Rule CG-RES-009
Research recruitment: what rule CG-RES-009 checks
Rule CG-RES-009 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.
CG-RES-009 · Blocks approval · Citation checked against stored text
A research ad must not promise benefit or safety, treat payment as the draw, or skip eligibility and health screening, because that is undue influence and misstates the study.
Source: FDA information sheet "Recruiting Study Subjects"; FDA information sheet "Payment and Reimbursement to Research Subjects"; 21 CFR 50.20; 21 CFR 312.7(a)
Safer wording: Say it is a research study, what it tests, who may take part, and that participants are screened. Mention payment plainly without making it the draw.
21 CFR 50.20, 21 CFR 312.7(a) · Needs counsel review
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