Recruitment Tools (Advertisements, Information Items and other materials) used for recruitment or retention of subjects
The IRB is required to review all recruitment tools (advertisements, Information Items, flyers, press releases, internet postings, and other materials, etc.). Recruitment tools are not approved or valid for subject recruitment without an IRB approval stamp containing the approval and expiration dates (Audio and video tools and bulk preprinted materials may be excused from the approval stamp requirement). A sample of the item(s) may be submitted, approved, and stamped for documentation purposes.
Only IRB approved recruitment tools, considered fair, honest and appropriate by the IRB, may be used in the conduct of subject recruitment. Recruitment materials should be included with your initial and continuing review applications.
A recruitment tool informs potential subjects of a research activity and provides them with an opportunity to contact the researcher. Investigators are required to use the following guidelines when developing recruitment tools:
- name and address of the clinical investigator and/or research facility (letterhead is acceptable).
- 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 the benefits of study participation, (if any) i.e. a free health examination.
- time or other commitments required.
- the location of the research and the person or office to contact for further information.
- in drug or device studies, no claim should be made as to the superiority, safety or effectiveness of the drug or device. Proprietary names of study products may not be used.
- do not provide excessive monetary or other incentives that could be interpreted as inappropriate or coercive.
- are consistent with protocol.
Due to contractual obligations, recruitment tools should not include any proprietary identifiers, contain therapeutic or outcome claims or mention the corporate sponsor by name.
If the tools are not ready at the time of the initial application, investigators may submit the material as an amendment to an already approved project. Requests for approval of recruitment tools following initial IRB review of the protocol should allow sufficient time for any necessary revisions prior to publication. Recruitment tools, press releases, UofL Today submissions, etc., may qualify for expedited review. An investigator may request assistance from the HSPPO in developing UofL Today submissions to ensure that their announcement meets the above guidelines as well as the 75 word limit impose by UofL Today.
Occasionally, retention incentive items are provided by corporate sponsors to participants enrolled in research studies (e.g., pens, calendars, tote bags, refrigerator magnets, umbrellas, etc.) If the sponsor expects to provide such incentives, a list of the incentives to be provided should be included as part of the IRB review.
IRB Review of Research Websites
When information posted on a research website goes beyond directory listings with basic descriptive information, such information is considered part of the informed consent process and therefore requires IRB review and approval.
Basic descriptive information includes:
- study title
- purpose of the study
- protocol summary
- basic eligibility criteria
- study site location(s), and
- how to contact the study site for further information.
Information exceeding such basic listing information includes descriptions of study risks and potential benefits, or solicitation of identifiable information. If you wish to use a website to recruit subjects for a study and more that the above basic information is included, you must have IRB approval of the website prior to making it available to the public.