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Rule CG-RES-010

Research recruitment: what rule CG-RES-010 checks

Rule CG-RES-010 is one of the checker's research recruitment rules. It cites 21 CFR 50.20, 21 CFR 312.7(a). The reason, source and safer wording are below.

  1. CG-RES-010 · Blocks approval · Citation checked against stored text

    Research ads must not promise access to better treatment or use urgency and heroism to push enrollment, because that overstates benefit and pressures participants.

    Source: FDA information sheet "Recruiting Study Subjects"; 21 CFR 50.20 (no undue influence); 21 CFR 312.7(a)

    Safer wording: Say it is a research study, what it tests, who may take part, and that benefit is not guaranteed. Remove urgency and heroism.

    21 CFR 50.20, 21 CFR 312.7(a) · Needs counsel review

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