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human subjects protection office

Institutional Review Board Meetings, Instructions, Forms and Samples

There are currently three IRB panels constituted at the Health Center that meet on a monthly basis.  Panel 01 meets for the first convened meeting of the month,  Panel 02 meets for the second convened meeting of the month and Panel 3 meets for the third convened meeting of the month.  With one exception studies requiring full board review are initially assigned to Panel 01,  02 or 03 based on submission date of the application.  The one exception is that any study proposing to involve prisoners as subjects (including via chart reviews) must be reviewed by Panel 02 which has a prisoner advocate as a member. Once a study has been assigned to a panel it remains under that same panel's oversight for the life of the study.  IRB Panel 4 meets on an as needed basis and only reviews studies involving research with embryonic stem cells.

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 any of the following individuals for assistance:

Name: Phone Number Area of Focus
Patricia Gneiting (860-679-4849) Expedited and Exempt Submissions
Donna Horne (860-679-4851) Full Board Panel 2 or 3 Submissions
Pamela Colwell (860-679-1019) Full Board Panel 1 or 3 Submissions
Marcy Chasse (860-679-8729) Outgoing Correspondence to PIs

For each submission, save the relevant documents to your hard drive and complete accordingly. Always refer back to the web site or the shared Institutional Review Board e-mail folder 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 The IRB reserves the right to return outdated forms.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 or whose training is more than 3 years old are also required to complete the CITI Basic Course Requirement and submit the completion certificate to the Human Subjects Protection Office.  Biomedical investigators whose initial CITI training is expiring must complete the CITI GCP course.  Social and behavioral investigators whose initial CITI training is expiring must complete the CITI social and behavioral refresher course. 

Forms for Determining Whether IRB Review is Required: 

Human Subject Research Determination Form (7/10/08)

Performance Improvement/Quality Improvement Determination Form

Quality Improvement/Performance Improvement Determination Form

INSTRUCTIONS for IRB Applications, Closures, Continuations, Modifications: 

Instructions for Application for Initial and Continuing  (rev. 7/11/08)
Instructions for Addendum to Application to Request Continuing Review (4/8/08)
Instructions for Application for Registry/Repository  (3/6/6)
Instructions for Appendix B, Application for DSMP/B (rev. 8/15/05)
Instructions for Request for Closure/Completion  (8/15/05)
Instructions for Request for Modification  (rev. 6/16/08)
Instructions for Application for Expedited Continuation Under Category 8A or 8C Only,  (4/8/08)
FORMS - Routine IRB forms (Application, Closure, Continuing Review, Modification Review etc. ):
Checklist for Initial and Continuing Review (rev. 7/15/08)
Application  for Initial and Continuing Review  (rev. 3/06)
Application Addendum to Request Continuing Review (3/7/07)
Application for Expedited Continuation Under Category 8A or 8C Only (5/7/07)
Application Appendix A (GCRC Resource Request) (Rev. 3/20/07)
Application Appendix B (DSMP/B Template) (Rev. 8/15/05)
Application Appendix C (UCHC as Coordinating, Lead or Statistical Center) (8/15/05)

Application Appendix D (Enrollment Targets)

Conflict Disclosure Form (required with 4/13/06 submission deadline)

IDE Statement of Investigator Obligations

IND Statement of Investigator Obligations
Principal Investigator's Appointment of Personnel for Coverage
Request for Exemption (Rev. 7/8/08)
Request for Expedited Review (Rev. 8/15/05)
Request for Modification (Rev. 6/16/08)
Request for Study Closure / Completion (Rev. 8/15/05)
Individual Investigators Agreement
Problem Report Form (03/06)

CONSENT - IRB Templates for Standard Consent / Assent & Requests for Waivers

Informed Consent Checklist (rev. 3/28/08)
Standard Informed Consent Template (03/28/08)
Short Form Consent Documents (from U. Minnesota)
Assent Document (UMass)
Assent Document (UCLA)
Acceptable Contract Vs. Consent Language
Sample Pregnancy Language for inclusion in consent forms
Request for Waiver or Alteration to Requirements of Consent (rev. 1/07)
Request for Waiver or Alteration of Consent for Projects Conducted by or Subject to the Approval of State or Local Government Officials (rev. 3/06)
Request for Waiver of Consent for Planned Emergency Research (rev. 3/06)
Request to Waive Documentation of Consent (03/06)
HIPAA Forms: 
HIPAA Authorization to Use & Disclose (9/26/2007)
HIPAA Authorization to Add PHI to a Research Registry (10/07)
HIPAA Request for Waiver of Authorization
HIPAA Certification of De-Identification
HIPAA Assurance of Preparatory to Research or Decedent Research
HIPAA Limited Data Set Certification
HIPAA Data Use Agreement (external)
PROTOCOL - Sample Documents
Protocol Design (ICH Guidelines - Chapter 6)
Guidelines for Writing a Protocol
VULNERABLE POPULATIONS
Protections for Pregnant Women, Fetuses and Neonates - Forms B204-207 (Rev. 3/06)

Protections for Prisoners - Form C (3/06)

Protections for Children / Decisionally Impaired Adults - From D404-407 (rev. 3/06))
Protections for Other Vulnerable Groups - Form S (3/06)   

TRACKING - IRB Tracking Templates

Adverse Event Log  
Protocol Deviation Log

REGISTRIES / REPOSITORIES*

Application for Registry/Repository Initial and Continuing Review (3/6/06)
Application Addendum for Registry/Repository Continuing Review
Sample Consent for Registry
Sample Protocol for Research Registry (University of Pittsburgh)
Sample Protocol for Research Registry (New York University Medical School)

HUMANITARIAN USE DEVICE* 

Humanitarian Use Device Application Form
Humanitarian Use Device Consent Template
Humanitarian Use Device Continuation Form

Humanitarian Use Device Modification Form

MISCELLANEOUS Documents
Adverse Event Reporting Policy - Memo for Sponsors
Guidelines for Assessing Risk
Sample IRB Key Personnel Training Letter

Brochures

Employee Orientation (pdf version)
Rights and Responsibilities of Research Volunteers - English  (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
*Also review sections for routine IRB forms, HIPAA forms and vulnerable populations for additional forms that may be required (e.g. checklist, HIPAA Authorization, Appendices etc.)
  
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