Legal and ethical issues in clinical pharmacy research--informed consent, Part II.
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.
D002986:Clinical Trials as Topic; D032962:Consent Forms; D030881:Disclosure; D004282:Documentation / Q000592:standards*; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D011996:Records / Q000592:standards; D014481:United States