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OTSG Regul rl tion Boards, Comnissions and Committcds a . DOD Instruction 5030.29, 1 2 May 1964, " Invest i eat ional Use of Drugs bythe Department of Defense. 8 October 1975, "Use o f Human Subjects in Xesearch, Development, TesC 2nd i n Humans and the Use of Schedule I Controller : Substances. " r rc qu cst s for approval of Tiif Surgeon General tor the participation afn man subjects in bio cedi c zl and h chav i oral rc sea rc il,develop n cnt, test or eva lu - ation activities,inc1u ding hospital cl iriiccil invest ie ation projects, conducted within or funded by the Dcpartinmt of the Army.I .
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3. BOMD RESPONSIBTLTTIES. The Board is the principal body of the Office of ??le Surgeon Geiiernl (OTSG) for assessInent of practices and procedures by which the US Army employs hum n subjects in research, development, test and evaluation activities,including but not limited t3clinical investigation activities. The Board will consider and recommend policy to The Surgeon Gen cr alto maintain the quality of practices consistent with contemporary moral,ethical and legal standards. types of research protocols involving human subjects and make recommendations on them for appr ov nl / d is a opr oval to The Surgeon General. The Board will consider the following a. The Board will act as the Army Investigation al Drug Review Board on investigation al drug proposals submitted under provisions of AR 40-7 and DOD Instruction 5030.29 (reference la and le). b . The Board will review hospital clinical investigation protocols re qui i ing Board review under provisions of AR 4 0 - 38. C . The Board wi1.l review protocols submitted under provisions of AR 7025(reference IC) at the request of the Assistant Surgeon General for Research 4. BOARD ?IE\lEFRSHIP. The Board will consist of the following members appointed by The Surgeon General: r - (1) The Assistant Surgeon General for Research and Development (ASG/R&D) or his design ee as Chairman. , (2). Chief, Human Use Review Office,Office of The Surgeon General. (3) Atleast three other members who are physicians and qualified to evaluate research Fr z pos als.Atleast one of these members should be a Boar@ certified specialist in surgery and another in internal medicine. (4) The Pharmacy Consultant,Directorate of Kea;-!: Care Operations. (5) Tvo members pro Ees sion d ly qua liE icd in the behavioral or allied (6)A Chaplain or other member ofthe Clergy. (7) Judge Advocate, US Amy Medic31 Research and Development Coinrand. (8) Another member qu al if icd to evaluate the acceptability of research proposals in tcnns of community act i tudes.
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(1) Investigation al Drug Review Officer, Amy Invest i eat ional Drug RevLcv Board or another officer of the Human Use Review Office who acts as (2) Principal Investigator(s) may be invite Z ' to attend meetings of the Board at the discretion of the Chairman. c. Alternates. Two alternates will be designated for each rcember t o h sure adequate representation at Board meetings if the voting members are unable to attend. Voting members will nominate their alternates € or approval by t h e Board Chairman. &on& with the permanent members to gain familiarity with Board policies and Alternates will be encouraged to attend Roard meetings d.Consultants. The Chairman orthe Chief ofthe Hunan Use Review Office may request verbal or written con suit ation on medi.ca1 - scientific or ethical - legal matters from qualified military or civilian specialists. we. Ad Hoc Subcommittees. The Chairman may appoint subcommittees o f the Board to consider special issues or special types of research protocols and make recomnendations to the entire Board. Subcommittees may consist of must be a permanent voting Board member. permanent or alternate members but atleast one member of each subcommittee c a.Initial Protocol Review. Upon receipt of an application for approval o f The Surgeon General to use humans as research su hj ect s,whether or not useof ai: invest iz at ional drug is proposed,the application will be ' sent to HQDA (DASG-RD-Hd) NASH DC 20314. Applications for use of investigation al drugs submit tz d under Dr o visions of Ail 40-7 will be reviewed by the Investigation al Drug Review Officer, Army Invest i Rational Drug Review Board. Other proposals will be appropriately processed by other Human Use Review see map prop ria r2to the Chief, Human Vse Review Of rice art he Board Chaim.an. The Human :'se Review Office will request clarification or comments from protocol xth or s when they are required for further processing. .b. Board X ee tings. !;:lien Roard rcvi ~ wo f :i protocol is required by Army r e - gul ation, the Ilunan Use Review Oli icc will idrward cop ics to Board mcnbers for review prior to the meetings.The Cli air mn n will set the time of the meetinK, and tlic Human Use Heview OZEice will mikc necessary arrangements
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c. Voting on Board Recommc'hdations. A Board decision will be based on a simple majority vote of members present. membc'rs. An opinior: from the Judge Advocate or his representative will be re quir cd be for ra formal Board dk c is ion can b e made. This opinion may b e submitted to the Board in writ hg if.the legal representative is unable to which will be incorporated into minutes of the meeting for presentation to The Quoru!il will consist of line Disse ? ting,opinions will be presenceed along with Board recommendations d. Approval of Board Recommendations. The Surgeon General or his design ee .of there csn n end at ions of the Board as stated in the minutes. e . OTSG Approval of Low Risk Clinical Investigation Protocols Previously Clinic a lApproved by Yledical Center Coma it tees Under Provisions of AR 40-38. Investigation Protocols involving human subjects in low risk studies, which neither involve invest.ig ation a1drugs nor other vise require formal Board approval under provisions of AR 4 0 - 38,ma v ordinarily be approved by the Chief,,. Human Use Rcview Office under the. direction of the Assistant Surgeon General for Research and Developnent. Eszmples o f low risk stud ics are those in vol v - (1) Analysis of hair and nail clippings collected in an on disfiguring manner and the analysis of deciduous teeth. .- (2)Collection and analysis of excreta and external secretions ineluc!ing feces, urine, sweat, saliva, ceruaien and tears or swab cultures px i mens of (3) Recording of data by physical sensors applied either superficially or at a distance and which do not inv,olve significant input of energy in t,, the subject. Such procedures include,but are not necessarily limited to electro myo graph y and detection of naturally occurring radioactivity. (4)Collection for analysis oE blood samples by veni puncture,in amounts not exceeding450ml in a six week period, from subjects 18 years of age and over who are not anemic. or th crap zu tic procedures or comparisons oE two o r more gc ncr all yz cc ep ted alternate proc edu rcs. Such studies m3y be approved only after it has been determined that the siro to - col contains a de qin te provisions for oh ta icing the f rer, informed, vo tun tar v consent of the s uh.jects and that tlic protocol Ims been approved by il prop, ~ rly constituted ho spit ; ll Clinical In vc stig a tian Conunittee and llumnn Use Committee.
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.Protocols which appear not to conply with Army regulations or which involve substantive issues related to OTSG policy on use o E hurnan subjects will be presented to the Board for action. protocols approved under provisions of this sect inn. At each meetisg o f Llie Board, tte Chief, f. Records Retention. The Human Use Revieit Office brill main t - i n official files of the actions of the Board and The Surgeon General on proposals for three years after the completion of the project,or rejection - of the app lica tic n. year period to the Washington X at ional Records Cater IAN AR 340-15-1. The Investigation al DruS Review Officer, Army In v z stig at ional Drug Review Board, will maintain the official files on invest cg at ional drug projects. Records will be permanently retired after this three, g.Processing Reports. The Human Use Review Office will review clinical investigation reports submitted under pn visions of AR 40-38 and reports on investigation al drugs submitted under ?r.ovisions of AR 40-7. The Fluman Use Review Office will arrange for appr3pri a tees pert professional review of such reports and will take appropriate action td bave authors COI ~ C C ~d ef ici enc ies. The Human Use Review Of fic z will present invest i - gat ional drug reports to the Board along with reE arch proposals if the investigator plans to chanse the protocol in the coming year. The Human Use Review Office will also bring to the Board ' s attention any reports which disclose unusual or untoward reactions or my other reports at che dis - c re tion of the Board Chairman. Annual reports or other information required by the Food and Drug Ada in is t ration on Depart nr ns of the Army Investigation al New Drug ApT li cations (ISD'S) may be released to the Food and Drug Administ ration on behalf of The Surgeon General by the 3oard Chairman actin;: as the Chairman, Army Investigation al Drug Review Brrard. Lieutenant Colonel, YSC Assistant Fzecutive Officer Assist an : Executive Ofricer