Advertising and Recruitment Letter Guidelines

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Advertising Guidelines

Recruitment Letter Guidelines and Sample Letter

 

Advertising Guidelines

These guidelines follow FDA guidance. Review the recruitment guidelines for more info about recruiting patients via advertising.

The content of any advertisements, notices and/or media materials must be limited to the following information

  • Name and address of the investigator or research facility.
  • Condition under study and/or purpose of the research.
  • Summary of the eligibility criteria.
  • Brief list of participation benefits, if any (e.g., a no-cost health examination).
  • Time or other commitment required.
  • Location of the research.
  • Contact info for the person or office to reach for further information.
  • Include a reference to UCSF. An exception may be made for national recruitment campaigns but these will be reviewed on a case-by-case basis.

Ensure that the advertisements, notices and/or media do NOT include the following

  • State or imply or imply a certainty of favorable outcome or other benefits beyond what was outlined in the consent document and the protocol.
  • Make claims, either explicitly or implicitly, that the research procedures are safe or effective for the purposes under investigation.
  • Make claims, either explicitly or implicitly, that the research procedures are known to be equivalent or superior to other drugs, biologics or devices.
  • Use terms such as “new treatment,” “new medication” or “new drug” without explaining that the test article is investigational.
  • Promise “free medical treatment” when the intent was only to say participants would not be charged for taking part in the investigation.
  • Emphasize the payment or the amount to be paid, by such means as larger or bold type.
  • Characterize payment for participation as a benefit of the research. (The amount and method of payment can be stated, but should not be included in the benefits section.)
  • Include any language that announces the investigator cannot be held liable or at fault for any research related event.
  • Allow for compensation towards the investigational agent once FDA approved.

The IRB must approve all advertisements before they are used to ensure that the mode of communication and content of the ads include accurate information and are not coercive. See the Recruitment Methods page for a list of materials that need IRB review.

The IRB should review the final copy of printed ads to evaluate the relative font size used and other visual effects. When advertisements are to be taped for broadcast, the IRB should review the final audio/video tape. The IRB may review and approve the wording of the advertisement prior to taping to preclude re-taping because of inappropriate wording. 

Note: The UCSF IRB does NOT have to review a study sponsor’s national recruitment campaign materials if these materials will be reviewed and approved by a central IRB or commercial IRB.

Recruitment Letter Guidelines and Sample Letter

Review the recruitment guidelines for more info about recruiting patients by letter. Submit the recruitment letter for IRB review and approval.

Recruitment letters should include the following information

  • Name the PI.
  • Explain how the patient’s name was obtained.
  • Describe basic study purpose, procedures and time commitment.
  • Provide the name and phone number to call for questions and enrollment.
  • Clarify that participation is voluntary.
  • Print the letter on the PI’s departmental letterhead.
  • Be signed by someone already involved in the patient’s care. (Note: The IRB’s usual policy is that patients identified through chart review should be approached by someone already involved in their care. Direct approach by someone not involved in the patient’s care is an exception, but may be approved in some circumstances. The application should explain why the study cannot be done unless the researchers approach subjects directly.) 

We have written a sample recruitment letter, which you can view below or download as a Word doc. Adjust the content for your particular study.

Sample recruitment letter

Date

Patient Name
Address 1
Re: A Research Study You May Be Interested In

Dear Mr/s. [Name],
Two researchers at UCSF, Drs. _____________________ and _________________, are studying _____________________________________.

A review of your medical records suggests you might be eligible to participate in this study. Participation will involve [describe basic study design from subject point of view: e.g., being randomly assigned to take one of two treatments for a disease, one of them experimental; being randomly assigned to take an experimental medication for treatment of a disease or a placebo; spending 3 nights at UCSF having blood drawn every three hours, etc]. Study participation will last for [number of days, weeks or months] and will involve at least ______ visits to the researchers’ office.

If you may be interested in participating in this study or have questions, please call Dr. _____________________ at [phone number]. No one will call you about the study unless you call them first.

Participating in research is voluntary. It won’t affect your treatment at [site at which patient is being treated] if you decide not to call about the study or decide not to participate.

Sincerely,

[Name of patient’s physician - preferred] and/or [Name of PI]