Jan 19, 2022, 16:59 PM
Feb 20, 2023, 23:40 PM
Mar 20, 2022, 20:45 PM
Feb 17, 2022, 11:24 AM
Feb 9, 2022, 14:15 PM
Jan 20, 2022, 11:37 AM
Jan 19, 2022, 17:01 PM
Resources: For Accreditation - Evaluation Instrument
Table of Contents
USE OF THE EVALUATION INSTRUMENT FOR ACCREDITATIONTHE FIVE SECTIONS OF ELEMENTS AND STANDARDSGLOSSARY OF TERMSSUMMARY OF REVISIONSDOMAIN I: ORGANIZATION
STANDARD I-1STANDARD I-3STANDARD I-4 STANDARD I-5 STANDARD I-6 STANDARD I-7 STANDARD I-8 STANDARD I-9DOMAIN II: INSTITUTIONAL REVIEW BOARD OR ETHICS COMMITTEE
ELEMENT I.1.A ELEMENT I.1.B ELEMENT I.1.C. ELEMENT I.1.D ELEMENT I.1.E. ELEMENT I.1.F. ELEMENT I.1.G. ELEMENT I.1.H.STANDARD I-2
STANDARD II-1 STANDARD II-2DOMAIN III: RESEARCHER AND RESEARCH STAFF
ELEMENT II.2.A. ELEMENT II.2.B. ELEMENT II.2.C. Element II.2.D. Element II.2.E. Element II.2.F. Element II.2.G. Element II.2.H. Element II.2.I.STANDARD II-3
ELEMENT II.3.A. ELEMENT II.3.B. ELEMENT II.3.C. ELEMENT II.3.D. ELEMENT II.3.E. ELEMENT II.3.F. ELEMENT II.3.G.STANDARD II-4 STANDARD II-5
STANDARD III-1TABLES INTERNATIONAL ADDENDA
ELEMENT III.1.A. ELEMENT III.1.B. ELEMENT III.1.C. ELEMENT III.1.D. ELEMENT III.1.E. ELEMENT III.1.F. ELEMENT III.1.G.STANDARD III-2
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: 3.1.7, 4.8.15
- 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:
- Policies and procedures describe the criteria to waive the requirement to obtain consent for planned emergency research.
- When following DoD requirements:
- 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:
- Policies and procedures describe the criteria to approve planned emergency research.
- 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) guideline:
- Policies and procedures require that the participant or the participant’s legally authorized representative is informed about the clinical trial as soon as possible and provides consent if the participant wishes to continue.
- When following VA requirements:
- VHA does not conduct planned emergency research.
- 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