REQ FOR DETERMINATION INFORMED CONSENT DRUG AND VACCINES

File: 970101_sep96_decls31_0005.txt
Page: 0005
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







        past 25 years. (for additional details see BB-IND-161 and BB-IND
        3 72 3) .

        5. Militarv combat exigency

             Pentavalent (ABCDE) Botulinum toxoid will be administered to
        all service members in an area of operation who are considered at
        risk to imminent exposure to botulinal toxins. Pentavalent
        (ABCDE) Botulinum toxoid will be administered to accomplish the
        military mission and preserve the health of each service member
        and the safety of the unit of military personnel threatened.
        This will be necessary without regard to what might be any
        individuals personal preference for no vaccination or an
        alternative treatment, should any individual have such a personal
        preference.

        6. -Consideration of alternatives.

             There is no alternative prophylactic protection against the
        effects of Botulinum Toxins (ABCDE).

        7. Nature of the disease or condition involved.

             Botulism is a life threatening disease.

        S. Best interests of military personnel.

             Under the circumstances presented, withholding Pentavalent
        Botulinura Toxoid (ABCDE) from any individual service member
        threatened with Botulism toxin intoxication would be contrary to
        the best interests of that individual.

        9. Information to be provided to recipients of the IND.

             Recipients of Pentavalent (ABCDE) Botulinum Toxoid will
        receive information from the medical personnel administering the
        vaccination concerning the drug. This information will include:
        a. the fact that Pentavalent Botulinum toxoid (ABCDE) is an
        investigational new drug (IND), b. minor to moderate reactions to
        the vaccine are possible and these should be reported to medical
        personnel, c. Pentavalent Botulinum toxoid is the only
        prophylactic treatment (prevention) for Botulism. Additionally,
 remain in the immediate area
        for 30 minutes after receiving each dose to monitor immediate
        adverse effects. A 48 hour post vaccine arm examination will be
        requested. Vaccinees will be informed that they are to report
        any adverse local and/or systemic reactions that occur within one
        week after administration of the vaccine. (See BB-IND 3723
        Informational Brochure, Attachment 1).

        10. Institutional Review Board app val,

             A duly constituted and designated institutional review board
        carefully considered--the use of Pentavalent (ABCDE) Botulinum

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