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.

HHS.gov
  • About HHS
  • Programs & Services
  • Grants & Contracts
  • Laws & Regulations
  • HIPAA for Individuals
  • Filing a Complaint
  • HIPAA for Professionals
  • Newsroom

Breadcrumb

  1. HHS
  2. HIPAA Home
  3. For Professionals
  4. FAQ
  5. 313-Do HIPAA's requirements for authorization and the Common Rule's requirements for informed consent differ?
  • 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)
  • Health Information Technology (41)
  • Incidental Uses and Disclosures (10)
  • Judicial and Administrative Proceedings (8)
  • Limited Data Set (6)
  • Marketing (18)
  • Marketing - Refill Reminders (16)
  • Mental Health (35)
  • Minimum Necessary (14)
  • Notice of Privacy Practice (20)
  • Personal Representatives and Minors (12)
  • 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 Access and Research (58)
  • Right to an Accounting of Disclosures (8)
  • Right to File a Complaint (1)
  • Right to Request a Restriction (3)
  • Safeguards (13)
  • Security Rule (24)
  • Smaller Providers and Businesses (145)
  • Student Immunizations (8)
  • Telehealth (11)
  • Transition Provisions (3)
  • Treatment, Payment, and Health Care Operations Disclosures (30)
  • Workers Compensation Disclosures (5)

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

Answer:

Yes. Under the Privacy Rule, a patient’s authorization is for the use and disclosure of protected health information for research purposes. In contrast, an individual’s informed consent, as required by the Common Rule and the Food and Drug Administration’s (FDA) human subjects regulations, is a consent to participate in the research study as a whole, not simply a consent for the research use or disclosure of protected health information. See our research section and frequently asked questions about the research provisions for more information about the Common Rule.

For this reason, there are important differences between the Privacy Rule’s requirements for individual authorization, and the Common Rule’s and FDA’s requirements for informed consent. However, the Privacy Rule’s authorization elements are compatible with the Common Rule’s informed consent elements. Thus, both sets of requirements can be met by use of a single, combined form, which is permitted by the Privacy Rule.

For example, the Privacy Rule allows the research authorization to state that the authorization will be valid until the conclusion of the research study, or to state that the authorization will not have an expiration date or event. This is compatible with the Common Rule’s requirement for an explanation of the expected duration of the research subject’s participation in the study. It should be noted that where the Privacy Rule, the Common Rule, and/or FDA’s human subjects regulations are applicable, each of the applicable regulations will need to be followed.

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

Content created by Office for Civil Rights (OCR)
Content last reviewed January 9, 2023
Back to top
  • Contact HHS
  • Careers
  • HHS FAQs
  • Nondiscrimination Notice
  • HHS Archive
  • Accessibility
  • Privacy Policy
  • Viewers & Players
  • Budget/Performance
  • Inspector General
  • Web Site Disclaimers
  • EEO/No Fear Act
  • FOIA
  • The White House
  • USA.gov
  • Vulnerability Disclosure Policy

Sign Up for Email Updates

Receive the latest updates from the Secretary, Blogs, and News Releases.

Sign Up
HHS Logo

HHS Headquarters

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