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 (Galina Prpich x4849, Stephen MacKinnon x8729) are also available to provide assistance.

The following general information may be helpful to investigators.

• Investigator Guide – *new 2024*
• Top Reasons for IRB Submission Delays & Tips

 

• 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
  • UConn Health Academic IT page on Data Management & Sharing Plans
  • 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
• Storrs Research and Cross-campus collaboration
  • Guidelines
• Student Research
  • Guidelines for Student Research at Institutions External to UConn Health

 

 

 

Our Mission

The Human Research Protection (HRP) Education & Outreach (E&O) program is a unified cross campus initiative to provide education and outreach to all who are involved in research involving human subjects. Our mission is to equip researchers with the knowledge and tools needed to navigate the regulatory landscape of human subjects research.

Through proactive engagement, the program aims to support researchers and promote ethical practices that enhance understanding of human subjects protections across the university community.

The HRP Education & Outreach program goals are to:

• Inform the research community about the latest developments in human subjects protection, including news, guidance, and regulatory updates.
• Educate researchers, IRB members, and IRB staff through tailored outreach and ongoing learning opportunities.
• Support investigators through compliance reviews, self-monitoring tools, and personalized assistance to promote high-quality, ethically sound research.

By offering these resources, we seek to reduce compliance burdens and foster a culture of collaboration and integrity in research involving human participants.

 

What We Offer

The Education & Outreach program offers a variety of resources designed to support researchers, IRB members, and IRB staff. We welcome your feedback and ideas as we grow our offerings.

IRB Office Hours

Connect one-on-one. Meet with HRP staff to ask questions, seek guidance, or discuss specific concerns:

• UConn Health IRB: Sign up for virtual office hours (Link is only valid if logged into the UCH Office365 Domain)
• UConn (Storrs & Regional Campuses) IRB: Sign up for office hours

Workshops & Trainings

Custom education or training: Request a session tailored to your department, unit or class. Content is designed to meet your research specific needs. To request a training or education session, please click the link below and complete the form, including a brief description of the topic or area you would like the session to cover.

Upcoming trainings:

InfoEd training: For questions related to the use of InfoEd, please contact the UConn IRB at irb@uconn.edu.

iRIS training: For individual or group training session on iRIS, please contact the UConn Health IRB at irb@uchc.edu.

FDA-Regulated Research Training Sessions – UConn Storrs

To support research teams conducting studies subject to FDA regulations under 21 CFR Part 312 (Investigational New Drug Application) or 21 CFR Part 812 (Investigational Device Exemptions), the HRPP offers completion of a two-part training process:

· Pre-Study Implementation Session: Designed to prepare teams before initiating FDA-regulated research.

· Post-Implementation Assessment: Conducted after the enrollment of the first five participants to evaluate and support ongoing compliance.

HRP staff will provide an overview of relevant guidance and institutional policies, with a focus on adhering to Good Clinical Practice (GCP). Participants will also learn about the essential components of a Regulatory Binder and its role in maintaining compliance throughout the research process

To schedule these sessions, please complete our Training and Education Request Form.

New Investigator Training – UConn Health

This education session is offered to researchers who are new to UConn Health or are new to submitting to the IRB for the first time. This session is offered on a recurring schedule. Please visit our Bookings page and select “First Time PI Training (UConn Health)” to book a spot in one of these upcoming trainings.

FDA Regulated Research – Sponsor-Investigator Compliance Review – UConn Health Researchers who will fill the dual role of Sponsor and Investigator when conducting studies subject to FDA regulations under 21 CFR Part 312 (Investigational New Drug Application) or 21 CFR Part 812 (Investigational Device Exemptions) are required to complete a compliance review prior to submitting their study for IRB review. This session is conducted to ensure that the Sponsor-Investigator is aware of and prepared to meet the dual responsibilities of Sponsor and of Investigator under the FDA regulatory requirements. Please contact Rebecca Burke at burke@uchc.edu to schedule a session.

Upcoming sessions:

IRB Workshop

9/19/2025 from 2:30pm-4:30pm

Location: Whetten Graduate Center, Conference Room 300A

An in-person interactive session designed to help researchers navigate IRB processes and avoid common pitfalls in the submission process. Ideal for students and new investigators.

Target Audience: UConn Storrs faculty/staff/students involved in human subjects research Registration Link

Informed Consent

10/8/2025 from 10:00am-11:30am

Location: Homer Babbidge Library, Class of 1947 Room

This in-person session will review regulatory requirements for informed consent/assent and highlight best practices for obtaining and documenting consent in human subjects research.

Target audience: UConn Storrs faculty/staff/students involved in human subjects research Registration Link

Research Compliance Monitoring

Human subjects research at UConn and UConn Health is monitored by the HRP Education & Outreach program. The goal of the monitoring program is to assess compliance of human subjects research with federal, state, local law, and UConn policies, identifying areas for improvement, and providing recommendations and support based on best practices, current policies and the principles set forth in the Belmont Report. More information about the monitoring program can be found in our policies and standard operating procedures.

All active studies are subject to such reviews, including exempt research or studies where a reliance agreement is in place with another institution.

Studies may be randomly selected for a compliance review or chosen for other reasons as described in the applicable policies and procedures. Categories of compliance reviews include routine, informed consent, for-cause, IRB-directed, and investigator-initiated.

A detailed report summarizing the review findings, required actions, and recommendations will be sent to the researcher. Additionally, findings from the review may be shared with individuals responsible for research oversight to reinforce compliance with policies and regulatory requirements. Findings from these reviews help inform and shape future educational offerings.

Related Policies & Procedures:

• UConn HRPP Standard Operating Procedures
• UConn Health HSPP Monitoring of IRB Approved Studies Policy 2009-005.0

 

Contact Us

We are here to support your research. Reach out to ask questions, request a consultation, or share feedback.

Email: hrp-education@uconn.edu

Team Contacts:

• Joan Levine, MPH, CIP – Team Lead
• Rebecca Burke, MS
• Ellen Ciesielski

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 (Galina Prpich 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 **
  • Human Subject Research Determination (HSRD) Form when project involves FDA-regulated product
• 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 (4/25/25; add external inst. confirmation for external collaborators)
• 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  (4/25/25; add external inst. confirmation for external collaborators)
• 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 (1/14/2025)

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 (4/29/2025 – 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  6/10/2025

There are two Institutional Review Board (IRB) panels constituted at UConn Health. Institutional policy number 2002-42, Review and Approval of Research Involving Human Subjects (PDF), assigns authority and responsibility to the IRBs.  Panels 1 and 2 meet once per month. With the following exception, studies requiring full board review are assigned to a panel based on the submission date of the initial application.

Exception:

• Any study proposing to involve prisoners must be assigned to Panel 02 which has a prisoner advocate as a member.

Once a study is assigned to a panel it remains under the oversight of that same panel for the life of the study.  The IRB Office is located on the 5th floor of the L Building.

Federal regulations (e.g. 45 CFR 46, 21 CFR 50 and 56) require that the IRB review and approve any non-exempt research involving human participants, or exempt research that requires limited IRB review, prior to it being started and that, in the majority of cases, legally effective informed consent of the subject or the subject’s legally authorized representative is obtained prior to any involvement in the study.  At UConn Health the IRB is also responsible for determining if research meets criteria for exemption.

Vested with an ethical imperative to safeguard the rights and welfare of human subjects in research studies, the IRB reviews protocols to assure that the research activities proposed include no unnecessary risks, minimize potential risks to subjects, and that overall potential benefit to the subject, or to society, is reasonable in relation to the risks. The Board also measures the importance and significance of the scientific knowledge potentially gained against risks to study subjects.

“Risks to subjects are minimized by:

• using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk;
• and whenever appropriate using procedures already being performed on the subjects for diagnostic or therapeutic purposes.”

The IRB examines and approves all proposed informed consent forms to ensure that subjects are provided with a clear and complete explanation of the study and its potential benefits and risks.  When applicable, the IRB also ensures that additional protections afforded under regulation to children, pregnant women, and prisoners have been addressed.

In general, the membership of IRB meets on the first, and  third working Mondays of each month; applications requiring review by the full IRB are due 12 working days prior to the meeting. Applications requesting exempt status or expedited review may be submitted at any time. Once approved, when continuing review is a requirement protocols must be reviewed at least annually. All studies, including exempt studies, are subject to audit by the Research Compliance Monitor.

Finally, approval for emergency and therapeutic use of investigational new drugs (IND) must be obtained from the IRB.

There are two Institutional Review Board (IRB) panels constituted at UConn Health. Institutional policy number 2002-42, Review and Approval of Research Involving Human Subjects (PDF), assigns authority and responsibility to the IRBs.  Panels 1 and 2 meet once per month. With the following exception, studies requiring full board review are assigned to a panel based on the submission date of the initial application.

Exception:

• Any study proposing to involve prisoners must be assigned to Panel 02 which has a prisoner advocate as a member.

Once a study is assigned to a panel it remains under the oversight of that same panel for the life of the study.  The IRB Office is located on the 5th floor of the L Building.

Federal regulations (e.g. 45 CFR 46, 21 CFR 50 and 56) require that the IRB review and approve any non-exempt research involving human participants, or exempt research that requires limited IRB review, prior to it being started and that, in the majority of cases, legally effective informed consent of the subject or the subject’s legally authorized representative is obtained prior to any involvement in the study.  At UConn Health the IRB is also responsible for determining if research meets criteria for exemption.

Vested with an ethical imperative to safeguard the rights and welfare of human subjects in research studies, the IRB reviews protocols to assure that the research activities proposed include no unnecessary risks, minimize potential risks to subjects, and that overall potential benefit to the subject, or to society, is reasonable in relation to the risks. The Board also measures the importance and significance of the scientific knowledge potentially gained against risks to study subjects.

“Risks to subjects are minimized by:

• using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk;
• and whenever appropriate using procedures already being performed on the subjects for diagnostic or therapeutic purposes.”

The IRB examines and approves all proposed informed consent forms to ensure that subjects are provided with a clear and complete explanation of the study and its potential benefits and risks.  When applicable, the IRB also ensures that additional protections afforded under regulation to children, pregnant women, and prisoners have been addressed.

In general, the membership of IRB meets on the first, and  third working Mondays of each month; applications requiring review by the full IRB are due 12 working days prior to the meeting. Applications requesting exempt status or expedited review may be submitted at any time. Once approved, when continuing review is a requirement protocols must be reviewed at least annually. All studies, including exempt studies, are subject to audit by the Research Compliance Monitor.

Finally, approval for emergency and therapeutic use of investigational new drugs (IND) must be obtained from the IRB.

Institutional Animal Care and Use Committee
UConn Health Center
263 Farmington Avenue
Farmington, CT 06030-1523
Phone: 860-679-3429
Fax: 860-67-1005
Email: ooacc@uchc.edu

 

Committee Contacts

Name	Title	Phone	Email
Alison D. Pohl, MS, rLATg, CPIA	Research Compliance Monitor II IACUC Administrator	860-679-4129	pohl@uchc.edu
Lisa A. Chuba, BS, LAT	Research Compliance Monitor I  PAWS Coordinator	860-679-2456	lchuba@uchc.edu
Stephen Crocker, Ph.D.	IACUC Chair	860-679-8750	crocker@uchc.edu
Melissa Caimano, Ph.D.	IACUC Vice-Chair	860-679-8390	mcaima@uchc.edu
Ramaswamy Chidambaram, BVSc, MSc, Ph.D.	Director, CCM and Attending Veterinarian	860-679-2248	ramaswamy@uchc.edu
Dan Sasso, B.S.	Chemical Specialist (working with chemical hazards in animals)	860-679-4062	sasso@uchc.edu

 

Leadership Contacts

Name	Title	Phone	Email
Michael Centola, MHS, CIP	AVP, Research Compliance and Integrity	860-679-6568	centola@uchc.edu
Melanie Lucas, MS, CPIA	Director of Research Compliance – Animal Research and Safety	860-486-2459	melanie.lucas@uconn.edu

The purpose of the OCTR is to provide clinical researchers administrative assistance with the following tasks:

• Contract and clinical trial budget negotiations
• Fiscal set up and oversight of Banner research accounts including account reconciliation and closeout
• Development of viable study budgets
• Identification of studies that qualify for Medicare reimbursement as “qualifying clinical trials”
• Identification of research subjects and research charges, through quality monitoring and audit, to assure research financial compliance

OCTR provides fiscal support services to principal investigators and administrative staff conducting clinical trials or research at UConn Health. Newly approved clinical trials will be assigned a fund number on the university’s Banner accounting system. This account will be set up and administered in our office in order to track study related financial activity.

• Banner Fund Set-up
• Initial Budget and Budget Supplements
• IPAS+
• Sponsor Payments
• Study Related Expenses

Banner Fund Set-Up

OCTR staff will assign a clinical trial INFOED number and assign a Banner fund number to the study. The six digit fund code is unique to the study and will be used to designate all transactions associated with the study in the university’s Banner accounting system. In addition to the six digit fund code, a complete set of coding will include the organization code, account code and program code. FOAPAL refers to:

FUND	Organization	Account	Program	Activity	Location
600000	40000	75501	31

Once the Banner fund is set-up, we will notify you by email.

 

Initial Budget and Supplements

Once the Banner fund account has been established, OCTR staff will load the initial budget into Banner. The initial budget will be set at a portion of the expected income and expense anticipated over the course of the study. A memo will be sent to the Study Administrator and the Principal Investigator (PI) detailing the accounts and amount of funds included in the initial budget.

Supplements to the budget will be completed as the study progresses, subjects are added and payments are received. A memo will be sent notifying administrative staff and the PI of each new budget supplement.

Institutional Prior Approval System (IPAS) or No Cost Extension

Frequently studies are extended beyond the contractual end date of the original agreement between the sponsor and the PI. Once an addendum to the clinical trial agreement (CTA) has been completed, the study administrator should initiate an IPAS+ Form.

OCTR will then extend the study on Banner.

Sponsor Payments

Payments by check are received in research finance and by wire in general accounting. If you receive the check directly, please deliver the check to research finance as soon as possible (MC 5335).

Once deposited, OCTR will be notified of the payment and a copy of the check will be scanned and sent by email to the study administrator.

Study Expenses

Study Expenses Payable by Invoice

Study administrative staff may need to invoice the sponsor periodically for reimbursement of items requiring an invoice to the sponsor (refer to Budget Workbook and CTA). An invoice template is provided for this purpose. Pay careful attention to the payment section of the executed CTA for information on when an invoice is required. Start-up costs generally fall into this category.

Expenses

Once the setup of the fund is complete, study related charges can be initiated for payment by the administrative staff and will be reflected in the fund’s financial results. Reflection of proper time and effort (T&E) by the PI, study coordinator and administrative staff will not be charged to the fund automatically.

Allocation of study related T&E must be initiated by the study staff. Please refer to Research Finance › Policies & Procedures › Time and Effort Reporting.

When reviewing proposed studies, the Institutional Review Board (IRB) works very closely with several other offices and committees. The interaction between the IRB and these various departments or committees is described below. The descriptions are limited to this interaction and are not representative of the entire function of the department or committee. The IRB application checklist directs the investigator as to when to contact these various departments or committees.

Financial Conflict of Interest in Research Committee (FCOIC): On an annual basis, all investigators are required to disclose significant financial interests to the FCOIC. The FCOIC will determine if a conflict of interest exists. If so, the FCOIC institutes a conflict of interest management plan. The FCOIC provides the IRB with copies of such plans. Investigators must also disclose any conflicts of interest within each IRB application. This ensures 1) that any conflict of interest is being addressed in accordance with the management plan and 2) that any new conflicts that develop during the course of the year are addressed. Investigators are encouraged to become familiar with the individual financial conflict of interest in research policy. Investigators may contact Gus Fernandez-Wolff in the Office of the Vice President for Research for additional information.

Environmental Health and Safety (EHS): Investigators proposing a research study that will use ionizing radiation, non-ionizing radiation, biological material, or hazardous chemicals must obtain a Risk Assessment Report from EHS. Investigators may contact Steve Jacobs for additional information.

EPIC in Research:  When a clinical research study will utilize Epic (UConn Health’s electronic medical record system) for scheduling, billing, or ordering the Epic Command Center is responsible for building the profile of that study within the system.  The study build submission form must be completed and submitted to the Command Center for this to occur. Questions should be directed to servicedesk@uchc.edu.

Institutional Biosafety Committee (IBC): Investigators must obtain approval from the IBC prior to seeking local IRB approval for research studies that deal with recombinant DNA. Investigators may contact ibc@uchc.edu for additional information.

Office of Clinical and Translational Research (OCTR): Investigators proposing a research study that is sponsored by an external source, typically an industry sponsor, must have a fully executed contract in place. When the sponsor is providing for subject injury, the IRB must receive the final contract prior to granting final IRB approval. Both the OCTR and the IRB will verify that language regarding subject injury is consistent between the consent form and the contract. Studies that will generate charges, whether sponsored or investigator originated, must also have an approved budget in place, confirmation that it is in process, or confirmation from the budget office that a budget workbook is not necessary. Investigators may contact Ella Sun or Donald Deyo for more information.

Sponsored Program Services (SPS): Investigators proposing a study that is grant supported or funded by a private non-profit agency will need to route the proposal through SPS. The IRB must review all funded grant applications. In general, federal grant applications will require IRB review once the determination is made that funding will occur. At such time investigators must submit a complete IRB application, in addition to the grant application, to the IRB. Non-federal grant applications typically require that IRB review occur prior to a funding decision having been made. Investigators may contact Paul Hudabenko for additional information.

Stem Cell Research Oversight (SCRO) Committee: UConn’s Stem Cell Research Oversight Committee (SCRO) provides oversight of all ethical issues related to the derivation and research use of human stem cell lines at all schools, colleges, campuses, and research arms of UConn regardless of the source of funding, and reviews all proposals submitted by University investigators for funds from the State of Connecticut. The SCRO Committee will ensure that sensitive research is well-justified and that inappropriate research is not conducted. Review by the SCRO Committee will supplement but not replace the usual reviews for compliance with federal, state, and local regulations (e.g., reviews by IACUC, IRB, IBC, etc.). Investigators may contact Ellen Ciesielski for additional information.

 

UConn Health holds a Federalwide Assurance which is an agreement between this institution and the government, in particular the Office for Human Research Protections within the Department of Health and Human Services, that assures that whenever UConn Health engages in non-exempt human subjects research conducted or supported by any federal department or agency that has adopted the Common Rule, UConn Health will comply with the terms of the assurance. While the assurance is applicable to federally funded research, UConn Health applies equivalent protection standards to all human subject research, regardless of the funding source.  Mr. Michael Centola, Associate Vice President for Research Integrity, is the assurance signatory official who holds ultimate responsibility to ensure compliance with the terms of our FWA. The operational aspect of that responsibility has been delegated to the Director of the Human Subjects Protection Program who is designated as the Administrator of our FWA. Our FWA number is 00006064 and its expiration date is March 10, 2030.

The vision of the Human Subjects Protection Program at UConn Health is to provide complete protection to all volunteer subjects enrolled in research studies and to have that protection be an integral part of a fluid process that responds to the needs of the subject, the researcher, and the institution.

• HSPP Full Description (Word)

The primary mission of the Human Subjects Protections Program is to ensure that the rights and welfare of those who participate in research studies are protected. This mission is carried out by first ensuring that all research involving human subjects is reviewed and approved by the Institutional Review Board prior to initiation and subsequently by continuing review and monitoring of approved studies. These functions ensure that studies are being conducted in accordance with the ethical principles of autonomy, beneficence and justice as set forth in the Belmont Report, and in compliance with internal policies, and Federal regulation.

The Director of the Human Subjects Protection Program (HSPP) has oversight responsibility of the Institutional Review Boards and Regulatory Specialists, the Research Compliance Monitor, the Education and Development Specialist, and the HSPP Scientific Review Committee. The Director of the HSPP cannot influence or change any decision made by the IRB. As outlined in the organizational chart (PDF), the HSPP reports to the Associate Vice President for Research Integrity and Regulatory Affairs, who in turn reports to the Vice President for Research, Innovation and Entrepreneurship.

Investigators and study personnel are encouraged to call the office for assistance in preparing an application for the IRB or with any other questions, comments, suggestions and/or concerns.

The HSPP is inclusive of the following individuals:

• Shemetra Owens, Associate Director, 617-800-6991, sheowens@uchc.edu
• Julia Blair, Administrative Manager, 860-679-7555, jblair@uchc.edu
• Stephen MacKinnon, Regulatory Specialist, 860-679-8729, mackinnon@uchc.edu
• Galina Prpich, Regulatory Specialist, 860-679-4849, prpich@uchc.edu
• Rebecca Burke, Research Compliance Monitor, 860-679-3054, burke@uchc.edu  
• Katherine Hayden Ames, Reliance and IRB Coordinator, 860-679-8802 khayden@uchc.edu
• Dr. Julian Ford, IRB Chair Panel 1 & 2, 860-679-8778, jford@uchc.edu
• Dr. Upendra Hegde, IRB Co-Chair Panel 2, 860-679-4249, uhegde@uchc.edu
• Dr. Ruchir Trivedi, IRB Vice Chair Panel 1, 860-679-2799, rtrivedi@uchc.edu
• Dr. Julie Wagner, Chair, Scientific Review Committee, 860-679-4508, juwagner@uchc.edu