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Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

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Latest Update: April 5, 2024
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Table of Contents

INTRODUCTION
USE OF THE EVALUATION INSTRUMENT FOR ACCREDITATION
THE FIVE SECTIONS OF ELEMENTS AND STANDARDS
GLOSSARY OF TERMS
LIST OF STANDARDS AND ELEMENTS
SUMMARY OF REVISIONS
DOMAIN I: ORGANIZATION
STANDARD I-1  
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 I-3
STANDARD I-4  
ELEMENT I.4.A. ELEMENT I.4.B. ELEMENT I.4.C.
STANDARD I-5  
ELEMENT I.5.A. ELEMENT I.5.B. ELEMENT I.5.C. ELEMENT I.5.D.
STANDARD I-6  
ELEMENT I.6.A. ELEMENT I.6.B.
STANDARD I-7  
ELEMENT I.7.A. ELEMENT I.7.B. ELEMENT I.7.C.
STANDARD I-8  
ELEMENT I.8.A. ELEMENT I.8.B. ELEMENT I.8.C. ELEMENT I.8.D. ELEMENT I.8.E.
STANDARD I-9
DOMAIN II: INSTITUTIONAL REVIEW BOARD OR ETHICS COMMITTEE
STANDARD II-1  
ELEMENT II.1.A. ELEMENT II.1.B. ELEMENT II.1.C. ELEMENT II.1.D. ELEMENT II.1.E.
STANDARD II-2  
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  
ELEMENT II.4.A. ELEMENT II.4.B. ELEMENT II.4.C.
STANDARD II-5  
ELEMENT II.5.A. ELEMENT II.5.B.
DOMAIN III: RESEARCHER AND RESEARCH STAFF
STANDARD III-1  
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 III.2.A. ELEMENT III.2.B. ELEMENT III.2.C. ELEMENT III.2.D.
TABLES
TABLE II.2.A.1.
TABLE II.2.C.1.
TABLE II.2.F.1.
TABLE II.3.F.1.
TABLE II.3.G.1
TABLE II.3.G.2.
INTERNATIONAL ADDENDA
Country-Specific Addenda

SUMMARY OF REVISIONS

summary of revisions: Updates and Corrections

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


Proceed To: DOMAIN I: ORGANIZATION