Recruitment and Advertising
Federal regulations require that an Institutional Review Board (IRB) review and have authority to approve, disapprove, or require modifications to the methods and materials that investigators propose for use in recruiting subjects.
Recruitment is the start of the informed-consent process, and may include:
- Newspaper advertisements
- Other public print media
- On-campus flyers
- Radio and television advertisements
- Web-based recruiting
- “Dear Doctor” letters
- Other methods
Recruitment plans and materials should be reviewed and approved by the IRB at initial protocol review. However, when the Principal Investigator decides after approval of a study protocol to advertise for subjects, the recruitment materials may be submitted as a modification to the ongoing study*.
When advertisements can be compared easily to the approved consent document, the IRB Chair, or other designated IRB member, may review and approve them by expedited means. If the IRB reviewer has concerns, or when other complicating issues are involved, the proposed advertisement is referred for review at a convened (full-board) meeting of the IRB.
For direct advertising, the IRB reviews the information contained in the advertisement and the mode of its communication. This review is to determine whether the procedure for recruiting subjects may create undue influence and/or states or implies a certainty of favorable outcome or other benefits beyond what is contained in the consent document and the protocol. This review is especially critical when a study may involve subjects who are likely to be vulnerable to undue influence.
Advertisements to recruit subjects should be limited to the information the prospective subjects need to determine their eligibility and interest. When appropriately worded, the following items may be included in advertisements:
- The name and address of the Principal Investigator and/or research program
- The condition under study and/or the purpose of the research
- In summary form, the criteria that will be used to determine eligibility for the study
- A brief list of participation benefits, if any (e.g., a no-cost health examination)
- The time or other commitment required of the subjects
- The location of the research and the office to contact for further information
Please keep in mind:
- No claims should be made, either explicitly or implicitly, that a drug, biologic, or device under study is safe or effective for the purposes under investigation, or that a test article is known to be equivalent or superior to any other treatment.
- Advertising for recruitment into clinical trials should not use terms such as "new treatment," "new medication," or "new drug" without explaining that the test article under study is investigational.
- Advertisements should not promise "free medical treatment" when the intent is only to say subjects will not be charged for taking part in the investigation.
- Advertisements 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.
All recruitment ads and collateral materials must first be submitted to the IRB for review and approval, either with the initial protocol application or as a modification to an ongoing study. Once the IRB has reviewed and approved the content of the recruitment materials, the PI can send the materials to the marketing office for layout.
There are standard templates for all materials. Because copy length, language requirements, size of purchased space, and other factors can affect layout and branding, all materials intended for off-campus audiences will be produced by a professional designer at no cost to the PI or Department.
Please adhere to the following steps for each type of promotional materials:
Newspaper Ads and Other Public Print Media (e.g. Magazines)
Please email the IRB-approved ad (as a PDF) and the exact dimensions of the ad(s) to to Nela Moore, email@example.com, of the Office of Communications, Marketing, and Public Affairs. Dimensions need to be specified in actual inches rather than column inches. Phone: 214-648-3404.
When flyers will be posted only on campus, the IRB must first review and approve the wording. For on-campus flyers, the use of the official University logo is discouraged. Please note that cutting and pasting the University logo from online sources is prohibited and any use of the official logo requires approval from the Office of Communications, Marketing, and Public Affairs.
When flyers will be posted off campus, the IRB must first review and approve the text. Once the IRB has reviewed and approved the wording, please email IRB-approved copy (in PDF format) and the exact dimensions of the flyer(s) to Nela Moore, firstname.lastname@example.org, of the Office of Communications, Marketing, and Public Affairs. Dimensions need to be specified in sheet size (8 ½ x 11, 11 x 17, etc.). Indicate whether the flyer will have tear-offs at the bottom. Phone: 214-648-3404.
Radio and Television Ads
When advertisements are to be taped for broadcast, the IRB must first review and approve the wording of the script. Once the IRB has reviewed and approved the script, final copy of all radio and television advertisements must then be submitted to the AVP for Marketing for final approval. Phone: 214-648-7500, fax: 214-648-7503, email: email@example.com.
Things to consider before placing ad requests
- Do you have a dedicated phone line for the study subjects by which they can either reach a live person or listen to a recording that specifically identifies the study and communicates to the caller that they have called the correct number?
- Do you have the means to return subject calls within 24 hours?
- Do you have the means to explain the study goals clearly and concisely to callers?