The sponsor may submit model advertising or participant study materials on behalf of all or some of the investigators participating in a protocol. These materials will be approved without investigator-specific contact information, which can be added by the investigator after approval.
When submitting materials for review, please use the Recruitment and Participant Study Material Submission Cover Page located in the forms section.
Quorum Review offers five types of IRB review:
- Model Recruitment and Participant Study Material Review
- Mini-model Recruitment and Participant Study Material Review
- Site Recruitment and Participant Study Material Review
- Generic Material Review
- National and Regional Recruitment Campaign Review
Helpful Hints For Creating Recruitment/Study Materials
When creating recruitment and participant study materials, please note the following guidelines:
- 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 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.”