Waiver of Informed Consent Language

Sample language which can be copied and used in your IRB application or amendment

Common Rule” (§46.116) specifies that informed consent can be waived when: “(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; [and] (3) The research could not practicably be carried out without the waiver or alteration.”

The justification for a physician (or patient) waiver is as follows:

A clinical quality improvement intervention that is deemed acceptable for the total population without obtaining consent, should also be deemed acceptable through random allocation since randomization produces more useful information without increasing risk to participants [This justification satisfies Common Rule (§46.116), Criteria 1].
A clinical quality improvement intervention that is deemed acceptable for clinical operations does not require the consent of physicians (or patients). Against that standard, randomization does not increase involuntariness beyond what was already acceptable without consent in operations. Therefore, there is no additional alteration subject's welfare or rights than is already acceptable in the clinical setting [This justification satisfies Common Rule (§46.116), Criteria 2].
Seeking out consent from clinicians (and patients) is burdensome and bothersome for what amount to operational changes to the clinic. Persons not wanting to take extra-time to consent may decline. The resultant sample then no longer represents the underlying population. Making the research not practicable, because the sample now contains a higher proportion of more motivated participants — those willing to complete the consent procedures and a group that may exclude the participants who could benefit the most. The trial no longer reflects what might happen if the intervention was assigned to everyone [This justification satisfies Common Rule (§46.116), Criteria 3].