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Institutional Review Board Instructions, Forms, and Samples

Note:  Many of the links to documents on this page have been removed (indicated by LR); and many documents have been revised (DR) because of  the transition to the electronic IRB system, IRIS.   The electronic system is available at https://imedris.uchc.edu   For UCHC students and employees, your UCHC 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 sessions before using the IRIS electronic submission system for the first time.  Contact  Mayra Cagganello (860-679-8802) with questions pertaining to IRIS training.  After reviewing educational material on this site, if additional guidance is needed regarding the IRB submission process (e.g. initial submission, continuing review, request for modification, problem report form),  Mayra can also provided education related to preparing an IRB submission .  The IRB Coordinators (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 The IRB reserves the right to return outdated forms.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 should be well formulated before you begin the process of preparing an IRB application. 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 exempt status. 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 the Checklist for Initial and Continuing review 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 via e-mail regarding any needs for additional information or clarifications.

All documents are in Word format unless otherwise noted.

NOTE:  With the conversion to IRIS, the electronic IRB submission system,  some of the documents have been revised to be compatible with the electronic system (e.g. by removing section that were to be completed by the IRB).  These forms are denoted by DR for document revised.   For studies imported into IRIS (number will be IE- in the IRIS system), you may attach the paper versions of the forms you have already submitted to the IRB in the past to your electronic submissions (e.g. forms for protections of vulnerable populations resubmitted at continuing review).

Forms for Determining Whether IRB Review is Required
Human Subject Research Determination Form (03/28/14)
Quality Improvement/Performance Improvement Determination Form (03/28/2014)
Instructions
Instructions for Appendix B, Application for DSMP/B (August 15, 2005)
Routine UCHC IRB Forms
Checklist for Initial and Continuing Review Full Board (8/8/14)
Checklist for Initial and Continuing Review Expedited and Exempt  (8/8/14)
Checklist for Recruitment Material (5/11/2012)
Application Appendix A (CRC Resource Request) (10/15/13 by CRC)
Application Appendix B (DSMP/B Template) (3/4/10)
Application Appendix C (UConn Health Center as Coordinating, Lead or Statistical Center) (8/15/05)
Application Appendix D (Enrollment Targets) (1/15/09 by GCRC)
Application Appendix E (GWAS Sharing Plan)
Application Appendix F (Dept. of Defense Addendum)
Application Appendix G (Community Based Participatory Research)
Application Appendix H (National Institute of Justice)
Application Appendix I (Department of Energy)  (5/15/14)
Application Appendix J (Federal Bureau of Prisons)  (5/15/14)
FERPA  Verification Form (7/24/14)
Individual Investigator Agreement
Significant Financial Interests of Study Personnel  (7/23/14 - required for ALL studies) 
Protocol Template for Investigator Initiated Research (4/1/2010)
Participant Feedback Form (3/8/2010)
UCHC IRB Templates for Standard Consent/Assent and Requests for Waivers
Informed Consent Checklist Full Board Studies (DR 3/28/14)
Informed Consent Checklist Expedited Research  (DR 3/28/14)
Informed Consent Checklist - Genetic Research Addendum
Informed Consent Checklist - Stem Cell Research Addendum
Informed Consent Checklist - National Institute of Justice Requirements Addendum
Informed Consent Template - Full length  Instructional (primarily for full board studies)  (6/2/14) 
Informed Consent Template - Abbreviated / Use of Addendums for Risks  ( 4/8/14 primarily for FB studies)
Informed Consent Template / HIPAA Authorization - Addendum for Sub-study (10/30/13)
Informed Consent Template - Expedited Research with Sample Language (DR)
Informed Consent Template - Expedited Research with Headings Only (DR)
Informed Consent Template - National Institute of Justice, Reporting Abuse
Short Form Consent Documents
Assent Document (from the University of Massachusetts)
Acceptable Contract Vs. Consent Language
Sample Pregnancy Language for Inclusion in Consent Forms
Request for Waiver or Alteration to Requirements of Consent (DR)
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 (03/14)
Request to Waive Documentation of Consent   (DR)
Participant Feedback Form (3/8/10)
Participant Feedback Form (Spanish)
Genetic Information Non-Discrimination Act (GINA) Handout (05/09)
CICATS Forms
 Local Requirements Checklist (2/15/11 - added CCMC requirements; 10/6/10 - this document is a work in progress and requirements will be added as they become available or revised as necessary.  Please check back often.)
 Saint Francis Hospital and Medical Center Consent Addendum
UCHC HIPAA Forms
HIPAA Authorization to Use and Disclose (10/30/13)
HIPAA Authorization to Add PHI to a Research Registry (1/10/11)
HIPAA Request for Waiver of Authorization
HIPAA Certification of De-Identification
HIPAA Assurance of Preparatory to Research or Decedent Research (1/6/14)
HIPAA Limited Data Set Certification
HIPAA Data Use Agreement (external)
Sample Documents & Guidelines
Document Categories in IRIS
Department of Defense - Guidelines for Funding from US Army Medical Research and Material Command
Determination of Human Subjects Research - Exempt Categories (9/15/11)
What Documents Do I Need to Submit for a Chart Review Study? (12/09/11)
Tips for Writing Low Literacy Informed Consents (10/23/12)
Sample Cover Letter for Survey Studies (7/7/11) 
Sample Follow-up Letter for Survey Studies  (7/7/11) 
Sample Permission Letter  (8/20/2013)
Template Privacy Certificate for National Institute of Justice (word)     (pdf fillable version)
Sample IRB Key Personnel Training Letter
General Protocol Template for Investigator Initiated Research (4/1/2010) 
Surveys, Interviews, Questionnaires Protocol Template (version1) 
Review of Documents, Records, Medical Charts Protocol Template (03/02/2012) 
What Documents Do I need to Submit for a Review of Data/Specimens? (05/24/2013) 
Guidelines for Chart Review Submissions (12/9/2011)  
Sample Flyer (5/11/2012)
Protocol Design - ICH Guidelines - Chapter 6 (PDF)
Guidelines for Writing a Protocol
Protocol Deviation Log
Enrollment Guidance (08/15/13)
UCHC Vulnerable Population Forms
Protections for Pregnant Women, Fetuses and Neonates - Forms B204-207 (2/25/09)
Protections for Prisoners - Form C (2/25/09)
Protections for Children/Decisionally Impaired Adults - Form D404-407 (2/25/09)
Protections for Other Vulnerable Groups - Form S (2/25/09)
Registries/Repositories
Sample Consent for Registry (9/17/09)
Sample Protocol for Research Registry (from Florida Hospital)
Enrollment Breakout Form
Humanitarian Use Device*
Humanitarian Use Device Consent Template (RTF)
Adverse Event Documents
Guidelines for Assessing Risk
Guideline for Describing Probability of Side Effects in Informed Consent Forms
Adverse Event Log
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 (Excel, 8/8/14 changes to submission checklists)


*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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