Subject Recruitment and Advertisement

The beginning of the informed consent process starts with recruiting subjects. By regulations and common sense, involvement of persons considering participating in a clinical trial begins with his or her obtaining information on a specific clinical trial for which he or she may be eligible. The sponsor, the principal investigator, the study coordinator, and the IRB are all involved in the recruitment process.

All recruitment materials and practices must be reviewed and approved by the IRB (advertisements, World Wide Web sites, medical records, databases, newsletter, letters, referrals, etc.) prior to initiating any recruitment. The IRB will assess whether the recruitment process promotes voluntary participation and is not coercive.

Advertisement Approval Form

Copy Guidelines

FDA Recruiting Guidelines

OHRP Recruiting Guidelines