Recruitment and Retention

Recruitment efforts and materials (advertisements, flyers, telephone scripts, newspaper ads, radio and television announcements, bulletin board tear-offs, Internet postings and posters) are part of the informed consent process and the participant selection process. Consequently, the IRB must review and approve all recruitment procedures and materials before use.

Retention efforts and materials must also be reviewed and approved prior to use.

A copy of the approved material(s) will be stamped with the IRB approval stamp and returned to you.

Note: Approved materials will be reviewed at the time of continuing review and are subject to change. Please do not print more items than you expect to use within the year of approval, as revisions may be required with the continuing review.

When to submit to the IRB

• Informational materials and direct advertising for research participants are considered the start of the informed consent process, and should be submitted for review with the initial application;
• If the investigator decides at a later date to add recruitment materials, to change currently approved materials and/or to include retention efforts or materials, they must be submitted as an amendment to the study;
• Materials must be submitted in their final format, with a description of how they will be used and/or distributed, including where and by whom.

Appropriate content and format

• Materials may state that participants will be compensated or reimbursed, but specific dollar amounts should not used;
• Materials that are to be taped for broadcast - transcripts must be submitted for review and approval;
• The materials may not be coercive or unduly influential, and should not promise “free medical treatment," a cure, or other benefits beyond those identified in the consent document and the protocol;
• If experimental drugs or devices are involved in the research, no claims may be made (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;
• Materials may not contain the terms "new treatment," "new medication" or "new drug" unless an explanation that the test article is experimental is also included.

Items that must be included in recruitment materials

• Study title or “user-friendly” short title;
• A short, lay description of the type of research being done and why;
• The word "research" must be included in the description;
• The name of the person to contact and the number to call for more information;
• That the research is being conducted at the University of Mississippi Medical Center;
• The Principal Investigator's name and department;
• The specific location(s) where the research interventions will occur, if other than UMMC.

Information that may be included in recruitment materials

• In summary form, the criteria that will be used to determine eligibility for participation in the research;
• A description of the time commitment and duration of the participants' participation, and number of visits required;
• A brief description of any expected benefits of research participation (free or increased medical care or monitoring and/or free study drug are not considered benefits of participating in the study).

Retention materials

• Retention materials should follow similar guidelines, as appropriate.