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MEDDl1- J A Research Us e of Human Subj ects Chief, Operations & Programs Judge Advocate G February 1969 regarding a DF from CRD, undated. subject as above, which forwarded a Staff Study written by COL Herbert L. Ley, Jr., MC, dated 7 January 1969, subject : Review of Department of the Amy Policy on Use of J-bman Subjects in Research, Reference i s made t o DD Form 95, dated 31 January 1969, requesting comments recommended by COL Ley i n paragraph 5b(l) is the best first st cr in a complete program of DA review of extramural, i.e., contract and grant,research with humans. (In tr arm ral research is adequately covered in existing regulations .) the contract is awarded. step,although coordination with the AID RR(for extramural research involving drugs) would have tobe expedited i n order notto hold up award of the contract. step should be random pos t-award "surveillancetf by project officers,contract personnel, and attorneys. 3. There i s no legal objection to the changes recommended by COL Ley i n paragraph Sf. however, that this is potentially an explosive area and a highly sensitive one. Regarding COL Howie's first question i n paragraph 3a of the DF: The course The second ste should be review of the policies and procedures of the hopeful contractor +e ore The Contract Review Board is an i d e a l mechanism -is Regarding COL Ilowie's second question i n paragraph 3b: I t should be noted, above, the Contract Review Board is considered an ideal instrument for medical-legal review of extramural research but not llallTtr e search (if lt all t tincludes intramural research). As COL Ley points out, AR 70-25 is " basically sound," and AR 40-7 is required by t h e DoD-DIiEIJ Memorandum. Regarding COL liowie's third question in paragraph 3c: As stated in paragraph 2 Thus, intramural research is well covered. Other points about COL Ley's study are offered: a. Paragraph 5c - Al: 40-7 is presently in revision(at the direction of the h . Paragraph 5d - The AVP case mentioned by COL Ley indicates a "thing" ;nay well be a trdrugft as well as a "device." of that regulation suggests a definition for fldrugf' which could include "devices ." Thus, AMEDD will have the method a t hand to regulate the use of "drug-devices." Ihe present AR 40-7 definition of ltdrug,f' However, the proposed revision Washington National Record Center Oflice of the Army Surgeon General