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MEMORANDUM THRU Director, Military Ergonomics Division SUBJECT: Report of the Human Subjects Research Review Board 1. Your protocol entitled, "Interaction of Hydration and Metabolic Intensity on Thermoregulatory ResEonses During by the HQ USAMRDC Human Subjects Research Review Board, provided cevisions are made to the consent form and additional information is subm$tted as noted in enclosuge. 2. Upon receipt of your revised protocol, I will forward it to the Human Use Office at our Headquarters for their final
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OFFICE OF THE SURGEON GENERAL FALLS CHURCH, VA 22041-3258 MEMORANDUM FOR Commander, U.S. Army Researc.. Institute of Environmental Medicine, ATTN: SGRD-UE-2, SUBJECT: Protocol Entitled "Interaction of Hydration and Metabolic Intensity on Thermoregulatory Responses During 1. Enclosed is a copy of the portion of the minutes of the approved by The Surgeon General. 2 . Subject protocol was approved with the stipulation that Use Review and Regulatory Affairs Office within thirty days. Research may not commence until the investigator receives acknowledgement from this office that the revisions have been received, and that they meet the requirements of the HSRRB. 3 . Change of investigators for investigational drug and device protocols must be reported immediately. Other responsibilities of principal investigators are outlined in the enclosed excerpt ~ c o n s e ~ n ~"ma.-These revisions should be submitted to the Human Chief, Human Use Review and Regulatory Affairs Office I
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SUBJECT: Minutes of the Meeting of the Human Subjects Research Review Board, 9 May 1990 13. The following protocols A-H (encls 19-26) were acted upon by the Board. The appropriate review committees will review these studies annually unless otherwise stated. Intensity on Thermoregulatory Responses During Exercise-Heat (1) BOARD'S RECOMMENDATION: Approved, provided the following additional information is submitted and revisions are made to the consent form: should be provided. Th6 name and curriculum vitae of the medical monits3 r d 4 Medical Center fnstitutiona Review (c)p With reference to the consent form: ' paragraph 6, line 5 on the third page are misspelle:.w-^Also, the paregrapii-+3A,on.the fourth page of the total volume of blood.to&e 2 Suggest that subjects be informed, in lay terms, in
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EXCERPT FRCK OTSG REGULATION 15-2, 11 JANUARY 1988 RES PCI J SIE ILI TIES OF PRINCIPAL INVESTIGATOR TO h ~ + iri ? nt irn ried i ate hazards to the human s uc je ctor c the rs. (301) 663-2165) (non - duty hours call AUTOVOM 343-7114 or(301) 663 - 7114 antli ask tor the USAfJRLC duty officer)s eric us or cn expect ea a averse experiences which occur to the human suk j ect written report will follow the initial telephone call within3 fir,a i report in acc cr dance with Title21, Coae of Federal conF li ance inspect i cn by the Food and Drug Administration(FCA) or other oLt side govern nen tal agEncy concerning clinical invEst ica tic nor research. (a) " Serious adverse experience " means any ex serie n ce that a cve rsc ; rug c xp ori ecce includes any acv sr se drug ex per isn ce that in p tien thc spit a ii z ation, cr is acc n genital a no mail.,cancer,cc e x [ ; Erie n ce that is not identified in nature,severity, or i r : vest iga to rbr c chur e is not required,that is nc t identifies in nature,severity,or frequency in the risk in for nation Ces crib id in the general invest ig at is calF ls ncr elsewhere in the current app lick t icc,as amerided.