Human Subjects Research
IRB Waiver of Informed Consent
There are certain research methodologies which could not be practicably carried out without a waiver of some or all of the required elements of informed consent.
In these special cases, the researcher must demonstrate that the confidentiality of participants is adequately protected. The informed consent process can be modified or waived for research that is documented to meet all of the following criteria:
- The research involves no more than minimal risk to the participants;
- The waiver or alteration will not adversely affect the rights and welfare of the participants;
- The research could not be practicably be carried out without the waiver or alteration; and
- Whenever appropriate, the participants will be provided with additional pertinent information after participation.
It is advisable to discuss these exceptions with the IRB staff prior to submitting your IRB application. These exceptions are evaluated on a case-by-case basis by the IRB. Provide the documentation supporting your waiver request in the IRB application response to question 12.
The staff can also assist with the development of the consent document(s) (if any) you will use.