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Subject selection and recruitment

Robert Hood

09/09/2008 10:16 am

Help for researchers: Subject Selection and Recruitment

Subject Selection and Recruitment Investigators should use fair and equitable subject selection and recruitment practices that avoid placing participants at risk of coercion or undue influence. Equitable subject selection and recruitment require that people not be excluded from research for non-scientific grounds, or because recruitment is difficult. Federal granting agencies have long required a plan for minority recruitment of underrepresented minorities in clinical trials and research; this practice has been codified into policy. This federal policy reasonably sets an expectation about recruitment for research studies, and this expectation is reflected in the Department’s questions about recruitment and subject selection on the IRB application. Groups in need of special recruitment and retention plans include:
  • Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis
  • Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.
  • Individuals from disadvantaged backgrounds, including individuals who come from a family with an annual income below established low-income thresholds, and individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.
To make required regulatory determinations, materials the IRB needs to review include, but are not limited to:
  • the setting in which research is conducted (for example, at a County Health Department; for research conducted at a CHD, the researcher needs to upload a signed letter of support from the CHD Administrator/Director)
  • whether participants would be vulnerable to coercion or undue influence
  • subject selection (inclusion / exclusion criteria)
  • recruitment plans, including materials (advertisements, flyers) and information about who will recruit
  • the amount and timing of any reimbursement to participants (for example, the IRB will consider whether reimbursement is condition on participants completing the trial)
Required Determinations by the IRB A regulatory criterion for IRB approval is that selection of participants is equitable. IRB members will consider both the selection (inclusion and exclusion) criteria and the proposed plans for recruitment of participants. IRB members will evaluate whether selection criteria and recruitment practices meet this criterion.
Accreditation Elements Include, but are not limited to:
  • Element III.1.D: The Investigator or research staff recruits participants in a fair and equitable manner, weighing the potential benefits of the research to the participants against their vulnerability and the risks to them.
  • Element II.5.A: The Research Review Unit has and follows written policies and procedures to evaluate the equitable selection of participants from various populations and sub-populations, when applicable, and considers whether inclusion and exclusion criteria impose fair and equitable burdens and benefits.
Regulations 45 CFR §46.111(a)(3), 45 CFR §46.116, 21 CFR §56.111(a)(3), 21 CFR §56.20
Guidance FDA Information Sheets: Recruiting Study Subjects, Payment to Research Subjects
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