Instructions for Individual Authorization Form for Use or Disclosure of Protected Health Information (PHI) for Research Purposes
Instructions to Investigators and staff:
To use or disclose protected health information with authorization by the research participant, the investigator must obtain an authorization that satisfies the requirements of 45 CFR 164.50(c)(2). The Privacy Rule includes a general set of authorization requirements that apply to all uses and disclosures, including those for research purposes. Those are listed below.
The Authorization may be used as a stand-alone document, or may be inserted into the standard informed consent document for the study. Three templates are provided for your use, as follows:
- Template for Investigator Sponsored Research: Individual Authorization Form for Use or Disclosure of PHI
- Template for Outside Sponsored Research: Individual Authorization Form for Use or Disclosure of PHI
- Authorization Section for Use in Standard Informed Consent Document for Research Studies
The LBH IRB must review PHI Authorization sections of standard patient consent forms and approve the changes before use of the revised form can be implemented. Submission of Individual Authorization forms is requested by the IRB, but is not required for Authorization Forms prior to use . Individual Authorization forms will be reviewed by the IRB to insure that all required elements are satisfactorily included. .
Instructions on the forms appear in italics, and areas to be completed are highlighted. Electronic copies can be obtained from Patty Lohinski at. Please remove highlighting and complete the information requested in the blanks as applicable to the study.
Required Elements for Individual Authorization and Consent Forms
All Individual Authorizations and Consent Form sections for Use or Disclosure of Protected Health Information must include all of the following elements:
1A description of the personal health information to be collected in the study that is to be used or disclosed.
2Identification of the individual(s) or organizations involved in the study or in activities related to the study who are authorized to use or disclose the information.
3Identification of individuals organizations involved in the study or in activities related to the study who may receive the information.
4Description of each purpose of the requested use or disclosure.
5Signature of the individual and date, or signature of an authorized personal representative. When a personal representative is to sign, a description of the representative’s authorization must be attached.
6Notice to the individual that authorization to use PHI may be revoked or withdrawn at any time by a request made in writing.
7The potential for information disclosed pursuant to this authorization to be subject to redisclosure by the recipients and no longer may be protected by the Federal Privacy Act
8The authorization must be written in plain language.
The following two special provisions also apply to research authorizations, as distinct from authorizations for other purposes:
9Unlike other authorizations, an authorization for a research purpose may state that the
authorization does not expire, that there is no expiration date or event, or that the
authorization continues until the “end of the research study;” and
10An authorization for the use or disclosure of protected health information for research may be combined with a consent to participate in the research, or with any other legal permission related to the research study.