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Preparation of an effective informed consent document presents significant problems to those investigators not familiar with federal and institutional requirements. This article examines a detailed format for preparation of an informed consent instrument. Prepared by the authors and supplied to potential clinical investigators by a university institutional review committee, the guidelines incorporate Department of Health, Education, and Welfare regulations. An example consent form is provided.

The continued growth of hospital and clinical pharmacy should be paralleled by the development of sound research methods justifying innovative practices. Such research will, on occasion, require experimentation involving human subjects. The principal means of assuring that the welfare of research participants is not compromised is through the procurement of effective informed consent. Pharmacists, like many other health professionals, have had relatively little exposure to methodology involved in the writing of an informed consent instrument. A comprehensive document must not only conform to the requirements of federal regulatory agencies, but must also satisfy various institutional guidelines. Past instances of unethical human experimentation are discussed, and a format for preparation of an informed consent instrument is examined. Circumstances requiring informed consent and identification of the basic elements of consent are also explained.