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 ยง 46.116.f. If you would like to talk through things please feel free to reach out to the Solutions IRB administrative team, at reviews@solutionsirb.com or 1-855-226-4472.
By: Cora Crawford
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