ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Deceased individuals. Afforded privacy rights under the HIPAA Privacy Rule, even though not considered "human subjects" protected under the Common Rule. As is the current practice, all research protocols involving the review of medical records of deceased subjects or of living and deceased subjects require review and approval by the HRC/IRB and can be conducted without informed consent and authorization only if the protocol satisfies the criteria for a waiver. If the research includes access to the records of decedents, the investigator will be asked to document that the decedents PHI will only be used for research and that the information is necessary for the research. The covered entity may require the investigator to provide proof of death.

Publication Source: Committees on Human Research

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