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.

• Investigator Guide – *new 2024*

 

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