Clinical research recruitment: 72 matched rules, 20 that block approval

• State law25
• Regulatory status17
• Research recruitment16
• Offers and pricing7
• Patient quotes and reviews3
• Efficacy and proof2
• Platform policy2

Federal and general rules first, blocking before warning, citations checked against stored text before the rest. Rules with their own page link there.

1. CG-MED-009 · Blocks approval · Citation checked against stored text

   Medicare marketing that offers free gifts for a Medicare number, claims a plan covers everything, urges action in hours, or switches a plan without consent violates CMS marketing and telemarketing rules.

   Source: 42 CFR 422.2263 (Medicare Advantage marketing); 42 CFR 422.2264 (permitted contact); Telemarketing Sales Rule, 16 CFR Part 310

   Safer wording: Do not use urgency, free-gift offers or coverage absolutes. Never take a Medicare number to enroll or switch without a documented request, and use the CMS required disclaimers.

   42 CFR 422.2263, 42 CFR 422.2264, 16 CFR Part 310 · Needs counsel review

2. CG-OIG-101 · Blocks approval · Citation checked against stored text

   OIG warns that a Medicare Advantage plan paying doctors or their office staff, in gift cards or in kind, to refer or recommend patients for enrollment can violate the federal anti-kickback statute and steer people into plans that do not fit them. CMS also bars a provider acting for a plan from accepting compensation for marketing or enrollment. Applies to plan sponsors, agents and providers.

   Source: OIG Special Fraud Alert (December 2024) on suspect payments in marketing arrangements related to Medicare Advantage and providers, part II; 42 CFR 422.2266(d)(1)(ix); 42 U.S.C. 1320a-7b

   Safer wording: Do not pay or reward providers or their staff for recommending a plan or for enrollments. Describe plans on their merits and tell people they can compare plans at medicare.gov.

   42 CFR 422.2266, 42 CFR 422.2266(d)(1)(ix), 42 U.S.C. 1320a-7b · Needs counsel review

3. CG-OIG-102 · Blocks approval · Citation checked against stored text

   OIG warns about payments from health care professionals to agents and brokers to recommend or refer Medicare Advantage enrollees to the professional, for example to be named an enrollee's primary care provider. Enrollees often do not know about the payment. DOJ settled with Oak Street Health for $60 million over allegations it paid agents about $200 per referred beneficiary. Applies to providers, agents and brokers.

   Source: OIG Special Fraud Alert (December 2024) on suspect payments in marketing arrangements related to Medicare Advantage and providers, part III; 42 U.S.C. 1320a-7b(b); DOJ Oak Street Health settlement (September 18, 2024)

   Safer wording: Do not pay agents or brokers per referral, per enrollee or per patient steered to your practice. If you use an agent, pay only compensation that CMS rules and counsel have cleared, and never tie it to which provider the enrollee picks.

   Oak Street Health settlement, 42 U.S.C. 1320a-7b · Needs counsel review

4. CG-REG-052 · Blocks approval · Citation checked against stored text

   A product labeled "for research use only" but sold with dosing guides, stacks or shipping to consumers is a drug marketed for human use. FDA reads intended use from the circumstances of sale, not from the label disclaimer. Most of these peptides are not approved for any use, and several are on FDA's list of bulk substances that raise safety concerns for compounding.

   Source: FDCA 201(g)(1); 21 CFR 201.128 (intended use is shown by the circumstances of sale); FDA bulk drug substances guidance for compounding (503A); FTC Act section 5

   Safer wording: Do not sell or describe unapproved peptides for human use. If a peptide is a prescription drug that a licensed pharmacy compounds for a patient with a prescription, say that, and make no performance claims.

   21 CFR 201.128 · Needs counsel review

5. CG-RES-001 · Blocks approval · Citation checked against stored text

   A recruitment ad must not say or imply the study drug or device is safe or effective for what is being studied, or equivalent or superior to another treatment. That is also a violation of the rules on promoting investigational products.

   Source: 21 CFR 312.7(a); 21 CFR 812.7(d); FDA information sheet "Recruiting Study Subjects" (IRBs review advertising for recruitment); 21 CFR 56.111(a)(3)

   Safer wording: Say what the study is testing ("this study is testing whether the drug is safe and effective") without saying or implying that it is.

   21 CFR 312.7(a), 21 CFR 812.7(d), 21 CFR 56.111(a)(3) · Needs counsel review

6. CG-RES-002 · Blocks approval · Citation checked against stored text

   FDA says recruitment ads should not use "new treatment", "new medication" or "new drug" without explaining that the product is investigational, because it leads people to expect an improved product of proven worth.

   Source: FDA information sheet "Recruiting Study Subjects"; 21 CFR 56.111(a)(3); 21 CFR 50.20

   Safer wording: Say the product is investigational ("a study of an investigational drug that is not yet approved by the FDA").

   21 CFR 56.111(a)(3), 21 CFR 50.20 · Needs counsel review

7. CG-RES-003 · Blocks approval · Citation checked against stored text

   FDA says ads should not promise "free medical treatment" when the point is only that participants are not charged for taking part in the research.

   Source: FDA information sheet "Recruiting Study Subjects"; 21 CFR 50.20

   Safer wording: List real benefits plainly, such as a no-cost health examination, and say participants are not charged for study procedures.

   21 CFR 50.20 · Needs counsel review

8. 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

9. 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

10. CG-RES-009 · Blocks approval · Citation checked against stored text

    A research ad must not promise benefit or safety, treat payment as the draw, or skip eligibility and health screening, because that is undue influence and misstates the study.

    Source: FDA information sheet "Recruiting Study Subjects"; FDA information sheet "Payment and Reimbursement to Research Subjects"; 21 CFR 50.20; 21 CFR 312.7(a)

    Safer wording: Say it is a research study, what it tests, who may take part, and that participants are screened. Mention payment plainly without making it the draw.

    21 CFR 50.20, 21 CFR 312.7(a) · Needs counsel review

Sample wording we wrote to test these rules, run through the real engine at build time. The rule ids, reasons, sources and safer wording are the rule-set's own.

1 page below meet the gate: at least 6 applicable rules and at least 3 that belong to that state or platform alone.