Robert Hood
03/27/2008 10:18 pm
IRB Committee Member Help: Is selection of subjects equitable?
| Belmont principle
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Justice
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| Where to start: initial application
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Subjects section, Question A
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| Where to start: continuing review application
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Subjects Information section, Questions A-W
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| Required IRB determinations
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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
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| General Consideration
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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.
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| Accreditation Element
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Element II.3.C. The IRB or EC has and follows written policies and procedures to evaluate the equitable selection of participants.
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| Regulations
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45 CFR §46.111(a)(3); 21 CFR §56.111(a)(3)
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| Guidance
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none
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| OHRP Guidebook
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Chapter 3: Basic IRB Review
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