REQ FOR DETERMINATION INFORMED CONSENT DRUG AND VACCINES

File: 970101_sep96_decls31_0013.txt
Page: 0013
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


                   5 In line 1, paragraph 1, third page, the word "be"
           should 6e- deleted.

                   6 It is suggested that the phrase "which may relate to
           your wil7lingness to further participate' in lines 12-13,
           paragraph 3, third page be deleted.

                   (3) BOA.RD'S VOTE: Twelve in favor (unanimous).

              c. Protocol C - "Selection of Live Attenuated Dengue Vaccine
           Candidates," submitted by Carol 0. Tacket, M.D., University of
           Maryland (Log No. A-5407) (encl 14).

                   (1) COMMENTS: Members felt a statement should be added
           to the consent form describing the procedure to be followed if a
           subject wanted to withdraw from the study after having received
           vaccine and while in the isolation ward.

                   (2) BOARD'S RECOMMENDATION: Approved, only for the
           portion of the study to be performed at the University of
           Maryland, provided the following additional information is
           submitted and revision made to the orotocol and consent form:

                   (a) If an advertisement is to be used to recruit
           volunteers for this study, a copy should be provided for review.
           Also, a copy of the test to be given to volunteers to assess
           comprehension of the study should be provided.

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

                   (c) The exclusion criteria on pages 10-11 should
           indicate that subjects who are allergic to or have suffered a
           reaction to neomycin, other similar antibiotics such as
           streptomycin or gentamicin, or have suffered a reaction to a
           similar vaccine will be excluded.

end
           of paragraph two under Design of the Experimental Clinical Trial
           in the consent form: Should you elect to withdraw from the study
           after receiving t-he @i-iccine for any re,-son, 7ou ,iill be stroncly
           encouraged to have follow-up medical attention.
                   (3) BOARD@S VOTE: Twelve in favor (unanimous).


                                            5

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