REQ FOR DETERMINATION INFORMED CONSENT DRUG AND VACCINES

File: 970101_sep96_decls31_0011.txt
Page: 0011
Total Pages: 16

Subject: REQ FOR DETERMINATION INFORMED CONSENT DRUG AND VACCINES        

Unit: OTSG        

Parent Organization: HSC         

Box  ID: BX003201

Folder Title: REQUESTS FOR DETERMINATION INFORMED CONSENT DRUGS                                               

Document Number:       1001

Folder Seq  #:         16












         SGRD-HR
         SUBJECT: Minutes of the Meeting of the Human Subjects Research
         Review Board, 10 October 1990


             a. NNBC Reconnaissance Squad Operations," submitted by
         CPT Mark D. Troutman, TEXCOM Armor and Engineer Board (Log No.
         A-5133) (encl 6). It was noted that this study is completed.

             b. "Tank Combat Service Support and Mobility Test,"
         submitted by William J. Chaudoin, TEXCOM Armor and Engineer Board
         (Log No. A-5169) (encl 7). It was noted that this study is
         completed.

             C. "Protection Factor Evaluation of Foreign Respirator
         Technology," submitted by Mr. William Fritch, CRDEC (Log No.
         A-4716) (encl 8). It was noted that this study is ongoing.

             d. "Validation of Respirator Measurements Taken with an
         Automated Data Acquisition System," submitted by Ms. Linda
         Strickler, CRDEC (Log No. A-4930) (encl 9). It was noted that
         this study is continuing.

         8. Report of an adverse event in the study entitled "Effects of
         Pyridostigmine Bromide on Thermoregulatory, Metabolic and
         Cardiorespiratory Responses to Cold Stress," HURC #378, submitted
         by CPT W. Keith Prusaczyk, ms, USARIEM (Log No. A-5150) was
         presented for information (encl 10).

         9. At its 13 September 1990 meeting, the Board was to consider
         whether to modify its policy regarding pregnancy testing of
         research subjects. A decision on that modification was withheld
         until the question of reliability, sensitivity and specificity of
         pregnancy test kits could be resolved. Ms. Miller-Scott provided
         information which indicated that those test kits could detect
         pregnancy within 3 days after conception or 10 days after a
         missed menstrual period (encl 11). The test could be used the
         day of vaccine administration since results are available within
ost is $170.00 for 50 tests.     It was
         the consensus of the Board that there was no need to modify the
         policy as it is now written.

         10. The following protocols A-F (encls 12-17) were acted upon by
         the Board.   The appropriate review committees will review these
         studies annually unless otherwise stated.

             a. Protocol A - Amendment to Protocol Entitled "Interaction
         of Hydration and Metabolic Intensity on Thermoregulatory
         Responses During Exercise-Beat Stress," HURC #400, submitted by
         Michael N. Sawka, Ph.D., USARIEM (Log No. A-5300) (encl 12).

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Document 16 f:/Week-36/BX003201/REQUESTS FOR DETERMINATION INFORMED CONSENT DRUGS/req for determination informed consent drug and :12249609312932
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003201
Unit = OTSG
Parent Organization = HSC
Folder Title = REQUESTS FOR DETERMINATION INFORMED CONSENT DRUGS
Folder Seq # = 16
Subject = REQ FOR DETERMINATION INFORMED CONSENT DRUG AND
Document Seq # = 1001
Document Date =
Scan Date =
Queued for Declassification = 01-JAN-1980
Short Term Referral = 01-JAN-1980
Long Term Referral = 01-JAN-1980
Permanent Referral = 01-JAN-1980
Non-Health Related Document = 01-JAN-1980
Declassified = 24-DEC-1996