Which items should the IRB/IEC review regarding participant recruitment?

• A. Advertisements for recruitment and information on the recruitment process.
• B. Trial budget and funding sources.
• C. Laboratory procedures.
• D. Site location.

Answer: (A)

IRB/IEC oversight of recruitment focuses on how participants are invited to join and what information they receive. The materials used to recruit people and the description of the recruitment process must be reviewed to ensure they are accurate, not misleading, and presented in a way that supports voluntary, informed decision making. This includes clear explanations of what participation involves, potential risks and benefits, time commitments, and how to contact someone for questions or to consent. The language should avoid coercion or undue influence and should align with the study’s inclusion and exclusion criteria so recruitment does not misrepresent who is eligible.

Budget and funding sources are administrative and about finances, not how participants are recruited. Laboratory procedures pertain to how the study is conducted, and site location relates to logistics rather than the content and method of recruitment itself.