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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

ELEMENT III.1.A.

ELEMENT III.1.A.: Researchers and research staff know which of the activities they conduct are overseen by the Human Research Protection Program, and they seek guidance when appropriate.
Researchers and research staff should understand which activities are overseen by the HRPP or seek guidance. They should have an understanding of the definitions of what constitutes research involving human participants according to legal and regulatory definitions and the organization’s policies and procedures. When necessary, they should be aware of the process to obtain an opinion from the HRPP and whom to contact.

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

  1. Essential requirements:
    1. Policies and procedures pertaining to Element I.1.A. that address essential requirements.
  2. When following DHHS regulations:
    1. Policies and procedures pertaining to Element I.1.A. that address DHHS-specific requirements.
  3. When following FDA regulations:
    1. Policies and procedures pertaining to Element I.1.A. that address FDA-specific requirements.

  4. 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

Outcomes

  • Researchers and research staff understand which activities are overseen by the HRPP and when to seek guidance. 

Proceed To: ELEMENT III.1.B.