HELP:  Individuals are strongly encouraged to review the iRIS User Guides, and/or attend an iRIS training session before using the iRIS electronic submission system for the first time.  Guides are available by clicking the Help button within iRIS.  After reviewing the material, if you still have questions pertaining to the use of iRIS, contact  the HSPP at irb@uchc.edu.  The IRB Regulatory Specialists (Patricia Gneiting x4849, Stephen MacKinnon x8729) are also available to provide assistance.

The following general information may be helpful to investigators.

• Adverse Event Reporting
• Census Data
• Certificate of Confidentiality
• Clinical Trials.Gov
• CT Institute for Clinical and Translational Science
• D.o.D. – Guidelines for Funding from US Army Medical Research Material Command
• dbGAP-Instructions to Access Controlled Individual level Data
• dbGaP IRB Certification Form
• Expanded Access for Non-Emergency or Emergency Use for an Individual Patient (FDA site)
• Federal Regulations
• Financial Compliance in Clinical Trials
• Glossary of Lay Terms / Plain Language
• Guidance for Posting Clinical Trial Consent Forms
• Guidelines for Research Collaborations with Jackson Labs
• Guidelines for Student Research at Institutions External to UConn Health
• HSPP/IRB Operating Policies
• Human Subjects Training Requirement
• ICH – Good Clinical Practice Guidelines
• Informed Consent – Special Considerations for Genome Research
• Institutional Policies Related to Human Subject Research
• IRB Charges for Industry Sponsored Studies
• IRB Forms and Instructions
• IRB Meeting Dates and Submission Deadlines
• NIH Electronic Protocol Writing Tool
• NIH Policy for Data Management and Sharing (effective 1/25/2023)
• NIH Genomic Data Sharing Information
• NIH FDA Final Clinical Trial Template for Phase 2 and 3
• NIH Guide for Writing a Data Management & Sharing Plan
• Data Storage Finder (tool from Cornell University)
• NIH Single IRB Review Mandate
• NIH Single IRB Review Mandate FAQs
• Preparing a Protocol (refer to protocol templates and guidance documents available on forms page)
• Public Act No. 05-149 An Act Permitting Stem Cell Research
• Quality Assurance or Improvement vs. Research
• Recombinant DNA
• Sample Data Sharing Plan from NIH Addressing Key Elements
• Sample Data Sharing Plan form National Institute of Allergy and Infectious Diseases
• IRB Policies, Forms and Documents Updates- November, 2023