7. Is patient authorization required to use and disclose protected health information for research?
Generally, a research participant must execute a written authorization to use his/her protected health information for research. There are 3 exceptions to this general rule:
1. IRB Waiver: The researcher can seek a waiver of the authorization requirement from the IRB. The IRB only can approve a waiver if it will pose no more than a “minimal risk” to the privacy of individuals and the research cannot practicably be conducted without the waiver.
2. Preparatory Review: The researcher must represent that the uses and disclosures are necessary for the research and no protected health information will be removed from the covered entity providing the information.
3. Decedent Research: The researcher must represent that the access is necessary for research and that the use or disclosure is solely for the purpose of reviewing the protected health information of the deceased.
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