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REQUIRENtLNTS GOVLIINING
r ACTIVITIES WITH HUI@LAN SU3JSCTS
u Complete Revision May 2, 1977
812
I SCOPE
This policy statement applies to all uses of human subjects at or
under the sponsorship of Stanford Research Institute. It is intend,@@i
to comply with Department cf Health, Education and Welfare (DHEW) rules
and regulations for the protection of human subjects, and is concerned
with the protection of any individual.who may be at risk as a consequence
of participation as a subject in an experimental 7c-tivity. An individual
is considered to be at risk if he or she "may be exposed to the possibil-
ity of injury, incluTing physicaL, psychological, or social injury, as a
consequence of participation as a subject in any research, development, or
related activity which departs from the application of those established
and accepted methods necessary to meet his needs, or which increases the
ordinary risks of daily life, including the recognized risks inherent in
a chosen occupation or field of service."I
11 STATEMENT OF PRINCIPLES
SRI adheres to the statement of principles issued by the World Medi-
cal Association, 1841 Broadway, New York, New York 10023. Known as the
Declaration of Helsinki, this statement was last revised in 1975. Copies
are available from the Chairman of the SRI Human Subjects Committee.
Ill HUMAN SUBJECTS COMMITTEE
The Human Subjects Committee was established to perform the reviews
and make the determinations required under this policy. The Committee
is appointed by the Vice President and Chairman, Office of Research Opera-
tions. Appointments are reviewed from time to time, but no less often
than annually.
The Committee consists of eleven members. Six members constitute
a quorum. The quorum shall include two medical doctors for cases chat
involve medical or surgical questions or investigational new drugs (IND).*
Final approval or disapproval requires a unanimous vote of the Committee
members present and voting. Unfavorable action by the Committee can Do
reversed by-a subsequent vote of the Committee on the basis of additional
information or revision of the question.
lTitle 45, Code of Federal Regulations, Part 46.
*SRI itself does not perform experiments with humans as subjects in medi-
cal, surgical, or IND studies, but such studies may be performed by other
organizations of recognized competence in association with work at the
Institute. The requirements of DHEW and the Food and Drug Administration
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The Committee meets at least once a month, usually on the second
Tuesday, and maintains a written record of its actions. Replacement of a
Committee member by an alternate of comparable experience and competence
is permissible for some limited period or in respect to a particular case.
No member of the Committee shall be involved in either the initial or
continuing review of an activity in which he or she has a direct responsi-
oility, except to provide information as requested.
If the final decision of the Committee is to disapprove proceeding
with a project, that decision cannot be reversed by any other Institute
authority. However, the division executive director and the ascending
management levels have the authority and responsibility to disapprove,
discontinue, suspend, or limit any activity at any time wnen that execu-
tive judges such action to be necessary for the protection of the rights
and,welfare of human subjects.
IV REVIEW OF INITIAL PROPOSALS INVOLVING HUMAN SUBJECTS
SRI participation in activities involving human subjects can come
about in various ways. The activity is conducted sometimes at the Insti-
tute and sometimes on the premises of a subcontractor or collaborator.
most commonly, it is supported under a prime contract or grant, but it
can also be carried out in other ways, such as on an overhead account
or as a voluntary activity. Whatever the basis, the Manager of Contract
Administration Services is designated to initiate the process by which
it is to be determined if human subjects would be placed at risk, and he
must be notified when a plan to use human subjects reache7the proposal
stage or an equivalent state of preparation if no formal proposal is con-
templated. A proposal, whether formal or informal, will always be neces-
sary for evaluation. The Institute does not participate in certain classes
of research with human subjects, such as those involving fetuses, pregnant
women, or human in vitro fertilization. If a researcher is in doubt as
to the acceptabirity of a concept for research with human subjects, he
or she should consult the Chairman of the Human Subjects Committee before
a detailed proposal is prepared. No activities involving human subjects
may be begun before an evaluation has been completed by the Committee.
A. Forwarding of Proposals and Requests for Review
The Manager of Contract Administration Services will direct that a
copy of each proposal that involves human subjects be sent.to the Chairman
oi the Human Subjects Committee, who will advise the proposal author and
division executive director regarding the submission of a Request for Re-
view. The completed Request for Review, including supporting attachments,
will be submitted to the Committee via the division executive director.
If the
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subjects, she will sign and forward the Reques tor Review to t e
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Chairman of the Committee. At this stage, the nature of the human sub-
ject involvement should be well-defined. *
Whenever feasible, proposals should be reviewed before submission
to the client. However, when this cannot reasonably be done and client
rules permit,t the proposal may be submitted with aopropriate notifica-
tion that the Committee's review is yet to be accomplished. The review
should be accomplished expeditiously thereafter, and the client will be
advised of any consequent material change in protocol. In no event may
actual work with human subjects be initiated prior to approval by the
Committee. For timely consideration, the completed Request for Review
should reach the Chairman at least ten working days before the Committee
meeeting at which it is to be reviewed.
B. Dete",ining Whether or Not Subjects Are at Risk
If needed by the Committee, the proposal author will be present when
the proposal and Request for Review are considered. Consultants from with-
in or outside the Institute may be used to advise the Committee. A quorum
of the Committee will decide if, in its judgment, the human subjects would
be at risk, as defined on Page I of this policy. Those cases that are
fou@_d To-place the subjects at risk will be processed as provided below.
V REVIEW OF INITIAL PROPOSALS WITH SUBJECTS AT RISK
Initial proposals with subjects at risk are reviewed and acted on
as described in this section. The pr-ocedure followed is intended to con-
form to DHEW policy as expressed in Reference 1, and includes:
- Consideration of the risks in relation to the benefits.
- Assessment of the adequacy and appropriateness of consent
procedures.
- Review of the protecti.on afforded the rights and welfare of
the subjects.
However, wilen a protocol cannot be prepared until certain project work
has been completed, the Request for Review may be submitted initially
in such detail as is possible for a tentative review in principle to
meet requirements for timely review, followed by a full review when the
protocol has been prepared. Favorable completion of the full review is
necessary before human subjects may be involved.
tIn the absence of a written notice requiring earlier action, DHEW foL-
lows a rule that it must receive the results of a review within 60 days
after the deadline for submission of a proposal, or 60 days after the
submission date Men therlo
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'rhis procedure will be carried out through consultation with the project
personnel, assistance from consultants as required, and evaluation by a
quorum of the Committee.
A. Consideration of Risks Relative to Benefits
The protocol will be carefully scrutinized to evaluate the potential
risks to the subjects and to compare those risks with the probable bene-
fits that are likely to ensue to the participants and to humanity in gen-
eral. The protocol should be distinctly stated so as to leave no doubt
about the purpose and nature of the research and to permit identification
of any unnecessary or unacceptable risks. Risks must be well defined,
and the reason for assuming them easily understood by the participant.
The procedures must be shown to be likely to result in an adequate assess-
ment of the particular problem. Compensation can never be used as an
undue inducement.
B. Informed Consent of Subjects
In every case, the informed consent of each human subject must be
obtained prior to participation in the experimental activity. Normally,
the consent will be in writing on a form approved by SRI's General Coun-
sel, signed by the subject or his or her legal representative, and wit-
nessed. The form will also bear the signature of the principal investi-
gator. In cases involving nominal risk and approved by the Committee,
the informed consent may be obtained orally, with the briefing of the
subject documented in writing by the principal investigator. A copy of
each consent form or briefing will be filed with the Committee.
The following information will be provided, whether in written form
or by oral briefing:
- A fair explanation of the procedures to be followed, includ-
ing identification of those that are experimental.
- A description of any attendant discomforts and risks.
- A description of the expected benefits.
- When applicable, a disclosure of appropriate alternative pro-
cedures that would be advantageous for the subject.
- An offer to answer any inquiries about the procedures.
- An instruction that without prejudice the subject may with-
draw his or her consent and discontinue participation in the
project at any time.
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The consent agreement shall be legally effective and shall include no
exculpatory language through which the subject is made to waive any of
his or her legal rights or to release the Institute from liability for
negligence.
C. Protection of the Rights and Welfare of Subjects
Special attention will be directed to the protocol to ensure that
the rights and welfare of the subjects will be adequately protected.
Provisions will be included for emergency situations if there is reason
to believe that emergencies might arise. Information will be handled
in such a manner as to prevent unauthorized parties from tracing or iden-
tifying it with a particular human subject. Preservation of the confi-
dentiality and security of data according to the requirements of the
client, the Institute, and applicable law will be the direct responsibil-
ity of the principal investigator and his division executive director.
When specified in Reference 1, additional protections for certain cate-
gories of subjects (e.g., children) will be observed in the application
of this policy.
D. Committee Action
After reviewing a protocol, a quorum of the Committee may approve$
approve conditionally, or disapprove. Approval will be communicated in
writing to the principal investigator and the division executive direc-
tor. If the approval is conditional, the Committee itself may formulate
explicit terms under which the activity might proceed, or it may make
approval dependent on revision of the protocol to meet specified general
requirements. If the protocol is disapproved, the reasons for disapproval
will be stated in writing to the principal investigator and the division
executive director. Unfavorable action can be reversed by a subsequent
favorable vote of a quorum of the Committee on the basis of a revised
protocol or resubmission of the original question with additional sup-
porting information..
Before introducing any material change after the initial approval
has been given, the protocol revised to reflect the proposed change must
first be submitted to and approved by a quorum of the Committee. As in
the initial review, the Committee may approve, approve subject to speci-
fied restrictions, or diapprove. if unanticipated hazardous conditions
emerge, they must be reported immediately by the principal investigator
to the Committee, which will then determine the circumstances, if any,
under which the project may continue.
At the time of the initial approval, the Committee will indicate
the nature and frequency of reevaluation necessary to ensure continued
acceptability of the protocol.
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E. Amendment to Proposal
When, in order to meet the Committee's requirements, there is a ma-
terial change in the protocol compared with that described in a proposal
issued to a research client, a formal amendment or revision of the pro-
posal should be prepared and forwarded to the client through normal pro-
posal channels.
VI REVIEW OF CONTINUING PROJECTS THAT INVOLVE HUMAN SUBJECTS
The continuing review of previously approved projects that involve
human subjects will be conducted by a quorum of the Committee at inter-
vals determined by the most recent assessment of risk. At a minimum,
such projects will be reviewed at yearly intervals; any potentially haz-
ardous projects will be reviewed at intervals of every six months, or
more frequently commensurate with the risk. Spot checks will be made
from time to time at the judgment of the Committee. The review data will
be kept on file. The Committee may elect to review the records of human
subject participation and may interview the investigational staff and
persons at risk as necessary.
VII COOPERATIVE ACTIVITIES
W`hen SRI -Ls to have access to human subjects through another organi-
zation, in addition to its review of any related human subject involve-
ment by SRI, the Human Subjects Committee will assure itself that the
proposed human subject involvement by the other organization is prima
facie acceptable and that it has been approved by a committee established
by the other organization to make such reviews. If the work of SRI is
sponsored by DHEW, the review committee of the other organization must
have been established according to DHEW requirements.
V111 RECORDS
Minutes of meetings are retained in the Committee files for ten
years after origination. When no project* ensues, case files will be
retained for three years. Case files that concern active and formerly
active projects will be retained for at least five years after project
completion. Principal investigators will transmit executed consent
forins to the Committee chairman to be placed in the project case file,
*The term project is used to denote any form of an activity, whether or
not under contract.
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and will keep records of subject participation in logs that are trans-
mitted to the Committee chairman prior to project completion.*
IX PRUMULGATION
Copies of this statement of policy are provided to aLl division exec-
utive directors and division business oftices. Copies are available from
members of the Human Subjects Committee and from Contract Administration
Services. Proposal authors are referred to this policy by the Request
for Review.
Consent forms and records of subject participation may be retained by
nnotner urganization when it conducts research with human subjects while
acting on behalf of or in collaboration with the Institute.
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