Boards, Commissions and Committees Human Subjects Research Review Board

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DEPARTMENT OF THE ARMY OFFICE OF THE SURGEON GENERAL Boards, Commissions and Committees HUMAN SUBJECTS RESFARCH REVIEW BOARD a. DOD Instruction5030.29.12 May 1964, " Investigation al Use of Drugs by the Department o f Defense." , E. Amy Regulation 70-25, 31 July1974. "Use o f Volunteers as Subjects d. US Army Medical Research and Development Comand Regulation 70-25, 8 October 1975, "Use of Human Subjects in Research, Development. Test and c e. Army Regulation 40-7. 4April1975. "Use of Investigation al Drugs i n Humans and the Use of Schedule I Controlled Substances." f . Army Regulation 40-38, 2 3 February 1973, "Clinical Investigation h. DA Message, 1220442 September 1975, " Interim Change t o AR 40-38." 2 . PURPOSE. This regulation establishes the Human Subjects Research Review (reference lg) and establishes procedures t o be followed upon receipt of requests for approval o f The Surgeon General for the participation of human * subjects in biomedical and behavioral research, development, test or evaluMion activities,including hospital clinical investigation projects, conducted within or funded by the Department of the Army. DA Message, 15,15302 July 1975. " Interim Change to AR 40-38." . Board (here in called the "Board") as required by paragraph 7 , AR 40-38 , ' Whio re gul at ton supersedes OTSG Regulation 7 0 - 4.7 December 1972. and OTSG Memorandum 1 5 - 4 , 2 April 1974.

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3. nOARD RESPONSIBILITIES. The Board is the principal body of t h e Office of me SUrgMn General (OTSC) for assessment of practices and procedures by which t h e US Army employs hrnnan subjects .in research, development, test and evahation activities, including but not limited t o clinical investigation . kneral to maintain the quality of practices consistent with contemporary mrd, ethical and legal standards. type0 of research protocola involving human subjects and maka recommendations The Board will consider and recommend policy t o The Surgeon The Board will consider the foliowing a.. The Board will act as the Army Investigation al Drug Review Board on laws tiga tion81 drug proposals submitted under provisions of AR 40-7 and DOD Instruction 5030.29 (reference l a and le). b. The Board will review hospital clinical investigation protocola roquiring Board review under provisions-of AB 40-38. c. me Board w i l l review protocols aubmitted under provisions of AR 7025 (reference lc) atthe request of the Assistant Surgeon General for Research appointed by The Surgeon General: The Board will consist of the following members (1) The Assistant Surgeon General for Research and Development (ASC/R6D) orhis designee 80 Chaftman. Chief, Human Use Review Office, Office of The Surgeon General. A t least three other members who are physicians and qualified to evaluate research proposals. A t least one of these members should be a Board certified specialist in surgery and another in dnternal medicine. The Pharmacy Consultant. Directorate of Health Care Operations. Two members professionally qualified in the behavioral or allied A Chaplain or other member of the Clergy. Judge Advocate, US Army Medical Research and Development Cornand. Another member qualified to evaluate the acceptability of research . proposals i n terms of cornunity attitudes.

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(1) Investigational Drug Review Officer. Army Investip.ationa1 Drug Review Board o r another officer of the Human Use Review Office who acts as (2) Principal Investigator(s) may be invited t o attend meetings of the Board at the discretion of the Chairman. E. Alternates. Two alternates will be designated for each member t o iiisure adequate representation a t Board meetings i f the voting members are by the Board Chairman. along with the permanent members t o gain familiarity with Board policies and Voting members will nominate their alternates €or approval Alternates will he encouraged to attend Board meetings d. Consultants. The Chairman or the Ch bf of the Human Use Review Office nay request verbal o r written consultat%mn on medical-scientific or ethical-legal matters from qualified military or civilian specialists. e. Ad Hoc Subcommittees. The Chairman may app o ik subcomittees of the Board t o consider special issues o r special types of research protocols and make recommendations t o the entire Board. Subcommittees may consist of petlpanent OK alternate members but atleast oncmember of each subcommittee aunt be a permanent votlng Board member. a.Initial Protocol Review. Upon receipt of an application for approval of The Surgeon General t o use humans a s resear& subjects, whether o r not use of an investiqational drug is proposed, thr application will be sent to HQDA (DASC-RD-HR) WASH DC 20314. Applications for use of investigational drugs subnitted under provisions of AR 60-7 w i n be reviewed b y :he Investigational Drug Review Officer, Army Investigational Drug Review Board. Other proposals w i l l be appropriately processea by other Human Use Review aeems appropriate t o the Chief., Human Use Rev-Office or the Board Chairman. The Human Use Review Office will request clar m cation or co ante from protocol authors when they a r e required for fumher processing. Protocols will be sent to wasultants for review if this b. Board Meetings. When Board review of P protocol is required by Army regqlation. the Human Use Review Office will bard copies to Board members for review prior to the meetings. The Chai-will set the time o f the .we ting, and the Human Use Review Office willmtlre necessary arran gd ut s

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c. Voting on Board Recommendations. A Board decision w i l l be based on a simple majority vote of members present. votlng members or alternates of which st least three must bo permanent voting members. An opinion from the Judge Advocate orhis representative will be required before a formal Board decision can be made. submitted to the Board in writ lng if the legal representative is unable to which will be incorporated into minutes of the meeting for presentation t o The Quorum will consist of nine This opinion may be Dissenting opinions w i l l be Dresented along with Board recornendations d. Approval of Board Recoumendationa. The Surgeon General or h i s designee will indicate, i n writing, his approval, i n whole or in part, or his disapproval of the recommaadations of the Board as stated in the minutes. Clinic a lApproved by Medical Center Committees Under Provisions of AR 40-38. Investigation Protocols involving human subjects in low risk studies, which neither Involve in vee tip t ional drugs nor othervise require formal Board approval under provisions of AR 40-38, may ordinarily be approved by the Chief, Ilmn Use Review Office under the direction of the Assistant Surgeon General €or Research and Developacnt. lag the following procedures: i Examples of IOUt iv k studies are those 1nvoI.vmanner and the analysis of deciduous teeth. Analysis of hair and n a i l clippings collected in s nondisfiguring Collection and analysis of excreta and external secretions including feces, urine, meat,saliva, cerumen and tears o r suab culture specimens of or nt8 distance and which do not invol-re significant input of energy into the eubject. Such procedures include, but are not necessarily limited t o weighing. electrocardiography, electroencephalography, echocardiography, electromyography and detection of naturally occurring radioactivity. Recording of data by physical 'sensors applied either superficially (4) Collection for analysis o€.blood samples by venipuncture, i n amounts not exceeding 450 ml i n n e i x week period, from subjects 18 years of age and over who a r e not anemic. (5) Studies involving generally accepted, medically indicated diagnostic o r therapeutic procedures or comparlsons of two or more generally accepted alto mate procedures. Such studies may be approved only after it has been determined that the protocol contains adequate provisions f o r obtaining the free, informed, voluntary consent of the subjects and that the protocol has been appfpved by a properly constituted hospital Clinical Investigation Committee and Human Use Committee.

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ProtoCole which appear not to comply with Army regulations or vhich involve nubstantive issuea related to OTSG policy on use of human subjects will be prcnented t o the Board for action. Human Use Review Office, w i l l provide the Board with information about protocol8 approved under provisions of this section. A t each meeting of the Board, the Chlef, f . Records Retention. The Human Use Reviev Office will maintain official files of the actions of the Board and The Surgeon Gene'ral on proposals for three years after the completion of the project,or rejection of the application. Records will be permanenrly retired arter chis three year period to the Washington National Record8 Center IAW AR 340-18-1. The Investigational Drug Review Officer, Amy Investigational Drug Revlev Board, vi11 maintain the official files on invesciRationa1 drug projects. g. Processing Reports. The Human Use Review Offkce will review clinical investigation reports submitted under provisions of AR 40-38 and reports on investigational drugs submitted under provisions of AR 40-7. The Human Use Review Office will arrange for appropriate expert professional review of such reports and will take appropriate action to have authors gational drug reports t o the Board along with research proposals i f the investigator plans t o change the protocol in the coming year. Use Review Office will also bring t o the Board's attention any reports vhich disclose unusual o r untoward reactions OK any other reports a t the dis - cretion of the Board Chairman. Annual reports or o t h e r information required by the Food and Drug Administration on Department of t h e Army Investigational New Drug Applications (IND'a) may be released to the Food and Drug Administ ration on behalf of The Surgeon General by the Board Chairman acting a s the Chairman. Array Investigation al Drug Review Board. 6. Effective date €or implementation of this board is 1April 1976. Tke Human Use Review Office will prasant investiAesistant Executive Officer Assistant Executive Officer