Does the HIPAA Privacy Rule prohibit researchers from conditioning participation in a clinical trial on an authorization to use/disclose existing protected health information?
No. The Privacy Rule does not address conditions for enrollment in a research study. Therefore, the Privacy Rule in no way prohibits researchers from conditioning enrollment in a research study on the execution of an authorization for the use of preexisting health information. Can researchers continue to access existing databanks or repositories that are maintained by covered entities, even if those databases were created prior to the compliance date without patient permission or without a waiver of informed consent by an Institutional Review Board (IRB)? Yes. Under the HIPAA Privacy Rule, covered entities may use or disclose protected health information from existing databases or repositories for research purposes either with individual authorization as required at 45 CFR 164.508, or with a waiver of individual authorization as permitted at 45 CFR 164.512(i). See the fact sheet and frequently asked questions about the research provisions on this web site for more information about Ins
Related Questions
- Does the HIPAA Privacy Rule prohibit researchers from conditioning participation in a clinical trial on an authorization to use/disclose existing protected health information?
- Does the Privacy Rule permit a covered entity to use or disclose protected health information pursuant to an authorization form that was prepared by a third party?
- My State requires consent to use or disclose health information. Does the HIPAA Privacy Rule take away this protection?
