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 Advertisements
• Web-based Recruiting
• Other

Recruitment 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.
When direct advertising is to be used, the IRB reviews the information contained in the advertisement and the mode of its communication.  The purpose of this review is to determine whether the procedure for recruiting subjects may be coercive 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.

*Exception: the web-based “Find A Clinical Trial” recruitment system is designed to route Internet advertisement requests electronically using the ERGO system.  See “Web-based Recruiting” below. 

Content Guidelines
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:

1. the name and address of the Principal Investigator and/or research program;
2. the condition under study and/or the purpose of the research;
3. in summary form, the criteria that will be used to determine eligibility for the study;
4. a brief list of participation benefits, if any (e.g., a no-cost health examination);
5. the time or other commitment required of the subjects; and
6. the location of the research and the office to contact for further information.

Please keep in mind the following:

• No claims should be made, either explicitly or implicitly, that the drug, biologic or device is safe or effective for the purposes under investigation, or that the test article is known to be equivalent or superior to any other drug, biologic or device.
• Advertising for recruitment into investigational drug, biologic or device studies should not use terms such as "new treatment," "new medication" or "new drug" without explaining that the test article 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.

Procedure for Newspaper Ads and Other Public Print Media
Newspaper advertisements are to be submitted to the IRB in the pre-approved format (click here to see template).   Newspaper ads submitted to the IRB in the pre-approved format need to undergo additional brief (48 hours) copy review by the Office of News and Publications after IRB approval is received.  Submit both the IRB-stamped copy of the text and the draft ad as it will appear in publication to the Office of News and Publications for review.

Ads produced using a format that is different than the pre-approved template need graphic standards review by the Office of News and Publications after the IRB approves the text.  Please leave adequate time (2-3 weeks) for design services and note that there may be a charge for design assistance.

Procedure for Other Public Print Media (e.g. Magazines)
Other print media advertisements are to be submitted to the IRB first for content review.   Once the IRB approves the content, the ads need to undergo additional review by the Office of News and Publications.  Submit both the IRB-stamped copy of the text and the draft ad as it will appear in publication to the Office of News and Publications for review.  Please leave adequate time for design services and note that there may be a charge for design assistance.

Procedure for Flyers (On Campus)
On campus flyers are to be submitted to the IRB in the pre-approved format (click here to see template).   On campus flyers submitted to the IRB in the pre-approved format do not need to undergo additional review by the Office of News and Publications after IRB approval is received.  Flyers produced for off-campus distribution need review and approval by the Office of News and Publications.

Procedure for Radio Ads
When advertisements are to be taped for broadcast, the IRB should review the final audio tape. The IRB may review and approve the wording of the radio script prior to taping to preclude re-taping because of inappropriate wording. The review of the final taped message prepared from IRB-approved text may be accomplished through expedited procedures. Advertisements for radio and television should include a complete script.

Final copy of all radio and television advertisements must be submitted to the Office of News and Publications after IRB approval is received.

Procedure for Web-based Recruiting
UT Southwestern hosts a “Find a Clinical Trial” website that health care providers and prospective subjects can use to search for open studies.  To have your study listed in the university’s “Find a Clinical Trial” website database, complete the ERGO form by clicking here (on campus only).

Other web-based recruitment, such as mass e-mails and banner ads, require special permission from News and Publications.  Please consult the IRB for assistance.

Other Types of Recruitment
News and Publications does not allow brochures for research studies. The only exception is the distribution of brochures published by the study sponsor (professionally created). If the sponsor brochure contains a local phone number, which is answered by UT Southwestern staff, then it may contain the UT Southwestern logo.

All sponsor study brochures must be submitted to the Office of News and Publications for review after IRB approval is received.

Contacting The Office of News and Publications
Heidi Cannella, Director
Email: Heidi.Cannella@UTSouthwestern.edu
Office Address: E06.102
Office Phone: 214-648-3404
Office Fax: 214-648-9119
Mail Code: 9060

Graphic Standards Manual