Association for the Accreditation
of Human Research Protection Programs, Inc. ®

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Download as PDF
Latest Update: May 15, 2022

Table of Contents

INTRODUCTION DOMAIN I: ORGANIZATION DOMAIN II: INSTITUTIONAL REVIEW BOARD OR ETHICS COMMITTEE DOMAIN III: RESEARCHER AND RESEARCH STAFF TABLES

ELEMENT II.3.A.

ELEMENT II.3.A.: The IRB or EC has and follows written policies and procedures for identifying and analyzing risks and identifying measures to minimize such risks. The analysis of risk includes a determination that the risks to participants are reasonable in relation to the potential benefits to participants and to society.
Minimization of risks
A criterion for approval of research is that risks to participants are minimized by using procedures that are consistent with sound research design and do not unnecessarily expose participants to risk, and whenever appropriate, by using procedures already being performed on the participants for diagnostic or treatment purposes. The IRB or EC should evaluate whether research submitted for review satisfies this criterion. IRB or EC members should understand how to apply this criterion. They should recognize risks whose probability or magnitude can be reduced by using procedures that are consistent with sound research design and that do not unnecessarily expose participants to risk. If the research context involves procedures already being performed for diagnostic or treatment purposes, the IRB or EC should recognize risks whose probability or magnitude can be reduced by using those procedures. If the research context does not involve such procedures, this strategy for minimizing risks is not applicable.

Risk-potential benefit analysis
Another criterion for approval of research is that risks to participants are reasonable in relation to potential benefits, if any, to participants, and the importance of the knowledge that may reasonably be expected to result. The IRB or EC should evaluate whether research submitted for review satisfies this criterion. The IRB or EC should be able to recognize the likelihood and magnitude of harms and benefits, and understand the importance of the knowledge reasonably expected to result. The IRB or EC should be cognizant of the range of harms, including physical, social, economic, psychological, and legal harm. The IRB or EC should also be cognizant of the range of benefits. Direct benefits to participants can take the form of therapy, education, information, resources, or empowerment. 

In all research, the IRB or EC should evaluate the importance of the knowledge that is likely to result from the research.

Resources
The IRB or EC should evaluate each research study to ensure that it has the resources necessary to protect research participants. Such resources include staffing and personnel, in terms of availability, number, expertise, and experience; psychological, social, or medical services, including counseling or social support services that may be required because of research participation; psychological, social, or medical monitoring, ancillary care, equipment needed to protect participants, and resources for participant communication, such as language translation services.

An organization, such as an independent review board, that does not provide all necessary resources should evaluate the resources of the local site. This might be accomplished by a case-by-case review of resources at each site. For example, an IRB can evaluate the adequacy of resources based on a description of facilities and personnel provided by the researcher. The precise resources required are protocol specific.

Regulatory and guidance references


Required written materials

  1. Essential requirements for IRB or EC review:
    1. Policies and procedures describe the process for identifying and analyzing risks, and identifying measures to minimize risks.
      1. Applications include information allowing the IRB or EC to conduct an analysis of the risks and potential benefits, such as:
        1. The purposes of the research.
        2. The scientific or scholarly rationale.
        3. The procedures to be performed.
        4. A description of the procedures being performed already for diagnostic or treatment purposes.
        5. The risks and potential benefits of the research to participants.
      2. In order to approve research, policies and procedures have the IRB or EC determine that:
        1. Risks to participants are minimized by using procedures that are consistent with sound research design and that do not unnecessarily expose participants to risk.
        2. Risks to participants are minimized, when appropriate, by using procedures already being performed on the participants for diagnostic or treatment purposes.
        3. Risks to participants are reasonable in relationship to the potential benefits, if any, to participants, and the importance of the knowledge that may be expected to result.
        4. Research studies have the resources necessary to protect participants:
          1. Adequate time for the researchers to conduct and complete the research.
          2. Adequate number of qualified staff.
          3. Adequate facilities.
          4. Access to a population that will allow recruitment of the necessary number of participants.
          5. Availability of medical or psychosocial resources that participants may need as a consequence of the research.
  2. When following DoD requirements:
    1. The definition of minimal risk in 32 CFR 219 does not include the inherent occupational risks that certain participants face in their everyday life, such as those:
      1. Encountered by Service members, law enforcement, or first responders while on duty.
      2. Resulting from or associated with high-risk behaviors or pursuits.
      3. Experienced by individuals whose medical conditions involve frequent tests or constant pain.


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

    • Application form
    • Reviewer checklist

    Outcomes

    • IRB or EC members approve research according to the criteria of approval pertaining to risks and potential benefits.
    • When considering risks, the IRB or EC considers physical, psychological, social, economic, and legal risks.
    • When considering benefits, the IRB or EC considers direct benefits, if any, to participants and the importance of the knowledge likely to result from the research.
    • Research studies have the resources necessary to protect participants.

    Proceed To: ELEMENT II.3.B.