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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.G.

ELEMENT III.1.G.: Researchers and research staff have a process to address participants’ concerns, complaints, or requests for information.

Researchers and research staff should be open to participants’ complaints or requests for information.  Researchers and research staff should respond appropriately to such complaints or questions.

Researchers should explain to research participants how to contact the research staff to ask questions about the research or express concerns or complaints about the research.

A common, although not exclusive, mechanism for providing contact information is language in the consent document.


Regulatory and guidance references

DHHS: 45 CFR 46.116(a)(6), 45 CFR 46.116(a)(7)
FDA: 21 CFR 50.25(a)(6), 21 CFR 50.25(a)(7)
VA: 38 CFR 16.116(a)(6), 38 CFR 16.116(a)(7), VHA Directive1200.05(3), 5

Required written materials

  1. Essential requirements: 
    1. Policies and procedures describe the way in which the organization provides research participants with information on how to contact the researchers or research staff in regards to:
      1. Concerns, complaints, or questions about the research study.
      2. Requests for information.

Common types of materials that may be used to meet the element

  • Researcher manual

Outcomes

  • Researchers and research staff provide information and processes for participants to submit concerns, complaints or requests for information.
  • Researchers and research staff respond to complaints and requests for information from participants.
  • Researchers and research staff involve the IRB or EC and other components of the HRPP in response to complaints or request for information.

Proceed To: STANDARD III-2