PROTECTION OF HUMAN SUBJECTS

• Document Type: CREST
• Collection: STARGATE
• Document Number (FOIA) /ESDN (CREST): CIA-RDP96-00788R001500140003-9
• Release Decision: RIFPUB
• Original Classification: K
• Document Page Count: 18
• Document Creation Date: November 4, 2016
• Document Release Date: May 15, 2000
• Sequence Number: 3
• Publication Date: March 8, 1983
• Content Type: RS

Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140003-9
PRO
ECTIC
CODE OF F 'DE RAL. REGULATIONS
R 46
Revised a,% of arch 8, 1983
Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140003-9
3, .I
 } Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140003-9
NAT'ION'AL. RESEARCH ACT
PUBLIC LAW 93-348
JULY 12, 1974
SEC. 212. (a) Part I of title IV of the Public Health Service Act, as
amended by section 103 of this Act, is amended by adding at the end the
following new section:
"INSTITUTIONAL, RI.VIEW BOARDS; ETHICS GUIDANCE PROGRAM
"Six. 474. (a) The Secretary shall by regulation require that each entity
which applies for a grant or contra :t under this Act for any project or
program which involves gilt, conduct of biomedical or behavioral research
involving human subjects submit in or with its application for such giant 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 of 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 are responded to promptly and appropriately,"
(b) The Secretary of flcr+lth, Education, and Welfare shall within 240
days of the date of the enactment of this Act promulgate such regulations as
may be required to carry out section 474(a) of the Public Health Service
Act. Such regulations shall apply with respect to applications for grants and
conmicts under such Act submitted after promulgation of such regulations,
THE ('ODE OF FEDERAL REGULATIONS,
45 CFR 46, IMPLEMENTS THESE AMENDMENTS
TO THE PUBLIC HEALTH SERVICE ACT.
Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140003-9
 Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140003-9
CODE OF FEDERAL REGULATIONS
TITLE 45
PUBLIC WELFARE
DEPARTMENT OF HEALTH AND HUMAN SERVICES
NATIONAL INS'TIT'UTES OF HEALTH
OFFICE FOR PROTECTION FROM RESEARCH RISKS
PART 46-PROTECTION OF HUMAN SUBJECTS
REVISE -0 OF MARCH 8, 1983
Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140003-9
 CA owed For Release 2000/08/08: CIA-RDP96-00788RO01500140003-9
46.114 Cooperative research.
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
' ubcontractor with the prince
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
car all of these subjects, each
cooperating institution shall comply
with these regulations as though it
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 IRE,
or Similar arrangements aimed at
avoidance of duplication of effort.
46.115 1kB records.'
(a) An institution, or where
appropriate an [RB, shall prepare and
maintain adequate documentation of
LG^1.11 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
inv:rstigators, and reports of injuries
to subjects.
(2) Minutes of IRB meetings which
shall be in sufficient detail to show
tttenddance at the meetings; actions
taken by the [R13; the vote on these
actions including the number of
r emher% 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 IRE and the
investigators.
(5) A list of 1R13 members as
required by ? 46. lt3(h)(3).
(6) Written procedures for the IRE
as required by ? 46.103(h)(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 be 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.
0 46.116 General requirements
for Informed consent.
Except as provided elsewhere in
this or other subparts, no investigaror
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 subiect 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 tojlac.subject or the
representatiivtw.,No,informed consent,
whether oral or. t.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
ii identification of any procedures
which are experimental;
(2) A description of any reasonably
foreseeable risks or discomforts to the
4 subject,
(3) A description of any benefits to
9 the subject or to others which may
reasonably be expected from the
'research;
(4) A disclosure of appropriate
? alternative procedures or courses of
treatment. J any, that might be
advantageous to she 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 D
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
(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 he provided
to each subject:
Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140003-9
 A-s'c`Pp$troved For Release 2000/08/08 : CIA-RDP96-00788R001500140003-9 page 13
verifying, perhaps through sampling,
t",aat approved procedures for
induction of individuals into the
activity are being followed, and (ii)
monitoring the progress of the
activity and intervening as ,necessary
through such steps as visits to the
activity site and continuing evaluation
to determine if any unanticipated
risks have arisen);
(3) Carry out such other
responsibilities as may be assigned by
the Secretary.
(b) No award may be issued until
the applicant or offeror has certified
to the Secretary that the Insrtitutional
Review Board has made the
determinations required under
paragraph (a) of this section and the
Secretary has approved these
determinations, as provided in
? 46. 120 of Subpart A of this part.
ic) Applicants or offerors seeking
support for activities covered by this
subpart must provide for the
designation of an institutional Review
1341.1rd, subject to approval by the
Secretary, where no such Board has
beer. established under Subpart A of
this part.
46,206 General limitations.
(a) No activity to which this
subpart is applicable may be
undertaken unless:
(1) Appropriate studies on animals
::i:d nonpregnant individuals have
heci.,a completed;
(2) Except where the purpose of
the activity is to meet the health
acedi of the another or the psitticular
(ia:us, the risk to the fetus is minimal
and, in all cases, is the least possible
risk for achieving the objectives of
tl'tc activity.
('r Individuals engaged in the
acuviiy will have no part in: (i) Any
decisions as to the timing, method,
ane1 procedures used to terminate the
pregnancy, and (ii) determining the
viability of the fetus at the,
termination of the pregnancy; and
(4) No procedural changes which
may cause greater than minimal risk
cc) the fetus or the pregnant woman
w;il he introduced into the procedure
for terminating the: pregnancy solely
in the interest of the activity,
(b) No inducements, monetary or
otherwise, may be offered to
terminate pregnancy for purposes of
the activity.
(40 FR 33528. Aug. R. 1475. as amended at
40 FR 51638. Nov. 6, 19751
46.207 activities directed
toward pregnant women as
subjects.
(a) No pregnant woman may be
involved as a subject in an activity
covered by this subpart unless: (I )
The purpose of the activity is to meet
the health needs of the mother and the
fetus will be placed at risk only to the
minimum extent necessary to meet
such needs, or (2) the risk to the fetus
is minimal.
(b) An activity permitted under
paragraph (a) of this section may be
conducted cnly if the mother and
father are legally competent and have
given their informed consent after
having been fully informed regarding
possible impact on the fetus, except
that the father's informed consent
need not be secured it': (1) The
purpose of the activity is to meet the
health needs of the mother; (2) his
identity or whereabouts cannot
reasonably be asp-ertained; (3) he is
not reasonably available: or (4) the
pregnancy resulted from rape.
46.2139 Activities directed
toward f,etusea in utero its
subjects.
(a) No fetus in wer?o may he
involved a.s a subject in any activity
covered by this subpart unless: (1)
The purpose of the activity is to meet
the health need% of the particular fetus
and the fetus will he placed at risk
only to the minimum extent necessary
to meet such need,, or (2) the risk to
the fetus unposed by the research is
minimal and the purpose of the
activity is the development of
important biumedi, al knowledge
which cannot be obtained by other
means.
(b) An activity permitted under
paragraph (a) of this section may he
conducted only if the mother and
father are legally competent and have
given their informed consent, except
that the father's consent need not be
secured if: (1) His identity or
whereabouts cannot reasonably be
ascertained, (2) he is not reasonably
available:, or (3) the pregnancy
resulted from rape.
46.209 Activities directed
tows rd fetustas ex utero,
including nonviable fetuses, as
subjects.
(a) Until it has been ascertained
whether or not a fetus ex utcro is
viable, a fetus ex utero may not be
involved as a subject in an activity
covered by this subpart unless:
(1) There will be no added risk to
the fetus resulting from the activity,
and the purpose of the activity is the
development of important biomedical
knowledge which cannot be obtaincd
by other means, or
(2) The purpose of the activity is to
enhance the possibility of survival of
the particular fetus, to the point of
viability.
(h) No nonviable fetus may be
involved as a subject in an activity
covered by this subpart unless:
(1) Vital functions of the fetus will
not be artificially maintained,
(2) Experimental activities which
of themselves wound terminate the
heartbeat: or respiration of the fetus
will not be etriployed, and
(3) The purpose of the activity is
the development of important
biomedical knowledge which cannot
be obtained by otter means.
(r) In the event the fetus ex utero
is found to be viable, it may be
included as a subject in the activity
only to the extent permitted by and in
accordance with the requirements of
other subparts of this part.
(d) An activity permitted under
paragraph (a) or (b) of this section
may he conducted only if the mother
and father are legally competent and
have given their informed consent,
except that the father's informed
consent need not be secured if: (1) his
identity or whereabouts cannot
recsonably be ascertained, (2) he is
Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140003-9
 e l CIA-RDP96-00788 R001500140003-9 45 ,mss 46
NOTICES
HUMAN SUBJL,-C-Ts
Minimum Criteria Identifying the
Viable Fetus
On March 13, 1975, regulations
were published in the FEoERAI
R EctSTE R (40 FR 11854) relating to the
protection of human subjects in
teet arch, development, and rehited
activities supported by Department of
health. Education, and Welfare
grants and contracts. These
regulations are codified at 45 CFR
Part 46.
Elsewhere in this issue of the
FEDERAL R E:tOSTkR, the Secretary
is amending 45 CFR Part 46 by,
among other things, adding a new
Subpart li? to provide additional
protections pertaining to research,
development, and related activities
involving fetuses. pregnant women,
and vn vitro fertilization.
Section 46,203(d) of Subpart 13
provides inter alia as follows:
The Secretary may from time to time,
taking into .sccc mnt medical advances,
publish in the FEDERAL R r.t;tsTEa
guidelines to assi.sr in deaerminieg whether a
fetus is viable fair purposes of this subpart,
This notice is published in
accordance with ? 46.203(d). For
purposes of Subpart B. the guidelines
indicating that a fetus other thein a
dead fetus within the meaning of
? 46.203(1) is viable include the
following:
an estimated ges,ra.tionat age of 20 weetts or
more and a by weight of 500 grams or
more
FEDERAL RECUSTER, VOL RA,
AUGUST 6, 19Th
Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140003-9