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Subject: INFORMATION BRIEFING                                            

Unit: OTSG        

Parent Organization: HSC         

Box ID: BX003204

Folder Title: MULTISHIELD-TOPICAL SKIN PROTECTANT                                                             

Document Number:          2

Folder SEQ  #:         22








                         ELEMENTS OF DRAFT FDA REVISION
                        OF INFORMED CONSENT REGULATIONS
                                         (21 CFR 50)





                      0  Waive informed consent when not feasible AND contrary
                          to the best interests of the soldier

                      *  DoD must justify that a medical emergency exists

                      0 DoD must justify that individuals will not be able to act in
                          their own best interests

                      0  All submissions for waiver reviewed and approved by a
                          DoD human use committee

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Document 5 f:/Week-36/BX003204/MULTISHIELD-TOPICAL SKIN PROTECTANT/information briefing:11049609102626
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003204
Unit = OTSG
Parent Organization = HSC
Folder Title = MULTISHIELD-TOPICAL SKIN PROTECTANT
Folder Seq # = 22
Subject = INFORMATION BRIEFING
Document Seq # = 2
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 = 04-NOV-1996