ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Authorization

Document designating permission. The HIPAA Privacy Rule requires authorization or waiver of authorization for the use or disclosure of identifiable health information for research (among other activities). The authorization must indicate if the health information used or disclosed is existing information and/or new information that will be created during the research. The authorization form may be combined with the informed consent form, so that a subject need sign only one form. An authorization must include the following specific elements: a description of what information will be used and disclosed and for what purposes; a description of any information that will not be disclosed, if applicable; a list of who will disclose the information and to whom it will be disclosed; an expiration date for the disclosure; a statement that the authorization can be revoked; a statement that disclosed information may be redisclosed and no longer protected; a statement that if the individual does not provide an authorization, s/he cannot receive research-related treatment; the subject's signature and date.

Publication Source: Committees on Human Research

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