Rule CG-RES-050
Research recruitment: what rule CG-RES-050 checks
Rule CG-RES-050 is one of the checker's research recruitment rules. It cites 21 CFR 312.7(a), 21 CFR 50.20 and more. The reason, source and safer wording are below.
CG-RES-050 · Blocks approval · Citation checked against stored text
A clinical trial ad that calls the study promising or a breakthrough, says it cures patients, or promises placement within a set time describes the experimental treatment as better than the alternatives and sets false expectations. FDA and IRBs treat recruitment ads as part of informed consent and expect them to stay neutral about safety and effectiveness.
Source: 21 CFR 312.7(a) (no claims of safety or effectiveness for an investigational drug); 21 CFR 50.20 (no exculpatory language, informed consent); FDA Information Sheet, Recruiting Study Subjects; 45 CFR 46.116
Safer wording: State the condition studied, the purpose, who may qualify and whom to contact. Avoid "promising", "breakthrough", "new treatment" and promises about placement or outcome. Have the IRB approve the final wording.
21 CFR 312.7(a), 21 CFR 50.20, 45 CFR 46.116 · Needs counsel review
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