The electronic submission system, iRIS, is available at https://imedris.uchc.edu. Your UConn Health username and password will grant you access to the system.
GET HELP: Individuals are strongly encouraged to review the iRIS User Guides, and/or attend an iRIS training session before using iRIS for the first time. Contact the HSPP at irb@uchc.edu with questions pertaining to iRIS training. The IRB Regulatory Specialists (Patricia Gneiting x4849, Steve MacKinnon x8729) are also available to provide assistance.
All documents submitted to the IRB must be typed. Cells on the forms will expand to accommodate text. If you cannot access the documents, experience a problem with the formatting, or have general questions about preparing a submission to the IRB contact one of the individuals noted above.
For each submission, save the relevant documents to your hard drive and complete them accordingly. Always refer back to this web site when submitting forms to the IRB to ensure you are using the most recent version of the document. The IRB reserves the right to return outdated forms. A log describing changes that have been made is available at the bottom of the page.
Human Subjects Training
All key personnel associated with a study, including those authorized to obtain consent, must complete human subjects training. Completion of this training will be verified by staff within the IRB. New investigators and research personnel who have not yet completed training should complete the CITI Basic Course Requirement. For those whose training is more than 3 years old, a CITI refresher course is available.
Starting the IRB Process
Your research protocol and plans for implementation of it (e.g. recruitment process, consent process) should be well formulated before you begin the process of preparing an IRB application. When UConn Health will be the IRB of Record, the first step is to determine whether your study will require review by the full board or whether it will qualify for expedited review or exempt status. To make this determination first review the categories of research that may qualify for an exemption. If the research does not appear to qualify for exempt status, review the categories of research that may be permitted under expedited review. If the research does not appear to qualify for exempt status or expedited review, full board review will be required and the submission deadlines will apply. Once you have determined the type of review that is required you should use the applicable Checklist from the list below and prepare/provide those documents that are relevant to your study. Use this checklist to communicate with the IRB if you need to convey information about your submission. If items on the checklist do not pertain to your study indicate NA. Once all of your material is complete it is attached to the on-line application in the iRIS system. The IRB staff will then screen the submission and communicate with you regarding any corrections or clarifications that may be needed.
All documents noted below are in Word format unless otherwise noted.
Determining Whether IRB Review is Required
- Human Subject Research Determination (HSRD) Form (6/20/2022 Changed Contact information) ** Instructional Guide for HSRD Form **
- Sample Don’t Ask – Don’t Tell Agreement for Coded Information and/or Specimens (1/16/2020)
- Guidelines for UConn Health Students Conducting External Research (4/5/2024)
Instructions
- Information and Forms related to use of EPIC in research
- Instructions for Students Residents or Fellows Doing Research_at_Hartford HealthCare_or_CT Children’s Medical Center (06/20/2022)
- Instructions for Facilitated Review for Collaborative Research with Neighboring Facility (10/12/2022)
- Instructions for Appendix B, Application for DSMP/B (8/15/2005)
- Instructions for Requesting Reliance Upon Advarra IRB (2/13/2024, updated contacts at Advarra and consent template injury language section)
- Instructions for Requesting Reliance Upon WCG (formerly, Western IRB) (5/17/2024, updated WCG contact, consent template 2nd payer section)
- Instructions when Utilizing the SMART IRB Initiative (11/20/2023)
Routine UConn Health IRB Forms
- Application Checklist for Initial and Continuing Review Full Board (10/3/24; add IT approval for AI; update HIPAA waiver info)
- Application Checklist for Initial Exempt Application (10/3/24 – add IT approval for AI; update HIPAA waiver info )
- Application Checklist for Initial and Continuing Review Expedited (10/3/24 – add IT approval for AI; update HIPAA waiver info)
- Application Checklist to Request Facilitated Review for Industry or Cooperative Group Sponsored Study, or study utilizing the SMART IRB Initiative (10/3/24 – add IT approval for AI)
- Application Checklist to Request Facilitated Review for Research with Neighboring Facility (1/27/2023)
(e.g. student/resident research at Hartford Healthcare, CCMC, St. Francis, UConn-Storrs) - Application Checklist – Single Patient Expanded Access (9/22/2022)
- Application Appendix A (CRC Resource Request) (09/14/2023 by CRC)
- Application Appendix B (DSMP/B Template) (4/28/2015, prior version grandfathers for approved studies)
- Application Appendix C (UConn Health as Coordinating, Lead or Statistical Center) (8/15/2005)
- Application Appendix D (Enrollment Targets) (1/15/2009 by GCRC)
- Application Appendix E (Genomic Data Sharing Certification) (11/7/2014)
- Application Appendix F (Dept. of Defense Addendum) (11/20/2023)
- Application Appendix G (Community Based Participatory Research)
- Application Appendix H (National Institute of Justice)
- Application Appendix I (Department of Energy) (5/15/2014)
- Application Appendix J (Federal Bureau of Prisons) (5/15/2014)
- Application Appendix K (Department of Education – Federal) 8/29/2014
- Application Appendix L (Determining Need for Review by Recombinant DNA Advisory Committee) (7/1/2016)
- Confirmation of Available Resources Form (incl Inpatient Stays) (2/08/2023)
- FERPA Verification Form (7/24/2014)
- Individual Investigator Agreement (9/17/2024)
- Protocol Template (3/15/2018)
- Participant Feedback Form (6/20/2022)
- Participant Feedback Form in Spanish (6/20/2022)
- Permission to Treat During A Lapse in Approval (12/20/2017)
- Recruitment Material Checklist (2/3/2022)
- Request for Exemption Form (11/20/2023)
- Request for Expedited Review Form (1/16/2019)
- Request form to use UConn Health as a Recruitment Site – Without Engagement (3/20/24)
- Significant Financial Interests of Study Personnel (8/27/2017)
UConn Health IRB Templates for Standard Consent/Assent and Requests for Waivers
- Main Consent Form Checklist (11/20/2023)
- Main Consent Template (1/24/2023 – revised for NIH DMS policy guidance)
- Consent Checklist – Addendum to Transition to Revised Common Rule (1/16/2019)
- Consent Checklist to Request Facilitated Review for Multi-Center (e.g. Industry Sponsored) Study (1/24/2023 – updated IRB phone #s)
- Consent Checklist – Genetic Research Addendum (2/14/2020, clarified wording)
- Checklist – Gene Transfer Studies Addendum (11/7/2016, from NIH Appendix M)
- Consent Checklist – Stem Cell Research Addendum
- *NEW* Consent Checklist – Department of Defense Addendum (11/20/2023)
- Consent Checklist – National Institute of Justice Requirements Addendum
- Consent Checklist Bureau of Prisoners (3/5/2018)
- Consent Template / HIPAA Authorization – Addendum for Sub-study(5/16/2016)
- Consent Template – National Institute of Justice, Reporting Abuse
- Short Form Consent Documents
- Assent Document (from the University of Massachusetts)
- Request for Full or Partial Waiver Informed Consent (11/20/2023)
- Request To Alter Element(s) of Consent(11/20/2023)
- Request for Waiver or Alteration of Consent for Projects Conducted by or Subject to the Approval of State or Local Government Officials (DR)
- Request for Waiver of Consent for Planned Emergency Research (11/20/2023)
- Request to Waive Documentation of Consent (12/19/2017)
- Genetic Information Non-Discrimination Act (GINA) Handout (10/2024-fixed broken link)
- Genetic Information Non-Discrimination Act (GINA) Handout – Spanish(7/2020, pdf)
- Acceptable Contract Vs. Consent Language
- Sample Pregnancy Language
Vulnerable Population Forms
- Form B204 – Research Involving Pregnant Women, or Fetuses – (2/22/2022-clarified instructions)
- Form B205 – Research Involving Neonates -(2/25/2009)
- Form B206 – Research Involving Placenta or Fetal Material(2/25/2009)
- Form B207 – Research Involving Pregnant Women, Fetuses or Neonates not Otherwise Approvable (2/25/2009)
- Form C – Protections for Prisoners – (2/25/2009)
- Form D– Additional Protections for Children Involved as Subjects in Research (4/3/2017)
- Form S– Protections for Other Vulnerable Groups – (12/9/2014)
UConn Health HIPAA Forms
- HIPAA Authorization to Use and Disclose (09/14/2023)
- HIPAA Authorization to Use and Disclose – Spanish (9/14/2023)
- HIPAA Request for Alteration or Waiver of Authorization (11/12/2019)
- HIPAA Certification of De-Identification (11/13/2024)
- HIPAA Assurance of Preparatory to Research or Decedent Research (6/20/2022)
dbGaP Access Request
- dbGaP Access Request Form for IRB Certification (6/20/2022 – added new contact information)
Sample Documents & Guidelines
- Guidance for Completing Continuation Form (10/12/2022)
- Guidance on Closure of Human Subject Research Studies (07/05/2023)
- Checklist for Low Literacy Informed Consent Forms (03/24/2022)
- Study Document Categories in IRIS
- Enrollment Guidance (8/15/2013)
- Department of Defense Organizational Chart (4/27/2015)
- Guidance for Preparing a Chart Review Study (10/12/2022)
- Guidelines for Research Collaborations with Jackson Labs (6/29/2016)
- Guidelines for Funding from US Army Medical Research and Material Command
- Guidelines Protocol Design – ICH – Chapter 6 (PDF)
- Guidelines for Writing a Protocol
- NIH Electronic Protocol Writing
- NIH Final FDA Clinical Trial Template for Phase 2 and 3
- Protocol Deviation Log
- Sample Cover Letter for a Survey Study (09/02/2022)
- Data Management & Sharing Plans
- UConn Health Academic IT page on Data Management & Sharing Plans
- Sample Data Sharing Plan from National Institute of Allergy and Infectious Diseases
- Sample Data Sharing Plan and Consent Language from NIAAA
- Sample Data Sharing Plan from NIH Addressing Key Elements
- Sample Flyer(11/8/2021)
- Sample Follow-up Letter for Survey Studies(7/7/2011)
- Sample IRB Key Personnel Training Letter
- Sample Permission Letter(8/20/2013)
- Sample Phone Script for Screening Prior to Consent (2/7/2022)
- Template for Privacy Certificate for National Institute of Justice (word version)
- Template for Privacy Certificate for National Institute of Justice (pdf fillable version)
- Tips for Writing Low Literacy Consent Forms (10/23/2012)
Registries/Repositories
- Sample Consent for Registry (05/10/2022)
- HIPAA Authorization to Add PHI to a Research Registry (6/28/2019)
- Sample Protocol for Research Registry (from Florida Hospital)
- Enrollment Break Out Form
Humanitarian Use Device
- HUD Consent Template (8/8/2017)
Adverse Event Documents
- Guidelines for Assessing Risk
- Guideline for Describing Probability of Side Effects in Informed Consent Forms
- Adverse Event Log
Document Change Reference Log
Change Log 11/13/2024