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Dear Colleagues,
Every year, AAHRPP reviews its Evaluation Instrument for Accreditation to determine whether any updates are needed to reflect changes to laws, regulations, and guidance related to the protection of research participants. The Evaluation Instrument is intended for use by organizations seeking accreditation and by peer reviewers who evaluate organizations and provides the information necessary to meet each Standard.
In this revision, the updates to the Standards, Elements, and Table II.3.F.1. include the following:
International Conference on Harmonisation – Good Clinical Practice (ICH-GCP):
- ICH-GCP(E6)(R2) requirements have been reintroduced. Because not all organizations have transitioned to ICH-GCP(E6)(R3), AAHRPP is again including E6(R2) content to evaluate organizations that continue to follow ICH-GCP(E6)(R2).
- ICH-GCP(E6)(R3) references, issued in January 2025, were revised as applicable.
- Where ICH-GCP(E6)(R3) overlaps with or updates E6(R2), corresponding revisions have been incorporated into the document, along with descriptions of the relevant guideline content.
US Department of Veterans Affairs (VA): Requirements were previously listed in an incorrect position within two Elements (Elements III.2.B. and III.2.C.) and have now been updated and relocated to the appropriate VA section. In connection with this change, new Essential Requirements were added for Element III.2.B. and Element III.2.C., and Outcomes were updated accordingly.
US Department of Energy (DOE): Reference and description were updated (Element III.2.C.). The DOE regulation reference and related description were revised to reflect the clarification of DOE Order 443.1C, Chg.1, Protection of Human Research Subjects.
A full summary of the 2026 revisions as well as prior updates is at: Summary of Revisions, on the AAHRPP website.
Sincerely,
The AAHRPP Team
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