FDAnews Drug Daily Bulletin

Committee Defines When Informed Consent May Be Waived

Aug. 8, 2007

The Office of Human Research Protections (OHRP) should develop guidance for the institutional review boards (IRBs) that oversee research studies on human subjects to help them decide when to grant requests to alter or waive informed consent requirements, the Secretary’s Advisory Committee on Human Research Protections (SACHRP) recommended at its July 30-31 meeting.

HHS regulations allow such informed consent waivers or alterations for certain minimal risk studies that could not be practicably carried out otherwise, so that the interests of subjects can be balanced with society’s interests in research. This applies only to studies that are federally funded or otherwise under the purview of OHRP. FDA-regulated (industry-sponsored) trials are not eligible, nor should these waivers be confused with the waivers of informed consent that may be granted under either FDA or OHRP rules for certain types of emergency research, SACHRP stressed.

New OHRP guidance is needed because at present, IRBs may be inappropriately granting informed consent waivers due to uncertainty in applying the criteria and inconsistency in reviewing the research, according to SACHRP’s Subpart A Subcommittee. This subcommittee, which deals with the application of the Federal Policy for the Protection of Human Subjects (the Common Rule), drafted the recommendations that the full committee approved. The subcommittee added that IRBs may not be granting informed consent waivers in some cases when they could.

SACHRP said the proposed OHRP guidance should state that IRBs should not grant informed consent waivers just because investigators say it would be impracticable to get informed consent. Rather, such waivers should only be granted if requiring informed consent would make it impracticable to do the study.