Compliance

Do physician outreach materials for a clinical trial need IRB approval?

By TrialNotice · Updated
Five professionals reviewing printed documents around a long conference table in a formal meeting room
Short answerGenerally not, under FDA guidance. Materials intended for health professionals, such as "dear doctor" letters and doctor to doctor letters, are not direct advertising and do not need prior IRB review, even when they solicit study subjects. Anything intended for prospective patients, such as flyers, posters, and ads, does. Your IRB can set stricter rules, so confirm its written policy.
This article is general information, not legal or regulatory advice. Confirm requirements with your IRB before using any recruitment material.

What does FDA guidance say?

FDA's guidance on recruiting study subjects describes direct advertising as material intended for prospective subjects, such as newspaper, radio, TV, bulletin boards, posters, and flyers. It specifically excludes communications intended for health professionals, such as "dear doctor" letters and doctor to doctor letters, even when they solicit study subjects (FDA).

How do central IRBs apply it?

WCG IRB follows this guidance and does not require prior review of doctor to doctor letters, press releases, or media interviews, and it does not need copies of those materials (WCG). Other IRBs, especially institutional ones, may choose to review physician materials anyway. Always check your IRB's written policy.

Where does the line get crossed?

  • Patient handouts inside a physician packet. A flyer meant for the waiting room is direct advertising and needs IRB review, even if it arrives in the same envelope as a physician letter.
  • Letters the physician forwards to patients. If the material is written to be seen by patients, treat it as patient facing.
  • Any payment to referring physicians. FDA has said referral payments should be submitted to and reviewed by the IRB (FDLI), and WCG IRB does not allow referral fees at all (WCG). See finder's fees explained.

What is a practical checklist?

  1. Write the physician letter for physicians only, in clinical language.
  2. Keep any patient facing piece separate and submit it to the IRB.
  3. Keep the letter factual: the study, criteria, location, and contact. No promises of benefit.
  4. Check your IRB's written policy on physician communications.
  5. Keep a copy of every version mailed.

Related: what to include in a clinical trial referral letter to physicians.

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Sources

  1. FDA, "Recruiting Study Subjects" guidance for IRBs and clinical investigators
  2. WCG, "Does the IRB need to approve doctor to doctor letters?"
  3. Food and Drug Law Institute, "Legal and Ethical Considerations for Offering Clinical Trial Recruitment Payments and Enrollment Incentives"
  4. WCG, "May I pay a physician for referring a patient to our study?"

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