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Institutional Review Board Instructions, Forms, and Samples

The electronic system is available at https://imedris.uchc.edu. For UConn Health students and employees, your UConn Health credentials will grant you access to the system.

GET HELP: Investigators, study personnel and students are strongly encouraged to review the IRIS User Guides, and/or attend an IRIS training session before using IRIS  for the first time.  Contact  Mayra Cagganello (860-679-8802) with questions pertaining to IRIS training. After reviewing educational material on this site and available in the Help section within IRIS, if additional guidance is needed regarding the IRB submission process (e.g., initial submission, continuing review, request for modification, problem report form), contact Mayra for guidance. The IRB Regulatory Specialists (Donna Horne x4851, Patricia Gneiting x4849, Pamela Colwell x1019) are also available to provide assistance if Mayra is not available.

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 accordingly. Always refer back to the 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 The IRB reserves the right to return outdated forms.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 the IRB Office. New investigators and research personnel who have not yet completed training are required to complete the CITI Basic Course Requirement.  For those whose training is more than 3 years old, a CITI refresher course is required.  Biomedical investigators conducting clinical trials whose initial CITI training is expiring must complete the CITI GCP course as the refresher course. Biomedical investigators not conducting clinical trials must complete the CITI biomedical refresher course.  Social and behavioral investigators whose initial CITI training is expiring must complete the CITI social and behavioral refresher course.

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 determined the type of review that is required you should review  either the Checklist for Expedited and Exempt Submissions or the Checklist for Full Board Studies 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 are in Word format unless otherwise noted.

Forms for Determining Whether IRB Review is Required

Instructions

Routine UConn Health IRB Forms

UConn Health IRB Templates for Standard Consent/Assent and Requests for Waivers

Vulnerable Population Forms

  • Form B204 – Research Involving Pregnant Women, or Fetuses – (2/25/2009)
  • 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)

CICATS Forms

UConn Health HIPAA Forms

dbGaP Access Request

Sample Documents & Guidelines

Registries/Repositories

Humanitarian Use Device

Adverse Event Documents

Brochures
Employee Orientation
Rights and Responsibilities of Research Volunteers (PDF version)
Rights and Responsibilities of Research Volunteers – Chinese (PDF only)
Rights and Responsibilities of Research Volunteers – French (PDF version)
Rights and Responsibilities of Research Volunteers – German (PDF version)
Rights and Responsibilities of Research Volunteers – Greek (PDF version)
Rights and Responsibilities of Research Volunteers – Italian (PDF version)
Rights and Responsibilities of Research Volunteers – Polish (PDF version)
Rights and Responsibilities of Research Volunteers – Portuguese (PDF version)
Rights and Responsibilities of Research Volunteers – Russian (PDF version)
Rights and Responsibilities of Research Volunteers – Spanish (PDF version)
Student Tips (PDF version)
Document Change Reference Log
Change Log (Excel, 11/29/2016- added consent checklist addendum for gene transfer studies, and revised main full board consent checklist to reference the addendum.)