Participant Recruitment

When submitting materials for review, please use the Recruitment and Participant Study Material Submission Cover Page located in the forms section.

Some sponsors request that we obtain their approval for any recruitment materials submitted by sites. To find out if written sponsor approval is required for your study contact the Site Support Team or the sponsor of the research. Submission of materials without sponsor approval when such approval is required will result in delays.

When a site submits its own advertising or recruitment materials, the Board’s approval to use those materials extends only to that site.

For more details view the Participant Recruitment and Participant Study Materials Guidelines on the forms tab.

Helpful Hints For Creating Recruitment/Study Materials

When creating recruitment and participant study materials, please note the following guidelines:

Do’s

  • Do make plain that the solicitation is for the purpose of participation in research and not for the provision of medical care. Do use the term “research” (or a synonym) when describing the study.
  • Do use the term “investigational” (or a synonym) if a test article or treatment is referenced in the advertisement.
  • Do indicate that the research involves the “investigational use” of an approved drug if applicable to the study.
  • Do make sure that the material complies with applicable state and local laws.
  • Do submit the material in final format, including site-specific information as appropriate and graphics that will be used.
  • Do make mention of the research study in the advertisement.

Do not

  • Do not use language or graphics that may be coercive or misleading.
  • Do not state or imply a guarantee of benefits, cures, or favorable outcomes.
  • Do not emphasize “free” treatment or study products.
  • Do not claim the study product or treatment is superior to other options.
  • Do not place emphasis on payment, including bolding or highlighting the compensation language.
  • Do not use the terms “safe,” “effective,” “new,” “best,” “cure,” “treatment,” “therapy,” or “free.”