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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 II.1.C.

ELEMENT II.1.C.: The organization has and follows written policies and procedures to separate competing business interests from ethics review functions.   
The IRB or EC review process should be free of conflict of interest so that the IRB or EC member’s obligation to protect participants or ensure the integrity of the review process is not compromised by competing business interests. Competing business interests can influence the review process when individuals responsible for business development serve on the IRB or EC or are involved in the day-to-day operations of the IRB or EC. For example, the director of grants and contracting, the vice president for research, or deans of research who are responsible for raising funds or garnering support for research should not serve as IRB or EC members or be involved in the daily operations of the IRB or EC.

For-profit independent IRBs or ECs should separate the business function of the company from the ethics review function.  IRB or EC members should not own equity in the company and senior officers in the company who are responsible for business development should not be involved in the daily operation of the review process, such as reviewing or triaging protocols.

Regulatory and guidance references

  • None

Required written materials

  1. Essential requirements:
    1. Policies and procedures prohibit individuals who are responsible for business development from:
      1. Serving as members on the IRB or EC.
      2. Carrying out day-to-day operations of the review process.
    2. Policies and procedures prohibit IRB or EC members from owning equity in the organization, if appropriate.

Outcomes

  • The organization separates the business functions from the ethics review function.
  • Individuals involved in the business function or in research development do not serve as members of the IRB or EC and do not carry out the day-to-day operations of the review process.

Proceed To: ELEMENT II.1.D.