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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.D.

ELEMENT III.1.D.: Researchers determine that the resources necessary to protect participants are present before conducting each research study. 
Researchers should have the resources required to conduct research in a way that will protect the rights and welfare of participants and ensure the integrity of the research. These resources might include personnel, time, and access to a study population. Researchers should not commence a research study without adequate resources to protect participants and should stop a research study if resources become unavailable.

Regulatory and guidance references


Required written materials

  1. Essential requirements:
    1. Policies and procedures pertaining to Element II.3.A. that address essential elements.
    2. The policies and procedures pertaining to Element II.3.A also address the written material requirements for this Element.  If the same policies and procedures are provided to researchers and research staff, simply reference those documents in the application for this Element.  If there are additional materials, such as an Investigator Handbook or Web pages for researchers, that are not included in the materials used to support Element II.3.A, but are in support of Element III.1.D., include them here. 
    3. Researchers are responsible to:
      1. Ensure that there are adequate resources to carry out the research safely.  This includes, but is not limited to, sufficient investigator time, appropriately qualified research team members, equipment, and space.
      2. Ensure that research staff are qualified (e.g., including but not limited to appropriate training, education, expertise, credentials and, when relevant, privileges) to perform procedures assigned to them during the study.
  2. When following VA requirements:
    1. Researchers and their staff conducting human participants research must be credentialed and privileged as required by current local and VA requirements. Researchers and their research staff may only perform those activities in a research study for which they have the relevant credentials and privileges.

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

  • Researcher manual

Outcomes

  • When conducting a research study, researchers have the resources necessary to protect human participants, including:
    • Adequate time for the researchers to conduct and complete the research.
    • Adequate number of qualified staff.
    • Adequate facilities.
    • Access to a population that will allow recruitment of the necessary number of participants.
    • Availability of medical or psychosocial resources that participants may need as a consequence of the research.
    • A process to ensure that all persons assisting with the research are adequately informed about the protocol and their research-related duties and functions.

Proceed To: ELEMENT III.1.E.