Human Use Committee Guidelines for the Preparation of Protocols

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Each protocol submitted for review must contain infomation in sufficient detail and be written with sufficient clarity for the Committee t o be able to render an informed judgement. Protocols must be signed by the principal investigator or project director..Itis the responsibility of the secretariat to forward protocols for Committee action. Inadequate protocols will be returned and hence may result in unnecessary delays in submitting proposals,Protocols for research to be done in cooperation ' with another institution must be approved by the respective tillman Use Committees of both. a minimum, protocols should consist of the following elements : Describe the proposed research, it s - significance,and explain its" possible bene fic s to the subject ls) ana LO soc let3in general,using language that is intelligible to educated laypersons,. Tell what has already been done in animals or phantoms and state why studies with human subjects are now necessary or desirable. Specify how the subject pop ul atl on will be selected and, if app lica S le give an ex plan atl on for using special population groups, sucn as minors,prisoners,the msn tally disabled or ot ner s whose ability to gl ve voluntary, informed consent may b e in question. State if the projected work involves research on the nature and effect : of rnari juans ana ha luc in a tory drugs,drug abuse,or investigation al Kent ion where in the Laboratory or cooperating institution and precisely how tne huaan subjects are to be studied, and include in this description the number of subjects, an estimate of t ne duration of the investigation, and an indication of the methods of analysis to Examine the potential harm to the subjects from physical agents,such a s noxious c nen ical s or ionizing radiations (where applicable, computa the whole bod; dose and that to the organ is)at risk), and outline the meesures t o be taken to safeguard t ne subjects against such effect : Cons lder tn epo ssl ble psycho i og ical,emotion el or socially deleterious effects upon the subjects, and describe the means to betaken to assessment of tn eir probable effectiveness. Include with each prc to col submitted to the Con-iittee a consent fom. The consent for n should be written in language ref i dil yu no ers tani aS le to the subject,should explain exactly what isto be done and why, an( should compare any risks that may not be clear to t ne subject to risk : with which he/she Is more likely to be familiar (e.8. " the radiation