Rule CG-RES-005
Research recruitment: what rule CG-RES-005 checks
Rule CG-RES-005 is one of the checker's research recruitment rules. It cites 21 CFR 56.111(a)(3), 21 CFR 56.111(b) and more. The reason, source and safer wording are below.
CG-RES-005 · Blocks approval · Citation checked against stored text
A recruitment ad must not state or imply a certainty of cure or favorable outcome, or benefits beyond what the consent document and protocol describe.
Source: FDA information sheet "Recruiting Study Subjects"; 21 CFR 56.111(a)(3); 21 CFR 56.111(b); 21 CFR 50.20
Safer wording: Describe what the study involves and who may take part. Do not promise or imply benefit, since people in a study may not benefit.
21 CFR 56.111(a)(3), 21 CFR 56.111(b), 21 CFR 50.20 · Needs counsel review
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