REQ FOR DETERMINATION INFORMED CONSENT DRUG AND VACCINES

File: 970101_sep96_decls31_0014.txt
Page: 0014
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


              d. Protocol D - nPlacebo-Controlled Double Blind Study to
          Determine the Efficacy of Topical Niclosamide 1% Lotion in the
          Prevention of Naturally occurring Schistosomiasis in Egyptian
          Farmers," submitted by P. K. Podgore, D.O., USAMRU-3 (Log No.
          A-5410) (enci 15).

                  (1) BOARD'S RECOMMENDATION: Approved, provided the
          following additional information is submitted and revisions made
          to the consent form:

                  (a) The curriculum vitae of the medical monitor should
          be provided, when available.

                  (b) With reference to the consent form:

                  I It is stated on page 12 of the protocol that urine and
          stool collections will occur when lotion application begins, six
          weeks thereafter and at four-week intervals after that. Item 3e
          of the consent form makes reference to provision of stool and
          urine specimens every other week. Please clarify.

                  2 Subjects must be provided a copy of the form; a
          statement to that effect must be included.

                  3 A space should be provided for the typed/printed
          address of the,subject and the typed/printed name of the witness.

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

              e. Protocol B - "Safety of an Equine Heptavalent Botulinal
          Antitoxin in Humans,' submitted by LTC Maria H. Sjogren, Mc,
          USAMRIID (Log No. A-5412) (encl 16).

                  (1) BOARD'S RECOMMENDATION: Approved, provided the
          investigators understand that the study may not begin, even with
          approval by The surgeon General, until 30 days after the
          Investigational New Drug (IND) application has been received at
ve
          been raised by FDA to its implementation. The minutes of the
          USAMRIID Scientific Review Committee at which this protocol was
          Considered should @e orovided, when available.
                               1

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


                                         6

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