Emergency Research (Planned and Approved) with Exception from Informed Consent

Overview

The Food and Drug Administration (FDA) regulation at 21 CFR 50.24, and Office for Human Research Protections (OHRP) Secretary’s Waiver, allows a narrow exception to the requirement to prospectively obtain and document informed consent from research participants. According to the regulation, IRBs may approve certain emergency research protocols in which participants are unable to give informed consent at the time of enrollment due to their medical condition.

These studies require additional steps to ensure that potential participants in the communities where the study takes place have adequate opportunity to learn about the study at any time:

• “Community Consultation” prior to IRB submission of the full study protocol
• “Public Disclosure” (such as advertisements)
  • before study initiation, of plans for the investigation and its risks and expected benefits
  • after study completion, of study results and the demographics of the study population.

The IRB also approves and oversees these additional steps.

Guidance Documents

• IRBMED flowchart on extended process for approval and oversight of EFIC studies
• U-MIC presentation: Exception from Informed Consent Requirements for Emergency Research
• FDA Guidance: Exception from Informed Consent for Studies Conducted in Emergency Settings
• OHRP Guidance: Emergency Research Consent Waiver
• IRBMED Position Statement 2007 on Allowing Exception From Informed Consent For Emergency Care Research

UNIT: Institutional Review Boards (IRBMED)

TOPICS: FDA (Drugs, Devices & Biologics) / Informed Consent & Assent / Investigator & Study Team Responsibilities / Regulations & Policies (Federal, State & Local)

TAGS: Regulatory