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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.B.

ELEMENT II.1.B.: The IRB or EC has qualified leadership (e.g., chair and vice chair) and qualified members and staff. Membership and composition of the IRB or EC are periodically reviewed and adjusted as appropriate.
IRB or EC chairs, members, and staff involved in review should have the knowledge, skills, and abilities necessary to carry out the function of the IRB or EC. The membership of the IRB or EC must be qualified through the experience and expertise, or the use of consultants (See Element II.1.E.) to review the research.  Which individuals have this expertise is unimportant, provided the expertise is available and applied.

Policies and procedures should define the requirements to be an IRB or EC chair, member, staff, and describe the periodic evaluation of their performance. Policies and procedures should describe the periodic review and adjustment of the membership and composition of the IRB or EC.

See AAHRPP Tip Sheet 7

Regulatory and guidance references


Required written materials

  1. Essential requirements:
    1. Policies and procedures describe the membership and composition of the IRB or EC, including:
      1. The appointment of:
        1. IRB or EC members.
        2. IRB or EC chairs and vice-chairs when appropriate.
        3. Alternate members.
      2. The function of alternate members.
      3. The periodic assessment and feedback provided to:
        1. IRB or EC members.
        2. IRB or EC chairs, and vice-chairs when appropriate.
        3. IRB or EC staff.

    Outcomes

    • The IRB or EC is sufficiently qualified through the experience, expertise (professional competence), and diversity of its members to protect the rights and welfare of research participants.
    • IRB or EC chairs, members, and staff are knowledgeable.
    • The composition of the IRB or EC is periodically evaluated and, when necessary, adjusted so that the membership and composition of the IRB or EC meet legal or regulatory and organizational requirements.
    • IRB chairs, vice-chairs and members are periodically evaluated and provided feedback.

    Proceed To: ELEMENT II.1.C.