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Survivors Guide to Medical Research in Prison
When one thinks of all the “Survivor Guides” that could be written for prisoners, the last one that comes to mind is for participating as a trial subject in medical research experiments. Yet medicine is science. Scientific theories and developments must be tested to become valid, and the introduction of new drugs or treatments is part of this scientific process. Therefore, human “guinea pigs” are needed to determine the safety and effectiveness of new treatments. To be a subject in a research trial is an important responsibility – trial subjects participate in finding possible cures and therapies for themselves, their loved ones and the greater good of society.
However, history has shown that unscrupulous and unethical researchers have exploited prisoners and other vulnerable populations (such as children or the mentally ill). With a shortage of trial subjects outside the prison population, and a greater demand for vaccines, lifestyle drugs and profits, prisoners are attractive medical research subjects. They are readily available, inexpensive to use, and held in a highly controlled environment.
Therefore, included below are some concerns and recommendations that prisoners should take into account when participating in medical or experimental studies.
Informed Consent
The first thing that you as a research subject should understand is the concept of informed consent. Informed consent must be in writing and explain clearly the benefits and risks of the experiment. Do not sign an informed consent form if you do not understand it. Make the researchers explain any items that are unclear; ask them to clarify the risks and any side effects. If they refuse or make you feel like your questions are unwelcome, then walk away from the trial. An ethical researcher will ensure that a trial subject understands the risks and benefits of a research study. Only by understanding the risks can you weigh the benefits of treatment and determine if the compensation you receive is adequate.
If you want to participate but have difficulty reading or understanding the informed consent form, do not feel pressured. Seek help from a “jailhouse lawyer,” an outside volunteer chaplain, or another outside prison volunteer. It is best to speak with someone who is not employed by the Department of Corrections.
Understand Procedures
Ensure that procedures which require invasive techniques are documented and explained thoroughly. Invasive techniques include biopsies or giving blood samples. You can never be forced by a researcher to have invasive techniques performed; you must give your consent. Biopsies to organs such as the liver carry the risk of death from internal bleeding. Blood samples carry important information about you, from DNA to genetic details about your health. An ethical researcher will explain how your tissue or blood samples will be disposed of once the study is complete.
Understand who is responsible ?if you get sick
In the past, some researchers have used informed consent forms that make the test subject responsible for any long-term ill effects caused by the experiment. Never sign a consent form that makes you responsible for obtaining or paying for medical care if the experiment fails or causes adverse reactions or injuries. Many researchers are from major universities that have medical centers. You should verify that you will receive treatment for any problems caused by the experiment; if this is not stated on the informed consent form, request it in writing. An ethical researcher will agree to this request or revise the informed consent protocol for the trial study. Ethical researchers will be concerned about you as a person and any harm their research may cause.
Understand who the sponsor is
Understand who is sponsoring the trial. Ask if it is not stated on the forms that you are requested to read or sign. Is it a hospital, the government, a drug company, etc.? Some research trials such as the Holmesburg experiment in Pennsylvania, as documented in Allen Hornblum’s book Acres of Skin, involved financial conflicts of interest among the researchers and drug companies. When things went terribly wrong, many of the prisoners lost their class action lawsuit because they had difficulty finding a responsible party to sue within the statute of limitations period. In addition, knowing the sponsor will let you know who to contact for medical care if you are injured by the experiment.
Understand that experimentation and medical care are not always the same
Understand that a medical doctor as a researcher is a scientist. Henry Beecher, a noted research historian, stated in 1959 that a doctor is dedicated to his patient and a researcher to his protocol. In many correctional institutions, medical care is inadequate. Although you may volunteer believing you will receive better health care, the researcher is under no obligation to treat you for ailments that are not related to the trial study. Further, the treatment being tested may not necessarily be the cure for your medical problem – which is why you are testing it as a research subject.
Ask to be rewarded for success
If you have a disease and the research trial is successful, make sure you can be part of the subsequent therapeutic use of the drug. Many drugs and treatments that are proven successful and approved for use may never reach the trial subject for therapeutic purposes. Although the trial subject may have risked his or her life to help researchers, the cost of the therapy once on the market is often prohibitive to those who participated in the experimental studies.
In recent years, researchers conducted HIV drug trials in third world countries due to the vast number of HIV or AIDS infected research subjects. However, after the trials many researchers abandoned the subjects with no further treatment; they exploited them as test subjects to help commercialize a drug, while the subjects could not afford the drug treatment themselves. An ethical researcher or sponsor should assure that you will reap some benefits if the experiment is successful. Remember, the successful treatment would not have been possible without you and other research trial subjects.
Understand side effects … ?they can kill you
You should fully understand any side effects and seek medical attention if necessary. Many drugs are later taken off the market as a result of severe side effects, which may cause serious injuries. Therefore, notify the researcher immediately if you experience side effects; if they continue, demand that you receive medical treatment. An ethical researcher will not allow a trial subject to suffer because of the experiment or its side effects.
Understand the drug phase ?that is being tested
Drug trials are classified by different phases. Understand the phase of the drug trial and what the objective is according to that phase. If this information is not on the informed consent form, then ask the research team. You may believe you are in a trial because the treatment will be therapeutic for you. However, the researcher may only be testing the safety of different dosages of a drug. In general, the following are standard classifications for drug research trials:
Phase I – Small trials that assess safety, tolerability, and the action of the drug in the body and what it does to the body. This usually requires healthy volunteers, and this phase may have significant risks to the research subjects.
Phase II – Conducted on larger groups to test the safety, toxicity, effectiveness and dosing requirements. This phase is still research and not medical care. If the drug shows adverse results in these categories, it may be reformulated or dropped by the researcher or sponsor completely.
Phase III – Drug trials conducted on a larger population of test subjects. This helps to establish that the drug being tested does what the researchers claim. In many cases, this is the last trial before marketing approval. Drugs like Vioxx were still approved after this phase. This phase does not guarantee complete safety or a lack of adverse side effects.
Phase IV – This is usually known as the Post Marketing Surveillance Trial. The sponsor or regulatory agencies may require or request this phase. The sponsor may use this phase to determine a competitive advantage over another company’s drug. In this phase the drug already has been approved, but the study is looking for longer-term safety issues or side effects, or interactions with other drugs. If the drug is proven unsafe it is removed from the market (a recent example being Vioxx, an anti-inflammatory medication).
Who was the prisoner advocate that approved the trial?
When a research protocol is approved, a committee known as the Institutional Review Board (IRB) should have approved it. Unfortunately, the institution or sponsor that is conducting the study selects many of the IRB members. Sometimes IRB members are unfamiliar with the science behind the trial as well as the unique prison environment. Therefore, when conducting research trials in prison, federal regulations require that each IRB include at least one advocate for the prisoner trial subjects (Note: this may not apply to privately-funded research).
In some cases researchers have violated this provision. In approving prison medical experiments, it is unethical not to have a prisoner advocate on the IRB, or to choose someone who has a conflict of interest to serve on the IRB. For example, one institution received a warning letter stating that a prison guard who was an IRB member did not constitute a “prisoner advocate.”
No one who is paid by the Department of Corrections should be considered an IRB member who represents you as a research trial subject. Ask about the qualifications of the IRB member who represented the interests of prisoners when the research study was approved, and what makes them qualified to act as an IRB prisoner advocate.
Ensure your confidentiality ?and privacy
Make sure that the researcher has safeguards in place to maintain your medical privacy and confidentiality from others in or outside the institution. There have been cases in the past where prisoners’ files were marked by color-coding to indicate they were in an HIV/AIDS trial. Therefore, it was apparent to guards and other prisoners by looking at the color-coding of the files that those prisoners may have HIV or AIDS.
Additionally, your privacy can be invaded by your own actions. It is not unusual for a researcher to be on a set schedule. For example, if an HIV researcher arrives at the prison every Wednesday at 10.00 A.M. and you are taken from your cell to the medical unit every Wednesday at 10:00 A.M, it may become known that you are in a research study for HIV medications. Therefore, the prison environment itself may present problems in ensuring the privacy of trial subjects.
Summary
Both the prisoner trial subject and the researcher have stakes in the success of experimental drug studies. An ethical researcher will assure that subjects are treated well and fairly. Researchers should be willing to fully explain the informed consent form and make changes based on prisoners’ concerns or questions. Remember that medicine is a commercialized industry; the financial success of a new drug cannot happen without volunteer trial subjects. Therefore, understand the importance of your participation and the responsibility that you and the researcher share.
Greg Dober is a freelance writer in healthcare ethics. He obtained his Master of Arts in Bioethics and Health Policy from Loyola University of Chicago in Illinois. Currently, he is enrolled in the Doctorate of Health Care Ethics (DHCE) program at Duquesne University’s Center for Healthcare Ethics in Pittsburgh. He is a member of the American Society of Bioethics and Humanity (ASBH) and the American Academy for the Advancement of Science (AAAS), and authored PLN’s cover story on prison medical experiments in our March 2008 issue.
However, history has shown that unscrupulous and unethical researchers have exploited prisoners and other vulnerable populations (such as children or the mentally ill). With a shortage of trial subjects outside the prison population, and a greater demand for vaccines, lifestyle drugs and profits, prisoners are attractive medical research subjects. They are readily available, inexpensive to use, and held in a highly controlled environment.
Therefore, included below are some concerns and recommendations that prisoners should take into account when participating in medical or experimental studies.
Informed Consent
The first thing that you as a research subject should understand is the concept of informed consent. Informed consent must be in writing and explain clearly the benefits and risks of the experiment. Do not sign an informed consent form if you do not understand it. Make the researchers explain any items that are unclear; ask them to clarify the risks and any side effects. If they refuse or make you feel like your questions are unwelcome, then walk away from the trial. An ethical researcher will ensure that a trial subject understands the risks and benefits of a research study. Only by understanding the risks can you weigh the benefits of treatment and determine if the compensation you receive is adequate.
If you want to participate but have difficulty reading or understanding the informed consent form, do not feel pressured. Seek help from a “jailhouse lawyer,” an outside volunteer chaplain, or another outside prison volunteer. It is best to speak with someone who is not employed by the Department of Corrections.
Understand Procedures
Ensure that procedures which require invasive techniques are documented and explained thoroughly. Invasive techniques include biopsies or giving blood samples. You can never be forced by a researcher to have invasive techniques performed; you must give your consent. Biopsies to organs such as the liver carry the risk of death from internal bleeding. Blood samples carry important information about you, from DNA to genetic details about your health. An ethical researcher will explain how your tissue or blood samples will be disposed of once the study is complete.
Understand who is responsible ?if you get sick
In the past, some researchers have used informed consent forms that make the test subject responsible for any long-term ill effects caused by the experiment. Never sign a consent form that makes you responsible for obtaining or paying for medical care if the experiment fails or causes adverse reactions or injuries. Many researchers are from major universities that have medical centers. You should verify that you will receive treatment for any problems caused by the experiment; if this is not stated on the informed consent form, request it in writing. An ethical researcher will agree to this request or revise the informed consent protocol for the trial study. Ethical researchers will be concerned about you as a person and any harm their research may cause.
Understand who the sponsor is
Understand who is sponsoring the trial. Ask if it is not stated on the forms that you are requested to read or sign. Is it a hospital, the government, a drug company, etc.? Some research trials such as the Holmesburg experiment in Pennsylvania, as documented in Allen Hornblum’s book Acres of Skin, involved financial conflicts of interest among the researchers and drug companies. When things went terribly wrong, many of the prisoners lost their class action lawsuit because they had difficulty finding a responsible party to sue within the statute of limitations period. In addition, knowing the sponsor will let you know who to contact for medical care if you are injured by the experiment.
Understand that experimentation and medical care are not always the same
Understand that a medical doctor as a researcher is a scientist. Henry Beecher, a noted research historian, stated in 1959 that a doctor is dedicated to his patient and a researcher to his protocol. In many correctional institutions, medical care is inadequate. Although you may volunteer believing you will receive better health care, the researcher is under no obligation to treat you for ailments that are not related to the trial study. Further, the treatment being tested may not necessarily be the cure for your medical problem – which is why you are testing it as a research subject.
Ask to be rewarded for success
If you have a disease and the research trial is successful, make sure you can be part of the subsequent therapeutic use of the drug. Many drugs and treatments that are proven successful and approved for use may never reach the trial subject for therapeutic purposes. Although the trial subject may have risked his or her life to help researchers, the cost of the therapy once on the market is often prohibitive to those who participated in the experimental studies.
In recent years, researchers conducted HIV drug trials in third world countries due to the vast number of HIV or AIDS infected research subjects. However, after the trials many researchers abandoned the subjects with no further treatment; they exploited them as test subjects to help commercialize a drug, while the subjects could not afford the drug treatment themselves. An ethical researcher or sponsor should assure that you will reap some benefits if the experiment is successful. Remember, the successful treatment would not have been possible without you and other research trial subjects.
Understand side effects … ?they can kill you
You should fully understand any side effects and seek medical attention if necessary. Many drugs are later taken off the market as a result of severe side effects, which may cause serious injuries. Therefore, notify the researcher immediately if you experience side effects; if they continue, demand that you receive medical treatment. An ethical researcher will not allow a trial subject to suffer because of the experiment or its side effects.
Understand the drug phase ?that is being tested
Drug trials are classified by different phases. Understand the phase of the drug trial and what the objective is according to that phase. If this information is not on the informed consent form, then ask the research team. You may believe you are in a trial because the treatment will be therapeutic for you. However, the researcher may only be testing the safety of different dosages of a drug. In general, the following are standard classifications for drug research trials:
Phase I – Small trials that assess safety, tolerability, and the action of the drug in the body and what it does to the body. This usually requires healthy volunteers, and this phase may have significant risks to the research subjects.
Phase II – Conducted on larger groups to test the safety, toxicity, effectiveness and dosing requirements. This phase is still research and not medical care. If the drug shows adverse results in these categories, it may be reformulated or dropped by the researcher or sponsor completely.
Phase III – Drug trials conducted on a larger population of test subjects. This helps to establish that the drug being tested does what the researchers claim. In many cases, this is the last trial before marketing approval. Drugs like Vioxx were still approved after this phase. This phase does not guarantee complete safety or a lack of adverse side effects.
Phase IV – This is usually known as the Post Marketing Surveillance Trial. The sponsor or regulatory agencies may require or request this phase. The sponsor may use this phase to determine a competitive advantage over another company’s drug. In this phase the drug already has been approved, but the study is looking for longer-term safety issues or side effects, or interactions with other drugs. If the drug is proven unsafe it is removed from the market (a recent example being Vioxx, an anti-inflammatory medication).
Who was the prisoner advocate that approved the trial?
When a research protocol is approved, a committee known as the Institutional Review Board (IRB) should have approved it. Unfortunately, the institution or sponsor that is conducting the study selects many of the IRB members. Sometimes IRB members are unfamiliar with the science behind the trial as well as the unique prison environment. Therefore, when conducting research trials in prison, federal regulations require that each IRB include at least one advocate for the prisoner trial subjects (Note: this may not apply to privately-funded research).
In some cases researchers have violated this provision. In approving prison medical experiments, it is unethical not to have a prisoner advocate on the IRB, or to choose someone who has a conflict of interest to serve on the IRB. For example, one institution received a warning letter stating that a prison guard who was an IRB member did not constitute a “prisoner advocate.”
No one who is paid by the Department of Corrections should be considered an IRB member who represents you as a research trial subject. Ask about the qualifications of the IRB member who represented the interests of prisoners when the research study was approved, and what makes them qualified to act as an IRB prisoner advocate.
Ensure your confidentiality ?and privacy
Make sure that the researcher has safeguards in place to maintain your medical privacy and confidentiality from others in or outside the institution. There have been cases in the past where prisoners’ files were marked by color-coding to indicate they were in an HIV/AIDS trial. Therefore, it was apparent to guards and other prisoners by looking at the color-coding of the files that those prisoners may have HIV or AIDS.
Additionally, your privacy can be invaded by your own actions. It is not unusual for a researcher to be on a set schedule. For example, if an HIV researcher arrives at the prison every Wednesday at 10.00 A.M. and you are taken from your cell to the medical unit every Wednesday at 10:00 A.M, it may become known that you are in a research study for HIV medications. Therefore, the prison environment itself may present problems in ensuring the privacy of trial subjects.
Summary
Both the prisoner trial subject and the researcher have stakes in the success of experimental drug studies. An ethical researcher will assure that subjects are treated well and fairly. Researchers should be willing to fully explain the informed consent form and make changes based on prisoners’ concerns or questions. Remember that medicine is a commercialized industry; the financial success of a new drug cannot happen without volunteer trial subjects. Therefore, understand the importance of your participation and the responsibility that you and the researcher share.
Greg Dober is a freelance writer in healthcare ethics. He obtained his Master of Arts in Bioethics and Health Policy from Loyola University of Chicago in Illinois. Currently, he is enrolled in the Doctorate of Health Care Ethics (DHCE) program at Duquesne University’s Center for Healthcare Ethics in Pittsburgh. He is a member of the American Society of Bioethics and Humanity (ASBH) and the American Academy for the Advancement of Science (AAAS), and authored PLN’s cover story on prison medical experiments in our March 2008 issue.
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