Advertising and Marketing Guidelines

According to FDA regulations, “an IRB is expected to review all the research documents and activities that bear directly on the rights and welfare of the subjects of proposed research.” This includes the methods and materials to be used to recruit subjects.

Direct advertising is considered by the FDA “to be the start of the informed consent and subject selection process.” For this reason, any direct advertising to the subject population (advertisements via newspaper, television, radio, posters, flyers, letters, postcards, etc.) must be reviewed and approved by the Providence Health Care IRB prior to use.

The Providence Health Care IRB must determine whether or not the direct advertising is “not unduly coercive” and does not promise a “certainty of cure” or “favorable outcome or other benefits” beyond what is outlined in the consent and the protocol.While news stories are not considered “direct advertising” and do not require IRB and approval, the information contained therein could be identical to that published in advertisements. Therefore, the guidelines for what is acceptable in ads should also be applied to news stories.

Guidelines

1. No claims should be made, either explicitly or implicitly, that the drug, biologic, or device is safe or effective for purposes under investigation or that the test article is known to be equivalent or superior to any other drug, biologic or device.

2. Terms such as “new treatment,” “new medicine,” or “new drug” should not be used without explaining that the test article is investigational.

3. Promises should not be made that the treatment is “free” when the intent is only to say subjects will not be charged for taking part in the investigation.

4. You may state that subjects will be paid, but should not emphasize the payment or the amount to be paid by such means as larger or bold type.

5. While not specifically required by the FDA to appear in ads, the following items may be included:

  • Name and address of the investigator and research facility.
  • Purpose of the research or condition under study.
  • Eligibility criteria for subject selection.
  • Brief list of participation benefits.
  • Time or other commitments required of subjects.
  • Person or office to contact for further information.

(Reference: FDA Information Sheets, Sept. 1998, 29–30)