. Md. 1979) (Lally was the Secretary of Public Safety and Correctional Services in Maryland at
the time the case was brought); Mackey v. Procunier, 477 F.2d 877 (9th Cir. 1973) (Procunier was
the Director of the California Department of Corrections at the time the case was brought).
317. See Boston, supra note 202, at 10.
318. McNeil v. United States, 508 U.S. 106 (1993).

REITER FINAL.DOC

2009]

4/30/2009 10:22:01 PM

EXPERIMENTATION ON PRISONERS

559

education level of most prisoners exacerbates the problem of meeting
timeliness deadlines and articulating a colorable claim.319
If a prisoner or former prisoner is successful in bringing a challenge to
participation in medical experimentation, he will still face unique hurdles
because of his prisoner status. First, any claim a prisoner makes about his
unmet needs will always be balanced against claims prison staff make about
limitations on institutional resources and requirements of institutional
regulations, especially safety.320 In other words, whereas a non-incarcerated
participant in medical experimentation might claim that the researchers failed
to warn him adequately of potential side effects of the experiment, or failed to
provide adequate follow-up care to alleviate such effects, a prisoner with a
similar claim will likely be required to counter institutional claims that
providing such information or care might have placed an undue burden on
institutional resources or been in conflict with institutional safety regulations.
In addition to having to overcome this balancing test of institutional
versus individual needs, prisoners seeking to challenge experimental
participation face potential claims of qualified immunity from public
employees. For instance, in Clay v. Martin, in which a prisoner challenged the
treatment he received while enrolled in drug experimentation at the Addiction
Research Center in Lexington, Kentucky, the court noted that although Clay
had presented a cognizable claim, he would still need to prove “whether 42
U.S.C. § 233(a) protects these Public Health doctors against tort actions for
injuries inflicted before its effective date, and whether, if so, the doctors were
acting within the scope of their employment.”321
If a prisoner does successfully present a cognizable claim, and the claim
survives counter-arguments about qualified immunity and the needs of
institutional regulation, courts still must assess whether informed consent
existed. Often, if a court finds that informed consent did exist, then this finding
is used as a proxy for assuming that the experiment was valid, thereby
preventing the prisoner from either challenging the treatment he received or
seeking damages. As one author noted:
It has been held that constitutional remedies will not be granted if the
subjects are granted the ability to withdraw from the experiment at any
time during such experiment. This is a major problem when the
informed consent provisions of 45 C.F.R. § 46.116(a) require that
every consent form contain a statement informing subjects that they
may discontinue participation at any time without penalty or loss of
benefits.322

319. See supra note 184 (referencing low literacy levels of prisoners).
320. See, e.g., Washington v. Harper, 494 U.S. 210, 224-25 (1990).
321. Clay v. Martin, 509 F.2d 109, 114 (2d Cir. 1975) (citation omitted).
322. Brian Paul Wyman, Biomedical and Behavioral Research on Juvenile Inmates:
Uninformed Choices and Coerced Participation, 15 J.L. & Health 77, 99-100 (2000-01).

REITER FINAL.DOC

560

4/30/2009 10:22:01 PM

CALIFORNIA LAW REVIEW

[Vol. 97:501

In addition to these clear constitutional standards, one other aspect of case
law indirectly governs experimentation on human subjects in general and on
prisoners in particular: the legal standard for medical neglect. For prisoners, the
bar for establishing medical neglect is so high as to be almost impossible to
satisfy. Whereas an average citizen pursuing a claim for improper medical
treatment could bring a civil case subject to a standard tort evaluation of duty,
breach, and causation, a prisoner must also establish that experimental
procedures were “cruel and unusual” within the confines of the Eighth
Amendment: “It is only where an inmate’s complaint of improper or inadequate
medical treatment depicts conduct so cruel or unusual as to approach a
violation of the Eighth Amendment’s prohibition of such punishment that a
colorable constitutional claim is presented.”323
The standards go on, in extensive case law, to place further limitations on
prisoner challenges to medical care. “The act or omission by the official must
either be intentionally injurious, reckless, callous, grossly negligent, shocking
to the conscience, unconscionable, intolerable to fundamental fairness, or
barbarous.”324 True, a prisoner might face relaxed standards in attempting to
sue a drug company rather than a prison official. However, prison officials will
likely ultimately be responsible for identifying and providing any follow-up or
side-effect-related care a prisoner participating in an experiment might need,
unless the researcher removes the prisoner to a non-government facility run
completely by private researchers—an unlikely circumstance. As such, a
prisoner seeking to challenge the medical care he has received relating to a
research experiment will face innumerable roadblocks in attempting to prove
that he received care so inhumane and insufficient as to be “cruel and unusual”
under the Eighth Amendment.
One court’s analysis of a prisoner’s claim regarding post-experimentation
medical treatment in prison in Pennsylvania is representative:
There is no evidence in the record of malice on the part of these
defendants. Quite to the contrary, the record shows that the primary
purpose of allowing the medical experiments is to provide a source of
income for the inmates. This particular test was reviewed by an outside
doctor, before approval. Finally, the nature of the claim itself is
medical, and yet none of the Prison defendants is a doctor. Nothing in
the record suggests that the Prison defendants knew or had reason to
know that the prison doctor, the guards, or Ivy Research would even be
negligent toward the plaintiff, let alone subject him to cruel and
unusual punishment. The most that can be said of the Prison
defendants on this record is that they were negligent in their
supervision. It is not enough for the plaintiff to characterize this
323. Gittlemacker v. Prasse, 428 F.2d 1, 6 (3d Cir. 1970).
324. Roach v. Klingman, 412 F. Supp. 521, 525 (E.D. Pa. 1976) (citing Rochin v.
California, 342 U.S. 165, 172 (1952); Ford v. Bd. of Managers, 407 F.2d 937, 940 (3d Cir. 1969);
Gittlemacker, 428 F.2d 1; Martinez v. Mancusi, 443 F.2d 921 (2d Cir. 1970)).

REITER FINAL.DOC

2009]

4/30/2009 10:22:01 PM

EXPERIMENTATION ON PRISONERS

561

negligence in a conclusory fashion as “gross” or “reckless” or
“malicious”, and then claim this gives rise to a constitutional
deprivation. Section 1983 is not designed to be a “font of federal tort
law” and the fact that a tort may have been committed by state officials
does not mean a federal right has been invaded.325
Indeed, it is hard to imagine any medical complications pursuant to a
biomedical experiment, particularly one that had passed the risk-benefit
analysis laid out in the 2006 IOM Report, that would be susceptible to a
prisoner lawsuit regarding inadequate medical attention or care—no matter
how abusive an experiment had become.
In sum, the standard for evaluating claims of medical mistreatment sets a
high bar that few prisoners can surmount. Recall the requirement in the federal
regulations governing human subjects research that valid informed consent
prohibits research subjects from waiving legal rights and also prevents
researchers from waiving legal responsibility. These informed consent
procedures are a prerequisite to almost any kind of human subjects
experimentation. Given the high bar any prisoner must meet in establishing a
prima facie claim of medical mistreatment, simply because he or she is a
prisoner, the prisoner’s status as prisoner constitutes a de facto waiver of the
right to sue. All of this analysis points to a vital problem with allowing research
on prisoners, given their current rights: prisoners’ effective waiver of the right
to sue for mistreatment is nearly indistinguishable from an explicit waiver on
an informed consent form. If the latter waiver might be dangerous enough to
have inspired a statute to prevent it, then the presence of an entire population
already circumstantially subject to such a waiver invites abusive research
practices. Indeed, the history of human subjects research suggests that such
abuse has been widespread, particularly in the absence of effective human
subjects protections—including, but not limited to, protections ensuring a
degree of self-advocacy prohibited of prisoners.
This analysis of the modern standards regulating experimentation on
prisoners, from across the world and within U.S. courts, suggests that the
protections for U.S. prisoner subjects of experimentation proposed in the 2006
IOM Report are inadequate. First, the proposed regulations are inadequate by
comparison to international medical and legal standards governing human
subjects research on vulnerable populations. Second, the proposed regulations
are inadequate within the context of current federal limitations on the rights of
prisoners to challenge conditions of confinement, healthcare, and unsatisfactory
treatment they might experience as the subjects of medical experimentation.

325.

Roach, 412 F. Supp. at 528 (citations omitted).

REITER FINAL.DOC

562

4/30/2009 10:22:01 PM

CALIFORNIA LAW REVIEW

[Vol. 97:501

IV
RECOMMENDATIONS: HOW SHOULD HUMAN SUBJECTS RESEARCH ON
PRISONERS BE REGULATED?
The 2006 IOM Report does not evaluate either the enforceability of
current human subjects regulations or the feasibility of enforcing even broader,
more individualized, regulatory authority.326 Because regulatory standards for
human experimentation are difficult to enforce, particularly in prison settings,
implementing more complex regulatory standards might simply lead to
confusion and haphazard enforcement.327 Before either legislators or the DHHS
attempt to implement complex and individualized risk-benefit standards, three
preliminary steps must be taken.
First, as the 2006 IOM Report recommends, current regulatory authority
should be expanded to cover all human subjects experimentation on prisoners
as well as people under correctional supervision. The Report is right to suggest
that information on prisoner experimentation should be better compiled and
better reviewed. However, the Report could have been more explicit in
acknowledging that medical research, both biomedical and behavioral, is taking
place in prisons across the United States today. The idea that the 1976 DHEW
Report virtually eliminated medical testing in prisons is simply a myth, as
demonstrated by the steady flow of researcher reprimands by the OHRP. Given
that medical experimentation is taking place behind closed doors, regulation is
unquestionably needed.
Second, once Congress has expanded regulatory oversight, and federal
agencies have attempted to implement this expansion and engage in more
rigorous and widespread oversight, a second step is required. Some
independent body, such as the Institute of Medicine, should evaluate the
success of this regulatory oversight. If the regulatory oversight continues to
reveal significant compliance problems, such as those the OHRP determination
letters discussed in Part I suggest exist today, then further revisions should be
made to the regulatory oversight mechanisms. No expansion of research on
vulnerable populations should take place until some independent body
determines that the regulatory authority of monitoring agencies has
successfully achieved widespread compliance with human subjects protections.

326. The report does discuss the legislative feasibility of expanding the legal authority of
the DHHS, just not the feasibility of implementing regulatory changes. 2006 IOM Report, supra
note 18, at 95-99.
327. See Part I infra (discussing the sheer number of determination letters sent annually to
agencies conducting federally-funded research projects on human subjects in violation of federal
regulations); see also Office of the Inspector General, Institutional Review Boards: A Time
For Reform, supra note 155, at ii-iii (noting that institutional review boards are overworked, face
conflicts of interest, and are insufficiently regulated).

REITER FINAL.DOC

2009]

4/30/2009 10:22:01 PM

EXPERIMENTATION ON PRISONERS

563

Third, in addition to evaluating the enforceability of current and potential
regulations, any body making or implementing recommendations regarding
prisoner research should consider U.S. prison conditions. Imperfect conditions
inside U.S. prisons can compromise prisoners’ ability both to provide informed
consent to participate in experimentation and to challenge inhumane practices.
Any regulation must both articulate the baseline human rights standards that
should exist in prisons and correctional facilities before consent can freely be
given, and also account for the many motivations, whether altruistic,
capitalistic, or some combination, that underlie a desire to use prisoners as the
subjects of medical experiments.
The 2006 IOM Report fails to clarify these baseline principles. Without
satisfaction of these pre-conditions, an individualized risk-benefit analysis of
research protocols seeking to incorporate prisoners is bound to lead to abuse
rather than protection of human subjects. The specter of pre-1976-era practices
in which prisoners participated in federally-approved experiments that had no
therapeutic purpose and caused long-term, permanent health damage, should
always ground the debate over how to regulate experimentation in prison.
Congress and the DHHS should only consider risk-benefit standards (and not
necessarily implement them) once these first three regulatory steps—expanding
oversight, evaluating oversight, and improving prison conditions—are
accomplished.
The key arguments in favor of allowing prisoner participation in human
subjects research are: (1) respect for individual autonomy, including prisoners’
rights to choose whether or not they want to participate in experiments, and to
weigh the risks and benefits of participation for themselves; (2) the potential for
improving prisoner healthcare, which in many places is already abysmal,
through targeted studies, or through an infusion of resources from those
agencies or individuals conducting the experiments; and (3) the transparency
achieved when agencies and individuals conducting tests gain access to and
become invested in prisons. Adequate human subjects regulations applied to
prisoners should further each of these three goals without compromising
prisoners’ basic human rights or physical health.
The 2006 IOM Report recommendations, which suggest a broader
application of federal regulations to all people under any form of correctional
supervision and the development of a national research database, will further
the goal of transparency and might also improve access to healthcare
information for prisoners and non-prisoners alike. However, the Report’s other
central recommendation, a risk-benefit framework, is not necessary to further
the goals of respecting individual autonomy, improving healthcare for
prisoners, or achieving transparency. In fact, the federal laws currently
regulating prisoner participation in experimental protocols already further each
of these goals, or at least have the potential to do so.
The best way to balance the basic rights of the prisoner population, almost

REITER FINAL.DOC

564

4/30/2009 10:22:01 PM

CALIFORNIA LAW REVIEW

[Vol. 97:501

universally acknowledged to be “vulnerable” by both U.S. and international
laws, is to prioritize and protect the basic rights of individuals within that
population over any other interests—whether scientific, social, or corporate.
First, prisoners should have access to experimental practices designed to
benefit their health and well-being. For instance, prisoners facing terminal
illnesses, whether cancer, tuberculosis, or HIV/AIDS, should be permitted to
enroll in experimental treatment programs. In fact, they should have access
equivalent to similarly afflicted persons outside of prison. However, prisoners
should have sufficiently adequate healthcare in prison to allow them to make an
actual and informed choice between enrolling in a drug trial and receiving
comfortable and humane care available through the prison.
Second, studies that are non-intrusive and present absolutely no health
risks, particularly behavioral research involving only voluntary, confidential
interviews, should be permitted. Indeed, both therapeutic and behavioral studies
would seem to be permissible under either the current Title 45 regulations,
based on the 1976 DHEW Report, or under the suggested Title 45 revisions,
based on the 2006 IOM Report. Neither the 1976 DHEW Report nor the current
federal regulations prevents prisoners from participating in experiments, which
address “conditions particularly affecting prisoners as a class,” or “which have
the intent and reasonable probability of improving the health or well-being of
the subject.”328 To the extent that prisoners do not participate in beneficial
experimental protocols, this non-participation has little to do with the
regulations currently limiting experimentation on prisoners. In fact,
experimentation in prison, even in its public heyday between 1950 and 1970,
never incorporated very many targeted therapeutic studies, but rather used
prisoners to further the interests of others: drug companies, National Institutes
of Health researchers, or individual physician-researchers.
Barring radical changes to federal regulation of private drug companies
and DHHS regulatory authority, to prison conditions in general, and to
prisoners’ ability to exercise their basic legal rights, no other experimental
studies should be permitted in prisons. In particular, non-therapeutic studies
should be prohibited. One might imagine a world in which prisons faced
minimal overcrowding; prisoners had access to adequate healthcare and the
ability to exercise legal rights to hold researchers accountable; and independent
educational or governmental authorities thoroughly reviewed research
protocols. In such a world, medical experimentation on prisoners, based on a
risk-benefit analysis, might be a reasonable proposal. Until such conditions are
met, however, medical experimentation on prisoners should be subject to
extremely tight control—tighter than that which currently passes for adequate
oversight, and far tighter than that which the 2006 IOM Report recommends.

328.

45 C.F.R. § 46.306(a)(2)(iii), (iv).

REITER FINAL.DOC

2009]

4/30/2009 10:22:01 PM

EXPERIMENTATION ON PRISONERS

565

CONCLUSION
Each argument in favor of allowing prisoner participation in medical
experiments presupposes a base level of acceptable conditions in prison and
ethical motivations among researchers. A review of the kinds of prison
conditions currently documented in the United States, the history of medical
experimentation in and out of these prisons, and current standards for medical
testing in general suggests that the kinds of prison conditions and ethical
standards presupposed in the 2006 IOM Report simply do not exist in our
prisons or in biomedical research generally. A further comparison of the 1976
DHEW Report, which led to the standards currently in place, and the 2006
IOM Report, which suggests changes in these standards, starkly reveals the
shortcomings in the ethical arguments in favor of more flexible standards.
International human rights standards, the common law of consent, and domestic
legal standards for challenging prison conditions in the United States further
confirm the legal problems inherent in moving to a case-by-case, risk-benefit
analysis of proposed medical experiments in prisons. All guidelines call for
clear procedures for subject complaint, self-exemption, and compensation for
damages, but many U.S. prisoners are legally deprived of exercising such
rights. Therefore, there is no way for research on prisoners to satisfy the
standards established in the Nuremberg Code and developed since.
In sum, before any risk-benefit analysis is implemented, minimal human
rights standards must be met. The choice to participate or not to participate in a
human subjects research project should not be a new kind of “prisoner’s
dilemma.” In addition, in discussing risk-benefit analysis, “risk” and “benefit”
must be generated solely from the perspective of the prisoner. In other words,
any weighing of risks and benefits should look at risks to the prisoner and
benefits to the prisoner, not risks to the prison or researchers, and not benefits
to corporations or society as a whole. A document that purports to show the
way forward in prison-based research must address these standards.
Until such a document exists, however, the 2006 IOM Report provides a
basis for debate and conversation, as well as a roadmap for expanded oversight
that Congress should legislate and the OHRP should implement. Congress
should change the definition of “prisoner” in Title 45, so that the term
incorporates a range of vulnerable populations under the supervision of the
criminal justice system, from those on probation and parole to those housed
within drug-addiction treatment programs. Congress and the OHRP should
work together to create a national database documenting every experimental
protocol—public or private; federal, state, or local—involving prisoners. The
Title 45 regulations currently on the books should be rigorously enforced, and
the effectiveness of the enforcement should be evaluated by some independent
agency, such as the IOM. Prisoners who do participate in human subjects
research should be assured adequate and humane prison conditions as well as

REITER FINAL.DOC

566

4/30/2009 10:22:01 PM

CALIFORNIA LAW REVIEW

[Vol. 97:501

access to the courts. Once these many conditions are met, then Congress, the
OHRP, and the IOM can debate again and reevaluate the frameworks, whether
categorical or risk-benefit based, for allowing or disallowing prisoner
participation in medical research.