Association for the Accreditation
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Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

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Latest Update: May 1, 2019
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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
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

STANDARD I-2

standard i-2: The organization ensures that the Human Research Protection Program has resources sufficient to protect the rights and welfare of research participants for the research activities that the organization conducts or oversees.

Resources include all needs of an HRPP, such as staff, consultants, IRBs or ECs, meeting space, equipment, finances, information technology systems, and space to store records securely, permit private conversations, accommodate computer and office equipment, and hold meetings.

There are no standards or formulas for sufficient resources; the determination is made based on outcome. If an organization meets all other Elements, resources will be judged sufficient. If an organization does not meet an Element, insufficient resources will be considered as a possible reason. An organization may rely on the services, such as the IRB or EC, contracting office, or conflict of interest committee, of another organization to supplement its resources. (See Standard I.9)


Regulatory and guidance references


Required written materials

  1. Essential requirements:
    1. The organization maintains adequate resources for support of the operations of the HRPP, including but not limited to resources such as space and personnel, in order to meet the accreditation standards.
      1. Policies and procedures describe the plan to evaluate resources needed for the HRPP.
      2. If the organization relies on the services or components of another organization, policies and procedures describe the steps followed (e.g., criteria, evaluation, or monitoring) to evaluate whether the service or component meets the relevant accreditation standards. (See Standard I-9) 
  2. When following DoD requirements:
    1. Policies describe the process to confirm approval by the appropriate DoD component prior to research starting. DoD component-level administrative review (CLAR) must be conducted when:
      1. Human participants research is conducted in a foreign country, unless conducted by a DoD overseas institution, or only involves DoD-affiliated personnel who are US citizens.
      2. The involvement of DoD personnel in the conduct of the research is secondary to that of the non-DoD institution.
      3. The research requires a waiver of informed consent pursuant to 10 USC 980, Subsection (b).
      4. The research is fetal research, as described in 42 USC 289g-289g-2.
      5. Large scale genomic data (LSGD) is collected from DoD-affiliated personnel. LSDG includes data derived from genome-wide association studies; single nucleotide polymorphisms arrays; genome sequencing; transcriptomic, metagenomic, epigenomic analyses; and gene expression data; etc.
      6. The research constitutes classified research involving human participants
      7. The research is required to be approved by the DOHRP (in addition to the COHRP) in accordance with DoDI 3216.02.
    2. Component review includes review of reliance agreements; see Standard I-9
  3. When following VA requirements:
    1. Policies and procedures indicate the facility director is responsible for ensuring provision of adequate resources to support the operations of the HRPP so that those operations are in compliance with all VA and other federal requirements that govern human participants research protection.
    2. The VA facility has an established or designated IRB by:
      1. Establishing its own IRB.
      2. Securing the services of an OHRP-registered IRB established by another VA facility, VA central IRB, or affiliated medical or dental school, or an IRB of another federal agency. In policies and procedures:
        1. The provision of services by another IRB, including the VA Central IRB, is established through a memorandum of understanding or other written agreement that outlines the responsibilities of the VA and the academic affiliate.
        2. When relying on another IRB, the memorandum of understanding requires the other IRB to comply with VA requirements when reviewing VA research.
        3. A VA facility’s own internal IRB cannot serve as an IRB of record for any non-VA entity except a DoD facility or a VA nonprofit research and educational foundation.
      3. If using the VA Central IRB, the facility director delegates authority to one or more individuals from the local VA facility to:
        1. Provide comments or suggestions to VA Central IRB, in response to VA Central IRB’s initial review considerations.
        2. Respond to VA Central IRB’s approval of the study on behalf of the VA facility as to whether the VA facility chooses to participate or declines to participate in the study. 
        3. Serve as liaison between the VA facility and both the local site researcher and VA Central IRB.

Outcomes

  • The organization has allocated the financial and personnel resources and space necessary to carry out the operations of the HRPP in order to meet the accreditation standards.
  • The organization periodically reviews the resources allocated to the HRPP and adjusts resources as needed.
  • The organization periodically evaluates key functions of the HRPP, such as the number of IRBs or ECs, the conflict of interest committee, the quality improvement program, the educational activities, sponsored programs, and pharmacy services, and makes adjustments so that key functions of the HRPP are accomplished in a thorough and timely manner.
  • When the organization relies on the services of another organization, the organization ensures that the services meet the relevant accreditation standards.

Proceed To: STANDARD I-3