October 15, 1971 Aye fas ec: Dr. Sonc Mr. Finn Dr. Aronson RESEARCH INVOLVING MEMAN SUBJECTS Any reasearch project, program or experiment which involves humen. subjects sust be approved by © review coamittee priur to the initiation of the study. This commttec will be appointed by the Director of tue Luboratory and will evaluate the riaks, benefits, en: safecuacds to the subject's asalth, safety and rivht to privacy. The comnittea shall ve so couposed taut only persons who are independent of the study in question shall sit at a given meatin:. The make-up ana responsibilities of tha committee shall ba consistent with the directives of the Feceral Foo! ans Dru: Adminiatration, the Departuent of Health Education. and Welfsze an. the Atomic Ener. Commission (see: Protection of gEhe individual ae o ResearchBuvject, U. 5. Dept. Hadlti, Education, an Welfare, PHS, May 1, 1964; Fesaral Re-israr, 3£, °03°<5050, L./1; HB! Policy Statement on Patient Corsent, HE Grants Adwinistration Manual, le4ue0!' through 140050.) Informetive rvecorcég of -eviews anc decisions shall he sept b che Comeittes anc contiouin, review si the studies shall be osde at sppropriate intervals uot to exceec one year, The principa! investic-ator involve: shall initiate Gouslttes review by submission oc the experimental desi-n, description end pretecel to his or her Depsrtment Chairman, who will, afte> avaluation, aither forvard the study to the Com:itres fer review oz return it to the principel investigator. Followin: its review, the Comaittee will return the proposal to the Depart- ment Chairmen recommendin: either approval or rejection, and the Chairman shall either approve the study or reject it. be adequately explained. Reesons for vajection of a proposal sball Wo project may be put into action withour the recommands- tion of approval by the Commitces. The project director or principal invegtiseator cust report cto the Comaittes anu? problems which arise or significant changes in procedure vhich eccur during the course of the experiment. BEST COPY AVAILABLE