The Institutional Review Board (IRB) may consider a waiver or alteration of the requirement for obtaining informed consent if all of the conditions are met.
To request a waiver, the research description should address each of the criteria listed below.
Note: To conduct research involving deception or passive consent procedures, these criteria must be met. See the Deception Debriefing and Permission to Use Data Form below.
This condition is satisfied if either the likelihood or the magnitude of harm/discomfort is no greater than what the subjects would ordinarily encounter in daily life or during routine clinical care.
The IRB will assess whether the subjects' rights, such as the "right to privacy", would be violated if the consent were waived. For example, in the case of "right to privacy", the IRB will consider the safeguards for minimizing the potential invasion of privacy and will consider the potential benefits of participation.
For example, obtaining informed consent would not be practicable if the investigator will have no direct contact with subjects and will not know their identities.
For example, a record review where an investigator securely retains an identifier in order to compare the same records at two points in time.
In social science research involving deception, it is common practice to debrief the subjects at the conclusion of the study. In other studies, however, it would not be appropriate to require debriefing. For example, if the research proposed collection of tissue without identifiers, it would not be possible for the investigator to provide additional information since the identities of the subjects would be unknown.
Even if all of the above conditions are met, the IRB is authorized to required an investigator to obtain informed consent. For example, the IRB may determine that the knowledge being sought is not important enough to justify the use of unaware subjects.
To request this waiver, check mark the box for "Request for Waiver of Informed Consent Process" under the Informed Consent section of the E-IRB application, and answer the questions as prompted.