When reviewing protocols, IRBs/IECs are primarily responsible forsafeguarding human subjectsby evaluating risks, benefits, and fairness in subject selection.
* 21 CFR 56.111(a)(3):"In making its determination the IRB shall determine that... selection of subjects is equitable."
* 45 CFR 46.111(a)(3):Repeats this requirement, emphasizing fairness across gender, race, age, and socioeconomic status.
Other options:
* Patient population availability (A) is afeasibility issue, addressed by investigators and sponsors, not IRBs.
* Education of the study team (C) is confirmed by thesponsor and investigator, not IRB.
* Funding sources (D) may raise conflict of interest concerns, but they are not IRB approval criteria per federal regulations.
Thus, IRBs focus onjustice and fairness in subject selectionas part of the Belmont Report principles.
References:
21 CFR 56.111(a)(3).
Belmont Report (Justice principle).