Skip to main content
U.S. flag

An official website of the United States government

Here’s how you know

Dot gov

Official websites use .gov
A .gov website belongs to an official government organization in the United States.

HTTPS

Secure .gov websites use HTTPS
A lock (LockA locked padlock) or https:// means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.

  • About HHS
  • Programs & Services
  • Grants & Contracts
  • Laws & Regulations
  • Radical Transparency
  • Big Wins
  • HIPAA for Individuals
  • Filing a Complaint
  • HIPAA for Professionals
  • Newsroom
Breadcrumb
  1. HHS
  2. HIPAA Home
  3. For Professionals
  4. FAQ
  5. 319-If consent was obtained before the compliance date but the IRB modifies the document is authorization required
  • Authorizations (30)
  • Business Associates (41)
  • Compliance Dates (2)
  • Covered Entities (14)
  • Decedents (9)
  • Disclosures for Law Enforcement Purposes (5)
  • Disclosures for Rule Enforcement (1)
  • Disclosures in Emergency Situations (2)
  • Disclosures Required by Law (6)
  • Disclosures to Family and Friends (28)
  • Disposal of Protected Health Information (6)
  • Facility Directories (7)
  • Family Medical History Information (3)
  • FERPA and HIPAA (10)
  • Group Health Plans (3)
  • Incidental Uses and Disclosures (10)
  • Judicial and Administrative Proceedings (8)
  • Minimum Necessary (14)
  • Notice of Privacy Practice (20)
  • Preemption of State Law (10)
  • Privacy Rule: General Topics (12)
  • Protected Health Information (2)
  • Public Health Uses and Disclosures (13)
  • Research Uses and Disclosures (20)
  • Right to an Accounting of Disclosures (8)
  • Right to File a Complaint (1)
  • Right to Request a Restriction (4)
  • Safeguards (13)
  • Security Rule (24)
  • Smaller Providers and Businesses (145)
  • Student Immunizations (8)
  • Transition Provisions (3)
  • Treatment, Payment, and Health Care Operations Disclosures (30)
  • Workers Compensation Disclosures (5)
  • Limited Data Set (6)
  • Marketing (17)
  • Marketing - Refill Reminders (16)
  • Personal Representatives and Minors (12)
  • Right to Access and Research (58)
  • Mental Health (35)
  • Health Information Technology (41)
  • Telehealth (11)

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?

Answer:

Yes. If informed consent or reconcent (ie., asked to sign a revised consent or another informed consent) is obtained from research subjects after the compliance date, the covered entity must obtain individual authorization as required at 45 CFR 164.508 for the use or disclosure of protected health information once the consent obtained before the compliance date is no longer valid for the research. The revised informed consent document may be combined with the authorization elements required by 45 CFR 164.508.

See Privacy Rule and Research and other frequently asked questions about research for more information about Institutional Review Boards and privacy.

Learn More:

  • 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)?

  • When is a researcher a covered health care provider under HIPAA?

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

 

 

Date Created: 12/20/2002
Last Updated: 03/14/2006

Content created by Office for Civil Rights (OCR)
Content last reviewed February 8, 2023
Back to top

Subscribe to Email Updates

Receive the latest updates from the Secretary and Press Releases.

Subscribe
  • Contact HHS
  • Careers
  • HHS FAQs
  • Nondiscrimination Notice
  • Press Room
  • HHS Archive
  • Accessibility Statement
  • Privacy Policy
  • Budget/Performance
  • Inspector General
  • Web Site Disclaimers
  • EEO/No Fear Act
  • FOIA
  • The White House
  • USA.gov
  • Vulnerability Disclosure Policy
HHS Logo

HHS Headquarters

200 Independence Avenue, S.W.
Washington, D.C. 20201
Toll Free Call Center: 1-877-696-6775​

Follow HHS

Follow Secretary Kennedy