For Researchers
New Protocol Application Instructions
Investigators must complete the Franciscan Children’s IRB Application Form and submit all required documents prior to review.
Submission includes:
- Protocol
- Consent/Assent documents
- Recruitment materials
- Study team qualifications (CVs)
- Sponsor documents (if applicable)
Ancillary / Other Required Reviews
Depending on study type, additional approvals may be required:
- HIPAA Privacy Review
- Conflict of Interest Review
- Radiation Safety Committee
- Pharmacy Review
- Data Security / IT Review
Recruitment & Enrollment Materials
All recruitment materials must be reviewed and approved by the IRB prior to use. Handling of recruitment materials must be described in the protocol
Advertisements must not be coercive or misleading.
Research Safety Guidelines
Investigators must implement appropriate safety monitoring plans.
Clinical trials may require a Data and Safety Monitoring Plan (DSMP) or Data Safety Monitoring Board (DSMB).