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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 I.8.A.

ELEMENT I.8.A.: The organization has a written agreement with the sponsor that addresses medical care for research participants with a research-related injury, when appropriate.
When appropriate, arrangements for medical care for research-related injury should be defined before the research starts and communicated to prospective participants. (See Element II.3.F.) This Element does not require any particular party, among the organization, sponsor or its agents, or participant to be responsible for such care; it requires that it be made clear to participants who will provide medical care and who will be responsible to pay for it.

This Element primarily applies only to the organization that conducts clinical research. If an organization conducts other types of research in addition to clinical research, this Element is generally not applicable, although there might be instances where research-related injury requiring medical care could occur. The organization should evaluate the risk of injury in the research conducted under its auspices and should make determinations whether medical care for research-related injury might be needed.

Regulatory and guidance references


Required written materials

  1. Essential requirements:
    1. Policies and procedures have contracts or other funding agreements indicate who will provide care and who is responsible to pay for it.
    2. For independent IRBs:
      1. If the organization contracts with sponsors or clinical research organizations, contracts or other funding agreements state that sponsors are required to indicate who will provide care and who is responsible to pay for it.
      2. Policies and procedures include the process used to ensure that contracts with the researcher indicate who will provide care and who is responsible to pay for it, such as an attestation or other written statement from the researcher or clinical research organization, for examples master service agreement or work order.
    3. When following VA requirements:
      1. For VA facilities:
        1. The appropriate VA Clinical Trial Cooperative Research and Development Agreement (CRADA) is used for research collaborations where:
          1. The industry Sponsor holds the FDA investigational device exemption (IDE).
          2. The industry Sponsor holds the FDA investigational new drug (IND) application and developed the protocol.
          3. The VA PI has substantially designed the protocol for clinical studies.

 



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

  • Contract template
  • Reviewer checklist for contract language

Outcomes

  • When appropriate, arrangements for medical care for research-related injury are defined before the research starts.
  • For independent IRBs attestations or other written statements or agreements describe who will provide care and who is responsible to pay for it.

Proceed To: ELEMENT I.8.B.