HIPAA "PRIVACY RULE" AUTHORIZATION LANGUAGE FOR CONSENT FORMS
If your research study requires that you obtain written authorization from subjects, please insert the following language into your consent document or print out as a separate document being sure to complete all sections that require specific study information as indicated in [brackets]. It's also important to note that under HIPAA subjects must receive a signed copy of their authorization, which is either a copy of the consent or a copy of the separate authorization document.
The following information explains how your medical information, referred to as protected health information or PHI, may be used by the investigators or shared (disclosed) with other people or groups for this research study. Please read this carefully.
Your decision to allow the use of your PHI is voluntary. [However,] If you do not give your permission (authorization) for the use of your PHI you will [not or still] be able to participate in this research study. What PHI will be collected?
If you give permission [insert names of Principal Investigator and Co-Investigators] and research staff members under their guidance would use the following PHI for this study: [insert description of health information to be collected including information from the subjects past medical records and information collected during the study.]
This information will be provided by [insert name of covered entity, for example, University Hospitals of Cleveland, The Metro health System, the Louis Stokes Cleveland Department of Veterans Affairs Medical Center] and/or created during the study as you receive care at [insert name of covered entity, for example, University Hospitals of Cleveland, The Metro health System, or the Louis Stokes Cleveland Department of Veterans Affairs Medical Center]. Why is this information needed?
This information is needed for this study because [insert purpose for use and/or disclosure]. Who will have access to my PHI and for how long?
In addition to the investigators and staff listed above, your PHI may be looked at by other groups involved with the study such as the [choose all that are applicable and insert: the Food and Drug Administration, the Department of Health and Human Services, the Institutional Review Board, Sponsors, your insurance company, the National Committee for Quality Assurance, etc]
Please understand that, in general, once you give your permission to release the information needed for this study, federal and state laws that protect your privacy might no longer protect this information.
The investigators for this study would like to have access to your PHI [choose one: until the end of the study, indefinitely, until specific date or event]. Do I have the right to access the PHI requested for this study?
[Choose one of the following statements as applicable]
You will have access to the PHI contained in your medical record that is related to this study. Or
You will have access to your medical record, but you will not have access to any information for this study that is in the medical record until the study is completed. If I give permission now, can I withdraw my permission in the future?
You have a right to withdraw your permission/authorization, in writing, at any time. To withdraw, contact [insert name of Privacy Contact or Principal Investigator] at [insert mailing address or email address] and let [him/her] know that you are withdrawing your authorization. All of the PHI that has already been collected about you for the study will continue to be used. However, the investigators will not be able to collect any additional information about you. Signature section of consent would also need to include the following:
Signature of Subject or Legally Authorized Representative: __________ Date: __________ Print Name of Subject or Legally Authorized Representative: __________ Description of Legally Authorized Representatives Authority: __________
Questions about HIPAA? For questions about our HIPAA education program and requirements, please contact Christian LaMantia, Director, at: clt@cwru.edu
or 216-368-4513 or your local IRB office.
