Approved For Release 2001/0 : CIA- - - pp 3/07 : CIA-RDP96-00788R001500160907-3 1, 1999 Development Command (USAMRDC) is of utmost concern to the Command, and is primarily the responsibility of the contractor or recipient who receives or is accountable to USAMRDNC for the funds awarded for the support of the project. However, the sensitivity of such research necessitates that the Command exercise prudence in its oversight responsibilities. The procedures employed shall be flexible and tailored to the requirements of the specific acquisi- tion. 2. It is the policy of USAMRDC that the Department of Health and Human Services (HHS) Regulation on Protection of Human Sub- jects, Food and Drug Administration Regulations on Investigational Drugs and Vaccines and Investigational Medical Devices, and Advertisement Guidelines for the Recruiting of Research Subjects shall be adhered to by USAMRDC contractors and recipients, with the addition of the following specific DOD/USAMRDC requirements. a. Informed consent must be obtained in advance from the subject, or in the case of research intended to be beneficial to the subject, the informed consent of the subject or a legal representative of the subject must be obtained in advance. b. Contractors and recipients shall provide all neces- sary medical care to research subjects for injury or disease which is the proximate result of participation in the research. Cc. Anatomical Substances (organs, tissues, or tissue fluids) obtained from autopsy shall not be used for research or investigational purposes without the expressed consent of the next of kin. It should be noted that a general autopsy consent may not, in itself, be sufficient. If autopsy tissue is to be used, the protocol should include a copy of the consent form used to obtain the tissue. d. Anatomical Substances (organs, tissues, or tissue fluids) obtained from a surgical procedure shall not be used for research or investigational purposes without the expressed consent of the patient or patient's legal representative. It should be noted that a consent to perform surgery may not, in itself, be sufficient. If excised tissue is to be used, the protocol should include a copy of the consent form used to obtain the tissue. e. Anatomical substances linked by identifiers to a particular person and used for research shall be donated for the purpose of research, and shall be lawfully acquired. The donor shall be the person from whom the substance is removed or, in the event of death or legal disability of the person from whom the substance is removed, the next of kin or legal representative of such person. Donation shall be made by written consent and the donor shall relinquish all ownership and/or rights to the sub- stance. If excised or autopsy tissue is to be used, the protocol should include a copy of the consent form used _ to obtain the tissue. Approved For Release 2001/03/07 : CIA-RDP96-00788R001500160007-3
Approved p For Release 2001/03/07 : CIA-RDP96-00788R001500160 007-3 £. Prisoners of war shall not be used as research subjects. g. Use of prisoners as research subjects shall follow 45 CFR 46, Subpart C. h. Studies conducted outside the U.S., its territories or possessions, which involve the use of non-U.5- citizens as subjects, in addition to compliance with 45 CFR 46 and above special DoD and USAMRDC requirements, shall comply with the laws, customs, and practices of the country jn which the study is to be conducted. The minimum standards to be adhered to are contained in the Declaration of Helsinki (Tab D)- The research proposal submitted for approval will document this action. In exceptional circumstances where laws, customs Or practices of the country involved take exception to particular procedural requirements of this provision (as, for example, the documentation of informed consent OF the procedures by which it is obtained), specific approval will be obtained from the Commander, u.S. Army Medical Research and Development Command as an integral part of proposal review and approval process. i. None of these provisions apply to epidemiological surveys involving no more than minimal risk. 4. The USAMRDC may inspect contractor records concerning human use- IV. Goals: 1. The Human Use Review and Regulator Affairs office all aspects of the USAMRDC (SGRD-HR) shall he responsible fOr extramural program involving the use of humans in research and testing, and use of human anatomical substances. SGRD-HR is specifically responsible for: a. Review of any proposal and consent form, contract, subcontract, grant, intragovernmental transfer of funds order, modification which involve the use of humans OF human anatomi substances. Review shall ensure: (1) that applicable pop directives,r Army Regulations, FDA and HHS regulations, and public laws will be complied with; (2) that appropriate validation of the human use process has occurred, and; (3) that the recipient OF contractor has an assurance of compliance with 45 CFR 46 satisfactory to the HHS, OF has provided sufficient information for negotiation with the USAMRDC of a special assurance of compliance. Approved p For Release 2001/03/07 : CIA-RDP96-00788R001500160 007-3
Approved For Release 2001/03/07 : CIA-RDP96-00788R001500160007-3 JUN 1990 b. Development, in coordination with the U.S. Army. Medical Research Acquisition Activity (SGRD-RMA), of special provisions to be included in RFPs, contracts, and grants. Develop-~ ment, in coordination with the Acquisition Management Office (SGRD-ACQ), of special provisions to be included in the BAA and intragovernmental transfer of fund orders. c. Participating in negotiations (in conjunction with SGRD-RMA or SGRD-ACQ) with prospective contractors for the develop- ment of special assurance of compliance with HHS 45 CFR 46. The SGRD-HR shall be the final approval authority for special assuran- d. Review and approval of proposals recommended for inclusion in the competitive range as a result of solicitations, and its accompanying consent form. Where applicable, advertise- ments used to recruit subjects will be reviewed. e. Assuring that all parties (e.g., contracting officer's representative (COR), Project Manager and Product Manager (PM), SGRD-ACQ, AMLO, and SGRD-RMA) are kept informed regarding issues relative to the use of humans. f. Monitoring contracts, grants, and orders funded by USAMRDC by means of documentation review or site survey (pre- and post-award) as required. g. Receiving reports of research related illnesses or injuries from principal investigators. 2. The SGRD-RMA shall be responsible for the following concerning the use of humans as research subjects or the use of human anatomical substances: a. Negotiation, in conjunction with SGRD-HR, of special assurances of compliance with regulations with prospective contrac- tors. b. Development, in coordination with SGRD-HR, of special provisions to be included in RFPs and contracts. c. When assigned contract administration, assuring compliance with contract terms. d. Approval of use of prisoners as research subjects, after review and approval of the Command Judge Advocate and SGRD-HR. 3. The SGRD-ACQ shall be responsible for the following concerning the use of humans as research subjects: a. Issuing required changes to this procedure. 4 Approved For Release 2001/03/07 : CIA-RDP96-00788R001500160007-3
Approved For Release 2001/03/07 : CIA-RDP96-00788R00150016007-3 1990 v b. Negotiation, in conjunction with SGRD-HR, of special assurances of compliance with regulations with other Government agencies. c. Development, in coordination with SGRD-HR, of special provisions to be included in intragovernmental transfer of fund orders. d. Approval of use of prisoners as research subjects, after review and approval of the Command Judge Advocate and SGRD-HR. e. Administration of intragovernmental orders to assure compliance with the order. 4. The U.S. Army Medical Materiel Development Activity shall assist and participate with SGRD-HR, SGRD-RMA, and SGRD-ACQ on all matters pertaining to the use of humans as research subjects in programs under their cognizance. 5. The Office of the Command Judge Advocate shall advise SGRD-HR, SGRD-RMA, and SGRD-ACQ on all legal matters pertaining to the use of humans as research subjects or the use of anatomical substances. 6. The appointed COR through the AMLO or PM shall assist and participate with SGRD-RMA, SGRD-HR, and SGRD-ACQ in administration of contracts, grants, and intragovernmental orders. Vv. Procedures: 1. Proposed contracts, RFPs, and proposals received under the BAA, and proposals from other Government agencies which are recommended for funding shall be reviewed by SGRD-HR prior to submission to SGRD-RMA for procurement or to SGRD-ACQ for intra- government transfer of funds. a. Clarifications or changes to proposals received in response to the BAA or from other Government agencies is the responsibility of SGRD-HR. Copies of all correspondence will be provided the affected AMLO. b. Clarification or changes in RFPs and contracts is the responsibility of SGRD-HR. All communications with the contractor will be through SGRD-RMA. 2. To permit timely award of the contract, the USAMRDC Form 9 and documentation may be submitted by SGRD-HR to SGRD-RMA or SGRD~ACOQ, even though all issues relating to the use of human subjects have not been resolved, on the condition that the Prohibi- tion of Use of Human Subjects provision will be included in the contract, grant, or order. Approved For Release 2001/03/07 : CIA-RDP96-00788R001500160007-3
Approved For Release 2001/03/07 : CIA-RDP96-00788R001500160097,3 1990 a. Comments on proposals submitted in response to specific RFPs shall be provided by SGRD-HR to SGRD-RMA prior to negotiation by SGRD-RMA with organizations in the competitive range. SGRD-HR shall provide SGRD-RMA recommendations for negotia- tion of provisions to be included in contracts to be awarded as the result of other than full and open competition, and provisions for changes or tasks after contract award. b. Upon receipt of required information, SGRD-HR shall review and approve the appropriate provision in the contract, grant, or order. c. SGRD-HR will review and approve task order protocols in accordance with the provisions of the contract. d. Upon resolution of all issues involving the use of humans in research, the clause entitled "Use of Human Subjects, Investigational Drugs, and Investigational Medical Devices" (TAB B) will be included in the contract. 3. Compliance by subcontractors with 45 CFR 46 and these procedures is the responsibility of the prime contractor, subject to the following: a. Subcontracts shall contain the prime contract clause Prohibition of Use of Human _ Subjects (Tab A) or Use of Human Subjects, Investigational Drugs, _and Investigational Medical of Devices (Tab 8B). The proposed subcontract and assurance compliance with 45 CFR 46 satisfactory to the HHS, or sufficient information for negotiation with USAMRDC of a special assurance of compliance, shall be submitted to SGRD-RMA for review and approval by SGRD-HR prior to award of the subcontract, or use of humans as research subjects. b. The SGRD-RMA will obtain comments and approval of SGRD-HR prior to SGRD-RMA approval of the subcontract or use of humans, or negotiation of a special assurance with the subcontrac- tor. c. The prime contractor shall be involved with and participate in all discussions and negotiation. Responsibility for compliance with 45 CFR 46 and this procedure shall be the responsibility of the prime contractor and  subcontractor(s) utilizing humans as research subjects. Subcontractors shall have Institutional Review Boards and follow 45 CFR 46, except under unusual circumstances where SGRD-HR and SGRD-RMA (or SGRD-ACQ) approve the prime’s assuming responsibility for the subcontractor in this regard. 4. The requirement for site visits, extent of examination of records, and discussions with researchers and research subjects Approved For Release 2001/03/07 : CIA-RDP96-00788R001500160007-3