Rule CG-TRK-008
Research recruitment: what rule CG-TRK-008 checks
Rule CG-TRK-008 is one of the checker's research recruitment rules. It cites 21 CFR 50.20, 21 CFR 56.109 and more. The reason, source and safer wording are below.
CG-TRK-008 · Blocks approval · Citation checked against stored text
Presenting a trial as lifesaving, inducing enrollment with testimonials and gifts, or recruiting without ethics review misleads prospective participants and bypasses human-subject protections.
Source: FDA information sheet on recruiting study subjects; 21 CFR 50.20 and 21 CFR 56.109; 45 CFR 46.116; FTC Act section 5
Safer wording: Describe the trial neutrally, state that benefit is unproven, and submit all recruitment material for IRB approval before use.
21 CFR 50.20, 21 CFR 56.109, 45 CFR 46.116 · Needs counsel review
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