ELEMENT III.1.E.

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

DHHS: 45 CFR 46.111(a)(3), 45 CFR 46.116
FDA: 21 CFR 56.111(a)(3), 21 CFR 56.20, FDA Information Sheets: Recruiting Study Subjects, Payment to Research Subjects
ICH-GCP: 4.3.3, 4.3.4, 4.8.3
VA: 38 CFR 16.111(a)(3), 38 CFR 16.116, VHA Directive 1200.05
AAHRPP Tip Sheet: Following the Guideline of the International Conference on Harmonisation – Good Clinical Practice (E6)

Required written materials

Essential requirements:
1. Policies and procedures pertaining to Element II.3.C. that address essential requirements.
When following DoD requirements:
1. Civilian researchers attempting to access military volunteers should seek collaboration with a military researcher familiar with service-specific requirements.
When following FDA regulations:
1. Policies and procedures pertaining to Element II.3.C. that address specific FDA regulations.
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.
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.
When following VA requirements:
1. Policies and procedures pertaining to Element II.3.C. that address specific VA regulations.
2. During recruitment process, VA researchers are responsible for:
  1. 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. If a contractor makes the initial contact by letter, the VA researcher must sign the letter.
  2. For studies in which information about the participant’s participation will be included in the participant’s VHA medical record, information must be given to the prospective participants as part of the informed consent process that information regarding study participation will be included in the medical 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.

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Table of Contents

ELEMENT III.1.E.