There are only two circumstances under which the regulations give IRBs authority to waive the mandate for obtaining legally effective informed consent from subjects.
- The IRB may approve a consent procedure that doesn’t include or which alters some or all of the consent requirements, or waive the requirement to obtain informed consent provided that:
- the research involves no more than minimal risk to subjects,
- the waiver or alteration will not adversely affect the rights and welfare of the subjects,
- whenever appropriate, the subjects will be provided with additional pertinent information after they have participated in the study, and
- the research could not be carried out without the waiver or alteration,
- The research or demonstration project is conducted by, or subject to, the approval of state or local government officials, and is designed to study, evaluate, or otherwise examine:
- Public benefit or service programs;
- Procedures for obtaining benefits or services under those programs;
- Possible changes in or alternatives to those programs or procedures; or
- Possible changes in methods or levels of payment for benefits or services under those programs; and
- the research could not practicably be carried out without the waiver or alteration
In each case, all of the points must be evident for a waiver. The IRB will consider whether a waiver is appropriate and may not grant one if they feel it is not in the best interest of the subjects.