ELEMENT II.4.C.

ELEMENT II.4.C.: The IRB or EC has and follows written policies and procedures for making exceptions to consent requirements for planned emergency research and reviews such exceptions according to applicable laws, regulations, codes, and guidance.

An IRB or EC should have policies and procedures to consider a request for a waiver of the requirement for consent for planned emergency research, unless the organization does not intend to conduct such research. Policies and procedures should account for the differences between various laws, regulations, codes, and guidance that govern such research, such as the FDA regulations and the DHHS regulations depending on whether the research is subject to FDA regulation.

Regulatory and guidance references

DHHS: 45 CFR 46 Waiver of Informed Consent Requirements in Certain Emergency Research (Federal Register, Vol. 61, No. 192, pp. 51531-51533, October 2, 1996), 45 CFR 46.116(f)
DOD: Instruction 3216.2, para. 4.2; SECNAVINST 3900.39D, para. 6a(3)and 7a(l); 10 U.S.C. 980 (a,b); 10 USC 980
FDA: IRB Information Sheets - Exception From Informed Consent for Studies Conducted in Emergency Settings
ICH-GCP(E6)(R3): II.2.4., III.1.2.6., III.2.8.8.
VA: VHA Directive 1200.05, Section 2
AAHRPP Tip Sheet: Following the Guideline of the International Conference on Harmonisation – Good Clinical Practice (E6)
AAHRPP Tip Sheet: Sufficient Information to Determine Whether the Criteria for Approval are Met

Required written materials

Essential requirements:
1. Policies and procedures describe the criteria to waive the requirement to obtain consent for planned emergency research.
When following DoD requirements:
1. When conducting emergency medicine research, policies and procedures describe the process to obtain approval from the DOHRP on behalf of the Secretary of Defense for a waiver of the advance informed consent provision of 10 USC 980.
When following FDA regulations:
1. Policies and procedures describe the criteria to approve planned emergency research.
2. The research plan must be approved in advance by the FDA and the IRB or EC, and publicly disclosed to the community in which the research will be conducted.
When following the ICH-GCP(E6)(R3) guideline:
1. Policies and procedures require:
  1. In emergency situations, where consent cannot be obtained prior to trial participation, consent should be obtained from the participant or their legally acceptable representative as soon as possible in accordance with applicable regulatory requirements and the processes approved by the IRB/EC.
  2. Where the protocol indicates that prior consent of the trial participant or the participant’s legally acceptable representative is not possible, the IRB/IEC should determine that the proposed protocol and/or other document(s) adequately address relevant ethical concerns and meet applicable regulatory requirements for such trials (e.g., in emergency situations).
When following VA requirements:
1. VHA does not conduct planned emergency research.

Outcomes

Waivers to the requirement to obtain consent for planned emergency research are granted in accordance with applicable laws, regulations, codes, and guidance.

Proceed To: STANDARD II-5

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Table of Contents

ELEMENT II.4.C.