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
                              Research Uses and Disclosures


    

    

    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

                    




Research Uses and Disclosures
  
  
  
      217-May a covered entity accept documentation of an IRB waiver of authorization
    Yes. The HIPAA Privacy Rule explicitly permits a covered entity to reasonably rely on a researcher’s documentation of an Institutional Review Board (IRB) or Privacy Board waiver of authorization pursuant to 45 CFR 164.512(i) that the information requested is the minimum necessary for the research purpose. See 45 CFR 164.514(d)(3)(iii).
Read the full answer
      302-Will HIPAA hinder medical research
    We do not believe that the Privacy Rule will hinder medical research. Indeed, patients and health plan members should be more willing to authorize disclosures of their information for research and to participate in research when they know their information is protected.
Read the full answer
      303-Are some criteria so subjective that IRB and privacy boards may makeinconsistent determinations
    Under the HIPAA Privacy Rule, IRBs and Privacy Boards need to use their judgment as to whether the waiver criteria have been satisfied.
Read the full answer
      304-Does HIPAA prohibit researchers from conditioning participation in a clinical trial on an authorization to use/disclose existing 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 pre-existing health information.
Read the full answer
      305-Does HIPAA permit creating a database for research purposes through an IRB or Privacy Board waiver
    Yes. A covered entity may use or disclose protected health information without individuals’ authorizations for the creation of a research database, provided the covered entity obtains documentation that an IRB or Privacy Board has determined that the specified waiver criteria were satisfied.
Read the full answer
      306-Can researchers access existing databanks or repositories created prior to the compliance date without permission
    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).
Read the full answer
      307-How does the Rule help IRBs handle the additional responsibilities imposed by the HIPAA Privacy Rule
    Recognizing that some institutions may not have IRBs, or that some IRBs may not have the expertise needed to review research that requires consideration of risks to privacy, the Privacy Rule permits the covered entity to accept documentation of waiver of authorization from an alternative body called a Privacy Board–which could have fewer members, and members with different expertise than IRBs.
Read the full answer
      308-By establishing new waiver criteria and authorization requirements, hasn't HIPAA modified the Common Rule
    No. Where both the Privacy Rule and the Common Rule apply, both regulations must be followed. The Privacy Rule regulates only the content and conditions of the documentation that covered entities must obtain before using or disclosing protected health information for research purposes.
Read the full answer
      309-Is documentation of IRB and Privacy Board approval required by the HIPAA
    No. The HIPAA Privacy Rule requires documentation of waiver approval by either an IRB or a Privacy Board, not both.
Read the full answer
      310-Does HIPAA require a covered entity to create an IRB or Privacy Board before using or disclosing protected health information for research
    The IRB or Privacy Board could be created by the covered entity or the recipient researcher, or it could be an independent board.
Read the full answer
      311-What does HIPAA say about a research participant's right of access to research records or results
    With few exceptions, the Privacy Rule gives patients the right to inspect and obtain a copy of health information about themselves that is maintained by a covered entity or its business associate in a “designated record set.”
Read the full answer
      313-Do HIPAA's requirements for authorization and the Common Rule's requirements for informed consent differ?
    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.
Read the full answer
      314-When is a researcher considered to be a covered health care provider under HIPAA
    A researcher is a covered health care provider if he or she furnishes health care services to individuals, including the subjects of research, and transmits any health information in electronic form in connection with a transaction covered by the Transactions Rule.
Read the full answer
      315-When can a covered determine whether a research component of the entity is part of their covered functions
    A covered entity that qualifies as a hybrid entity, meaning that the entity is a single legal entity that performs both covered and non-covered functions, may choose whether it wants to be a hybrid entity. If such a covered entity decides not to be a hybrid entity then it, and all of its components, are subject to the Privacy Rule in its entirety. Therefore, if a researcher is an employee or workforce member of a covered entity that has decided not to be a hybrid entity, the researcher is part of the covered entity and is, therefore, subject to the Privacy Rule.
Read the full answer
      316-If a research subject revokes authorization to disclose information can a researcher continue using the information already obtained
    Covered entities may continue to use and disclose protected health information that was obtained prior to the time the individual revoked his or her authorization, as necessary to maintain the integrity of the research study.
Read the full answer
      317-Can the preparatory research provision of the HIPAA Privacy Rule be used to recruit individuals into a research study
    The preparatory research provision permits covered entities to use or disclose protected health information for purposes preparatory to research, such as to aid study recruitment. However, the provision at 45 CFR 164.512(i)(1)(ii) does not permit the researcher to remove protected health information from the covered entity’s site.
Read the full answer
      318-Does HIPAA require documentation of IRB approval of an alteration or waiver of individual authorization
    No. Documentation of IRB or Privacy Board approval of an alteration or waiver of individual authorization is only needed before a covered entity may use or disclose protected health information under 45 CFR 164.512(i)(1)(i).
Read the full answer
      319-If consent was obtained before the compliance date but the IRB modifies the document is authorization required
    If informed consent or reconsent (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.
Read the full answer
      320-Can covered entities continue to disclose adverse event reports that contain information
    Yes. The Office for Human Research Protections is a public health authority under the HIPAA Privacy Rule. Therefore, covered entities can continue to disclose protected health information to report adverse events to the Office for Human Research Protections either with patient authorization as provided at 45 CFR 164.508, or without patient authorization for public health activities as permitted at 45 CFR 164.512(b).
Read the full answer
      321-Can covered entities continue to disclose information to the HHS Office for Human Research Protections
    Yes. The Office for Human Research Protections is a health oversight agency under the HIPAA Privacy Rule. Therefore, covered entities can continue to disclose protected health information to the Office for Human Research Protections for such compliance investigations either with patient authorization as provided at 45 CFR 164.508, or without patient authorization for health oversight activities as permitted at 45 CFR 164.512(d).
Read the full answerBack 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​