Guidance on Waivers of Authorization and Informed Consent

Listed below are the criteria for obtaining a Waiver of Authorization and a Waiver of Informed Consent. Where appropriate, e.g., retrospective chart reviews, you must request both waivers as part of your IRB application. Note, that while similar, they differ and all criteria must be met. In requesting these waivers, please consider the criteria as questions and provide full answers. It is not adequate to just say yes or to just list the criteria. For example, in your answer to A.1. a-c, of the Waiver of Authorization, an action plan must be provided. In addition, a complete description must be provided of why it would be impossible to conduct the research if you had to obtain Authorization (A.2) and Informed Consent (B.3).

A. Criteria for Waiver of Authorization Under the HIPAA Privacy Rule

1. The use or disclosure of protected health information involves no more than minimal risk to the individuals

  • a) There is an adequate plan to protect the identifiers from improper use and disclosure

  • b) There is an adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, unless there is a health or research justification for retaining the identifiers, or such retention is otherwise required by law

  • c) There are adequate written assurances that the protected health information will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research project, or for other research for which the use or disclosure of protected health information would be permitted by this subpart

2. The research could not practicably be conducted without the alteration or waiver

3. The research could not practicably be conducted without access to and use of the protected health information

B. Criteria for Waiver of Informed Consent Under the Common Rule

1. The research involves no more than minimal risk to the subjects

2. The waiver or alteration will not adversely affect the rights and welfare of the subjects

3. The research could not practicably be carried out without the waiver or alteration

4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation

The test of practicability is the same under both rules and may be met, for example by

  • The need for a large number of subjects

  • A presumed or demonstrated inability to contact subjects for whom contact information may not be accurate

  • The fact that many of the subjects may have died, or

  • The fact that a lack of data from a few subjects may make the number of subjects available for the study too few to make the study valid