Memo, Subject: Investigations Involving Human Subjects, Including Clinical Research: Requirements for Review to Insure the Rights and Welfare of Individuals: Clarification

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Division of Research Grants SUBJECT : Investigations Involving Human Subjects, Including Clinical Research: Requirements for Review to Insure the Rights and Welfare of Individuals: Clarification REFERENCE : PPO #l29, Revised, July 1, 1966 This report is to clarify issues raised by PHS grantees and staff regarding the meaning of the requirernents.of PPO 8129, Revised, July 1, 1966, subject: "investigations Involving Human Subjects, Including Clinical Research: Requirements for Review to Insure the Rights and Welfare of Individuals." This policy refers to all investigations that Involve human subjects, including investigations in the behavioral and social sciences. grantee institution I s responsible for assuring that the investigations are in accord with the laws of the community in which the investigations are conducted and for giving due consideration to pertinent ethical issuee. Appropriate groups of associates within the institution, and outside consultants if needed, are to be utilized to provide the neceGsary review. Institutions may designate separate groups in order to assure competence and independence.of review for particular areas. The principles of this policy apply most directly and comprehensively in those instances of social, behavioral, and medical science investigatione where a procedure may induce in the subject an altered state or condition potentially harmful to his personal welfare. administration of drugs, the requirement of strenuous pky6iCal exertion, and participaclon in psychologically or socially harmful activities are examples of 'experimental arrangements which require thorough scrutiny by instltutional review groups. and full documentation for the record. Surgical procedures, the Such procedures require continuing werview Aside from the above types of procedures, there is a large range of social and behavioral research in which no personal risk to the subject is involved. In those circumstances, regardless of whether the investigation is classified a6 behavioral, eocial, medical, or other, the iaeues of concern are the fully voluntary nature of the participation of tho subject, the maintenance of confidentiality of information obtained from the subject, and the protection of the eubject from m i s u m of the findings. Pot example,

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Archlvta mi Rocorb OMcr a major class of procedures in the social and behavioral sciences does no uore than observe or elicit information about the subject's statua, by means of administration of tests, inventories, questionnaires, or eurveyr of personality or background. o f voluntary participation, confidentiality, and propriety in use of the findings are the most generally relevant ones. However, such procedure6 m y in many instances not require the fully informed consent of the aubject or even his knowledgeable participation. In such instances full and 6peCifiC documentation is necessary for the record. In such instances, the ethical considerations PIany investigations in the social and behavioral sciences involve DrnccdUr88 designed to alter the status of the individual as, for example, studier of human learning, social perception, or group effectiveness. effects, if any, on the subject may be transitory or even =re or lcrr permanent, but they must be judged clearly not to be harmful or not to involve the risk of harm. In such research Ch8 Whatever the nature of the investigation, the concern for the protection of the subject and for the assurance of voluntary participation becomaa most critical when the subject is not of age or competence to make an adequate judgment in his own behalf. These are only some examples of issues which may arise. The fundamental point is that every project must be considered on an individual basis to clarify which, if any, such issues are present and to insure that there are adequately resolved by the specific design of its procedures. this reason, it is essential that the grantee Institution be responsible for the clarification and resolution of all ethical and other pertinent groups of associates, eatablished at the institution to provide cornbetent, of the investigation involved, such a review group can decide which i 6 S U O . are germane and ascertain the adequacy of provisions for protecting tho rights and welfare of human subjects in research, the appropriatenerr o f the methods used to secure informed consent, and the risks and potential benefits of the investigation. The appropriate mechanism for this purpose is the utilization o f Based on its knowledgeable scrutiny of the speclficr ORIGINATING OWICE: Offfce of the Director, Divieion of Research Cranta APPROVED BY: Grants Policy Officer, OSG Index: Clinical Rerearch Human Subjects: Behavioral Inveetigation~ Medical Science Invaetigotione Social Scienco Inveetigations