Michelle Keyvani BW706 Blog #4

Name of Guidance:
Exception from Informed Consent Requirements for Emergency Research

Status of Guidance:
Draft Guidance

Guidance Release Date:
This Guidance was released July 2006

Link to Guidance: http://www.fda.gov/RegulatoryInformation/Guidances/ucm127625.htm

Target Audience:
Sponsors, clinical investigators, and Institutional Review Boards (IRBs)

Laws and Regulations:
21 CFR 50.24 and the conforming amendments contained in 21 CFR Parts 56, 312, 314, 601, 812, and 814 provide an exception from the requirement to obtain informed consent from each subject, or the subject's legally authorized representative, prior to enrollment in a clinical investigation.

Summary:
An exception from the requirement to obtain informed consent applies to emergency research for which: (1) an Investigational New Drug Application (IND) or Investigational Device Exemption (IDE) is required, (2) that involves human subjects who have a life-threatening medical condition for which available treatments are unproven or unsatisfactory, (3) that involves subjects who because of their condition (e.g., incoherent) cannot give informed consent and (4) where the intervention must be administered before informed consent from the subjects' legally authorized representative is feasible.

"Studies involving an exception from the informed consent requirements may proceed only after a sponsor has received prior written authorization from FDA and the IRB has found and documented that specific conditions have been met."

Rationale:
The reason why this guidance is so important is because the emergency research permitted under 21 CFR 50.24 involves a particularly vulnerable population (persons with life-threatening conditions who can neither give informed consent nor actively refuse enrollment). This lack of autonomy creates a special need for FDA, sponsors, IRBs and clinical investigators to work closely together to protect the interests of this vulnerable population of subjects. At the same time, FDA needs to consider the unmet medical needs of such subjects and the potential for them to benefit from new therapies for such conditions.

Resulting Recommendations:
Under 21 CFR 50.24(a)(3), the IRB must find and document that participation in emergency research studies holds out the prospect of direct benefit to the subjects because: (1) the subjects are in a life-threatening situation that necessitates intervention, (2) appropriate animal and other preclinical studies support the potential for the intervention to provide a direct benefit and (3) the risks associated with the investigation are reasonable in relation to what is know about the medical condition of the potential class of subjects, the risks and benefits of standard therapy, if any, and what is known about the risks and benefits of the proposed intervention or activity.

Impact:
Being able to conduct emergency research without informed consent can facilitate the unmet medical needs of subjects and enable them the potential to benefit from new therapies for their conditions.