IRB Waiver of Informed Consent

Informed consent is one of the fundamental principals of ethical conduct in the use of human subjects and is mandated by Federal policy (45 CFR 46 section 116). Described in the Code of Federal Regulations, there are some circumstances where a request to waive the informed consent process may be permitted.

A waiver of informed consent is often requested in minimal risk research involving the administration of online or mailed surveys, telephone interviews, or when anonymous sensitive information is collected and the investigator does not want any paperwork that links the participants to the research. Subjects are presented (either verbally or in writing) with the same information required in a written consent document but the signing of the consent has been waived by the IRB.

The IRB may consider waiving the requirement for obtaining informed consent if all of the following conditions are met:

1. The research involves minimal risk to participants.

This condition is satisfied if either the likelihood or the magnitude of harm/discomfort is no greater than what the participants would ordinarily encounter in daily life or during routine clinical care.

2. The waiver will not adversely affect the rights and welfare of the participants.

The IRB will assess whether the participant’s rights would be violated if the consent were waived. For example, in the case of “right to privacy”, the IRB will consider the safeguards for minimizing the potential invasion of privacy and will consider the potential benefits of participation.

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

For example, obtaining informed consent would not be practicable if the investigator will have no direct contact with participants and will not know their identities.

4. Whenever appropriate, the participant will be provided with additional pertinent information after they have participated in the study.

If these conditions apply, an investigator may request the IRB waive some or all of the requirements for informed consent within their submitted protocol.

Note: In cases where the informed consent requirement is waived, the IRB may require the investigator to provide participants with a written statement regarding the research.