February 2026 updates

Standards, Elements, and Table II.3.F.1. were revised to once again include the ICH(E6) Guideline for Good Clinical Practice (GCP)(R2) requirements, after removing these in the 2025 version.  Not all organizations have transitioned to ICH-GCP(E6)(R3) and we are again including ICH-GCP(E6)(R2) to evaluate organizations that continue to follow R2.  References to ICH-GCP E6(R3), issued in January 2025, have been revised where 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.

VA Requirements were previously listed in an incorrect position within two Elements. They have now been relocated to the appropriate VA section. Additionally, new Essential Requirements have been added to the documentation for these Elements due to the repositioning of the VA requirements (Element III.2.B and Element III.2.C.).

The DOE regulation reference and content was revised to observe the clarification of DOE Order 443.1C, Chg.1, Protection of Human Research Subjects (Element III.2.C.).

Standards and Elements with updates related to ICH-GCP(E6)(R2), (E6)(R3)

• Element I.1.A.: Reference to ICH-GCP(E6)(R2) and description of relevant guideline content added. Where ICH-GCP E6(R3) overlaps with E6(R2), corresponding revisions have been incorporated, along with a description of the relevant guideline content.
• Element I.1.D.: Reference to ICH-GCP(E6)(R2) and description of relevant guideline content added. Where ICH-GCP E6(R3) overlaps with E6(R2), corresponding revisions have been incorporated, along with a description of the relevant guideline content.
• Element I.1.E.: Reference to ICH-GCP(E6)(R2) added.
• Element I.1.F.: Reference to ICH-GCP(E6)(R2) and description of relevant guideline content added. Where ICH-GCP E6(R3) overlaps with E6(R2), corresponding revisions have been incorporated, along with a description of the relevant guideline content.
• Standard I-2: Reference to ICH-GCP(E6)(R2) added.
• Element I.5.D.: Reference to ICH-GCP(E6)(R2) added.
• Element I.7.A.: Reference to ICH-GCP(E6)(R2) added.
• Element I.7.B.: Reference to ICH-GCP(E6)(R2) and description of relevant guideline content added. Where ICH-GCP E6(R3) overlaps with E6(R2), corresponding revisions have been incorporated, along with a description of the relevant guideline content.
• Element I.7.C.: Reference to ICH-GCP(E6)(R2) added.
• Standard I-9: Reference to ICH-GCP(E6)(R2) and ICH-GCP(E6)(R3) added.
• Element II.1.A.: Reference to ICH-GCP(E6)(R2) added. Reference to ICH-GCP(E6)(R3) revised.
• Element II.1.B.: Reference to ICH-GCP(E6)(R2) added.
• Element II.1.D.: Reference to ICH-GCP(E6)(R2) added.
• Element II.1.E.: Reference to ICH-GCP(E6)(R2) added. Reference to ICH-GCP(E6)(R3) revised.
• Element II.2.D.: Reference to ICH-GCP(E6)(R2) added.
• Element II.2.E.: Reference to ICH-GCP(E6)(R2) added.
• Element II.2.F.: Reference to ICH-GCP(E6)(R2) added.
• Element II.2.G.: Reference to ICH-GCP(E6)(R2) and description of relevant guideline content added. Where ICH-GCP E6(R3) overlaps with E6(R2), corresponding revisions have been incorporated, along with a description of the relevant guideline content.
• Element II.2.H.: Reference to ICH-GCP(E6)(R2) added.
• Element II.3.A.: Reference to ICH-GCP(E6)(R2) added. Reference to ICH-GCP(E6)(R3) revised.
• Element II.3.C.: Reference to ICH-GCP(E6)(R2) added. Where ICH-GCP E6(R3) overlaps with E6(R2), corresponding revisions have been incorporated, along with a description of the relevant guideline content.
• Element II.3.D.: Reference to ICH-GCP(E6)(R2) added.
• Element II.3.E.: Reference to ICH-GCP(E6)(R2) added. Reference to ICH-GCP(E6)(R3) revised.
• Element II.3.F.: Reference to ICH-GCP(E6)(R2) added. Where ICH-GCP E6(R3) overlaps with E6(R2), corresponding revisions have been incorporated, along with a description of the relevant guideline content.
• Element II.4.A.: Reference to ICH-GCP(E6)(R2) added. Where ICH-GCP E6(R3) overlaps with E6(R2), corresponding revisions have been incorporated, along with a description of the relevant guideline content.
• Element II.4.B.: Reference to ICH-GCP(E6)(R2) added.
• Element II.4.C.: Reference to ICH-GCP(E6)(R2) added. Reference to ICH-GCP(E6)(R3) revised. Where ICH-GCP E6(R3) overlaps with E6(R2), corresponding revisions have been incorporated, along with a description of the relevant guideline.
• Element II.5.A.: Reference to ICH-GCP(E6)(R2) added. Where ICH-GCP E6(R3) overlaps with E6(R2), corresponding revisions have been incorporated, along with a description of the relevant guideline content.
• Element III.1.C.: Reference to ICH-GCP(E6)(R2) added. Reference to ICH-GCP(E6)(R3) revised. Where ICH-GCP E6(R3) overlaps with E6(R2), corresponding revisions have been incorporated, along with a description of the relevant guideline.
• Element III.1.D.: Reference to ICH-GCP(E6)(R2) added. Reference to ICH-GCP(E6)(R3) revised. Where ICH-GCP E6(R3) overlaps with E6(R2), corresponding revisions have been incorporated, along with a description of the relevant guideline.
• Element III.1.E.: Reference to ICH-GCP(E6)(R2) added. ICH-GCP E6(R3) revised to delete the following:
  • During and following participation in a trial, the investigator/institution should ensure that adequate medical care is provided to a participant for any adverse events, including clinically significant laboratory values, related to the trial.
  • The investigator/institution should inform a participant when medical care is needed for intercurrent illness(es) of which the investigator becomes aware.
• Element III.1.F.: Reference to ICH-GCP(E6)(R2) added. Reference to ICH-GCP(E6)(R3) revised. Where ICH-GCP E6(R3) overlaps with E6(R2), corresponding revisions have been incorporated, along with a description of the relevant guideline.
• Element III.1.G.: Reference to ICH-GCP(E6)(R2) added.
• Element III.2.A.: Reference to ICH-GCP(E6)(R2) added. Reference to ICH-GCP(E6)(R3) revised. Where ICH-GCP E6(R3) overlaps with E6(R2), corresponding revisions have been incorporated, along with a description of the relevant guideline.
• Element III.2.B.: Reference to ICH-GCP(E6)(R2) added. Where ICH-GCP E6(R3) overlaps with E6(R2), corresponding revisions have been incorporated, along with a description of the relevant guideline.
• Element III.2.C.: Reference to ICH-GCP(E6)(R2) added.
• Element III.2.D.: Reference to ICH-GCP(E6)(R2) added. Where ICH-GCP E6(R3) overlaps with E6(R2), corresponding revisions have been incorporated, along with a description of the relevant guideline.
• Table II.3.F.1. Where ICH-GCP E6(R3) overlaps with E6(R2), corresponding revisions have been incorporated, along with a description of the relevant guideline.

VA requirements repositioning and new Essential Requirements (III.2.B and III.2C)

The VA Requirements were previously listed in an incorrect location and have now been relocated to the proper section. Additionally, new Essential Requirements have been added to the documentation. Outcomes were updated based on these changes.

 DOE reference and description updated (III.2.C.)

Reference to DOE was revised, along with the description.

Standards and Elements were revised primarily to reflect the ICH (E6) Guideline for Good Clinical Practice (GCP)(R3) issued in January 2025 [henceforth referred to as ICH GCP(E6)(R3)].

Standards and Elements with updates related to ICH-GCP(E6)(R3)

• Element I.1.A.: Reference to ICH-GCP(E6)(R3) and description of relevant guideline content added.
• Element I.1.D.: Reference to ICH-GCP(E6)(R3) and description of relevant guideline content updated.
• Element I.1.E.: Reference to ICH-GCP(E6)(R3) added.
• Element I.1.F.: Reference to ICH-GCP(E6)(R3) and description of relevant guideline content updated.
• Standard I-2: Reference to ICH-GCP(E6)(R3) updated.
• Element I.5.D.: Reference to ICH-GCP(E6)(R3)  added.
• Element I.7.A.: Reference to ICH-GCP(E6)(R3) removed.
• Element I.7.B.: Reference to ICH-GCP(E6)(R3) and description of relevant guideline content updated.
• Element I.7.C.: Reference to ICH-GCP(E6)(R3) updated.
• Standard I-9: Reference to ICH-GCP(E6)(R3) removed.
• Element II.1.A.: Reference to ICH-GCP(E6)(R3) updated.
• Element II.1.B.: Reference to ICH-GCP(E6)(R3) updated.
• Element II.1.D.: Reference to ICH-GCP(E6)(R3) updated.
• Element II.1.E.: Reference to ICH-GCP(E6)(R3) updated.
• Element II.2.D.: Reference to ICH-GCP(E6)(R3) updated.
• Element II.2.E.: Reference to ICH-GCP(E6)(R3) updated.
• Element II.2.F.: Reference to ICH-GCP(E6)(R3) updated.
• Element II.2.G.: Reference to ICH-GCP(E6)(R3) and description of relevant guideline content updated.
• Element II.2.H.: Reference to ICH-GCP(E6)(R3) updated.
• Element II.3.A.: Reference to ICH-GCP(E6)(R3) updated.
• Element II.3.B.: Reference to ICH-GCP(E6)(R3) removed.
• Element II.3.F.: Reference to ICH-GCP(E6)(R3) and description of relevant guideline content updated.
• Element II.3.C.: Reference to ICH-GCP(E6)(R3) and description of relevant guideline content updated.
• Element II.3.D.: Reference to ICH-GCP(E6)(R3) added.
• Element II.3.E.: Reference to ICH-GCP(E6)(R3) updated.
• Element II.3.F.: Reference to ICH-GCP(E6)(R3) and description of relevant guideline content updated.
• Element II.4.A.: Reference to ICH-GCP(E6)(R3) and description of relevant guideline content updated.
• Element II.4.B.: Reference to ICH-GCP(E6)(R3) updated.
• Element II.4.C.: Reference to ICH-GCP(E6)(R3) and description of relevant guideline content updated.
• Element II.5.A.: Reference to ICH-GCP(E6)(R3) updated.
• Element III.1.C.: Reference to ICH-GCP(E6)(R3) and description of relevant guideline content updated.
• Element III.1.D.: Reference to ICH-GCP(E6)(R3) updated.
• Element III.1.E.: Reference to ICH-GCP(E6)(R3) updated.
• Element III.1.F.: Reference to ICH-GCP(E6)(R3) updated.
• Element III.1.G.: Reference to ICH-GCP(E6)(R3) updated.
• Element III.2.A.: Reference to ICH-GCP(E6)(R3) and description of relevant guideline content updated.
• Element III.2.B.: Reference to ICH-GCP(E6)(R3) and description of relevant guideline content updated.
• Element III.2.C.: Reference to ICH-GCP(E6)(R3) updated.
• Element III.2.D.: Reference to ICH-GCP(E6)(R3) and description of relevant guideline content updated.
• Table II.3.F.1.: Relevant ICH-GCP(E6)(R3) guideline content updated.

Other revisions include:

• Element I.5.D., II.2.E., II.2.G., and II.2.H.: Revised to remove the requirement for DoD research that "promptly" be defined as 30 days or less, which is consistent with prior updates to the Evaluation Instrument in April 2024.
• Element I.7.A., Element I.7.B.: Added the phrase “investigational product” as a synonym for “test article” to reflect the use of the former in regulations and guidelines beyond the US FDA.
• Element II.1.A.:
  • Added the following language to the commentary: The IRB shall be sufficiently qualified through the experience and expertise of its members (professional competence), and the diversity of its members, including race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.
  • Revised the language at (1)(b)(ii) to: No IRB or EC has members of a single gender.
• Element II.1.B.: Corrected Tip Sheet reference.
• Element II.3.A.: Added the following language to the commentary on minimization of risks: The focus should be on the risks associated with study participation. For clinical trials involving patients, the focus should be on risks that go beyond those associated with usual medical care. The risks relating to test articles or investigational products that have a marketing authorization when used in the clinical trial context may differ from the usual care of patients and should be taken into consideration.
• Element II.3.C.: Clarified in Essential Requirements (1)(a)(vii) that IRB or EC applications include the method of all payments in addition to their amount and schedule.
• Element II.3.F.: Added to the commentary that as part of the IRB or EC should know the medium through which the informed consent process is conducted and potential technology used.
• Element II.5.A.: Clarified in Essential Requirements (1)(a)(i)(B) the type of documentation an IRB or EC might have in addition to or instead of an Investigator’s Brochure.
• Element III.1.G.: Added to Essential Requirements (1)(b) that questions about the trial should be answered to the satisfaction of the participant or the participant’s legally acceptable representative.

April 2024 updates

• Elements I.8.A., I.8.B., I.8.C., I.8.D. were revised to remove a requirement that sponsor agreements define "promptly" as 30 days or less.  
• Standards and Elements were revised to add requirements that apply only to Department of Veterans Affairs facilities (VA hospitals). The revision also clarified what is required of organizations that review for VAs (academic affiliates and independent IRBs) vs. what is required of VA hospitals and other VA facilities, so it is easier for organizations that review for VA facilities to understand the VA requirements that apply to them. The Standards and Elements that address requirements for VA facilities include:
  • Elements I.1.A., I.1.B., I.1.C., I.1.E., I.1.F., I.1.G., I.1.H.
  • Standard I-2
  • Standard I-3
  • Element I.4.A.
  • Elements I.5.A., I.5.B., I.5.D.
  • Element I.6.B.
  • Element I.7.C.
  • Standard I-9
  • Elements II.1.A., II.1.D.
  • Elements II.2.A., II.2.B., II.2.E., II.2.F., II.2.G., II.2.H., II.2.I.
  • Elements II.3.A., II.3.B., II.3.C., II.3.D., II.3.E., II.3.F., II.3.G.
  • Element II.4.A.
  • Elements II.5.A., II.5.B.
  • Elements III.1.B., III.1.C., III.1.D., III.1.E., III.1.F., III.1.G.
  • Elements III.2.B., III.2.C., III.2.D.

December 2022 updates

• Correction to Element II.3.E. to clarify that participants must be informed when information is recorded in the medical record.
• Correction to Element II.3.F. to remove the requirement that the consent document must include the date of IRB approval.
• Correction to Element II.4.A. to clarify that research involving a fetus, or human fetal tissue, in-utero or ex-utero cannot be conducted by VA investigators while on official VA duty, at VA facilities, or at VA-approved off-site facilities.

May 2022 updates

• Added new Element I.1.H. on emergency preparedness and response
• Updated requirements for the Department of Defense, Department of Energy, and Department of Veterans Affairs
• The Evaluation Instrument for Accreditation is now published via this website.  Organizations may download a pdf copy of the entire Evaluation Instrument for Accreditation.