Association for the Accreditation
of Human Research Protection Programs, Inc. ®

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Download as PDF
Latest Update: April 5, 2024
Get Accredited

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.D.

ELEMENT II.1.D.: The IRB or EC has and follows written policies and procedures so that members and consultants do not participate in the review of research protocols or plans in which they have a conflict of interest, except to provide information requested by the IRB or EC.   
The primary goal of the conflict of interest policy should be to prevent conflicting interests from interfering with the review process either by competing with an IRB or EC member’s or consultant’s obligation to protect participants or by compromising the credibility of the review process. Unlike financial conflict of interest of researchers and research Staff, there is no latitude for the management of an IRB or EC member’s conflict of interest. IRB or EC members must not participate in the review of any protocol in which they have a conflict of interest, except to provide information requested by the IRB or EC.
 
From time to time, IRBs or ECs use consultants to supplement the review process. Consultants should be queried as to whether they have a conflict of interest. If a consultant has a conflict of interest and is allowed to review the protocol, the IRB or EC should determine by what means the conflict of interest will be disclosed to the convened IRB or EC. 

An organization should define the criteria for determining whether an IRB or EC member or a consultant has a conflict of interest. This definition should be designed to capture all conflicts of interest that might affect review. When IRB or EC members or consultants have a conflict of interest, they may remain in the room to provide information requested by the IRB or EC. However, they should leave the room before deliberation and voting.

The definition of a conflict of interest should consider both financial and non-financial interests of IRB or EC members and consultants. For example, a non-financial conflict of interest exists when an IRB or EC member or consultant who reviews research is the spouse of the researcher. For financial interests, the level of interest considered to be a conflict should be at least as stringent as the level of a researcher’s financial interest that requires evaluation as a possible conflict of interest.

Regulatory and guidance references


Required written materials

  1. Essential requirements:
    1. Policies and procedures indicate IRB or EC members and consultants do not participate in any review in which they have a conflict of interest, except to provide information requested by the IRB or EC.
    2. Policies and procedures define when an IRB or EC member has a conflict of interest.
      1. The definition considers financial issues.
      2. The definition considers non-financial issues.
      3. The definition is at least as stringent as the level of a researcher’s financial interest that requires evaluation as a possible financial conflict of interest.
    3. Policies and procedures describe the process to identify IRB or EC members and consultants with a conflict of interest. These policies cover each type of review, such as:
      1. Review by a convened IRB or EC.
      2. Review by the expedited procedure.
      3. Review of unanticipated problems involving risks to participants or others.
      4. Review of non-compliance with regulations or laws or the requirements of the IRB or EC.
    4. Policies and procedures indicate IRB or EC members and consultants with a conflict of interest:
      1. Are excluded from discussion except to provide information requested by the IRB or EC.
      2. Are excluded from voting except to provide information requested by the IRB or EC.
      3. Leave the meeting room for discussion and voting.
      4. Are not counted towards quorum.
      5. IRB members with a conflict are documented in the minutes as being absent with an indication that a conflict of interest was the reason for the absence.

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

  • Disclosure form
  • Reviewer Checklist
  • IRB or EC Agenda
  • Announcement regarding conflict of interest

Outcomes

  • Conflicts of interest of IRB or EC members and consultants are identified and disclosed.
  • IRB or EC members and consultants do not participate in the review of any protocol in which they have a conflict of interest, except to provide information requested by the IRB or EC.

Proceed To: ELEMENT II.1.E.