FR SEE PUD Approved For Release 2003/09/16 : CIA-RDP96-00788R001100440002-1 AV MES PP APIOUL PAAR EAL NAR ORID TEC 7UECEE Prnberergy REQUIREMENTS GOVERNING Prapie ACTIVITIES WITH HUMAN SUBJECTS POrIC FO Bye ¢ REVIStt) Complete Revision May 2, 1977 PAGE [ty 1 I SCOPE This policy statement applies to all uses of human subjects at or under the sponsorship of Stanford Research Institute. It is intended 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 activity. an individual ls considered to be at risk if he or she ‘may be exposed to the possibil- ity of injury, including 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." Il STATEMENT OF PRINCIPLES SRI adheres to the statement of principles issued by the World Medi- cal Association, 184] 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. IIl 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 that ; 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 ve reversed by’a subsequent vote of the Committee on the basis of additional information or revision of the question. haastrntinieiaetammetemneenmeeteemeeme naan enramete Tl Ititle 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 (FDA d pABde dF GP Relea bee2doH/ 09706 y CHA-RDR9GCEOZ88R001100440002-1
Approved For Release 2003/09/16 : CIA-RDP96-00788R001100440002-1 TOPIC NO. 312 PAGE NO. 2 Tne 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- bility, except to provide information as requested. LE 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 SRL 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 ie 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 reaches the 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 acceptability 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 of the Human Subjects Committee, who will advise the proposal author and division executive director regarding the submission of a Request for ke- view. The completed Request for Review, inc Luding supporting attachments, will be submitted to the Committee via the division executive director. If the divigimmvac orineldise 2003 /69PR3t CIAAREP OG! 90410844000 subjects, he or she will sign and forward the Request for gG7t08 to 5
Approved For Release 2003/09/16 : CIA-RDP96-00788R001100440002-1 TOPIC NO. giz PAGE NO. 3 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 teasonably be done and client Tules permit,? the proposal may be submitted with appropriate 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. Determining 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 | of this policy. Those cases that are found to place the subjects at risk will be processed as provided below. VY 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 procedure 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 protection afforded the tights and welfare of the subjects. rien “However , when 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 soem proved Cor Males te Soda bgII6 {°@At-SP96-00788R001100440002-1
Approved For Release 2003/09/16 : CIA-RDP96-00788R001100440002-1 TOPIC NO. &l2 PAGE NO. 4 This 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. Approved For Release 2003/09/16 : CIA-RDP96-00788R001 100440002-1
' Approved For Release 2003/09/16 : CIA-RDP96-00788R001100440002-1 TOPIC NO. 812 PAGE NQ. S 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. Cc. 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. Lf& 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 co 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. Approved For Release 2003/09/16 : CIA-RDP96-00788R001100440002-1 woe ee
Approved For Release 2003/09/16 : CIA-RDP96-00788R001100440002-1 Toric NO. 812 PAGE NO. 6 BE. 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 When SRI is 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 nave been established according to DHEW requirements. VIII 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 forms 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. Approved For Release 2003/09/16 : CIA-RDP96-00788R001100440002-1