Skip to main content


U.S. flag
      An official website of the United States government
              Here’s how you know
        Here’s how you knowDot 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** (A locked padlock) or **https://** means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites. 
  Menu Close
          Enter the terms you wish to search for.
    Search
        








  
  
    

  
      

                                      About HHS
    
                        
                              
      
      
      Programs & Services
    
                        
                              
      
      
      Grants & Contracts
    
                        
                              
      
      
      Laws & Regulations                  
Health Information Privacy
  HIPAA for Individuals
    
                        
                                            
      
      
      Filing a Complaint
    
                        
                                            
      
      
      HIPAA for Professionals
    
                        
                                            
      
      
      Newsroom

              

    



Breadcrumb
    HHS
                              HIPAA Home
                              For Professionals
                              FAQ
                              313-Do HIPAA's requirements for authorization and the Common Rule's requirements for informed consent differ?


    

    

    Navigate to:
  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)Text resize icon

                    




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, 2023Back to top
    Contact HHS
    
                        
                                            
      
      
      Careers
    
                        
                                            
      
      
      HHS FAQs
    
                        
                                            
      
      
      Nondiscrimination NoticeHHS Archive
    
                        
                                            
      
      
      Accessibility Statement
    
                        
                                            
      
      
      Privacy Policy
    
                        
                                            
      
      
      Viewers & PlayersBudget/Performance
    
                        
                                            
      
      
      Inspector General
    
                        
                                            
      
      
      Web Site Disclaimers
    
                        
                                            
      
      
      EEO/No Fear ActFOIA
    
                        
                                            
      
      
      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 Headquarters
          200 Independence Avenue, S.W.
                  Washington, D.C. 20201
                  Toll Free Call Center: 1-877-696-6775​