PART 46—PROTECTION OF HUMAN SUBJECTS

Subpart A—Basic HHS Policy for Protection
of Human Research 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.
46.123 Early termination of research support:
Evaluation of applications and proposals.
46.124 Conditions.
Subpart B—Additional Protections Pertaining
to Research, Development,
and Related Activities Involving
Fetuses, Pregnant Women, and Human
In Vitro Fertilization
46.201 Applicability.
46.202 Purpose.
46.203 Definitions.
46.204 Ethical Advisory Boards.
46.205 Additional duties of the Institutional
Review Boards in connection with activities
involving fetuses, pregnant women,
or human in vitro fertilization.
46.206 General limitations.
46.207 Activities directed toward pregnant
women as subjects.
46.208 Activities directed toward fetuses in
utero as subjects.
46.209 Activities directed toward fetuses ex
utero, including nonviable fetuses, as
subjects.
46.210 Activities involving the dead fetus,
fetal material, or the placenta.

46.211 Modification or waiver of specific requirements.

Subpart C—Additional Protections Pertaining
to Biomedical and Behavioral
Research Involving Prisoners as Subjects
46.301 Applicability.
46.302 Purpose.
46.303 Definitions.
46.304 Composition of Institutional Review
Boards where prisoners are involved.
46.305 Additional duties of the Institutional
Review Boards where prisoners are involved.
46.306 Permitted research involving prisoners.
Subpart D—Additional Protections for
Children Involved as Subjects in Research
46.401 To what do these regulations apply?
46.402 Definitions.
46.403 IRB duties.
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Department of Health and Human Services § 46.101
46.404 Research not involving greater than
minimal risk.
46.405 Research involving greater than
minimal risk but presenting the prospect
of direct benefit to the individual subjects.
46.406 Research involving greater than
minimal risk and no prospect of direct
benefit to individual subjects, but likely
to yield generalizable knowledge about
the subject’s disorder or condition.
46.407 Research not otherwise approvable
which presents an opportunity to understand,
prevent, or alleviate a serious
problem affecting the health or welfare
of children.
46.408 Requirements for permission by parents
or guardians and for assent by children.
46.409 Wards.

AUTHORITY: 5 U.S.C. 301; 42 U.S.C. 289.
EFFECTIVE DATE NOTE: At 66 FR 3882, Jan.
17, 2001, the authority for part 46 was revised,
effective Mar. 19, 2001. At 66 FR 15352, Mar.
19, 2001, the effective date was delayed until
May 18, 2001, and at 66 FR 27599, May 18, 2001,
the effective date was further delayed until
Nov. 14, 2001. For the convenience of the
user, the revised text is set forth as follows:
AUTHORITY: 5 U.S.C. 301; 42 U.S.C. 289(a).

EDITORIAL NOTE: The Department of
Health and Human Services issued a notice
of waiver regarding the requirements set
forth in part 46, relating to protection of
human subjects, as they pertain to demonstration
projects, approved under section
1115 of the Social Security Act, which test
the use of cost—sharing, such as deductibles,
copayment and coinsurance, in the Medicaid
program.

For further information see 47 FR
9208, Mar. 4, 1982.

Subpart A—Basic HHS Policy for

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Protection of Human Research

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Subjects

AUTHORITY: 5 U.S.C. 301; 42 U.S.C. 289, 42
U.S.C. 300v–1(b) 
SOURCE: 56 FR 28012, 28022, June 18, 1991, unless otherwise noted.

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[56 FR 28012, 28022, 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.

(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

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(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 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.

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