REQ FOR DETERMINATION INFORMED CONSENT DRUG AND VACCINES

File: 970101_sep96_decls31_0012.txt
Page: 0012
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


                 (1) BOARD'S RECOMMENDATION: Approved.

                 (2) BOARD'S VOTE: Twelve in favor (unanimous).

            b. Protocol B - "Determination of Vecuronium Bromide
        Requirements in the Thermally Injured Patient,' submitted by
        CPT Roger L. Wesley, MC, USAISR (Log No. A-5403) (encl 13).

                 (1) COMMENTS: It was the opinion of the Board that
        third party consent should not be allowed in this study since
        there is no clear intention to benefit subjects who are unable to
        give their own consent. This is strictly prohibited by 10 USC
        980.

                 (2) BOARD'S RECOMMENDATION: Approved, provided no
        subject who cannot give his own consent is enrolled and the
        following additional information is submitted and revisions are
        made to the protocol and consent form:

                 (a) The name and curriculum vitae of the medical monitor
        should be provided.

                 (b) With reference to the consent form:

                 I In line 6, paragraph 1, second page, the word 'words"
        should @e changed to "works."

                 2 It is indicated in the protocol under medical
        Application that it is known that burn patients require higher
        doses of vecuronium, however, the fifth sentence, paragraph I on
        the second page of the consent form states "This study is being
        done to determine if the burned patient requires more vecuronium
        than nonburned patients." Recommend this sentence be revised to
        read "We know that burned patients need more vecuronium than
        nonburned  patients. This study is being done to determine how
        much more  vecuronium the burned patient requires.'

                 3 The last sentence in paragraph I on the second page
irectly
        from your  participation in this study; the information obtained
        will benefit future patients who are burned.

                 4 In line 3, paragraph 2, second page, the first
        occurrence of the word "you" should be deleted.


                                        4

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