The requirement for informed consent applies to all active studies unless the IRB grants a waiver of this requirement. IRB approval of studies as "exempt" does not necessarily mean that the research is exempted from the informed consent requirements.
In response to a request from the Principal Investigator and based on specific criteria (see below), the IRB may waive the requirement to obtain informed consent for some or all participants or it may approve a consent procedure which does not include, or which alters, some or all of the required elements of informed consent [NOTE – These elements are defined in 45 CFR 46.116(c) – c.f. Policy 21.3]. For research involving an FDA-regulated product, however, the IRB may only waive the requirement for informed consent in emergency situations.
For research that does not involve an FDA-regulated product, an IRB decision to waive or modify informed consent may be made on an expedited basis by the IRB Chair or designee during his/her expedited review of the study or amendments or by the convened IRB. The decision as to whether expedited or convened IRB review is necessary shall be made pursuant to regulations and policies on expedited or convened IRB reviews [c.f. Section 8].
An IRB decision to waive or modify informed consent requires that the IRB find and document that:
1) The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine:
a. Public benefit or service programs; OR
b. Procedures for obtaining benefits or services under those programs; OR
c. Possible changes in or alterations to those programs or procedures; OR
d. Possible changes in methods or levels of payments for benefits or services under those programs; AND
2) The research could not practically be carried out without the waiver or alteration
The IRB may also approve a consent procedure which does not include, or which alters some or all of the required elements of informed consent described in 45 CFR 46116(d)), or the IRB may waive the requirements to obtained informed consent, if the IRB finds and documents that:
1) The research involves no more than minimal risk to the subjects; AND
2) The waiver or alteration will not adversely affect the rights and welfare of the subjects; AND
3) The research could not practicably be carried out without the wavier or alteration; AND
4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation
The IRB may waive the requirement for the investigator to obtain a signed consent form for some or all participants (c.f. 45 CFR 46.117; 21 CFR 56.109) if it finds either that:
1) The only record linking the participant and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each participant will be asked whether the participant wants documentation linking the participant with the research, and the participant's wishes will govern (does not apply to research regulated by FDA); OR
2) 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
The IRB shall take into account special circumstances that may warrant waiving formal written consent. For example, fieldwork and ethnographic research may involve observations and interactions with subjects in their own environment, often over long periods of time. In such situations, there may be continuing and evolving protocol shifts such that informed consent statements may never accurately reflect the evolving experimental protocol.