Human Research Protection Program: Guidance

Waiver of Informed Consent

UW-Madison's IRBs may waive or alter some or all of the eight required elements of consent in accordance with federal regulations.

Research Not Subject to FDA Regulations

When research is not subject to FDA regulations, the federal Common Rule authorizes UW-Madison's IRBs to waive or alter the informed consent requirements in either of the following circumstances:

 

1. In research activities designed to study certain aspects of public benefit or service programs (See, 45 CFR 46.116(c)); or

 

2. If the IRB finds and documents all of the following:
1. the research involves no more than minimal risk to the subjects;
2. the waiver or alteration will not adversely affect the rights and welfare of the subjects;
3. the research could not practicably be carried out without the waiver or alteration; and
4. whenever appropriate, the subjects will be provided with additional information after participation. See, 45 CFR 46.116(d). 

Research Subject to FDA Regulations

When research is subject to the FDA regulations, a waiver or alteration of informed consent will be allowed only if research meets the criteria specified in 21 CFR 50.23, emergency use of a test article, or 21 CFR 50.24, planned emergency research.

 

In either case, a waiver or alteration of informed consent will not be granted solely for the convenience of the investigator.