Rule CG-RES-007
Research recruitment: what rule CG-RES-007 checks
Rule CG-RES-007 is one of the checker's research recruitment rules. It cites 45 CFR 164.512(i), 45 CFR 164.508 and more. The reason, source and safer wording are below.
CG-RES-007 · Blocks approval · Citation checked against stored text
Telling someone you picked them from their records means protected health information was used to find them. Using it to recruit needs an authorization or a documented HIPAA pathway, which is separate from IRB approval of the ad.
Source: 45 CFR 164.512(i); 45 CFR 164.508; 21 CFR 56.111(a)(7)
Safer wording: Describe who may qualify in general terms ("adults with type 2 diabetes may qualify") and do not say how you found the person.
45 CFR 164.512(i), 45 CFR 164.508, 21 CFR 56.111(a)(7) · Needs counsel review
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