Guidance

The IRB reviews recruitment methods, including advertisements, to ensure that they support the equitable selection of participants. The IRB also evaluates proposed advertisements and solicitations tp confirm they comply with regulatory requirements for informed consent. For more information on the topic of recruitment methods (including in-person recruitment, telephone calls, recruitment through databases containing health information, use of medical records for recruitment, etc.) please see the University of Utah IRB Guidance Recruitment Methods.

Advertising is a common method used by researchers to contact potential participants. Examples of advertisements include flyers, brochures, television ads, radio ads, social media ads, etc. When an individual is interested after encountering an ad, they should contact the research team directly. The investigator must obtain IRB approval prior to the use of all television, radio, print advertisements, e-mail solicitations, letters, websites, and other recruitment methods and materials intended for the recruitment of prospective research participants. Advertisements must be submitted to the IRB in their final form in to receive IRB approval for use.

Internet Advertising

Advertisements posted on the internet must adhere to the guidelines below. All advertisements must be approved by the IRB prior to posting. The researcher may submit the advertisement text to the IRB as a document for approval. The intended internet sites where the advertisements will be posted must be described in the Study Information section of the IRB application.

Researchers may use the Internet as a forum for disseminating study information to participants.  The use of websites, blogs, internet forums, and social networking sites for the dissemination of study information must be described in the Study Information section of the IRB application. The IRB requires the following statement to be posted on internet sites used for this purpose:

What should advertisements include?

Advertisements for recruitment should be limited to the information the prospective participants need to determine their eligibility and interest.  When appropriately worded, the following items may be included in advertisements.  The IRB does not require inclusion of all the listed items.

• The name and address of the investigator or research facility/building.
• The purpose of the research or the condition under study.
• In summary form, the criteria that will be used to determine eligibility for the study.
• A brief list of participation benefits, if any.
• The time or other commitment required of the participants.
• The location of the research and the person or office to contact for further information.

What is not acceptable in advertisements?

The IRB does not allow recruitment methods or advertisements that are misleading, inaccurate, exculpatory, coercive, or unduly influential. The IRB will review advertisements to ensure that they do not:

• State or imply a certainty of favorable outcome or other benefits beyond what is outlined in the consent document and protocol.
• Include exculpatory language.
• Emphasize the payment or the amount to be paid, by such means as larger or bold type. Please Note: The dollar amount to be paid to participants may be included in advertisements. However, the IRB may determine that stating the specific amount is coercive or unduly influential. In these instances, the IRB will only allow the advertisement to state that compensation will be offered without including the dollar amount.
• Promise “free treatment” when the intent is only to say participants will not be charged for taking part in the investigation.

What are the additional considerations for advertisements for FDA-regulated research?

The IRB advises all investigators conducting research subject to FDA regulation to review the FDA Information Sheet Recruiting Study Subjects. The IRB will review advertisements for FDA-regulated research to ensure that the advertisements do not:

• Make claims, either explicitly or implicitly, about the drug, biologic or device under investigation that are inconsistent with FDA labeling (e.g. stating the test article is known to be equivalent or superior to any other drug, biologic or device).
• Use terms such as “new treatment”, “new medication” or “new drug” without explaining that the test article is investigational.
• Allow compensation for participation in a trial offered by a sponsor to include a coupon good for a discount on the purchase price of the product once it has been approved for marketing.

Documents and References

FDA Information Sheet Recruiting Study Subjects

University of Utah IRB Guidance Topics Recruitment Methods

Points to Consider