Evaluation Instrument for AccreditationJan 19, 2022, 16:59 PM
INTERNATIONAL ADDENDAFeb 20, 2023, 23:40 PM
INTRODUCTIONMar 20, 2022, 20:45 PM
TABLESFeb 17, 2022, 11:24 AM
DOMAIN III: RESEARCHER AND RESEARCH STAFFFeb 9, 2022, 14:15 PM
DOMAIN II: INSTITUTIONAL REVIEW BOARD OR ETHICS COMMITTEEJan 20, 2022, 11:37 AM
DOMAIN I: ORGANIZATIONJan 19, 2022, 17:01 PM
STANDARD III-2Mar 19, 2022, 00:22 AM
STANDARD III-1Feb 9, 2022, 14:19 PM
Resources: For Accreditation - Evaluation Instrument
Evaluation Instrument for AccreditationDownload as PDF
Table of Contents
Regulatory and guidance references
- DHHS: 45 CFR 46.102(d), 45 CFR 46.102 (f)
- FDA: 21 CFR 50.3(a), 21 CFR 50.3(c), 21 CFR 50.3(g), 21 CFR 50.3(j), 21 CFR 56.102(c), 21 CFR 56.102(l)
- VA: 38 CFR 16.101(a), 38 CFR 16.102(d), 38 CFR 16.102(f), 38 CFR 16.102(f)(1), 38 CFR 16.102(f)(2)
Required written materials
- Essential requirements:
- Policies and procedures pertaining to Element I.1.A. that address essential requirements.
- When following DHHS regulations:
- Policies and procedures pertaining to Element I.1.A. that address DHHS-specific requirements.
- When following FDA regulations:
- Policies and procedures pertaining to Element I.1.A. that address FDA-specific requirements.
In the cases above, the policies and procedures pertaining to Element I.1.A also address the written material requirements for this Element. If the same policies and procedures are provided to researchers and research staff, simply reference those documents in the application for this Element.
If there are additional materials, such as an Investigator Handbook or Web pages for researchers, that are not included in the materials used to support Element I.1.A, but are in support of Element III.1.A, include them here.
Common types of materials that may be used to meet the element
- Researcher manual
- Researchers and research staff understand which activities are overseen by the HRPP and when to seek guidance.