February 2025 updates

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.