Document text
Machine-read from the scan, so expect some errors. Lines that couldn’t be read are left out.
Page 1
MEMORANDUM THRU Military Ergonomics Division SUBJECT: Report of the Human Subjects Research Review Board 1. Your protocol entitled, "Interaction of Hydration and Metabolic Intensity on Thermoregulatory ResRonses During by the HQ USAMRDC Human Subjects Research Review Board, provided revisions are made t o the consent form and additional information is submitted as noted in enclosure. 2. Upon receipt of your revised protocol, I the Human Use Office at our Headquarters for their final it to
Page 2
DEPARTMENT OF THE ARMY OFFICE OF THE SURGEON GENERAL FALLS CHURCH, VA 22041-3258 MEMO ~ ANDU HFOR Commander, U.S. Army Research Institute of Environmental Medicine, ATTN: SGRD-UE-Z, SUBJECT: Protocol Entitled "Interaction of Hydration and Metabolic Intensity on Thermoregulatory Responses During 9 May 1990 meeting of The Surgeon General's Human Subjects Research Review Board (HSRRB) which refers to the subject approved by The Surgeon General. Enclosed is a copy of the portion of the minutes of the 2. Subject protocol was approved with the stipulation that additional information is provided and revisions are made to the consent form. These revisions should be submitted to the Human 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 i n the enclosed excerpt 4. Please contact Ms. Marty Myers at AuTOVON 343-2165 or (301) 663-2165 if questions arise concerning this matter. Chief, Human Use Review and Regulatory Affairs Office
Page 3
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 following additional information is submitted and revisions are made to the consent form: should be provided. (a) The name and curriculum vitae of the medical monitor (b) When available, a copy of the Boston University Medical Center Institutional Review Board approval of this study should be provided. ( c ) With reference to the consent form: 1 The words "breathe" in paragraph 5 , line 13; "rebreatEe" in paragraph 5 , line 14; and "especially" in paragraph 6 , line 5 on the third page are misspelled. A l s o , the word "and" in paragraph 6, line 2 on that page should be deleted. paragrapE 3 on the fourth page of t h e total volume of blood to be drawn over the entire study. 2 Suggest that subjects be informed, in lay terms, in
Page 4
(t) TG i mme a i at ely repcrt ky telephone (AtJTOVON 343-2165 o r (301) 663-2165) (non - duty hours call AUTOVOM 343-7114 or (301) un expect ej a averse exF erie n ces which occur to the human suk j ect Le act is r, getcrt (CrLgs arid Eia ic gic s))sli cula be ussd and a writ tc n report will follow the initial telephone call within3 (6) Tc preF are,at a Fin in urn, arr annual Fro s res s rer crt cr fir,ai re,-crt in acc cr dance with Title 21, Coae of Fed era ! or cltner oG t side govern nc - n tal agency concerning clinical in vc stica tic nor research. * The fo llc win c definitions are found in Title21, Code of Federal sugs ~ s t sa significant hazard,contra indica tic n,tice eft ect lor ac vcr scG rt.9experience in ci ude sanya c verse drug exF erie n ce that in pat iGn th cz gita ii z ation, cr is acc n genital anomai;:, caf ice r,cr
Page 5
1. Reference Memorandum, SGRD-UE-2, 27 Feb 90, subject : Report of t h e USARIEM Human Use Review Committee - HURC, and Decisions and 2 . The suggested changes in the protocol,lt Interaction of Hydration and Metabolic Intensity on Thermal Responses t o ExerciseHeat Stress’l. (RE-3-90, HURC 1400) have been made and are detailed on the enclosed sheet. Encl Chief, Physiology Branch
Page 6
1. The protocol now conforms tothe Type Protocol for heart rate 2.a.l. The protocol and consent form indicate that testing my 2.a.2. No, the dehydration sessions and Heat Stress Tests will occur on separate days.This has been explained better, and I now state that only two Heat Stress Tests will be conducted ina giver, 2.a.3.Itis now stated that approximately 10additional he z t acclimation sessions will be completed. The protocol and con sex forn have been modified to address this point. 2.b. The. protocol now states that atleast one week will space each of t h e 6 € hypohydration Heat Stress Tests. 2.c. The protocol now states that they will perform several hours of light intensity exercise. environment, which has been added to the protocol. 2.e. The statement has been added to the protocol and consent 2.f.Infection has been added as a risk to the protocol and The biological half lives have been added to the protocol and 2.h. This has been modified as suggested. 2.i.This statement has been corrected. 2.j. These terms and others have been changed t o be less 2.k. These examples have been added t o t h e consent form,