The IRB may grant a waiver of informed consent in certain instances. (Not to be confused with a waiver of consent documentation, where consent other than written consent is obtained, please see our article Waiver of Documentation of Consent if you would like more information). A full waiver of consent completely waives the requirement to obtain informed consent. However, in order for a full waiver of informed consent to be granted there are certain criteria that must be met. In this article we will discuss the specific criteria, along with examples of when a waiver of informed consent may be granted.
For a waiver of informed consent to be granted the following criteria must be met;
- The research involves no more than minimal risk.
- The research could not be carried out practicably without the waiver.
- The waiver will not adversely affect the rights and welfare of the subjects.
- When appropriate, the subjects will be provided with additional information about their participation.
Below are examples of when a waiver of consent may be granted, pending the above is met;
- Retrospective chart reviews
- Studies of existing pathology specimens
- Public observation studies
If you have questions regarding your study and if a waiver of consent may apply, you can refer to the CFRs at § 46.116.f. If you would like to talk through things please feel free to reach out to the Solutions IRB administrative team, at firstname.lastname@example.org or 1-855-226-4472.
By: Cora Crawford