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Rule CG-RES-004

Research recruitment: what rule CG-RES-004 checks

Rule CG-RES-004 is one of the checker's research recruitment rules. It cites 21 CFR 50.20. The reason, source and safer wording are below.

  1. CG-RES-004 · Warns · Citation checked against stored text

    An ad may say participants will be paid, but should not emphasize the payment or the amount, for example with larger or bold type. Payment is a recruitment incentive and the IRB reviews the amount for undue influence.

    Source: FDA information sheet "Payment and Reimbursement to Research Subjects"; FDA information sheet "Recruiting Study Subjects"; 21 CFR 50.20

    Safer wording: Say that participants will be paid or reimbursed for time and travel, and leave the amount and schedule to the consent document.

    21 CFR 50.20 · Needs counsel review

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