CODE OF FEDERAL REGULATIONS
Revised as of March 8, 1983
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NATIONAL RESEARCH ACT
PUBLIC LAW 93-348
JULY 12, 1974
INSTITUTIONAL REVIEW BOARDS; ETHICS GUIDANCE PROGRAM
Sec. 212. (a) Part
! of title IV of the Public Health Service Acs, as
amended by section 103 of this Act.
is amended by adding at the end the
following new section:
“INSTITUTIONAL REVIEW HOARDS; ETHICS GUIDANCE PROGRAM
“Sec. 474. (a) The Secretary shall by regulation require that each entity
which applies for a grant or contract under this Act for any project or
program which involves the conduct of biomedical or behavioral research
involving human subjects submit in or with its application for such grant or
contract assurances satisfactory to the Secretary that
it has established
< in
accordance with regulations which the Secretary shall prescribe) a board (to
be known as an
‘Institutional Review Board’) to review biomedical and
behavioral research involving human subjects conducted at or sponsored by
such entity
in order to protect the rights ot the human subjects of such
research.
“(b) The Secretary shall establish a program within the Department
under which requests for clarification and guidance with respect to ethical
issues raised in connection with biomedical or behavioral research involving
human subjects arc responded to promptly and appropriately."
(b) The Secretary of Health, Education, and Welfare shall within 240
days of the date of the enactment of this Act promulgate such regulations as
may
tie required to carry out section 474(a) ot the Public Health Service
Act. Such regulations shall apply with respect to applications for grants and
contracts under such Act submitted after promulgation of such regulations.
THE CODE OF FEDERAL REGULATIONS,
45 CFR 46. IMPLEMENTS THESE AMENDMENTS
TO THE PUBLIC HEALTH SERVICE ACT.
salus ubi multi const!iarii
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CODE OF FEDERAL REGULATIONS
title 45
PUBLIC WELFARE
I
department of health and human services
national institutes of health
OFFICE FOR PROTECTION FROM RESEARCH RISKS
K
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PART 46-PROTECTION OF HUMAN SUBJECTS
REVISED AS OF MARCH 8, 1983
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45 CFR 46
PAfST 46—PROTECTION OF
HUMAN
SUBJECTS
Subpart A— Basic HHS Policy for
Protection of Human Research
Subjects
Set
4 IS
I0t
To what do these regulations apply?
46.J02
Definitions.
46 J03
Assurances.
i(}4
Section reserved.
46. 105
Section reserved.
46 106
Section reserved.
4610?
IRB membership.
46.108
IRB functions and operations.
46.
J 09
IRB review of research.
l SO
Expedited review procedures for
certain kinds of research involving no
more than minimal risk, ami for minor
changes
in approved research.
111
Criteria for IRB approval of
research.
46.
1 1?
Review by institution.
46.
1 !3
Suspension or tenmnaniim of IRB
approval of research.
4t>. 114
Cooperative research.
46.115
IRB records
} 16
General requirement*
lo.r informed
consent.
1 17
Documentation of informed
consent.
46.
I !&
Applications and proposals lacking
definite plans lor involve me r.S of human
subjects
46.
1 19
Research undertaken without the
intention of involving human subjects.
4t». 120
Evaluation and disposition of
applications and proposals.
t2l
Invests gat tonal new dng or device
30-day delay requirement.
46.122
Use of federal funds.
46.123
Early termination of research
fundin '; evaluation
of' subsequent
applications ami proposals.
(24
Conditions.
Subpart B-— Additional Protections
Pertaining to Research,
Development, and Related
Activities Involving Fetuses,
Pregnant Women, and Homan
In Vitro Fertilization
Sec.
46 201
Applicability.
46 202
Purpose
46.203
Definitions.
46.204
Ethical Advisory Board*.
46 205
Addition*) duties of the Institutional
Review Boards in connection with
activities involving fetuses, pregnant
women, or human in vitro fertilization.
46.206
General limitations.
46.20?
Activities directed toward pregnant
women as subjects.
46.208
Activities directed toward fetuses
in
ubero as subjects.
46.209
Activities directed toward fetuses cn
ulcro, including nonviahie fetuses, as
subjects.
46.210
Activities involving the dead fetus,
fetal
material, or the placenta.
46. 2 11
Modification or waiver of specific
requirements.
Subpart C— Additional Protections
Pertaining to Biomedical and
Behavioral Research Involving
Prisorters as Subjects
Sec.
46.301
Applicability
46.302
Purpose.
46.303
Definitions.
46.304
Composition of Irunturioniel Review
Boards where prisoners arc involved,
46.305
Additional duties of the Institutional
Review Boards where prisoners arc
involved
46.306
Perm used activities involving
prisoners..
Subpart D—Additional Protections
for Children Involved as Subjects in
Research
Sec.
46.401
To what do these regulations apply?
46.402
IXfmitiorii.
46.403
IRB dink*.
46.404
Research not involving greater than
minimal
risk.
46.405
Research involving greater than
minimal risk bui presenting the prospect
of direct benefit to the individual subjects,
46.406
Research involving greater than
minimal msk and no prospect of direct
benefit to individual subjects, but likely to
yield gcneralizjibtc knowledge about the
subject's disorder or condition.
46.407
Research not otherwise approvsble
which presents art opportunity to
understand, prevent, or alleviate a serious
problem Affecting the health or welfare of
children.
46.408
Requirements for pemhuiion by
parcirsts or guardians and for assent by
children.
45.409
Wards.
Authority: 5 U S
C*
301; sec. 474(a), 88
Slat. 352.(42 U.S.C. 289/~JUn.
Subpsrt A— Basic HUS Policy for
Protection of Human Research
Subjects
Source: 46 FR 8386, January 26,
1981, 48 FR
9269, March 4V 1988.
§ 46,101
To whs! do these
regulations apply?
(a) Except as provided in
paragraph (b) of this section, this
subpan applies to all research
involving human subjects conducted
by the Department of Health and
Human Services or funded in whole
or in part by a Department grant,
contract, cooperative agreement or
fellowship.
(
1 ) This includes research
conducted by Department employees,
except each Principal Operating
Component head may adopt such
nonsubstantive, procedural
modifications as may be appropriate
from an administrative standpoint,
(2)
It also includes research
conducted or funded by the
Department of Health and Human
Services outside the United States,
but in appropriate circumstances, the
Secretary may, under paragraph (e) of
this section waive the applicability of
some or
all of the requirements of
these regulations for research of this
type.
(b) Research activities in which the
only involvement of human subjects
will be in one or more of the
following^ategorifis are exempt from
these~rcguIations unless the research
is covered by other subparts of this
part;
(!) 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),
if
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information taken from these sources
is recorded
in such a manner that
subjects cannot be identified* directly
or through identifiers linked to the
subjects.
(3) Research involving survey or
interview procedures, except where
all of the following conditions exist:
ti) responses are recorded in such a
manner that the human subjects can
be identified, directly or through
identifiers linked to the subjects,
(ii)
the subject’s responses,
if (hey
became known outside the research,
could reasonably place the subject at
risk of criminal or civil
liability or be
damaging to the subject's financial
standing or employability, and
(iii)
the research deals with sensitive
aspects of the subject’s own behavior,
such as illegal conduct, drug use,
sexual behavior, or use of alcohol.
All research involving survey or
interview' procedures
is exempt,
without exception, when the
respondents are elected or appointed
public officials or candidates for
puhbc office.
<4) Research involving the
observation (including observation by
participants) of public behavior,
except where
all of (he following
conditions exist:
(i) observations are
recorded
in such
a manner that the
human subjects can be identified,
directly or through identifiers linked
to the subjects,
iii) the observations
recorded about the individual,
if they
became known outside the research,
cou:d reasonably place the subject
at
risk of criminal or civil
liability or be
damaging to the subject’s financial
standing or employability, and
(iii)
the research deals with sensitive
aspects of (he subject's own behavior
such as illegal conduct, drug
use,
sexual behavior, or use of alcohol.
(5) 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
i
subjects cannot be identified, directly
or through
identifiers linked
to the
subjects.
(6) Unless specifically requited by
statute (and except to the extent
specified
in paragraph
(i)), research
and demonstration projects which
are conducted by or subject to the
approval of the Department of
Health and Human Services, and
which are designed to study.,
evaluate, or otherwise examine:
(i)
programs under the Social Security
Act, or other 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.
(c) The Secretary has final
authority to determine whether a
particular activity
is covered by these
regulations.
(d) The Secretary may require that
specific research activities or classes
of research activities conducted or
funded by the Department, but not
otherwise covered by these
regulations, comply with some or
all
of these regulations.
(e) The .Secretary may also waive
applicability of these regulations to
specific reseat ch activities or classes
of research activities, otherwise
covered by these regulations. Notices
of these actions will be published
in
the Federal Register as they occur.
(f) No individual may receive
Department funding for research
covered by these regulations unless
the individual
is affiliated with or
sponsored by an institution which
assumes responsibility for the
research under an assurance Satisfying
the requirements of
this part, or the
individual makes other arrangements
with the Department.
(g) Compliance with these
regulations
will
in no way render
inapplicable pertinent federal,
state,
or local laws or regulations.
(h) Each subpan of these
regulations contains a separate
section describing to what the subpan
applies. Research which
is covered
by more than one subpart shall
comply with
all applicable subparts.
(i)
If, following review of
proposed research activities that are
exempt from these regulations under
paragraph (bX6), the Secretary
determines that a research or
demonstration project presents a
danger to the physical, mental, or
emotional well-being of a participant
or subject of the research or
demonstration project, then federal
funds may not he expended for such
a project without the written,
informed consent of each participant
or subject.
§ 46.10*2
Definitions.
(a) “Secretary “ means the
Secretary of Health and Human
Services and any other officer or
employee of (he Department of
Health and Human Services to whom
authority has been delegated.
(b) “Department” or “HH5“
means the Department of Health and
Human Services.
It)
‘‘‘Institution” means any public
or private entity or agency (including
federal,
state, and other agencies).
(d) “Legally authorized
representative” means an individual
or judicial or other body authorized
under applicable law to consent on
behalf of a pros pec live subject to the
subject’s participation in the
procedure! s) involved in the research
(e) “Research
* means a
systematic investigation designed to
develop or contribute to gemeralutabk
knowledge.
Activities which meet
this definition constitute “research”
for purposes of these regulations,
whether or not they arc supported or
funded 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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45 CFR 46
(0 “Hannan subject" means a
living individual about whom an
investigator (whether professional or
student) conducting research obtains
(I) data through intervention or
interaction with the individual, or
( 2 )
identifiable private information.
* Intervention V includes both
physical procedures by which data are
gathered (for example, venipuncture)
ami manipulations of the subject or
the subject’s environment shat are
performed for research purposes.
'“Interactiom
’ includes
communication or interpersonal
contact between investigator and
subject
r Private information’’
includes information about behavior
thaf 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
b> 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. t (he identity of the subject
is or
may readily be ascertained by the
investigator os associated with the
information)
in order for obtaining
the information to constitute research
involving human subjects.
(g) “Minimal risk "4 means that she
risks of harm anticipated
in the
proposed research are not greater,
considering probability ansi
magnitude, than those ordinarily
encountered
in daily life or during the
performance of routine physical or
psychological examinations or tests.
(h) ‘‘Certification!* means the
official notification by the institution
to the Department
in accordance with
the requirements of this part that
a.
research project or activity involving
human subjects has been reviewed
and approved by the institutional
Review' Board (IRE) in accordance
with the approved assurance on file at
HHS. (Certification
is required when
the research
is funded by the
Department and not otherwise exempt
in accordance with
§ 46.101(b)).
8 46 .lfo3
Aiomraitcci.
(a) Each institution engaged in
research covered by these regulations
shall provide written assurance
satisfactory to the Secretary that
it
will comply with the requirements set
forth
in these regulations.
(b) The Department will conduct or
fund research covered by these
regulations only
if the institution has
an assurance approved as provided
in
this section, and only
if the institution
has certified to the Secretary that the
research has been reviewed and
approved by an 1RB provided for in
the assurance, and
will be subject to
continuing review by the IRB, This
‘assurance 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 source of funding. This
may include an appropriate existing
code, declaration, or statement of
ethical principles, or
a statement
formulated h>
the institution
itself.
This requirement does not preempt
provisions of these regulations
applicable to Department -funded
research and
is not applicable to any
research in an exempt category listed
in
§ 46. 111!
.
(2) Designation of one or more
IRBs established
in accordance with
the requirements of this subpart, and
for which provisions arc made for
meeting space and sufficient staff to
support the IRB’s review and
reco rd k e e p in g duties.
(3) A
list of the KRB 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 [RB
deliberations; and any employment or
other relationship between each
member and the institution; for
example: full-time employee, part-
time employee, member of governing
panel or board, stockholder, paid or
unpaid consultant. Changes in IRB
membership shall be reported to the
Secretary,
(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 (he 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;
(iii) for insuring prompt
reporting to the IRB of proposed
changes in a research activity, and for
insuring that changes in approved
research, during the period for which
FRB approval has already been given,
may not be initiated without [RB
review and approval except where
necessary to eliminate apparent
immediate hazards to the subject; and
(iv)
for insuring prompt reporting to
the IRB and to the Secretary
! of
unanticipated problems involving
risks to subjects or others.
(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 these
regulations, and shall be filed in such
form and manner as the Secretary
may prescribe.
(d) The Secretary will evaluate
ail
assurances submitted in accordance
with these regulations through such
officers and employees of the
Department and such experts or
consultants engaged for this purpose
as the Secretary determines to be
appropriate. The Secretary ’s
evaluation will take into
consideration the adequacy of the
proposed [RB
in
light of the
anticipated scope of the institution’s
research activities and the types of
subject populations likely to be
• Report* should be filed wish the Office
for Protection from Research Risks, Nation®!
Institute® of Health, Department of Health
ami Human Services, Beihc%da, Maryland
20205
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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 Secretary may approve or
disapprove the assurance, or enter
into negotiations to develop an
approvable one. The Secretary may^
limit the period during which any
particular approved assurance or class
ot approved assurances shall remain
effective or otherwise condition or
restrict approval.
(0 Within 60 days after the date of
submission to HHS of an application
or proposal, an institution with an
approved assurance covering the
proposed research shall certify that
die application or proposal has been
reviewed and approved by the iRB.
Other institutions shall certify that the
application or proposal has been
approved by the IRB within 30 days
after receipt of a request for such a
certification from the Department.
If
the certification
is not submitted
within these time limits, the
application or proposal may be
returned to the institution,
§ 46,104
[Reserved]
i 46.105
[Reserved]
§ 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 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* backgrounds including
consideration of the racial and
cultural backgrounds of members 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,
including but not limited to subjects
covered by other subparts of this part,
the IRB shall include one or more
individuals who are primarily
concerned with the welfare of these
subjects.
(b) No IRB mu
y
consist entirely of
men or entirely of women, or entirely
of members of one profession.
(c) Each IRB shall include at least
one member whose primary concerns
are in no-n&cicntific areas; for
example: lawyers, ethicists, members
of the clergy.
(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
participating in the IRB’s
initial or
continuing review of any project
in
which the member has a conflicting
interest, except to provide
information lequested by the iRB.
(I) An IRB may,
in
its discretion,
invite individuals with competence
in
special areas to assist in the review of
complex issues which require
expertise beyond or in addition to that
available on the IRB. These
individuals may not vote with the
IRB.
§ 46,104
1KB functions and
operations.
In order to fulfill the requirements
of these regulations each IRB
shall:
(a) Follow written procedures as
provided
in
§ 46. 103(h)(4).
(b) Except when an expedited
review procedure
is used (sec
§ 46.
1 10), review proposed research
at convened meetings at which a
majority of the members of the IRB
arc present, including
at
least one
member whose primary concerns are
in nonacientific areas. In order for the
research to be approved,
it shall
receive the approval of a majority of
those members present at the
meeting.
(c) Be responsible for reporting to
the appropriate institutional officials
and the Secretary
1 any serious or
continuing noncompliance by
investigators with the requirements
and determinations of the IRB.
§ 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 these regulations.
(b) An IRB shall require that
ififormatkm given to subjects as p^rt
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
§ 46.1 17,
(d) An IRB shall notify
investigators and the institution in
*
writing of its decision to approve or
disapprove the proposed research
activity, or of rrmlificatfons 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
1 Returns should
tiled wsth the Office
for Protection from Research Risks. National
Institutes of Health. Department of Health
and Human Services, fteihcsda, Maryland
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a statement of the reasons for its
dtXippn and give the investigator an
opportunity to respond in person or in
writing.
(c) An IRB shall conduct
continuing review erf research covered
by these regulations at intervals
appropriate to the degree of risk, but
®m ie%% tlitin once per year, and shall
have authority to observe or have a
third party observe the consent
process and the research.
$46,110
Expedited review
procedures for certain kinds of
research involving no more than
mrinimaf risk, and for minor
changes in approved research*
(a) The Secretary has established,
and published
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, through periodic
republication
in the Federal
Register.
(bl An IRB may review some or ail
of the research appearing on the
list
through an expedited review
procedure,
if the research involves no
more than minimal risk. The IRB may
also use the expedited review
procedure to review minor changes in
previously approved research during
the period 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
rri
§ 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.
(d) The Secretary may restrict,
suspend, or terminate an institution
s
or IRB’s use of the expedited review
procedure when necessary to protect
the rights or welfare of subjects.
§46.111
Criteria for IRB
approval of research.
fa) In order no approve research
covered by these regulations the IRB
shall determine
that ail of the
following requirements arc satisfied:
(1) Risks to subjects arc
minimized:
(i) By using procedures
which are consistent with sound
research design and which do not
unnecessarily expose subjects to risk,
and (ia) whenever appropriate, by
using procedures already being
performed on die subjects for
diagnostic or treatment purposes.
(2) Risks to subjects are reasonable
in relation to anticipated benefits,
if
my,
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 long-range effects
of applying knowledge gained in die
research (for example, the possible
effects of die research on public
policy) as among (hose research risks
that fall within die 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.
(4) Informed consent will be
sought from cadi prospective subject
or the subject’s legally authorized
representative, in accordance with,
and to the extent required by
§46,116.
(5) InfoiTnedc^
be
appropriately documciitGd, an
accordance with, and to the extent
required by §46,117.
(6) Where appropriate, the research
plan makes adequate provision for
monitoring the data collected to
insure the safety of subjects.
(7) Where appropriate, there sirp
adequate provisions to protect the
privacy of subjects and to maintain
the confidential ity of data.
(b) Where some or all of the
>-t <-'%
subjects are likely to be vulnerable to
coercion or undue influence, such as
persons with acute or severe physical
or mental
illness, or persons who are
economically or educationally
disadvantaged, appropriate additional
safeguards have been included in the
study to protect the rights and welfare
of these subjects.
§ 46.1 12
Review by institution!.
Research covered by these
regulations that has been approved by
m 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.
S 46.10
Suspension or
termination of IRB approval of
research.
An IRB
shall have iUJlharjiy to
'*
suspend or terminate approval of
research than
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’a action and shall be repotted
promptly to the investigator,
appropriate institutional officials, and
the Secretary.
1 Reports should
b*: filed wills the Office
for Protection from Research Risks, National
Institute* of Health
„ Department of Health
and Human Sendees, Beihesda, Mary! and
20205.
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Nge •
§ 46.114
Cooperative research.
(4) Copses of all correspondence
seeking informed consent the
Cooperative research projects are
•
those* projects, normally supported
through grants, contracts, or similar
arrangements, which involve
institutions in addition to the grantee
or prime contractor (such as a
contractor with the grantee, or a
subcontractor with the prime
contractor), in such instances, the
grantee or prime contractor remains
responsible to the Department for
safeguarding the rights and welfare of
human subjects. Also, when
cooperating institutions conduct some
or
all of the research involving some
or
all of these subjects, each
cooperating institution shall comply
with these regulations as though
ft
received funds for
its participation in
the project directly from the
Department, except that in complying
with these regulations institutions
may use joint review, reliance upon
the review of another qualified IRB,
or similar arrangements aimed at
avoidance of duplication of effort.
§ 46. 1 15
1KB records*
~
(a) An institution, or where
appropriate an IRB, shall prepare and
maintain adequate documentation of
IRB
activities, including the
following:
( 1) Copies of ail 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
shad 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.
between the IRB and the
investigators.
(5) A
list of IRB members as
required by
§ 46.103(b)(3).
(6) Written procedures for the IRB
as required by
§ 46.103(b)(4).
(7) Statements of significant new
findings provided to subjects, as
required by
§ 46.116(b)(5).
(b) The records required by this
regulation shall he retained for at
least 3 years after completion of the
research, and the records shall be
accessible for inspection and copying
by authorized representatives of the
Department at reasonable times and
in a reasonable manner.
§ 46.116
General requirements
for Informed consent.
Except as provided elsewhere in
this or other subparts, no investigator
may involve a human being as a
subject
in research covered by these
regulations 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 jhc subject or the
representative, ^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,
(he institution or
its agents from
liability for negligence.
(a) Basic dements of informed
consent. Except as provided
in
paragraph (c) or (d) of this section,
in
following information shall be
provided to each subject:
’ ^ (DA statement that the study
involves research, an explanation of
the purposes of the research and the
expected duration of the subject’s
J
participation, a description of the
* procedures to be followed, and
identification of any procedures
(: which are experimental;
d
(2) A description of any reasonably
.foreseeable risks or discomforts to the
^ subject;
(3) A description of any benefits to
j the subject or to others which may
• reasonably be expected from the
^research;
i
(4) A disclosure of appropriate
1 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 ail &
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 subjects* rights, and whom
to contact
in the event of a research-
related injury to the subject; and
. W 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.
f
(h) Additional dements of
informed consent. When appropriate,
one or more of the following elements
of information shall also be provided
to each subject:
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(l)A statement that the particular
* treatment or procedure may involve
*jrisks? to the subject (or to the embryo
tor fetus,
if the subject
is or may
i become pregnant) which are currently
^unforeseeable;
**
(2) Anticipated circumstances
funder which the subject's
i participation may be terminated by
• the investigator without regard to the
m subject's consent;
(3) Any additional costs to the
“subject that may result from
^participation
in the research;
I
(4) The consequences of a
^subject's decision to withdraw front
jjthe research and procedures for
| orderly termination of participation
^by the subject;
(5) A statement that significant
} new findings developed during the
j course of the research which may
* relate
to the subject's willingness to
j continue participation
will be
(provided to the subject; and
f
<6) The approximate number of
’Subjects involved in the study.
'
<c> A«
• •pnjce<l«m
doeuoCiflClutJe 7 or
wb'ich ’alters,;»ome or allaOhc
*•*. ww
k
_
*'
mformed 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) programs
under the Social Security Act, or
other 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 sendees under
those programs; and
(2) The research could not
practicably be carried out without the
waiver or alteration,
,
.v
...
(d) An IRB may approve a consent
•procedure which does not include, or
which alteonijiofne or nil of the
clemau& of informed consent set
forth above, or waive the
requirements to obtain informed
consent provided the IRB finds and
documents that:
(!) The research involves no more
than minimal risk to the subjects;
(2) The waiver or alteration will
not ad vent: ly 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 mformed consent
requirements
in these regulations arc
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.
(0 Nothing in these regulations
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.
| 46.117
Ikwmentatlon 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) tn
this section, the
consent form may be either of the
following;
(l) A written consent document
that embodies the elements of
informed consent required by
i 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
subjeers 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 whist 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 «ummary, and die
person actually oouunmg 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 die 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 goverrt; 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 where the documentation
requirement
is waived, the IRB may
require the investigator to provide
subjects with a written statement
regarding the research.
§ 46.118
Applications md
proposals Sacking definite plans for
Involvement of human subjects.
Certain ty pcs of applications for
grants, cooperative agreements, or
contracts are submitted to the
Department with the knowledge
tit at
subjects may be involved within the
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