REQ FOR DETERMINATION INFORMED CONSENT DRUG AND VACCINES

File: 970101_sep96_decls31_0015.txt
Page: 0015
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



             f. Protocol F - "Administration of Pentavalent Botulinum
           xoid to At-RiSk Individuals During Operation Desert Shield,
           bmitted by LTC Kelly T. McKee, Jr., MC, USAMRIID (Log No.
           5413) (encl 17).

                 (1) COMMENTS: During the discussion of this protocol,
         LTC Sisson gave a summary of the status of DOD's request that the
         Food and Drug Administration (FDA) grant a waiver of the
         requirement to obtain informed consent (21 CFR 50) in view of the
         unique circumstances posed by operation Desert Shield. He
         explained that FDA had drafted a regulation to allow for that,
         but that the draft had been held up because the Department of
         Health and Human Services had asked the Justice Department for a
         legal opinion on the issue. The subject of 10 USC 980 has been
         raised as a roadblock, but that statute covers 'research," and
         what is proposed is not research; it's treatment. In any case,
         the Department of Justice is expected to render an opinion this
         week or next. While the laws allowing a physician to administer
         investigational drugs as the practice of medicine will provide us
         an exemption for some of the other investigational products we
         plan to use during Operation Desert Shield, because those are
         routinely used in the practice of medicine, those laws would not
         apply in the case of botulinum toxoid. The Department of Defense
         must have written permission from FDA that they consider it safe
         to proceed with such studies. Lieutenant Colonel Sisson pointed
         out that the FDA will rely heavily on the HSRRB'S opinion as to
         whether it feels it is reasonable to waive the obtaining of
         informed consent and why it feels it is not reasonable to obtain
     that consent.

                 (2) BOARD'S RECOMMENDATION: Approved, provided the
         investigators understand that the study may not begin, even with
         approval by The Surgeon General, until the FDA grants permission
         to waive the requirement to obtain informed consent. The minutes
         of the USAMRIID scientific Review committee at which this
         protocol was considered should be provided, when available.

                  (3) BOARD'S VOTE: Eleven in favor (Ms. Miller-Scott
         abstaining).

              ropies of four Operation Desert Shield protocols were
         distributed to Board members for a meeting to be held the week of
         14 October 1990.




                                         7

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