Institutional Review Board for Health Sciences Research (IRB-HSR)

Special Issues

Exception from Informed Consent (EFIC)

Even for an emergency use, the investigator is required to obtain informed consent of the subject or the subject's legally authorized representative unless both the investigator and a physician who is not otherwise participating in the clinical investigation certify in writing in the subject/subject's medical record all of the following [21 CFR 50.23(a)]:

If, in the investigator's opinion, immediate use of the test article is required to preserve the subject's life, and if time is not sufficient to obtain an independent physician's determination that the four conditions above apply, the clinical investigator should make the determination and, within 5 working days after the use of the article, have the determination reviewed and evaluated in writing by a physician who is not participating in the clinical investigation. The investigator must notify the IRB within 5 working days after the use of the test article [21 CFR 50.23(c)].

Planned Emergency Research and Exception from Informed Consent Requirements

Planned emergency research involves the systematic investigation of a condition experienced by individuals "in a setting where the emergency circumstances require prompt action and generally provide insufficient time and opportunity to locate and obtain consent from each subject's legally authorized representative" (FDA 2013).

In addition, "the research must have the prospect of direct benefit to the patient and must involve an investigational product that, to be effective, must be administered before informed consent from the subject or the subject's legally authorized representative can be obtained and in which there is no reasonable way to identify prospectively individuals likely to become eligible for participation." FDA Guidance

Planned emergency research is different than the emergency use of an investigational drug or device in a single patient. Emergency use of an investigational drug or device involves the treatment of a patient using an investigational drug or device outside of the research setting. For more information about emergency use of an investigational drug or device, see AG 3-11: Emergency Use Notification.

Per notice in the Federal Register (October 2, 1996) DHHS has waived the general requirements for informed consent for the class of research consisting of Emergency Research which falls under FDA regulations 21CFR50.24. Because informed consent cannot be obtained prior to initiating research procedures, there are many additional participant protections that must be in place before the IRB can approve planned emergency research.

Definitions

Legally Authorized Representative (LAR): an individual, or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research. [45CFR.46.102(c) and 21CFR50.3(l)]. Refer to AG 3-15 Use of Legally Authorized Representative (LAR)

Family Member: Both FDA and DHHS define a "family member" as any one of the following legally competent persons: spouse; parents; children (including adopted children); brothers, sisters, and spouses of brothers and sisters; and any individual related by blood or affinity whose close association with the subject is the equivalent of a family relationship.

Community Consultation: Providing the opportunity for discussion with, and soliciting opinions from, the community(ies) in which the study will take place and from which the study subjects will be drawn. These communities may not always be the same; when they are not the same, both communities should be consulted.

Public Disclosure (a) Before a planned emergency research protocol begins, the dissemination of information in the community(ies) in which the study will take place and from which the subjects will be drawn sufficient to allow a reasonable assumption that the communities are aware that the study will be conducted, and its risks and benefits; and (b) after the study has been conducted, the dissemination of information to the community(ies) in which the study was conducted and to scientific researchers sufficient to describe the study's demographic characteristics and the study's results.

Therapeutic Window: The protocol defines the time period, based on available scientific evidence, during which the intervention under investigation in the planned emergency research might reasonably produce a demonstrable clinical effect.

Conditions Required to Conduct Planned Research in Emergency Settings with Wavier of Consent and WAIVER OF HIPAA AUTHORIZATION

The IRB reviews the protocol and subsequent informed consent procedures to ascertain 'approvability.' If the protocol is not approvable by the IRB-HSR, because it does not meet the requirements or there are ethical concerns, explanatory documentation must be promptly supplied to the investigator and sponsor.

The convened IRB determines whether the research activity is subject to 21 CFR Sec. 50. If the research is FDA regulated, the IRB follows the FDA regulatory criteria to allow an exception to the requirement to obtain consent (Sec. 50.24).

21 CRF 50.24 (a) The IRB responsible for the review, approval, and continuing review of the clinical investigation described in this section may approve that investigation without requiring that informed consent of all subjects be obtained if the IRB (with the concurrence of a licensed physician* who is a member of the IRB and who is not otherwise participating in the clinical investigation) finds and documents each of the following points:

Last Modified: Wednesday, 28-Jun-2017 15:46:11 EDT