Informed consent is more of a conversation process, rather than a means for obtaining a signature. Federal regulations require written informed consent (meaning the use of an IRB-approved written consent form that is signed by the participant or the participant’s legal representative). Occasionally there are reasons to waive written consent or to alter the requirements of consent. Researchers are required to inform participants in written or verbal form of the primary purpose of the research project and of any procedures that they will undergo. Additionally, participants are to be informed of their rights regarding the study (voluntary participation, protecting anonymity and privacy) and any risks or benefits associated with the project.
Under certain circumstances, the use of written consent documents may be waived or alteration of the consent process may be approved. The IRB will take into consideration the risks and potential harms involved in these requests to approve. Review the below for more information.
Please note the IRB may approve waivers of informed consent for Expedited and Full Board ONLY. Requests are not required exempt research. An investigator may wish to keep identifties anonymous by not adding a signature block on a consent document. Waivers may only be requested when risks to participants are at or more than minimal risk. If you’re not sure, contract the ORPC.
Waiver of Documentation of Signed Informed Consent
Researchers can request that a participant not be required to sign a consent form prior to participation. In order to waive the signature requirement, referred to as verbal consent, ONE OF THE FOLLOWING must be applicable to Expedited and Full Board protocol studies:
- The only record linking a participant to the research is the consent from in studies where the principal risk is a breach of confidentiality.
- The research is minimal risk and only involves procedures for which consent is not normally sought.
- Participants will be wary of signing documents from a cultural perspective.
Waiver or Alteration of Elements of Informed Consent
In specific instances, any of the eight (8) elements of informed consent may be waived. To do so, ALL OF THE FOUR CRITERIA BELOW must be met for to Expedited and Full Board protocol studies:
- The research in its entirety involves no more than MINIMAL RISK to participants.
- The waiver or alteration will not adversely affect the rights or welfare of participants.
- The research could not practically be carried out without the waiver or alteration.
- Wherever appropriate, participants will be provided with additional pertinent information after participation.
Note: A waiver of for alteration of elements of informed consent request is required for any study using deception. Studies using deception must also include a debriefing statement.
Waiver of the Informed Consent Process
In rare cases, the entire consent process can be waived. To waive the consent process altogether, requests for this waiver must only accompany applications submitted to the IRB for full board review. ALL OF THE FOUR CRITERIA BELOW must be met:
- The research in its entirety involves no more than MINIMAL RISK to participants.
- The waiver will not adversely affect the rights and welfare of participants.
- The research could not practically be carried out without the waiver.
- Whenever appropriate, participants will be provided with additional pertinent information after participation.
Please contact the ORPC at least four (4) weeks prior to submission a full board application if the research procedures will involve the waiver of the informed consent process.