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OBTAINING INFORMED CONSENT

The committee will assist in the development of a proper investigation consent form commensurate with the task. The guidelines for the wording of such forms, for the methods by which patients or subjects are to be informed in a valid manner and for the limitations and exceptions to the rule that all subjects or their guardians must be informed and be given written consent are derived from those issued on August 24, 1966, by FDA commissioner J. P. Goddard (Title 21, Part 130.37, as published in the Federal Register of August 30, 1966). The basic guideline has been expanded, however, to include not only the use of new drugs but all other investigative procedures as well.

Consent will be obtained whenever possible from the subject himself. Whenever the subject is not legally or physically capable of giving informed consent because of age, medical incapacity or inability to communicate, or when the attending professional investigator believes that the giving of full information would be contrary to the best interest of the subject, a review committee may consider the validity of consent of the next of kin, legal guardians or by other responsible third parties who represent the subject's interest. The committee will determine if the consent, whether secured in writing or orally or implicit in the voluntary participation in a well advertised activity, is adequate in the light of risks to the subject, and the circumstances of the research. The committee will also determine if the information to be given to the subject or responsible third parties, orally or in writing, is a fair explanation of the procedure, the possible benefits, and the attendant hazards.