Sinai Research Institute - Required Documentation & Forms
Requirements for Submitting a New Research Project to IRB
- Request for project review by the IRB
- Statement of financial disclosures
- Patient Authorization Form for the Disclosure of PHI
- Revocation Form to Use of PHI
- Researcher Authorization Form for Studies Requesting Access to PHI without patient Authorization
- Data Use Agreement (Contract Between the SHS and Research Team for Use of PH in Research)
- FDA 1572 for Drug Studies and/or Investigator Information and Agreement Form for Medical Devices
- Proof of Successful Completion of National Institutes of Health's ON-line training Course, (http://cme.nci.nih.gov) Required for All Investigators and Research Teams
- Funding Documentation Check List (Please Include Budget)
- Curriculum Vitae for Principal Investigator, Sub-Investigators and Study Coordinators
- Complete Study Protocol
- Investigator Brochure and/or Marketing Material
- $1500 IRB Fee
- Informed Consent Form (English and Spanish)
- Letter to Institutional Review Board Requesting Approval for a Clinical Trial
Please contact Clemencia Quintero, IRB Coordinator at quic@sinai.org with any questions about this process.
