For ResearchersNew Protocol Application InstructionsInvestigators must complete the Franciscan Children’s IRB Application Form and submit all required documents prior to review.Submission includes:ProtocolConsent/Assent documentsRecruitment materialsStudy team qualifications (CVs)Sponsor documents (if applicable)Ancillary / Other Required ReviewsDepending on study type, additional approvals may be required:HIPAA Privacy ReviewConflict of Interest ReviewRadiation Safety CommitteePharmacy ReviewData Security / IT ReviewRecruitment & Enrollment MaterialsAll recruitment materials must be reviewed and approved by the IRB prior to use. Handling of recruitment materials must be described in the protocolAdvertisements must not be coercive or misleading.Research Safety GuidelinesInvestigators must implement appropriate safety monitoring plans.Clinical trials may require a Data and Safety Monitoring Plan (DSMP) or Data Safety Monitoring Board (DSMB).