Advertising for Research Participants

What are “Advertising and Recruitment Materials”?

Materials used to recruit subjects into research studies are viewed as an extension of the informed consent process and require IRB approval prior to use. This includes:

• Flyers, posters, newspaper ads, press releases, bulletins
• TV or radio spots
• Websites/Internet ads
• Electronic mailings
• Recruitment letters
• Scripts for telephone or other forms of personal contact

What to submit to the CYIRB

Advertising and recruitment materials should be submitted to the IRB for review in their “final format” (i.e., as they will be posted, presented, or as submitted to newspapers). If the material that is actually posted or presented differs from what was approved by the IRB, the revised version must be submitted to the IRB for approval. If an ad will be posted on the Internet, the Internet address (URL) and/or a copy of the “final” content of the webpage(s) or Internet ad must be provided to the IRB.

When and How to submit advertising and recruitment materials for approval

IRB approval is required prior to use of any advertising or recruitment materials. They may be submitted for approval at the time of Initial Submission for project approval or at any time during the course of the project as an Amendment to an already approved protocol. When the IRB approves the materials, they will generally be stamped with an approval date. The IRB approval will continue to be valid until/unless changes are made to the document/materials. If changes are made, the materials must be re-submitted and approved by the IRB prior to use.

Video or Audio Advertisements

If an advertisement will be audio or video-taped, it is recommended that IRB approval of the message content be obtained prior to taping in order to avoid the necessity to re-tape if the IRB requires changes.

Content Requirements:

Recruitment materials and advertisements must be consistent with information contained in the protocol and informed consent document.

All advertisements and recruitment materials must clearly state that the purpose for recruitment is research. In addition, the materials should generally contain the following elements:

• The name of the investigator or research facility (letterhead is acceptable).
• Title of project (optional).
• The condition under study or the purpose of the research.
• A summary of the criteria that will be used to determine eligibility for the study (in lay terms).
• The location where the research will be conducted.
• Time or other commitments required by the study.
• Indication whether compensation will be offered. The description of incentives should be straightforward and truthful (e.g., reimbursement for time, travel, or parking, or a no-cost health exam).
• The person or office to contact for further information including phone number and/or email address.

For drug, device, or biologic studies:

• The advertisement may not claim the safety or effectiveness of the drug or device under study.
• The advertisement may not claim that the drug or device under study is equivalent or superior to any other drug or device.
• The terms “new treatment,” “new medication,” or “new drug” may not be used because it inappropriately implies that safety and effectiveness have been determined. It must be clear that the drug or biologic is investigational, meaning non-FDA approved. Proprietary names of study products may not be used.
• Advertisements or recruiting tools must not include the promise of “free medical treatment” when the intent is only to say the participants will not be charged for taking part in the investigation.