There are two types of waiver requests that IRB will consider: a) waiver of Documentation of Informed Consent (i.e., verbal or implied consent) or b) Waiver of Informed Consent. In either case, it is the responsibility of the research to provide the necessary justification to the IRB committee. IRB will take into consideration the risks and potential harms involved in the research and consent process before granting a waiver.
A. Waiver of Documentation of Informed Consent
A waiver of documentation of informed consent is requested when a signed consent document is not required (i.e., verbal or implied consent). Consent will still be obtained from participants; however, they will not be required to sign the consent form.
There are only two circumstances when the IRB may waive the requirement to obtain a signed consent form:
For example, if you are conducting an online survey and the survey does not ask for any identifiable information. The consent form would need to contain a statement indicating that completing the survey implies consent to participate in the research.
Templates for Implied Consent
B. Waiver of Informed Consent
A waiver of informed consent could: (1) alter some or all of the required elements of informed consent or (2) completely waive the requirement to obtain informed consent. The IRB may approve a consent procedure that does not include or alters some or all of the required elements of informed consent provided:
Examples of types of studies in which some or all elements of consent may be waived include retrospective database with no identification, or studies of existing pathology specimens, observation research without interaction and studies that require deception or passive (opt-out) consent.