Waiver or Alteration of Consent
An IRB may approve a consent procedure that omits some or alters some of the elements of informed consent.
For an IRB to waive or alter consent, the IRB must find:
- The research involves no more than minimal risk to the participants.
- The research could not practicably be carried out without the requested waiver or alteration.
- If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format.
- The waiver or alteration will not adversely affect the rights and welfare of the participants.
- Whenever appropriate, the participants or legally authorized representatives will be provided with additional pertinent information after participation.
An IRB may approve a research proposal in which a researcher will obtain information or biospecimens for the purpose of screening, recruiting, or determining the eligibility of prospective participants without the informed consent of the prospective participant or the participant's legally authorized representative, if either of the following conditions are met:
- The researcher will obtain information through oral or written communication with the prospective participant or legally authorized representative.
- The researcher will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.
Waiver of Written Consent
An IRB may waive the requirement for the researcher to obtain a signed informed consent form for some or all participants if it finds any of the following:
- That the only record linking the participant and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. Each participant (or legally authorized representative) will be asked whether the participant wants documentation linking the participant with the research, and the participant's wishes will govern.
- That the research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside of the research context.
- If the participants or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to participants and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.
In cases in which the documentation requirement is waived, the IRB may require the researcher to provide participants or legally authorized representatives with a written statement regarding the research.