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Is selection of subjects equitable?

Robert Hood

03/27/2008 10:18 pm

IRB Committee Member Help: Is selection of subjects equitable?

Belmont principle Justice
Where to start: initial application Subjects section, Question A
Where to start: continuing review application Subjects Information section, Questions A-W
Required IRB determinations Is the selection of subjects equitable?
Take into account: the research purposes; the setting in which research will be conducted; whether prospective participants will be vulnerable to coercion or undue influence; the inclusion/exclusion criteria; participant recruitment and enrollment procedures; the amount and timing of payments to participants
General Consideration IRB committee members or reviewers using the expedited procedure need to determine that selection of participants is equitable. In determining whether selection of subjects is equitable, consider:
  • The selection (inclusion/exclusion) criteria.
  • Participant recruitment and enrollment procedures.
  • The influence of payments to participants.
Equitable subject selection requires that people not be excluded from research for non-scientific grounds. IRB committee members, or reviewers using the expedited procedure, should identify who is to be enrolled (Men? Women? Ethnic minorities? Children (rationale for inclusion/exclusion addressed)? Seriously-ill persons? Healthy volunteers?). Then IRB members should evaluate whether these subjects are appropriate for the protocol in making a determination whether subject selection is equitable.Evaluate the selection criteria (inclusion and exclusion criteria) to determine that participants are not excluded for non-scientific reasons. For example, if recruitment of minorities into a research study would be more expensive, this fact does not count as a reason why minorities should be excluded from participation in research.In addition, equitable subject selection requires that researchers attempt to recruit a potential subjects who are appropriate to answer the scientific question. For example, in a clinical investigation of a new drug intended for general use, the researcher should recruit a more or less representative sample of the population, which requires the researcher make plans for recruiting, and tracking recruitment, of racial and ethnic minorities, and women.
Accreditation Element Element II.3.C. The IRB or EC has and follows written policies and procedures to evaluate the equitable selection of participants.
Regulations 45 CFR §46.111(a)(3); 21 CFR §56.111(a)(3)
Guidance none
OHRP Guidebook Chapter 3: Basic IRB Review

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