PART 745—PROTECTION OF

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HUMAN SUBJECTS

Sec.
745.101 To what does this policy apply?
745.102 Definitions.
745.103 Assuring compliance with this policy—
research conducted or supported by
any Federal department or agency.
745.104–745.106 [Reserved]
745.107 IRB membership.
745.108 IRB functions and operations.
745.109 IRB review of research.
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§ 745.101 10 CFR Ch. III (1–1–01 Edition)
745.110 Expedited review procedures for certain
kinds of research involving no more
than minimal risk, and for minor
changes in approved research.
745.111 Criteria for IRB approval of research.
745.112 Review by institution.
745.113 Suspension or termination of IRB
approval of research.
745.114 Cooperative research.
745.115 IRB records.
745.116 General requirements for informed
consent.
745.117 Documentation of informed consent.
745.118 Applications and proposals lacking
definite plans for involvement of human
subjects.
745.119 Research undertaken without the intention
of involving human subjects.
745.120 Evaluation and disposition of applications
and proposals for research to be
conducted or supported by a Federal department
or agency.
745.121 [Reserved]
745.122 Use of Federal funds.
745.123 Early termination of research support:
Evaluation of applications and proposals.

745.124 Conditions.

AUTHORITY: 5 U.S.C. 301; 42 U.S.C. 7254; 42
U.S.C. 300v–1(b).

SOURCE: 56 FR 28012, 28018, June 18, 1991,
unless otherwise noted.

§ 745.101 To what does this policy

...

apply?

(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 § 745.102(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 § 745.102(e)
must be reviewed and approved, in
compliance with § 745.101, § 745.102 and
§ 745.107 through § 745.101 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
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.

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,

(5) Research and demonstration
projects (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
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, 28018, June 18, 1991; 56 FR 29756, June 28, 1991]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,

§ 745.102 Definitions.

( subpart D, except
for research involving observations of public
behavior when the investigator(s) do not participate
in the activities being observed.
§ 745.102 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.

(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.

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(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.

§ 745.103 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 in question, on file with the Office for Protection from Research Risks, HHS, and approved for Federal wide 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.

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[56 FR 28012, 28018, June 18, 1991; 56 FR 29756, June 28, 1991]

§§ 745.104–745.106 [Reserved]

§ 745.107 IRB membership.

(a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of it's 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.

...

(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.

§ 745.108 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 § 745.103(b)(4) and, to the extent required by, § 745.103(b)(5).

(b) Except when an expedited review procedure is used (see § 745.110), 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.

§ 745.109 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.

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

§ 745.110 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.

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(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.

§ 745.111 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:

...

(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.

§ 745.112 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.

§ 745.113 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, Department of Energy § 745.116 appropriate institutional officials, and the department or agency head.

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

§ 745.114 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
make similar arrangements for avoiding duplication of effort.

§ 745.115 IRB records.

(a) An institution, or when appropriate an IRB, shall prepare and maintain adequate documentation of IRB activities, including the following:

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

§ 745.116 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 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.

...

(Approved by the Office of Management and Budget under control number 9999–0020) Department of Energy § 745.119

§ 745.117 Documentation of informed consent.

(a) Except as provided in paragraph

...

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

§ 745.118 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 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 § 745.101

(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.

§ 745.119 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.

§ 745.120 10 CFR Ch. III (1–1–01 Edition)

§ 745.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal department or agency.

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 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.

§ 745.121 [Reserved]

§ 745.122 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.

§ 745.123 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.

...

(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).

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

Footnotes

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.