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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.1.H.

ELEMENT I.1.H.: The organization has and follows written policies and procedures specifically designed to protect the rights and welfare of research participants during an emergency. 
Emergency preparedness and response should be an integral part of the entire HRPP. Ensuring the safety and wellbeing of research participants is paramount. Organizations should develop a risk-based emergency preparedness and response plan to ensure sustainability of the HRPP to ensure the rights and welfare of research participants are protected. 

Regulatory and guidance references

  • DHHS: Effects of Disasters on Human Research Protections Programs Guidance (May 14, 2008)
  • FDA: Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies (September 2023)
  • AAHRPP Tip Sheet: Emergency Preparedness and Response

Required written materials

  1. Essential requirements:
    1. The HRPP has an emergency preparedness and response plan, appropriate to the size and complexity of the HRPP, that addresses how continuity of operations will be maintained to ensure human participant protections during an emergency. (Element I.1.A.)
    2. The emergency preparedness and response plan is periodically evaluated and, when necessary, adjusted to ensure continuity of operations.
    3. Organizations provide education about the organization’s emergency response and preparedness plan for IRB members and staff, researchers and research staff, and other persons in the HRPP. (Element I.1.E.)
    4. Persons in the HRPP are knowledgeable about the organization’s expectations during emergencies.

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

  • Plans
  • Educational Materials
  • Evaluation Reports

Outcomes

  • The organization plans for emergencies, educates those in the HRPP, and responds effectively to ensure the sustainability of the HRPP.


Proceed To: STANDARD I-2