The information on this page is provided to orient potential research study volunteers to the clinical research process.

To search for active clinical trials at UConn Health by topic area, click here.

Frequently Asked Questions

What is clinical research and how does it benefit society?
Clinical research is designed to evaluate health risks and to test new approaches to the diagnosis, treatment and prevention of specific diseases or disorders. Clinical research may help to improve the quality of healthcare or may involve gathering information about health risks. The knowledge that may be gained from this type of work can be of great value to our society. To ensure the safety of volunteers who enroll in clinical studies, each project must be approved by an Institutional Review Board (IRB) before it can begin. During the review process, the IRB evaluates the potential risks and benefits associated with the study and decides whether or not to approve it.

Who participates in clinical research studies?
All types of people are eligible to participate in research studies. Volunteers include adults, children, healthy individuals, and individuals with illness. Each study has a specific set of criteria that determines who is eligible to participate. People who choose to participate in clinical research studies may do so in hopes of improving their own health or advancing scientific knowledge about the cause, treatment and prevention of disease. Some people may benefit directly from participating in a study, for example if a drug being used in the study proves to be effective. Some people may not benefit directly, but their participation may help to advance knowledge that could benefit others in the future.

What are Gene Transfer Studies?
As stated in the brochure from the Office of Biotechnology Activities (OBA), thousands of genes are found in every cell in your body. Each of these genes contains a set of instructions that are read by the cell, allowing your body to make the proteins it needs. However, in may individuals, a gene’s instructions aren’t written properly, which can result in disease. In a gene transfer study, new genes are inserted into a person in an attempt to treat the disease. This is a relatively new area and researchers are trying to learn more about it to make sure it is safe to use in people and to see if it works.

Am I Eligible?
Your eligibility may be determined by various factors, depending on the nature of the study. If you meet the screening conditions, you will be given an “Informed Consent Form” containing a detailed written description of the project, any risks involved, and your rights as a participant. If the screening process involves any type of intervention, such as obtaining a blood sample or documenting personal health information , the consent process will be conducted prior to the screening to ensure that you are informed of what will be required of you and of any potential risks to your well-being. By signing and returning the consent form you agree to participate. If you should have second thoughts about participating, or become uncomfortable during the study, you have the right to withdraw at any time without any penalty whatsoever.

Who will be conducting the study?
Each study has a Principal Investigator (PI) who is in charge of the project. The PI may be a physician, a dentist, a basic research scientist or other faculty member. Colleagues of the PI from either within or outside the institution may also be involved with conducting the study. In addition to the PI and colleagues, a Research Coordinator or a Nurse, who is specially trained in clinical research, could be involved with conducting a study. The Research Coordinator or Nurse usually serves as your main point of contact regarding scheduling issues and any questions or problems you may have relating to the study.

What should I consider before deciding whether or not to participate?
Participating in clinical research may have a significant impact on your life. It is important that you are well informed and feel confident about your decision. You may want to consult with your doctor, family members and the research staff of the project to discuss any concerns you may have. Before finalizing your decision, be sure you know the answers to the following questions:

1. What are the major goals of the study?
2. What will be required of me?
3. What are the risks, how likely are they to occur and what will be done to minimize them?
4. What role will I play in the study – healthy volunteer or patient volunteer?
5. Is the study likely to benefit me directly?
6. What are the potential benefits to others?
7. How long is my participation required?
8. What discomforts, inconveniences and costs are involved?
9. Do I want to participate in this study?

What are my rights as a participant?
As a research participant, you have the right to:

1. be treated with respect,
2. know the risks involved with the study,
3. know what alternatives are available,
4. withdraw from the study without penalty,
5. have a sufficient amount of time to make your decision regarding participation,
6. know the name, credentials and contact information of the Principal Investigator,
7. know the purpose of the study,
8. know who will have access to your information,
9. know what procedures may be performed and what drugs may be used, and
10. ask questions during the informed consent process or at any time during the study.

What are my responsibilities?
In addition to complying with the specific requirements of a study in which you may enroll, you will also be expected to adhere to a general set of responsibilities. These responsibilities include:

1. arriving for all scheduled appointments or calling ahead if you are unable to keep an appointment,
2. arranging your own transportation to and from the study site(s),
3. following the directions of the researchers,
4. making sure your contact information is up to date,
5. providing accurate information about your past/present medical history if it is relevant to the study,
6. asking the researchers to answer any questions you may have at any point,
7. informing the research staff of any adverse events you experience while enrolled in the study, and
8. informing the Institutional Review Board Office if you feel your rights as a subject have been violated. The phone numbers for the IRB are 860-679-4849 or 860-679-8729.

Education Session:

• ” Things to Consider Before You Become a Participant in a Research Study” Presentation Flyer

Helpful Links:

• Active Clinical Trials at UConn Health
• About Research Participation from the Office of Human Research Protections
• The Center for Information and Study on Clinical Research Participants
• Research Advocacy Network
• Participant Newsletter

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.

• 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

Click Here to Go to iRIS if you are already familiar with using the system. 

GET HELP: iRIS is the electronic system used by research personnel and the Institutional Review Board (IRB) for the submission and review of research projects that will involve human participants.  Individuals who need to use iRIS are strongly encouraged to attend an iRIS training session before using the system for the first time.  Please review the training schedule and contact the HSPP at irb@uchc.edu  to register for a session.  Please register at least five business days prior to the training day.

Individuals external to UConn Health should go to iRIS and click the Request Account option, being sure to describe why the account is needed.

Per vendor requirements, training guides may not be posted to the web.  User manuals can be found in the Help section of iRIS.

iRIS Frequently Asked Questions:

How do I create an account in iRIS?

UConn Health employees: If you have an active UConn Health username and password, do not request an account.  Simply enter your network username and password (what you use to access your UConn Health email or unlock your computer)  to log in to iRIS and activate an account.

Individuals external to UConn Health should go to iRIS and click the Request Account option, being sure to describe why the account is needed and noting the name of the UConn Health person with whom they will be working.

How do I access iRIS from outside of UConn Health?

The web location for iRIS  is https://imedris.uchc.edu/

How do I add additional email addresses to my iRIS account?  

In iRIS, click on My Account Information under the My Assistant tab and you will find the option to add emails under the Profile tab.  See instructions in this guide.  Note, iRIS correspondence will only go to the Primary account.  For UConn Health users that account cannot be changed.  The additional email addresses will enable validation of training at external sites or provide the HSPP with another means of contacting the user, if necessary.

Do I need to submit the Principal Investigator’s C.V or biosketch when completing an application in iRIS?

Attachment of the C.V. or biosketch is necessary if the qualifications of the PI are not described within the application.

Who needs to sign the initial submission of an application in iRIS?

The Principal Investigator (PI) and all key study personnel listed on the application are required to electronically sign the initial application.  Contact persons and study authors are not required to sign the form if they have no other role on the study.

If the initial application has been returned for corrections from the screening phase, only the person responding to the corrections needs to sign the submission correction form associated to the application.  If the initial application has been returned for responses from the official IRB review process, only the PI would need sign the submission response form.  If other members of the study team are defaulted to being selected for inclusion in the signature routing process, you can uncheck the box to deselect their names when responding to changes required by the IRB.

Who needs to sign other types of submissions in iRIS?

Continuations, Modifications, Problem Reports Forms and Closure Forms:  Only the PI’s electronic signature is required for the submission types of continuation, modification, problem report or study closure.  If necessary, manually uncheck the names of the personnel who are not required to provide a signature.  When new personnel are being added to the study, they will be asked to sign the form by the IRB as a contingency for approval.

Submission Correction Forms: A submission correction form is generated from the IRB screening process which occurs prior to official review by an IRB member.  Only one person needs to sign this form; and it will most often be the person responding to the IRB Contingencies (e.g. a study coordinator).

Submission Response Forms:  A submission response form is generated after the IRB has conducted an official review.  The PI is the only person required to sign a completed review response form.

Who do I need to list as a study contact in the iRIS application?

The study contacts automatically receive all system generated correspondence (e.g. reminders to request continuations, notifications of lapses in approval, IRB approval letters).  The Principal Investigator and Study Coordinator(s) should always be listed in this section; as well as any persons who may be designated to complete IRB submission forms for the study. For studies applying to use resources of the Clinical Research Center (CRC), investigators should add Elizabeth Laska (CRC Nurse Manager) as a study contact.   Study contacts must be listed by individual names.

What should I do if I have problems attaching and /or opening documents in iRIS? 

 If you are unable to open documents and/or upload documents  you should make sure that your computer has a compatible browser (Internet Explorer 9.0 browser is preferred) and that the popup blocker setting is off.

How do I know if the IRB has received a submission I completed in iRIS?

To confirm that your submission has been routed by the system to the IRB you can go to your Study Assistant tab, and click on “My Studies.”  Then open the study you have completed and submitted. Once you are in the Submission tab, click on the Submission History and then on the Track Location. If the submission has arrived to the IRB queue, you will see the following statement: “UConn Health received the submission.”

If I am adding a modification form in iRIS and the modification includes adding a new person to the study team, does this person need to sign the modification form?

The modification form should be submitted to the IRB with the PI’s signature.   The IRB will then accept the personnel change and return the submission with a contingency that the person being added apply their signature.

Should the name of each person obtaining consent be listed in Section 3.2 –B of an initial application in iRIS?

Unless already identified as PI or a co-investigator,  yes, every person who will be obtaining consent must be listed in this section.

What documents should I submit with a continuation and/or a modification form?

The documents that are required for submission at continuation can be found on the submission checklist available on the HSPP website.  The documents required for a modification are submission specific so a checklist is not available.   In general you need to submit the revised version of any previously approved form, any new form not previously approved for use with the study (e.g. new recruitment material), or new information that pertains to the study (e.g. outcomes of meetings of the data safety monitoring board).

What  types of documents can I submit in iRIS?

You can attach a variety of document types, however iRIS can only stamp/approve documents that are submitted in Microsoft Words or PDF formats.  Furthermore, different documents types sometimes cause problems on the IRB review side, such as corrupting system generated pdf files.  Study personnel are strongly encouraged to convert other document types (e.g., excel, jpg, gif, ppt) to a PDF file prior to attaching them to a submission.

Can I work in iRIS using Mozilla Firefox  or Chrome?

Internet Explorer 9.0+ is the recommended browser.  Internet explorer is the browser used by the IRB and the browser upon which all training materials are based.  Per the vendor the system should also be compatible with Safari 6.0, Chrome 30.0+ or Firefox 24.0+.   The iRIS home page provides a link that will show compatible browsers.

Here is a list of acronyms used on our website and by the Office of Clinical & Translational Research.

BANNER         Financial Reporting System

CDA                Confidential Disclosure Agreement

CMP                Continuous Monitoring Process

CPOE              Computerized Physician Order Entry

CPT                 Clinical Procedural Terminology. codes for billing purposes

CRC                 Clinical Research Center

DCRC              Dental Clinical Research Center

F & A              Facilities & Administrative costs (formerly called “indirect costs”)

FOAPAL         Fund-Organization-Account-Program-Activity-Location. The abbreviation for the chart of accounts structure used by the Finance in the BANNER system

HSPO               Human Subjects Protection Office

IP                     Intellectual Property

IPAS                Institutional Prior Approval System

IRB                  Institutional Review Board

JDH                 John Dempsey Hospital

MAR                Medication Administration Record

NCD                National Coverage Decision 2000 (Medicare)

NCI                  National Cancer Institute

NIH                 National Institutes of Health; “NIH”

OCTR              Office of Clinical and Translational Research

PFS                  Patient Financial Services

PI                     Principal Investigator

PIC                  Protocol Induced Costs

POE                 Physician Order Entry

RA                   Research Assistant

RAF                 Research Administration and Finance

RC                   Routine Clinical Services. new Medicare terminology for Routine Care

RCM                Research Compliance Monitor

RFA                 Research Fiscal Administration

RFC                 Research Financial Compliance

SC                    Study Coordinator

SOM                School of Medicine

SODM             School of Dental Medicine

SPS                  Sponsored Program Services

T & E               Time and Effort

TV                   Transfer Voucher

UMG               UConn Medical Group

The purpose of the Research Financial Compliance Monitoring Program is to provide for continuous monitoring of financial compliance within all clinical research and clinical trials involving human subjects conducted within UConn Health, and to institute an audit plan that identifies and collects information necessary to support the UConn Health research compliance monitoring and audit activities.

Objective

The objective of the Research Financial Compliance Monitoring Program is to provide UConn Health investigators with:

• An internal mechanism for quality assurance, quality improvement and education pursuant to research financial/billing compliance and clinical research or clinical trials with human subjects.
• Practical support in the process of designing clinical trials budgets, assigning Protocol Induced Costs (PIC) and Routine Clinical Services (RC), identifying and complying with institutional policies as well as state and federal regulations and laws.

Selection of Studies

Most studies chosen for a compliance/billing audit will be clinical trials identified through a random process. There will be a focus on:

• Studies that combine both RC and PIC
• Investigator-initiated studies

Purpose

The Guide for the Care and Use of Laboratory Animals and the federal Animal Welfare Act require monitoring of animals subsequent to procedures, including surgical procedures, to which animals are subjected.

Appropriate monitoring criteria must be chosen based on consideration of the procedure(s) being performed, the expected and possible adverse effects animals may experience, the expected time course and progression of adverse effects, and the earliest predictive indicators of adverse effects.

It is essential that properly qualified personnel monitor the animals at appropriate intervals to ensure adequate observation and care of the animals. Optimally, studies should be terminated when animals begin to exhibit adverse clinical signs, if this endpoint is compatible with meeting research objectives, since such endpoints minimize pain or distress.

The IACUC is requiring different monitoring procedures that are predicated upon the type of species being used.

Action

USDA-Regulated Species (all animals other than mice (Genus mus), rats (Genus rattus), fish, frogs, axolotls, and birds)

All monitoring of regulated species must be documented in the animal record that is kept with the animals. At a minimum, the monitoring must consist of:

• Date of monitoring
• Time of monitoring
• Initials of personnel who performed the monitoring
• The condition of the animals

Non USDA-Regulated Species (mice, rats, birds, and cold-blooded vertebrates)

All monitoring of non-regulated species must have written documentation. As most of these animals do not have individual animal records, the requirement for monitoring is more general. Monitoring can be written on the animals’ cage card(s), in a laboratory notebook, in a computer spreadsheet (e.g., Excel), or any other written documentation system that the PI chooses to use. At a minimum, the monitoring must consist of:

• Date of monitoring
• Time of monitoring
• Initials of personnel who performed the monitoring
• The condition of the animals

All animals must be monitored in accordance with the monitoring for each procedure being performed described in the animal care and use protocol. Each protocol will state the parameters being evaluated, the frequency of monitoring, and the length of monitoring for every procedure described in the animal care and use protocol. It is the responsibility of the Principal Investigator to ensure that the post-procedure and post-surgical monitoring is being performed as described in the animal care and use protocol.

References

1. The Guide for the Care and Use of Laboratory Animals, National Academy Press, 2011.
2. 9 CFR Chapter 1 – Animal Welfare Regulations, 2013.
3. PHS Policy on the Humane Care and Use of Laboratory Animals, OLAW, 2015.
4. Animal Care Resource Guide, USDA, 2000.

Effective Dates:  June 6, 2024 thru June 30, 2027

Purpose

There are times when the IACUC approves protocols that include the use of common therapeutic drugs or materials, but subsequently, these drugs or materials become either temporarily or permanently unavailable. This could be due to various reasons including, but not limited to: a company discontinues production of the drug/material, a company changing the product in some what that makes its use unacceptable, a back-order on a drug, or an inordinate price increase of a product which essentially makes the product unavailable for use.

In order to help researchers maintain compliance with federal regulations when faced with this type of difficulty, and its implications for the affected animal care and use protocols, the UConn Health IACUC has instituted a policy on unexpected unavailability of commonly used therapeutic drugs and materials.

Action

1. When a researcher discovers that a drug or material is not available, he/she must consult with the Attending Veterinarian (AV) who will determine acceptable alternatives. These alternatives will be based on scientific requirements of the affected research protocol(s), the clinical requirements of the animals, and the professional judgment of the AV.

2. The AV will be responsible for informing the research community of the alternative(s) available for any drug or material used at the institution that is temporarily or permanently unavailable through the CCM pharmacy. It is the responsibility of the PI to consult with the AV to determine which alternative is best for his/her protocol(s).

3. If the drug/material is permanently unavailable, the IACUC gives authority to the AV to authorize changes to the affected protocols without a modification being immediately submitted to the IACUC. The AV will notify the IACUC Administrator of these instances. A modification will be required at whichever of the following instances first occurs during the course of the affected protocol:

• Submission of the annual review of the protocol;
• Submission of the 3 year renewal of the protocol; or
• Submission of another required modification to the protocol.

4. If the drug/material is temporarily unavailable, the IACUC gives authority to the AV to authorize changes to the protocols without a modification being submitted to the IACUC, but the PI must work with the AV to assure a return to the original drug or material when that drug or material again becomes available. The AV will notify the IACUC Administrator of these instances.

5. This policy dos not allow for the change in an experimental drug without a modification being submitted to, and approved by, the IACUC.

This Policy has been approved by a majority vote of the IACUC members.

Effective Dates: June 6, 2024 thru June 30, 2027

Purpose

In order to comply with the government regulations (USDA Animal Welfare Act and Animal Welfare Regulations, PHS Policy, and the Guide for the Care of Use of Laboratory Animals, 8th Edition), the UConn Health’s Institutional Animal Care and Use Committee (IACUC) has implemented a policy implementing a training form for individuals who receive training by the PI/laboratory staff.

Action

1. All individuals who perform research, testing, or training on laboratory animals must be trained on all procedures they will be expected to perform to comply with federal regulations.

2. All training must be documented in a written fashion.

3. If training is performed by the PI or senior laboratory staff members, the PI is responsible for maintaining training records for all procedures for which they train personnel to perform on laboratory animals.

4. All documentation of training must be submitted to the IACUC office when requested. IACUC office personnel must be allowed access to all training documentation records and be allowed to make copies.

Effective Dates:  June 2, 2022 through June 30, 2025

Purpose

Euthanasia is defined as the act of killing an animal by a method that induces rapid unconsciousness and death without pain or distress. In order to comply with federal regulations (USDA and PHS) and the Guide for the Care and Use of Laboratory Animals, the UConn Health’s Institutional Animal Care and Use Committee has established a policy on the use of CO₂ for euthanasia.

Action

1. Ideally, animals should be euthanized in their home cage.  If this is not possible (e.g., because an investigator is culling animals from multiple cages for euthanasia), the following will apply for transport of animals to the euthanasia station:
   1. The maximum cage density for euthanasia in a standard mouse cage will be 250 g/cage (approximately 8-10 mice)
   2. For cage densities greater than 125 g/cage in a standard mouse cage, animals must be euthanized within 30 minutes of being placed at these cage densities.
2. Compressed CO2 gas will be allowed to flow into an uncharged cage bottom or container.  Pre-filling of the chamber with CO2 is not allowed. As high concentrations of CO2 may be distressful to some species, gradual displacement of room air with the CO2 should allow for the anesthetic effect of CO2 to take place prior to asphyxiation which will result in the least amount of pain and/or distress to the animals.
3. For successive euthanasia procedures, the euthanasia chamber must be filled with room air before flooding with CO2 again.
4. To comply with the current AVMA Guidelines on Euthanasia, the flow rate into the euthanasia chamber must be at a rate of 30-70% of the total volume of the chamber per minute. To this end, a regulator must be used. The Euthanex® system is recommended by the IACUC; however, any commercial regulator system may be used as long as it meets the following criteria:
   1. The system must be AVMA compliant;
   2. The system must regulate a precise control of CO2 flow;
   3. The system must be calibrated specifically for CO2 gas; and
   4. The flow rate must be set by the factory and not be alterable by the user.
5. Death must be verified after euthanasia and prior to disposal. This typically should be done by visual examination (cessation of respiration and heartbeat), cervical dislocation, or thoracic trans-section.
6. CO2 euthanasia must be performed by individuals who are skilled in this method for the species in question and it must be performed in a professional and compassionate manner.
7. Unintended recovery of the animals after apparent death from CO2 is a documented occurrence. These incidents constitute serious non-compliance with PHS Policy and deviations from the provisions of the Guide.

References

1. Conlee, KM, Stephens, ML, Rowan, AN, and LA King. “Carbon Dioxide for Euthanasia: Concerns Regarding Pain and Distress, with Special Reference to Mice and Rats.” Laboratory Animals (2005) 30, 137-61.

2. Hawkins, P, Playle, L, Golledge, H, Leach, M, Banzett, R, Coenen, A, Coooper, J, Dannemann, P, Flecknell P, Kirkden, R, Niel, L, and M. Raj. Report of the Newcastle Consensus Meeting on Carbon Dioxide Euthanasia of Animals held on 2/27-28/06, University of Newcastle upon Tyne, UK, August 9, 2006.

3. PHS Policy on Humane Care and Use of Laboratory Animals Clarification Regarding Use of Carbon Dioxide for Euthanasia of Small Laboratory Animals. NIH Notice NOT-OD-02-062. July 17, 2002.

4. The Guide for the Care and Use of Laboratory Animals. National Research Council, 2011.

Effective Dates: June 2, 2022 through June 30, 2025