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IRB Application: Additional Study Materials
Section 4
FORM
L. Advertisements
If any materials will be used to recruit subjects for your research study, or used to retain a subject in the study, attach copies of the materials to be used. Advertisements must be reviewed and approved by the IRB prior to use.
In addition, print and media advertisements to the public are required to be reviewed by UK Public Relations PR) for compliance. The UK Clinical Research Development & Operations Center (CR-DOC) can produce PR compliant ads flyers upon request. See web site for guidelines and form submission to CR-DOC at http://www.mc.uky.edu/ukcro/guidelines_page.htm or at http://www.mc.uky.edu/ukcro/ad-recruit_page.htm.
Sponsor's National Advertising Campaigns
Human subjects recruitment material and related research information supplied to multi-site study locations does require IRB approval, but does not need review by UK PR. This applies to recruitment material that does not identify the University of Kentucky, informational brochures about drugs/devices, educational materials about the disease, dietary guideline booklets or other study-related information.
For additional details, see topic "Recruitment" or "Advertising" on ORI's Educational Materials, Regulations and Policy Guidance web page for the PI Guide to Identification and Recruitment of Human Subjects for Research document. For information about IRB review of clinical trial websites for recruitment, see topic "Clinical Trials" on the same web page for Guidance on IRB Review of Clinical Trial Websites.