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Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

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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 III.1.E.

ELEMENT III.1.E.: Researchers and research staff recruit participants in a fair and equitable manner.
Researchers should use fair and equitable recruitment practices in research and avoid practices that place participants at risk for coercion or undue influence.


Regulatory and guidance references



Required written materials

  1. Essential requirements:
    1. Policies and procedures pertaining to Element II.3.C. that address essential requirements.
  2. When following DoD requirements:
    1. Civilian researchers attempting to access military volunteers should seek collaboration with a military researcher familiar with service-specific requirements.  
  3. When following FDA regulations:
    1. Policies and procedures pertaining to Element II.3.C. that address specific FDA regulations.
  4. In the cases above, the policies and procedures pertaining to Element II.3.C. 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.C., but are in support of Element III.1.E., include them here.
  5. When following the ICH-GCP (E6) guideline:
    1. Policies and procedures describe that researchers are knowledgeable about the following responsibilities:
    2. The researcher informs the participant’s primary physician about the participant’s participation in the clinical trial if the participant has a primary physician and if the participant agrees to the primary physician being informed (not applicable to independent IRBs or ECs).
    3. Although a participant is not obliged to give his or her reasons for withdrawing prematurely from a clinical trial, the researcher makes a reasonable effort to ascertain the reason, while fully respecting the participant’s rights.
  6. When following VA requirements:
    1. Policies and procedures pertaining to Element II.3.C. that address specific VA regulations.
    2. (b) During recruitment process, VA researchers are responsible for:
      1. (i) Making initial contact with potential participants in person or by letter prior to initiating any telephone contact, unless there is written documentation that the participant is willing to be contacted by telephone about the study in question or a specific kind of research as outlined in the study.
        1. The initial contact must provide a telephone number or other means that the prospective participant can use to verify the study constitutes VA research.
      2. Ensuring that all original or digitalized signed and dated informed consent documents are maintained in the researcher’s research files, readily retrievable, and secure.
      3. Creating or updating a VA health record and creating a progress note for all research participants (Veterans or non-Veterans) who receive research procedures or interventions as inpatients or outpatients at VA medical facilities that are either used in or may impact the medical care of the research participant at a VA medical facility or at facilities contracted by VA to provide services to Veterans (e.g., Community-Based Outpatient Clinics or community living centers). Informed consent documents are not required to be in the health record.

Outcomes

  • Researchers and research staff develop and implement appropriate recruitment techniques.
  • Researchers and research staff understand the importance of equitable selection of participants.
  • Researchers and research staff use recruitment 
  • processes that are fair and equitable.

Proceed To: ELEMENT III.1.F.