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

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 5, 2025 through June 30, 2028

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. At CCM EuthanEx® system station, mice may only be euthanized using a mouse set-up and rats may only be euthanized using a rat set-up.  These set-uups are not interchangeable and must be used correctly.
6. Death must be verified after euthanasia and prior to disposal. This must be done by a physical method such as cervical dislocation, exsanguination, decapitation, or thoracic trans-section and/or removal of the heart.  Neonates euthanized by CO2 must be decapitated prior to disposal.
7. 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.
8. 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 5, 2025 through June 30, 2028

Purpose

In many cases, the use of drugs and chemicals in laboratory animals requires that a mixture be made. For example, ketamine and xylazine are frequently used by being made into a solution for an injection into animals. Or, alternately, drugs may need to be diluted in sterile saline prior to use.

Action

1. When making a mixture of drugs and/or chemicals in laboratory animals, documentation must be kept as to the identity of each individual drug/chemical used and their respective lot numbers and expiration dates.

2. If you are making drug mixtures (e.g., a working solution from stock) and plan to store the mixture for longer than the day it is made, mixtures must be made in a sterile container with a septum for re-use, such as sterile vials from Fisher Scientific or equivalent.  Alternately, a tube such as a vacutainer tube can be used; however, the stopper must be kept in and the drug mixture accessed by a needle using sterile technique (e.g., wipe septum with70% ethanol before obtaining mixture).  Sterile vacutainer tubes will be provided by Environmental Health & Safety should you choose to use that option.

3. If you are making a drug mixture and will use the entirety of it the day it is made, you can make your drug mixture in any sterile container (e.g., 15-ml Falcon Tube) as long as it is discarded that day.

4. Each mixture must be assigned an expiration date.  The expiration date will be the shortest expiration date of all drugs/chemicals used in the mixture, the expiration date of the sterile container used to make the solution, OR 1 month, whichever is soonest.

5. When storing expired controlled drugs in your laboratory, waiting for disposal with Environmental Health & Safety, the word “EXPIRED” must be on all containers.

Effective Dates:   December 7, 2023 through December 31, 2026

Purpose

The Public Health Service (PHS) policy on Humane Care and Use of Laboratory animals endorses US Government principles on use of Vertebrate Animals used in Testing, Research and Training, principle VII – “The living conditions of animals should be appropriate for their species and contribute to their health and comfort.” Based upon this, the Guide for the Care and Use of Laboratory Animals emphasizes “that animals should be housed with a goal of maximizing species-specific behavior and minimizing stress induced behavior”.

The primary aim of environmental enrichment is to enhance animal well-being by providing animals with sensory and motor stimulation, through structures and resources that facilitate the expression of species specific behavior and promote psychological well-being through physical exercise, manipulative activities, and cognitive challenges according to their species specific characteristics.

The environmental enrichment should be biologically relevant (i.e. hiding, gnawing, socializing, foraging, searching) so that it does not lose its enriching value over time. Environmental enrichment via physical manipulanda, structure, or substrate is preferred over nutritional enrichment.

All principal investigators working with laboratory animals are required to allow animal enrichment unless there is a scientific justification against the use of enrichment as approved by the Institutional Animal Care and Use Committee (IACUC). The justification must be included in an IACUC protocol submission and approved by the Attending Veterinarian (AV) and the IACUC.

Introduction of novel enrichment materials must be approved by the investigator and the AV before introduction.

Definitions

Physical manipulanda are non-nutritive objects that ca be altered by the animal or encourage fine motor movements. These include plastic/nylon chew toys – the preferred standard method of rodent enrichment at CCM.

Manipulanda are sanitized at least as frequently as the animal’s primary enclosure (cage).

Structure and substrate includes objects that allow an animal to isolate itself into different microenvironments, experience varied textures or materials. These include nesting materials, running wheels and hiding shelters.

Structure and substrate are replaced or sanitized at least as frequently as the animal’s primary enclosure (cage).

Nutritional enrichment may be provided in lieu of physical manipulanda, structure or substrate if necessary for research purposes.

Nutritional enrichment is accomplished by provision of novel foods or provision of small pieces of the normal diet in the bedding to stimulate foraging.

Procedure

Included in this are the Veterinarian Recommended Enrichment used currently at the CCM animal colony.

In addition, sometimes animals must be singly-housed due to various reasons such as incompatibility, pregnancy, surgery, medical isolation and other veterinary related issues.

Mice

• Social Housing: Animals are group housed whenever possible. Male mice may be housed singly due to their aggresive nature.
• Shelter: Nesting materials (e.g., Nestlets™); Igloos
• Other: Nylabones™

Rats

• Social Housing: Animals are group housed whenever possible. Male rats may be housed singly due to their aggressive nature.
• Shelter: Tubes (polycarbonate); Nesting materials may be desirable for dams nearing parturition and during lactation.
• Other: Nylabones™

Rabbits – most animals housed at CCM are male rabbits that are on surgical studies.

• Social Housing: All male rabbits are singly housed at CCM animal facility.
• Environmental Enrichment: Elevated shelves, toys (balls, bells, etc.)
• Dietary Items: Food items (e.g., alfalfa cubes/timothy hay/lettuce)
• Human Interaction: At least once a week, each rabbit becomes part of the human socialization program. The socialization consists of petting, brushing, to get the animals acquainted with human handling. Brushing reduces potential for hairballs.

Hamsters

• Social Contact: Group housed as much as possible; pair – or group-housed hamsters of same gender, except for pregnant females and incompatible animals.
• Nesting Material: Nestlet, tissue papers
• Other: Igloo, Jolly Ball™

Xenopus

• Being a prey species, Xenopus leavis are provided with shelter objects. The enrichment for X.leavis colony is the provision of PVC pipes. For the group housed X.leavis the number of enrichment (PVC) pipes depends on the density of the animals in the tank.
  • 1 to 5 frogs – 1 PVC pipe
  • 5 to 10 frogs – 2 PVC pipe

Fish

• The primary method of environmental enrichment is to be socially housed.  The use of artificial plants or other objects has been shown to have an effect on various aspects of fish metabolism.  If any artificial object is requested for the enrichment of fish requires the approval by the CCM Attending Veterinarian.

Implementation and Assessment

A successful well-being program depends on not only implementing but also on evaluating its effectiveness, and constant update to reflect our current knowledge. The principal investigators, research staff, veterinary staff and animal care technicians are involved at all times in decisions regarding psychological well-being and environmental enrichment.

References

1. Environmental strategies for laboratory animals. ILAR, Vol 46 (2), 2005.
2. “An Enriched Environment For The African Clawed Frog (Xenopus laevis)”: Lab Animal Magazine, May 1993, Vol. 22, Number 5, pp. 25-29.
3. Environmental enrichment program for hamsters. Institutional Animal Care and Use Committee, Cornell University, Ithaca, NY.
4. Guide for the Care and Use of Laboratory Animals – 8th edition. National Research Council, Washington DC. http://grants.nih.gov/grants/olaw/Guide-for-the-care-and-use-of-Laboratory-animals.pdf
5. Public Health Service Policy on Humane Care and Use of Laboratory Animals, OLAW, NIH. http://grants.nih.gov/grants/olaw/references/PHSpolicylabanimals.pdf

Effective Dates:      December 7, 2023 through December 31, 2026