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FAQs on Research Uses and Disclosures

This is guidance on the HIPAA Privacy Rule requirements for disclosures of protected health information by covered entities for research purposes.

Final

Issued by: Office for Civil Rights (OCR)

Research Uses and Disclosures

Privacy Boards and Institutional Review Boards | Research General Topics | General Research Disclosures

Privacy Boards and Institutional Review Boards

May a covered entity accept documentation of an external Institutional Review Board's (IRB) waiver of authorization for purposes of reasonably relying on the request as the minimum necessary?

Research General Topics

Will the HIPAA Privacy Rule hinder medical research by making doctors and others less willing and/or able to share with researchers information about individual patients?

Are some of the criteria so subjective that inconsistent determinations may be made by Institutional Review Boards (IRB) and Privacy Boards reviewing similar or identical research projects?

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 HIPAA Privacy Rule permit the creation of a database for research purposes through an Institutional Review Board (IRB) or Privacy Board waiver of individual authorization?

How does the Rule help Institutional Review Boards (IRB) handle the additional responsibilities imposed by the HIPAA Privacy Rule?

By establishing new waiver criteria and authorization requirements, hasn't the HIPAA Privacy Rule, in effect, modified the Common Rule?

Is documentation of Institutional Review Boards (IRB) and Privacy Board approval required by the HIPAA Privacy Rule before a covered entity would be permitted to disclose protected health information for research purposes without an individual's authorization?

Does the HIPAA Privacy Rule require a covered entity to create an Institutional Review Board (IRB) or Privacy Board before using or disclosing protected health information for research?

What does the HIPAA Privacy Rule say about a research participant's right of access to research records or results?

Do the HIPAA Privacy Rule's requirements for authorization and the Common Rule's requirements for informed consent differ?

When is a researcher considered to be a covered health care provider under HIPAA?

When does a covered entity have discretion to determine whether a research component of the entity is part of their covered functions, and therefore, subject to the HIPAA Privacy Rule?

If a research subject revokes his or her authorization to have protected health information used or disclosed for research, does the HIPAA Privacy Rule permit a researcher/covered health care provider to continue using the protected health information already obtained prior to the time the individual revoked his or her authorization?

Can the preparatory research provision of the HIPAA Privacy Rule at 45 CFR 164.512(i)(1)(ii) be used to recruit individuals into a research study?

Does the HIPAA Privacy Rule require documentation of Institutional Review Board (IRB) or Privacy Board approval of an alteration or waiver of individual authorization before a covered entity may use or disclose protected health information for any of the following provisions: (1) for preparatory research at 45 CFR 164.512(i)(1)(ii), (2)for research on the protected health information of decedents at 45 CFR 164.512(i)(1)(iii), or (3) a limited data set with a data use agreement as stipulated at 45 CFR 164.51?

If research subjects' consent was obtained before the compliance date, but the Institutional Review Board (IRB) subsequently modifies the informed consent document after the compliance date and requires that subjects be reconsented, is authorization now required from these previously enrolled research subjects under the HIPAA Privacy Rule?

Can covered entities continue to disclose adverse event reports that contain protected health information to the Department of Health and Human Services (HHS) Office for Human Research Protections?

Can covered entities continue to disclose protected health information to the HHS Office for Human Research Protections for purposes of determining compliance with the HHS regulations for the protection of human subjects (45 CFR Part 46)?

General Research Disclosures

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)?

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