When submitting a project through the eIRB system, researchers can request either a waiver of the need for signatures/documentation, or a waiver to alter or omit the entire consent process. In either case a detailed justification is needed.
Waivers of documentation allow for verbal consent procedures. The IRB will typically expect that subjects are given copies of the written script behind the verbal presentation. Documentation waivers also allow for online surveys to have a consent process on the first page, ending with a statement like "by clicking the ‘next’ button I agree to participate in the research project".
Requesting a Waiver of Signatures/Documentation
A waiver of the need for subjects to sign a consent form can be granted if any one of the following three conditions are met:
- The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern; or
- The research presents no more than minimal risk of harm to subjects, and involves no procedures for which written consent is normally required outside of the research context; or
- The subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate mechanism for documenting that informed consent was obtained.
It should be noted that in research involving the FDA, only the second of these justifications is recognized.
Requesting a Waiver or Alteration of the Consent Process
Significant alterations or complete waivers of the consent process may be granted if the IRB finds that all five of the following conditions have been met:
- The research involves no more than minimal risk to the subjects; and
- The research could not practicably be carried out without the waiver or alteration; and
- If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format; and
- The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
- Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.