Department of Justice

§ 46.101
46.123 Early termination of research support: Evaluation of applications and proposals.
46.124 Conditions.

(2) Limited personal telephone/fax
calls to locations within the office’s
commuting area, or that are charged to
non-Government accounts.
(b) The foregoing authorization does
not override any statutes, rules, or regulations governing the use of specific
types of Government property (e.g. internal Departmental policies governing
the use of electronic mail; and 41 CFR
(FPMR) 101–35.201, governing the authorized use of long-distance telephone
services), and may be revoked or limited at any time by any supervisor or
component for any business reason.
(c) In using Government property,
employees should be mindful of their
responsibility to protect and conserve
such property and to use official time
in an honest effort to perform official
duties. See 5 CFR 2635.101(b)(9),
2635.704(a), 2635.705(a).

AUTHORITY: 5 U.S.C. 301; 28 U.S.C. 509–510;
42 U.S.C. 300v–1(b).
SOURCE: 56 FR 28012, 28020, June 18, 1991,
unless otherwise noted.

§ 46.101 To
apply?

what

does

this

policy

(a) Except as provided in paragraph
(b) of this section, this 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.
This includes research conducted by
federal civilian employees or military
personnel, except that each department
or agency head may adopt such procedural modifications as may be appropriate from an administrative standpoint. It also includes research conducted, supported, or otherwise subject
to regulation by the federal government outside the United States.
(1) Research that is conducted or supported by a federal department or
agency, whether or not it is regulated
as defined in § 46.102(e), must comply
with all sections of this policy.
(2) Research that is neither conducted nor supported by a federal department or agency but is subject to
regulation as defined in § 46.102(e) must
be reviewed and approved, in compliance with § 46.101, § 46.102, and § 46.107
through § 46.117 of this policy, by an institutional review board (IRB) that operates in accordance with the pertinent
requirements of this policy.
(b) Unless otherwise required by department or agency heads, research activities in which the only involvement
of human subjects will be in one or
more of the following categories are
exempt from this policy:
(1) Research conducted in established
or commonly accepted educational settings, involving normal educational
practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the
effectiveness of or the comparison

[62 FR 23943, May 2, 1997]

PART 46—PROTECTION OF HUMAN
SUBJECTS
Sec.
46.101 To what does this policy apply?
46.102 Definitions.
46.103 Assuring compliance with this policy—research conducted or supported by
any Federal Department or Agency.
46.104–46.106 [Reserved]
46.107 IRB Membership.
46.108 IRB functions and operations.
46.109 IRB review of research.
46.110 Expedited review procedures for certain kinds of research involving no more
than minimal risk, and for minor
changes in approved research.
46.111 Criteria for IRB approval of research.
46.112 Review by institution.
46.113 Suspension or termination of IRB approval of research.
46.114 Cooperative research.
46.115 IRB records.
46.116 General requirements for informed
consent.
46.117 Documentation of informed consent.
46.118 Applications and proposals lacking
definite plans for involvement of human
subjects.
46.119 Research undertaken without the intention of involving human subjects.
46.120 Evaluation and disposition of applications and proposals for research to be
conducted or supported by a Federal Department or Agency.
46.121 [Reserved]
46.122 Use of Federal funds.

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§ 46.101

28 CFR Ch. I (7–1–01 Edition)

among instructional techniques, curricula, or classroom management
methods.
(2) Research involving the use of educational tests (cognitive, diagnostic,
aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
(i) Information obtained is recorded
in such a manner that human subjects
can be identified, directly or through
identifiers linked to the subjects; and
(ii) Any disclosure of the human subjects’ responses outside the research
could reasonably place the subjects at
risk of criminal or civil liability or be
damaging to the subjects’ financial
standing, employability, or reputation.
(3) Research involving the use of educational tests (cognitive, diagnostic,
aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not
exempt under paragraph (b)(2) of this
section, if:
(i) The human subjects are elected or
appointed public officials or candidates
for public office; or
(ii) Federal statute(s) require(s) without exception that the confidentiality
of the personally identifiable information will be maintained throughout the
research and thereafter.
(4) Research, involving the collection
or study of existing data, documents,
records, pathological specimens, or diagnostic specimens, if these sources are
publicly available or if the information
is recorded by the investigator in such
a manner that subjects cannot be identified, directly or through identifiers
linked to the subjects.
(5) Research and demonstration
projects which are conducted by or subject to the approval of department or
agency heads, and which are designed
to study, evaluate, or otherwise examine:
(i) Public benefit or service programs;
(ii) Procedures for obtaining benefits
or services under those programs;
(iii) Possible changes in or alternatives to those programs or procedures; or
(iv) Possible changes in methods or
levels of payment for benefits or services under those programs.

(6) Taste and food quality evaluation
and consumer acceptance studies,
(i) If wholesome foods without additives are consumed or
(ii) If a food is consumed that contains a food ingredient at or below the
level and for a use found to be safe, or
agricultural chemical or environmental contaminant at or below the
level found to be safe, by the Food and
Drug Administration or approved by
the Environmental Protection Agency
or the Food Safety and Inspection
Service of the U.S. Department of Agriculture.
(c) Department or agency heads retain final judgment as to whether a
particular activity is covered by this
policy.
(d) Department or agency heads may
require that specific research activities
or classes of research activities conducted, supported, or otherwise subject
to regulation by the department or
agency but not otherwise covered by
this policy, comply with some or all of
the requirements of this policy.
(e) Compliance with this policy requires compliance with pertinent federal laws or regulations which provide
additional protections for human subjects.
(f) This policy does not affect any
state or local laws or regulations which
may otherwise be applicable and which
provide additional protections for
human subjects.
(g) This policy does not affect any
foreign laws or regulations which may
otherwise be applicable and which provide additional protections to human
subjects of research.
(h) When research covered by this
policy takes place in foreign countries,
procedures normally followed in the
foreign countries to protect human
subjects may differ from those set
forth in this policy. (An example is a
foreign institution which complies
with guidelines consistent with the
World Medical Assembly Declaration
(Declaration of Helsinki amended 1989)
issued either by sovereign states or by
an organization whose function for the
protection of human research subjects
is internationally recognized.) In these
circumstances, if a department or

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Department of Justice

§ 46.102
(b) Institution means any public or
private entity or agency (including federal, state, and other agencies).
(c) Legally authorized representative
means an individual or judicial or
other body authorized under applicable
law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the
research.
(d) Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which
meet this definition constitute research for purposes of this policy,
whether or not they are conducted or
supported under a program which is
considered research for other purposes.
For example, some demonstration and
service programs may include research
activities.
(e) Research subject to regulation, and
similar terms are intended to encompass those research activities for which
a federal department or agency has
specific responsibility for regulating as
a research activity, (for example, Investigational New Drug requirements
administered by the Food and Drug Administration). It does not include research activities which are incidentally regulated by a federal department
or agency solely as part of the department’s or agency’s broader responsibility to regulate certain types of activities whether research or non-research in nature (for example, Wage
and Hour requirements administered
by the Department of Labor).
(f) Human subject means a living individual about whom an investigator
(whether professional or student) conducting research obtains
(1) Data through intervention or
interaction with the individual, or
(2) Identifiable private information.
Intervention includes both physical procedures by which data are gathered (for
example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes. Interaction includes
communication or interpersonal contact between investigator and subject.
Private information includes information about behavior that occurs in a

agency head determines that the procedures prescribed by the institution afford protections that are at least
equivalent to those provided in this
policy, the department or agency head
may approve the substitution of the
foreign procedures in lieu of the procedural requirements provided in this
policy. Except when otherwise required
by statute, Executive Order, or the department or agency head, notices of
these actions as they occur will be published in the FEDERAL REGISTER or will
be otherwise published as provided in
department or agency procedures.
(i) Unless otherwise required by law,
department or agency heads may waive
the applicability of some or all of the
provisions of this policy to specific research activities or classes of research
activities otherwise covered by this
policy. Except when otherwise required
by statute or Executive Order, the department or agency head shall forward
advance notices of these actions to the
Office for Protection from Research
Risks, Department of Health and
Human Services (HHS), and shall also
publish them in the FEDERAL REGISTER
or in such other manner as provided in
department or agency procedures.1
[56 FR 28012 and 28020, June 18, 1991; 56 FR
29756, June 28, 1991]

§ 46.102

Definitions.

(a) Department or agency head means
the head of any federal department or
agency and any other officer or employee of any department or agency to
whom authority has been delegated.
1 Institutions
with HHS-approved assurances on file will abide by provisions of title
45 CFR part 46 subparts A–D. Some of the
other Departments and Agencies have incorporated all provisions of title 45 CFR part 46
into their policies and procedures as well.
However, the exemptions at 45 CFR 46.101(b)
do not apply to research involving prisoners,
fetuses, pregnant women, or human in vitro
fertilization, subparts B and C. The exemption at 45 CFR 46.101(b)(2), for research involving survey or interview procedures or observation of public behavior, does not apply
to research with children, subpart D, except
for research involving observations of public
behavior when the investigator(s) do not participate in the activities being observed.

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§ 46.103

28 CFR Ch. I (7–1–01 Edition)

context in which an individual can reasonably expect that no observation or
recording is taking place, and information which has been provided for specific purposes by an individual and
which the individual can reasonably
expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is
or may readily be ascertained by the
investigator or associated with the information) in order for obtaining the
information to constitute research involving human subjects.
(g) IRB means an institutional review
board established in accord with and
for the purposes expressed in this policy.
(h) IRB approval means the determination of the IRB that the research
has been reviewed and may be conducted at an institution within the
constraints set forth by the IRB and by
other institutional and federal requirements.
(i) Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are
not greater in and of themselves than
those ordinarily encountered in daily
life or during the performance of routine physical or psychological examinations or tests.
(j) Certification means the official notification by the institution to the supporting department or agency, in accordance with the requirements of this
policy, that a research project or activity involving human subjects has been
reviewed and approved by an IRB in accordance with an approved assurance.

in question, on file with the Office for
Protection from Research Risks, HHS,
and approved for federalwide use by
that office. When the existence of an
HHS-approved assurance is accepted in
lieu of requiring submission of an assurance, reports (except certification)
required by this policy to be made to
department and agency heads shall
also be made to the Office for Protection from Research Risks, HHS.
(b) Departments and agencies will
conduct or support research covered by
this policy only if the institution has
an assurance approved as provided in
this section, and only if the institution
has certified to the department or
agency head that the research has been
reviewed and approved by an IRB provided for in the assurance, and will be
subject to continuing review by the
IRB. Assurances applicable to federally
supported or conducted research shall
at a minimum include:
(1) A statement of principles governing the institution in the discharge
of its responsibilities for protecting the
rights and welfare of human subjects of
research conducted at or sponsored by
the institution, regardless of whether
the research is subject to federal regulation. This may include an appropriate existing code, declaration, or
statement of ethical principles, or a
statement formulated by the institution itself. This requirement does not
preempt provisions of this policy applicable to department- or agency-supported or regulated research and need
not be applicable to any research exempted or waived under § 46.101 (b) or
(i).
(2) Designation of one or more IRBs
established in accordance with the requirements of this policy, and for
which provisions are made for meeting
space and sufficient staff to support
the IRB’s review and recordkeeping duties.
(3) A list of IRB members identified
by name; earned degrees; representative capacity; indications of experience
such as board certifications, licenses,
etc., sufficient to describe each member’s chief anticipated contributions to
IRB deliberations; and any employment or other relationship between
each member and the institution; for
example: full-time employee, part-time

§ 46.103 Assuring compliance with this
policy—research conducted or supported by any Federal Department
or Agency.
(a) Each institution engaged in research which is covered by this policy
and which is conducted or supported by
a federal department or agency shall
provide written assurance satisfactory
to the department or agency head that
it will comply with the requirements
set forth in this policy. In lieu of requiring submission of an assurance, individual department or agency heads
shall accept the existence of a current
assurance, appropriate for the research

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Department of Justice

§ 46.107

employee, member of governing panel
or board, stockholder, paid or unpaid
consultant. Changes in IRB membership shall be reported to the department or agency head, unless in accord
with § 46.103(a) of this policy, the existence of an HHS-approved assurance is
accepted. In this case, change in IRB
membership shall be reported to the
Office for Protection from Research
Risks, HHS.
(4) Written procedures which the IRB
will follow (i) for conducting its initial
and continuing review of research and
for reporting its findings and actions to
the investigator and the institution;
(ii) for determining which projects require review more often than annually
and which projects need verification
from sources other than the investigators that no material changes have occurred since previous IRB review; and
(iii) for ensuring prompt reporting to
the IRB of proposed changes in a research activity, and for ensuring that
such changes in approved research,
during the period for which IRB approval has already been given, may not
be initiated without IRB review and
approval except when necessary to
eliminate apparent immediate hazards
to the subject.
(5) Written procedures for ensuring
prompt reporting to the IRB, appropriate institutional officials, and the
department or agency head of (i) any
unanticipated problems involving risks
to subjects or others or any serious or
continuing noncompliance with this
policy or the requirements or determinations of the IRB and (ii) any suspension or termination of IRB approval.
(c) The assurance shall be executed
by an individual authorized to act for
the institution and to assume on behalf
of the institution the obligations imposed by this policy and shall be filed
in such form and manner as the department or agency head prescribes.
(d) The department or agency head
will evaluate all assurances submitted
in accordance with this policy through
such officers and employees of the department or agency and such experts
or consultants engaged for this purpose
as the department or agency head determines to be appropriate. The department or agency head’s evaluation will

take into consideration the adequacy
of the proposed IRB in light of the anticipated scope of the institution’s research activities and the types of subject populations likely to be involved,
the appropriateness of the proposed initial and continuing review procedures
in light of the probable risks, and the
size and complexity of the institution.
(e) On the basis of this evaluation,
the department or agency head may
approve or disapprove the assurance, or
enter into negotiations to develop an
approvable one. The department or
agency head may limit the period during which any particular approved assurance or class of approved assurances
shall remain effective or otherwise
condition or restrict approval.
(f) Certification is required when the
research is supported by a federal department or agency and not otherwise
exempted or waived under § 46.101 (b) or
(i). An institution with an approved assurance shall certify that each application or proposal for research covered
by the assurance and by § 46.103 of this
Policy has been reviewed and approved
by the IRB. Such certification must be
submitted with the application or proposal or by such later date as may be
prescribed by the department or agency to which the application or proposal
is submitted. Under no condition shall
research covered by § 46.103 of the Policy be supported prior to receipt of the
certification that the research has been
reviewed and approved by the IRB. Institutions without an approved assurance covering the research shall certify
within 30 days after receipt of a request
for such a certification from the department or agency, that the application or proposal has been approved by
the IRB. If the certification is not submitted within these time limits, the
application or proposal may be returned to the institution.
(Approved by the Office of Management and
Budget under control number 9999–0020)
[56 FR 28012 and 28020, June 18, 1991; 56 FR
29756, June 28, 1991]

§§ 46.104–46.106

[Reserved]

§ 46.107 IRB membership.
(a) Each IRB shall have at least five
members, with varying backgrounds to
promote complete and adequate review

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§ 46.108

28 CFR Ch. I (7–1–01 Edition)

of research activities commonly conducted by the institution. The IRB
shall be sufficiently qualified through
the experience and expertise of its
members, and the diversity of the
members, including consideration of
race, gender, and cultural backgrounds
and sensitivity to such issues as community attitudes, to promote respect
for its advice and counsel in safeguarding the rights and welfare of
human subjects. In addition to possessing the professional competence
necessary to review specific research
activities, the IRB shall be able to ascertain the acceptability of proposed
research in terms of institutional commitments and regulations, applicable
law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in
these areas. If an IRB regularly reviews
research that involves a vulnerable
category of subjects, such as children,
prisoners, pregnant women, or handicapped or mentally disabled persons,
consideration shall be given to the inclusion of one or more individuals who
are knowledgeable about and experienced in working with these subjects.
(b) Every nondiscriminatory effort
will be made to ensure that no IRB
consists entirely of men or entirely of
women, including the institution’s consideration of qualified persons of both
sexes, so long as no selection is made
to the IRB on the basis of gender. No
IRB may consist entirely of members
of one profession.
(c) Each IRB shall include at least
one member whose primary concerns
are in scientific areas and at least one
member whose primary concerns are in
nonscientific areas.
(d) Each IRB shall include at least
one member who is not otherwise affiliated with the institution and who is
not part of the immediate family of a
person who is affiliated with the institution.
(e) No IRB may have a member participate in the IRB’s initial or continuing review of any project in which
the member has a conflicting interest,
except to provide information requested by the IRB.
(f) An IRB may, in its discretion, invite individuals with competence in
special areas to assist in the review of

issues which require expertise beyond
or in addition to that available on the
IRB. These individuals may not vote
with the IRB.
§ 46.108

IRB functions and operations.

In order to fulfill the requirements of
this policy each IRB shall:
(a) Follow written procedures in the
same detail as described in § 46.103(b)(4)
and, to the extent required by,
§ 46.103(b)(5).
(b) Except when an expedited review
procedure is used (see § 46.110), review
proposed research at convened meetings at which a majority of the members of the IRB are present, including
at least one member whose primary
concerns are in nonscientific areas. In
order for the research to be approved,
it shall receive the approval of a majority of those members present at the
meeting.
§ 46.109

IRB review of research.

(a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered
by this policy.
(b) An IRB shall require that information given to subjects as part of informed consent is in accordance with
§ 46.116. The IRB may require that information, in addition to that specifically mentioned in § 46.116, be given to
the subjects when in the IRB’s judgment the information would meaningfully add to the protection of the rights
and welfare of subjects.
(c) An IRB shall require documentation of informed consent or may waive
documentation in accordance with
§ 46.117.
(d) An IRB shall notify investigators
and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval
of the research activity. If the IRB decides to disapprove a research activity,
it shall include in its written notification a statement of the reasons for its
decision and give the investigator an
opportunity to respond in person or in
writing.

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Department of Justice

§ 46.111
(d) The department or agency head
may restrict, suspend, terminate, or
choose not to authorize an institution’s or IRB’s use of the expedited review procedure.

(e) An IRB shall conduct continuing
review of research covered by this policy at intervals appropriate to the degree of risk, but not less than once per
year, and shall have authority to observe or have a third party observe the
consent process and the research.

§ 46.111 Criteria for IRB approval of
research.
(a) In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied:
(1) Risks to subjects are minimized:
(i) By using procedures which are consistent with sound research design and
which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already
being performed on the subjects for diagnostic or treatment purposes.
(2) Risks to subjects are reasonable
in relation to anticipated benefits, if
any, to subjects, and the importance of
the knowledge that may reasonably be
expected to result. In evaluating risks
and benefits, the IRB should consider
only those risks and benefits that may
result from the research (as distinguished from risks and benefits of
therapies subjects would receive even if
not participating in the research). The
IRB should not consider possible longrange effects of applying knowledge
gained in the research (for example,
the possible effects of the research on
public policy) as among those research
risks that fall within the purview of its
responsibility.
(3) Selection of subjects is equitable.
In making this assessment the IRB
should take into account the purposes
of the research and the setting in
which the research will be conducted
and should be particularly cognizant of
the special problems of research involving vulnerable populations, such as
children, prisoners, pregnant women,
mentally disabled persons, or economically or educationally disadvantaged
persons.
(4) Informed consent will be sought
from each prospective subject or the
subject’s legally authorized representative, in accordance with, and to the extent required by § 46.116.
(5) Informed consent will be appropriately documented, in accordance
with, and to the extent required by
§ 46.117.

(Approved by the Office of Management and
Budget under control number 9999–0020)

§ 46.110 Expedited review procedures
for certain kinds of research involving no more than minimal risk, and
for minor changes in approved research.
(a) The Secretary, HHS, has established, and published as a Notice in the
FEDERAL REGISTER, a list of categories
of research that may be reviewed by
the IRB through an expedited review
procedure. The list will be amended, as
appropriate after consultation with
other
departments
and
agencies,
through periodic republication by the
Secretary, HHS, in the FEDERAL REGISTER. A copy of the list is available
from the Office for Protection from Research Risks, National Institutes of
Health, HHS, Bethesda, Maryland
20892.
(b) An IRB may use the expedited review procedure to review either or both
of the following:
(1) Some or all of the research appearing on the list and found by the reviewer(s) to involve no more than minimal risk,
(2) Minor changes in previously approved research during the period (of
one year or less) for which approval is
authorized.
Under an expedited review procedure,
the review may be carried out by the
IRB chairperson or by one or more experienced reviewers designated by the
chairperson from among members of
the IRB. In reviewing the research, the
reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the non-expedited procedure
set forth in § 46.108(b).
(c) Each IRB which uses an expedited
review procedure shall adopt a method
for keeping all members advised of research proposals which have been approved under the procedure.

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§ 46.112

28 CFR Ch. I (7–1–01 Edition)

(6) When appropriate, the research
plan makes adequate provision for
monitoring the data collected to ensure the safety of subjects.
(7) When appropriate, there are adequate provisions to protect the privacy
of subjects and to maintain the confidentiality of data.
(b) When some or all of the subjects
are likely to be vulnerable to coercion
or undue influence, such as children,
prisoners, pregnant women, mentally
disabled persons, or economically or
educationally disadvantaged persons,
additional safeguards have been included in the study to protect the
rights and welfare of these subjects.
§ 46.112

make similar arrangements for avoiding duplication of effort.
§ 46.115

Review by institution.

Research covered by this policy that
has been approved by an IRB may be
subject to further appropriate review
and approval or disapproval by officials
of the institution. However, those officials may not approve the research if it
has not been approved by an IRB.
§ 46.113 Suspension or termination of
IRB approval of research.
An IRB shall have authority to suspend or terminate approval of research
that is not being conducted in accordance with the IRB’s requirements or
that has been associated with unexpected serious harm to subjects. Any
suspension or termination of approval
shall include a statement of the reasons for the IRB’s action and shall be
reported promptly to the investigator,
appropriate institutional officials, and
the department or agency head.
(Approved by the Office of Management and
Budget under control number 9999–0020)

§ 46.114

IRB records.

(a) An institution, or when appropriate an IRB, shall prepare and maintain adequate documentation of IRB
activities, including the following:
(1) Copies of all research proposals reviewed, scientific evaluations, if any,
that accompany the proposals, approved sample consent documents,
progress reports submitted by investigators, and reports of injuries to subjects.
(2) Minutes of IRB meetings which
shall be in sufficient detail to show attendance at the meetings; actions
taken by the IRB; the vote on these actions including the number of members
voting for, against, and abstaining; the
basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted
issues and their resolution.
(3) Records of continuing review activities.
(4) Copies of all correspondence between the IRB and the investigators.
(5) A list of IRB members in the same
detail as described is § 46.103(b)(3).
(6) Written procedures for the IRB in
the same detail as described in
§ 46.103(b)(4) and § 46.103(b)(5).
(7) Statements of significant new
findings provided to subjects, as required by § 46.116(b)(5).
(b) The records required by this policy shall be retained for at least 3
years, and records relating to research
which is conducted shall be retained
for at least 3 years after completion of
the research. All records shall be accessible for inspection and copying by authorized representatives of the department or agency at reasonable times
and in a reasonable manner.

Cooperative research.

Cooperative research projects are
those projects covered by this policy
which involve more than one institution. In the conduct of cooperative research projects, each institution is responsible for safeguarding the rights
and welfare of human subjects and for
complying with this policy. With the
approval of the department or agency
head, an institution participating in a
cooperative project may enter into a
joint review arrangement, rely upon
the review of another qualified IRB, or

(Approved by the Office of Management and
Budget under control number 9999–0020)

§ 46.116 General requirements for informed consent.
Except as provided elsewhere in this
policy, no investigator may involve a
human being as a subject in research
covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or

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Department of Justice

§ 46.116

the subject’s legally authorized representative. An investigator shall seek
such consent only under circumstances
that provide the prospective subject or
the representative sufficient opportunity to consider whether or not to
participate and that minimize the possibility of coercion or undue influence.
The information that is given to the
subject or the representative shall be
in language understandable to the subject or the representative. No informed
consent, whether oral or written, may
include any exculpatory language
through which the subject or the representative is made to waive or appear
to waive any of the subject’s legal
rights, or releases or appears to release
the investigator, the sponsor, the institution or its agents from liability for
negligence.
(a) Basic elements of informed consent. Except as provided in paragraph
(c) or (d) of this section, in seeking informed consent the following information shall be provided to each subject:
(1) A statement that the study involves research, an explanation of the
purposes of the research and the expected duration of the subject’s participation, a description of the procedures
to be followed, and identification of
any procedures which are experimental;
(2) A description of any reasonably
foreseeable risks or discomforts to the
subject;
(3) A description of any benefits to
the subject or to others which may reasonably be expected from the research;
(4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
(5) A statement describing the extent, if any, to which confidentiality of
records identifying the subject will be
maintained;
(6) For research involving more than
minimal risk, an explanation as to
whether any compensation and an explanation as to whether any medical
treatments are available if injury occurs and, if so, what they consist of, or
where further information may be obtained;
(7) An explanation of whom to contact for answers to pertinent questions
about the research and research sub-

jects’ rights, and whom to contact in
the event of a research-related injury
to the subject; and
(8) A statement that participation is
voluntary, refusal to participate will
involve no penalty or loss of benefits to
which the subject is otherwise entitled,
and the subject may discontinue participation at any time without penalty
or loss of benefits to which the subject
is otherwise entitled.
(b) Additional elements of informed
consent. When appropriate, one or
more of the following elements of information shall also be provided to
each subject:
(1) A statement that the particular
treatment or procedure may involve
risks to the subject (or to the embryo
or fetus, if the subject is or may become pregnant) which are currently
unforeseeable;
(2) Anticipated circumstances under
which the subject’s participation may
be terminated by the investigator
without regard to the subject’s consent;
(3) Any additional costs to the subject that may result from participation
in the research;
(4) The consequences of a subject’s
decision to withdraw from the research
and procedures for orderly termination
of participation by the subject;
(5) A statement that significant new
findings developed during the course of
the research which may relate to the
subject’s willingness to continue participation will be provided to the subject; and
(6) The approximate number of subjects involved in the study.
(c) An IRB may approve a consent
procedure which does not include, or
which alters, some or all of the elements of informed consent set forth
above, or waive the requirement to obtain informed consent provided the IRB
finds and documents that:
(1) The research or demonstration
project is to be conducted by or subject
to the approval of state or local government officials and is designed to
study, evaluate, or otherwise examine:
(i) Public benefit of service programs;
(ii) Procedures for obtaining benefits
or services under those programs;

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§ 46.117

28 CFR Ch. I (7–1–01 Edition)
consent required by § 46.116. This form
may be read to the subject or the subject’s legally authorized representative, but in any event, the investigator
shall give either the subject or the representative adequate opportunity to
read it before it is signed; or
(2) A short form written consent document stating that the elements of informed consent required by § 46.116
have been presented orally to the subject or the subject’s legally authorized
representative. When this method is
used, there shall be a witness to the
oral presentation. Also, the IRB shall
approve a written summary of what is
to be said to the subject or the representative. Only the short form itself
is to be signed by the subject or the
representative. However, the witness
shall sign both the short form and a
copy of the summary, and the person
actually obtaining consent shall sign a
copy of the summary. A copy of the
summary shall be given to the subject
or the representative, in addition to a
copy of the short form.
(c) An IRB may waive the requirement for the investigator to obtain a
signed consent form for some or all
subjects if it finds either:
(1) That the only record linking the
subject and the research would be the
consent document and the principal
risk would be potential harm resulting
from a breach of confidentiality. Each
subject will be asked whether the subject wants documentation linking the
subject with the research, and the subject’s wishes will govern; or
(2) That the research presents no
more than minimal risk of harm to
subjects and involves no procedures for
which written consent is normally required outside of the research context.
In cases in which the documentation
requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.

(iii) Possible changes in or alternatives to those programs or procedures; or
(iv) Possible changes in methods or
levels of payment for benefits or services under those programs; and
(2) The research could not practicably be carried out without the
waiver or alteration.
(d) An IRB may approve a consent
procedure which does not include, or
which alters, some or all of the elements of informed consent set forth in
this section, or waive the requirements
to obtain informed consent provided
the IRB finds and documents that:
(1) The research involves no more
than minimal risk to the subjects;
(2) The waiver or alteration will not
adversely affect the rights and welfare
of the subjects;
(3) The research could not practicably be carried out without the
waiver or alteration; and
(4) Whenever appropriate, the subjects will be provided with additional
pertinent information after participation.
(e) The informed consent requirements in this policy are not intended
to preempt any applicable federal,
state, or local laws which require additional information to be disclosed in
order for informed consent to be legally effective.
(f) Nothing in this policy is intended
to limit the authority of a physician to
provide emergency medical care, to the
extent the physician is permitted to do
so under applicable federal, state, or
local law.
(Approved by the Office of Management and
Budget under control number 9999–0020)

§ 46.117 Documentation of informed
consent.
(a) Except as provided in paragraph
(c) of this section, informed consent
shall be documented by the use of a
written consent form approved by the
IRB and signed by the subject or the
subject’s legally authorized representative. A copy shall be given to the person signing the form.
(b) Except as provided in paragraph
(c) of this section, the consent form
may be either of the following:
(1) A written consent document that
embodies the elements of informed

(Approved by the Office of Management and
Budget under control number 9999–0020)

§ 46.118 Applications and proposals
lacking definite plans for involvement of human subjects.
Certain types of applications for
grants, cooperative agreements, or contracts are submitted to departments or

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Department of Justice

§ 46.124

agencies with the knowledge that subjects may be involved within the period
of support, but definite plans would not
normally be set forth in the application or proposal. These include activities such as institutional type grants
when selection of specific projects is
the institution’s responsibility; research training grants in which the activities involving subjects remain to be
selected; and projects in which human
subjects’ involvement will depend upon
completion of instruments, prior animal studies, or purification of compounds. These applications need not be
reviewed by an IRB before an award
may be made. However, except for research exempted or waived under
§ 46.101 (b) or (i), no human subjects
may be involved in any project supported by these awards until the
project has been reviewed and approved
by the IRB, as provided in this policy,
and certification submitted, by the institution, to the department or agency.

others, and the importance of the
knowledge gained or to be gained.
(b) On the basis of this evaluation,
the department or agency head may
approve or disapprove the application
or proposal, or enter into negotiations
to develop an approvable one.
[56 FR 28012, 28020, June 18, 1991, as amended
at 61 FR 33658, June 28, 1996]

§ 46.121

[Reserved]

§ 46.122

Use of Federal funds.

Federal funds administered by a department or agency may not be expended for research involving human
subjects unless the requirements of
this policy have been satisfied.
§ 46.123 Early termination of research
support: Evaluation of applications
and proposals.
(a) The department or agency head
may require that department or agency
support for any project be terminated
or suspended in the manner prescribed
in applicable program requirements,
when the department or agency head
finds an institution has materially
failed to comply with the terms of this
policy.
(b) In making decisions about supporting or approving applications or
proposals covered by this policy the department or agency head may take
into account, in addition to all other
eligibility requirements and program
criteria, factors such as whether the
applicant has been subject to a termination or suspension under paragraph
(a) of this section and whether the applicant or the person or persons who
would direct or has have directed the
scientific and technical aspects of an
activity has have, in the judgment of
the department or agency head, materially failed to discharge responsibility
for the protection of the rights and
welfare of human subjects (whether or
not the research was subject to federal
regulation).

§ 46.119 Research undertaken without
the intention of involving human
subjects.
In the event research is undertaken
without the intention of involving
human subjects, but it is later proposed to involve human subjects in the
research, the research shall first be reviewed and approved by an IRB, as provided in this policy, a certification submitted, by the institution, to the department or agency, and final approval
given to the proposed change by the department or agency.
§ 46.120 Evaluation and disposition of
applications and proposals for research to be conducted or supported by a Federal Department or
Agency.
(a) The department or agency head
will evaluate all applications and proposals involving human subjects submitted to the department or agency
through such officers and employees of
the department or agency and such experts and consultants as the department or agency head determines to be
appropriate. This evaluation will take
into consideration the risks to the subjects, the adequacy of protection
against these risks, the potential benefits of the research to the subjects and

§ 46.124

Conditions.

With respect to any research project
or any class of research projects the department or agency head may impose
additional conditions prior to or at the
time of approval when in the judgment

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Pt. 47

28 CFR Ch. I (7–1–01 Edition)
the head of the requesting Departmental unit. The officials so designated shall not delegate this authority to others;
(d) The request adheres to the requirements set forth in § 47.4; and
(e) The notice requirements set forth
in section 1108(4) of the Act, or the requirements pertaining to delay of notice in section 1109 of the Act, are satisfied, except in situations (e.g., section 1113(g)) where no notice is required.

of the department or agency head additional conditions are necessary for the
protection of human subjects.

PART 47—RIGHT TO FINANCIAL
PRIVACY ACT
Sec.
47.1
47.2
47.3
47.4
47.5

Definitions.
Purpose.
Authorization.
Written request.
Certification.

AUTHORITY: 5 U.S.C. 301; 28 U.S.C. 509, 510;
section 1108 of the Right to Financial Privacy Act of 1978, 12 U.S.C. 3408.

§ 47.4

Written request.

(a) The formal written request shall
be in the form of a letter or memorandum to an appropriate official of
the financial institution from which financial records are requested. The request shall be signed by the issuing official, and shall set forth that official’s
name, title, business address and business phone number. The request shall
also contain the following:
(1) The identity of the customer or
customers to whom the records pertain;
(2) A reasonable description of the
records sought; and
(3) Such additional information as
may be appropriate—e.g., the date on
which the opportunity for the customer to challenge the formal written
request will expire, the date on which
the requesting Departmental unit expects to present a certificate of compliance with the applicable provisions of
the Act, the name and title of the individual (if known) to whom disclosure is
to be made.
(b) In cases where customer notice is
delayed by court order, a copy of the
court order shall be attached to the
formal written request.

SOURCE: Order No. 822–79, 44 FR 14554, Mar.
13, 1979, unless otherwise noted.

§ 47.1 Definitions.
The terms used in this part shall
have the same meaning as similar
terms used in the Right to Financial
Privacy Act of 1978. Departmental unit
means any office, division, board, bureau, or other component of the Department of Justice which is authorized to conduct law enforcement inquiries. Act means the Right to Financial Privacy Act of 1978.
§ 47.2 Purpose.
The purpose of these regulations is to
authorize Departmental units to request financial records from a financial
institution pursuant to the formal
written request procedure authorized
by section 1108 of the Act, and to set
forth the conditions under which such
requests may be made.
§ 47.3 Authorization.
Departmental units are authorized to
request financial records of any customer from a financial institution pursuant to a formal written request
under the Act only if:
(a) No administrative summons or
subpoena authority reasonably appears
to be available to the Departmental
unit to obtain financial records for the
purpose for which the records are
sought;
(b) There is reason to believe that the
records sought are relevant to a legitimate law enforcement inquiry and will
further that inquiry;
(c) The request is issued by a supervisory official of a rank designated by

§ 47.5

Certification.

Prior to obtaining the requested records pursuant to a formal written request, an official of a rank designated
by the head of the requesting Departmental unit shall certify in writing to
the financial institution that the Departmental unit has complied with the
applicable provisions of the Act.

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