UConn Health FCOI policies

• Individual Financial Conflicts of Interest in Research
• Institutional Conflicts of Interest in Research

Federal FCOI regulations

• Public Health Service (PHS)
• National Science Foundation (NSF)
• Food and Drug Administration (FDA)
• Department of Energy (DOE)
• NASA

Additional information on the PHS FCOI regulation

• NIH Financial Conflict of Interest page
• PHS Funded Agencies and Offices Covered Under the COI Regulations

Information related to faculty-affiliated companies

• Use of research space or equipment by external entities
• Guidelines for Faculty, Staff and Students who are affiliated with a company

Related University areas

• Consulting Office
• Ethics Liaison

The UConn Health IACUC is committed to the humane care and use of laboratory animals. The IACUC has oversight of all animal-related activities performed at UConn Health. It is the responsibility of the IACUC to ensure that all work performed with research laboratory animals used at UConn Health complies with all applicable federal, state, and institutional laws, policies, and guidelines.

IMPORTANT INFORMATION

InfoEd

For information on the InfoEd implementation for animal care and use, please go to the Protocol Page of this website.  For helpful “cheat sheets“, please go to the OVPR IT help page.

New Laboratory Animal Users

If you are new to using laboratory animals, please review our “Top Ten Actions for New Animal Users” page.  This will tell you in detail what you need to know and do in order to use laboratory animals here at UConn Health.

Accessing the Animal Facility

In order to access the animal facility, you need to contact the Center for Comparative Medicine (x2731) and ask them for a facility access request form.  The IACUC office does not grant facility access.  Before you can actually access the animal facility, the following actions must be completed:

1. You must be listed as an animal user on an active animal care and use protocol.
2. You must complete initial animal user training.
3. You must enroll in the Occupational Health Surveillance Program; this is a form that you complete on line.
4. You must complete training on use of expired materials in animals (this is sent to you when you register for training).
5. You must have a “medical clearance for animal use” appointment with a physician or nurse in Employee Health Service.

EuthanEx System

The IACUC is requiring that all euthanasia stations be equipped with the Euthanex® system. Please review the letter from the IACUC Chair regarding this issue. For more information, contact Dr. Chidambaram, Attending Veterinarian.

FCOI training requirements, as specified under federal regulations and UConn Health policy, will be complete once an investigator has submitted a financial disclosure form within the InfoEd External Interests / FCOI & FCO system.

All PHS-funded investigators must complete UConn Health FCOI training pursuant to PHS regulations 42 CFR 50.604(b) (1-3) and institutional policy prior to engaging in PHS-funded research and at least every four (4) years thereafter as well as under the following circumstances:

1. When the University’s FCOI policy changes such that Investigator requirements are affected.
2. When an investigator is new to the University (prior to engaging in PHS-funded research).
3. When the University finds that an investigator is not in compliance with the Policy or a management plan, as applicable.

The U.S. Department of Agriculture (USDA), Public Health Service (PHS), and institutional requirements dictate that every animal care and use protocol which uses USDA-regulated species and employs procedures which have the potential to cause more than momentary pain and/or distress to the animals have a “Search for Alternatives to Painful Procedures” be performed. These are frequently identified as “D” and “E” procedures in the animal care and use protocol form.

This following information includes links which can help you determine the painful/distressful procedures in your protocol and how to perform a search for alternatives. This does not have to be a literature search (though the USDA maintains that a literature search remains the best way to fulfill the search for alternatives requirement).

The IACUC has a document entitled “Meeting the Information Requirements of the Animal Welfare Act” which could be helpful for you in your search requirements. Please contact the IACUC office to have a copy sent to you.

Brief Outline of Conducting Literature Searches

Most investigators have difficulty when trying to meet the requirements of the AWA and the institution with the search for alternative to painful procedures. However, if you break the literature search procedure down into 5 simple steps, done prior to filling our your animal care and use application, it makes the process a little easier. Use of the alternatives search worksheet may be helpful.

Step One: Understand the Legislation and Regulatory Intent. USDA policy #12 is clear in its requirement that ALL potentially painful and/or distressful procedures performed on the laboratory animals must have an alternatives search. This may mean that your protocol more than likely requires more than one alternative search. PIs should be aware that the IACUC and federal regulations require that protocols do not unnecessarily duplicate previous research and that may require the PI to do a literature search; however, this does not mandate a narrative and assurance of compliance with this regulation is documented in Section 19 of the Animal Care and Use Protocol Application. This is NOT the same as the search for alternatives requirement which requires a narrative to explain each potentially painful and/or distressful procedure being performed in the protocol.

Step Two: Know Your Protocol. You should gather information about the area of study, including species and organ systems; important acronyms and international spellings; names of hormones, enzymes, CAS#, and trade names; prominent authors in the field; knowledge of possible alternatives; and previous searches, including the key words and search strategy used. List all your potentially painful and/or distressful procedures that you are performing and make sure that each one has an alternatives search performed.

Step Three: Formulate a Search Strategy. This is most easily done in two phases: phase one covers the aspects of reduction and refinement and provides a comprehensive view of the field of study, including techniques and common species used, and may address unnecessary duplication. This may address issues such as availability of cell or tissue culture, different models or simulations available, ability to use animals lower on the phylogenetic scale, etc. Phase two addresses potential alternatives to the potential painful / distressful procedures (e.g., the use of chemical castration instead of surgical castration of animals). The PI should list all the potentially painful and/or distressful procedures being performed in the protocol. A search for alternatives to each procedure needs to be performed. Please be aware that a procedure is still considered to be a potentially painful or distressful procedure even if the procedure is done under complete anesthesia and is a non-survival procedure (e.g., terminal thoracotomy for chemical fixation of the animal) under USDA and institutional definitions.

Step Four: Select Appropriate Databases. If you are performing a literature search to satisfy the search for alternatives requirement- listed below are multiple choices of databases in which to do your search. Take the time to select the appropriate databases.

Step Five: Provide a Completed Animal Care and Use Protocol to the IACUC. Principal investigators should complete and review the search before completing the protocol; address and evaluate the alternative possibilities and be prepared to support their use or non-use in writing; check to make sure the terminology, strategy, databases searched (minimum of two) and dates of search are provided; and keep a copy of the strategy, databases search, and years of search for future use.

Reminder: the search for alternatives does not have to be a literature search, although the USDA considers it the best method of searching for alternatives. Other searches can include: information provided at workshops and conferences, consultation with acknowledged experts in the field of research, and information from standard reference books.

Documentation Required in the Animal Care and Use Protocol Form for Searches

Literature Search: key words and/or search strategy used, the names of the databases used (must be at least two), the dates searched (must be at least five years), and the date the search was performed must be included in the animal protocol.

Expert Consultation: type of communication (email, phone call), date(s) of communication(s), information given during the communication(s), and a brief description of the expert (name, affiliated institution, and what makes than individual an expert) must be included in the animal protocol.

Meetings/Workshops: type of meeting, date(s) of meetings, sponsoring organization(s), and information received during the meeting must be included in the animal protocol.

Standard Reference Books: title of book, author or editor, publisher, date of publication, pages, and information contained in the reference book must be included in the animal protocol.

Search for Alternatives Examples

• Example of a search for alternatives for a research protocol (Word)
• Example of a search for alternatives for a training protocol (Word)

Alternative Search Websites

Tips for Searching for Alternatives to Animal Research and Testing
View slides from the workshop given by the USDA on Meeting the Information Requirements of the Animal Welfare Act.

Sample Literature Searches for Alternatives
These examples are provided by the Animal Welfare Information Center (AWIC). AWIC also provides low cost or no cost literature searches.

Databases

Virginia Commonwealth University Research Animal Welfare
This site from the Virginia Commonwealth University has information on how to perform searches.

Fund for the Replacement of Animals in Medical Experiments (FRAME)
This United Kingdom-based web site has excellent alternatives and databases.

Animal Welfare Information Center (AWIC)
This web site, run by the United States Department of Agriculture, is designed to provide both information and searchable databases for information on alternatives.

Johns Hopkins Center for Alternatives to Animal Testing (AltWeb)
This web site has information and one of the best alternatives search engines.

Scientists Center for Animal Welfare (SCAW)
This web site, run by the non profit organization SCAW, is dedicated to improving the welfare of all animals, with multiple publications listed.

Animal Welfare Institute (AWI) Enrichment and Refinement Database
This non-profit organization is based in the United Sates and publishes the book “Comfortable Quarters for Laboratory Animals”. This site has information and a search engine entitled “Database on Refinement of Housing and Handling Conditions and Environmental Enrichment for Laboratory Animals.”

National Centre for the Replacement, Refinement, and Reduction of Animals in Research
The National Centre for the Replacement, Refinement and Reduction of Animals in Research provides a UK focus for the promotion, development and implementation of the 3Rs in animal research and testing.

Universities Federation for Animal Welfare (UFAW)
This non-profit organization is based in the United Kingdom. The site has information in the form of links and publications.

Bibliography on Alternatives to Animal Testing (ALTBIB)
This site, a consortium sponsored by the National Toxicology Program of the US DHHS, has an excellent data base for identifying alternatives in biomedical research.

The ERGATT/FRAME/ECVAM Databank of in Vitro Techniques in Toxicology (INVITTOX)
This site has a search engine to identify in vitro alternatives to toxicity testing with a brief description of each test and links to full protocols.

Alternatives to Skin Irritation/Corrosion Testing in Animals (Invitroderm)
This site, devoted to dermatologic testing, has a searchable database.

Interagency Coordinating Committee for the Evaluation of Alternative Methods (ICCVAM) and its supporting center, National Toxicology Program Interagency Coordinating Committee for the Evaluation of Alternative Toxicologic Methods (NICEATM)
This federal agency is part of NIEHS and is assigned the role of developing and evaluating alternative models in toxicology testing.

National Agriculture Library (AGRICOLA)
This site is funded by USDA and will have citations for books, articles, and conferences to help in your search for alternatives.

Computer Retrieval of Information on Scientific Projects (CRISP)
This site is a searchable database of federally funded biomedical research projects conducted at universities, hospitals, and other research institutions. The database, maintained by the Office of Extramural Research at the National Institutes of Health, includes projects funded by the National Institutes of Health (NIH), Substance Abuse and Mental Health Services (SAMHSA), Health Resources and Services Administration (HRSA), Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDCP), Agency for Health Care Research and Quality (AHRQ), and Office of Assistant Secretary of Health (OASH).

PrimateLit
This site is updated twice per month (around the 3rd and 17th) and is dedicated to primate information. It is supported by an NIH grant and is a collaborative project of the Wisconsin Primate Research Center, the Washington National Primate Research Center, and the University of Wisconsin-Madison Libraries.

Subject Coverage of Commonly-used Databases

Agricola – general agriculture, animal science, chemistry and biochemistry, microbiology, cytology, human and animal nutrition, biotechnology, physiology, veterinary medicine, wildlife, zoology, entomology.

Biosis – general agriculture, aerospace biology, biochemistry and anatomy, bacteriology, cell biology, botany, anatomy, physiology, clinical medicine, pathology, biophysics, toxicology.

CAB – general agriculture, animal science and production, crop science, forestry, pest control, human nutrition, biotechnology, pesticides, veterinary medicine, machinery and buildings, ergonomics.

Medline – clinical medicine, experimental medicine, pharmacology, microbiology, administration, nutrition, anatomy and physiology, veterinary medicine, occupational medicine, toxicology and other medical topics.

Embase – clinical medicine, experimental medicine, pharmacology and drugs and potential drugs, biochemistry, developmental biology, forensic medicine, health economics, occupational health, toxicology.

General Information

Federal laws and Institutional policies require us to apply the principles of the 3Rs (replacement, reduction, and refinement) to animal research. U.S. Government Principle #3 states “The animals selected for a procedure should be of an appropriate species and quality and the minimum number required to obtain valid results.” PHS policy states that the institution provide “training or instruction in research or testing methods that minimize the number of animals required to obtain valid results and minimize animal distress, offered to scientists, animal technicians, and other personnel involved in animal care, treatment, or use.” The Animal Welfare Regulations state that the institution must include training in “The concept, availability, and use of research or testing methods that limit the use of animals or minimize animal distress.”

Reduction is desirable in any procedure, however directly humane, which employs large numbers of animals. Reduction is of great importance and, of all modes of progress on the three Rs, it is the one most obviously, immediately, and universally advantageous in terms of efficiency. One general way in which great reduction may occur is by the right choice of strategies in the planning and performance of whole lines of research. Many investigators settle early in their research career on some strategy that appears to suit them and are liable never to change from that strategy.

The term Reduction Alternatives describes methods for obtaining comparable levels of scientific procedures or for obtaining more information from a given number of animals. Proper statistical design is essential. The precision of an experiment depends mainly on the sample size and error variance. Careful attention must be given to the type of endpoint used. Qualitative endpoints (e.g., dead/alive) often involve severe pain and distress and generally provide less information than quantitative measurements. There is evidence that poor experimental design and inappropriate statistical analysis has lead to the inefficient use of animals. This may be due to a low level of statistical expertise in the investigators so that they are unaware of the potential value of obtaining statistical advise. Alternatively, they may be unable to do so because of a lack of qualified biometricians with experience in their field of interest. In a research project by Hume (1957), he showed that every time any particle of statistical method is properly used, fewer animals are employed than would otherwise have been necessary.

Common Methods to Reduce Animal Numbers

Power Analysis

Statistical significance and biological significance are not the same thing; however, statistical and biological significance can be linked through the use of statistical power analysis. The statistical power of a test is the probability of getting a statistically significant result, given that the null hypothesis is false. Power is proportional to the sample size, significance criterion and effect size, and is inversely proportional to the variance in the population. Effect size is a measure of biological significance: it is the difference between the results predicted by the null hypothesis and the actual state of the population being tested. Power analysis can be used to determine whether the experiment has a good chance of producing a statistically significant result if a biologically significant difference exists in the population. Or, in other words, whether the experiment has a high power, given a biologically significant effect size. What constitutes “high power” is best left to the researcher, but conventions of 0.8 and 0.95 have been suggested in the literature. It is beyond the scope of this general introduction to teach statistics to the researchers, but there are methods that are out there that are available. Consultation with a biostatistician can yield benefits to the PI and the experimental animals.

Pilot Studies

Pilot studies are a good way to reduce the number of animal used; the IACUC may even require a pilot study when reviewing a protocol. Pilot studies can be used to estimate variability and evaluate procedures and effects.

Appropriate Use of Endpoints

The precision of an experiment depends mainly on the sample size and error variance. Careful attention must be given to the type of endpoint used. Qualitative endpoints (e.g., dead/alive) often involve severe pain and distress and generally provide less information than quantitative measurements. More information can generally be found using quantitative endpoints and can, in some instances, lead to a reduction in the number of animals used during an experiment.

Sharing Animals

In some instances, it is possible to share research animals. For instance, animals euthanized by one investigator can provide tissue for use by another investigator. There are instances in which this should never be attempted (e.g., animals have been exposed to biological hazards, chemical hazards, and/or recombinant DNA), but it is a method to reduce animal numbers that should be explored by researchers.

Use Quality Animals and Veterinary Care

When PIs use the correct choice of an animal model- one that uses healthy, genetically similar animals- it generally decreases variability and, hence, animal numbers. You can minimize the loss of animals by providing good post-operative care, avoiding unintended breeding, and planning ahead so that the appropriate number of animals needed for the studies are ordered and/or bred.

Computer Simulations

Though not always possible, there are cases in which there are computer simulations available which can mimic functions of physiology. These are typically most helpful in the case of training protocols.

Use of Cell Culture

When possible, consider the use of cell cultures rather than animals. For example, there are in vitro systems which use cell culture to generate monoclonal antibodies rather than using laboratory animals.

Auto Controls

It would be helpful, whenever possible, to design experiments in which animals serve as their own control. For example, if a procedure were to be performed on a limb, instead of doing the procedure on both limbs of an animal- and having separate control animals- do a unilateral procedure with the control being the opposite limb. Though this is not always possible, it is a well-established method for reducing animal numbers.

New Instrumentation and Techniques

Using new instrumentation or innovative techniques that can improve precision can reduce the number of animals needed for a study. This has the added benefit of also being a refinement technique for the protocol.

Appropriate Experimental Design

Careful experimental design by appropriate choice of control groups and standardizing procedures to minimize variability; for example, University of Leicester researchers designed experiments to reduce the number of mice required to investigate treatment combinations in a study of tumors resulting in an average of 1.5 mice per treatment combination instead of the 20 to 40 mice per treatment combination usually used.

1. Respect for Life.  This principle requires that animals used n research should be of an appropriate species and health status and should involve the minimum number required to obtain valid scientific results.  It also recognizes that the use of different species may raise different ethical concerns.
2. Societal Benefit.  This principle entails that where animals are used, the assessment of the overall ethical value of such use should include consideration of the full range of potential societal good, the populations affected, and the burdens that are expected to be borne by the subjects of the research.
3. Non-maleficence.  This principle entails that the minimization of distress, pain, and suffering is a moral imperative.  Unless the contrary is established, investigators should consider that procedures that cause pain or distress in humans may cause pain or distress in other sentient animals.

Institutions that receive federal funding to conduct animal research must provide an occupational health program for individuals who work with animals. This is a requirement of the Public Health Service Policy on Humane Care and Use of Laboratory Animals. Workers who work with laboratory animals must be enrolled in the program not on the basis of contact hours or job title, but on the basis of risk associated with the work they perform.

Helpful Links

• UConn Health Occupational Health Surveillance Policy
• Safety concerns when working in animal areas
• Compassion Fatigue

Assessing Risks

We’ve provided a Risk Assessment Analysis to help give you the information you need to be safe on the job. Click on the animal(s) that you work with to see a risk assessment typically associated with that species. Please note that this is intended to supplement, not replace, information and advice you may receive from Employee Health Services, Environmental Health and Safety, or the Biosafety Officer nor is it intended to be a complete risk assessment. This is a starting point only. Please contact Employee Health Services for information specific to your personal situation. Everyone should be provided the safest work environment possible.

Information

• How to Enroll in the Occupational Health Program: What you need to do to enroll in this mandatory program.
• Requirements and Guidelines: Occupational Health Program requirements, guidelines, and general information.
• Risk Assessment Analysis: Learn more about your risks when working with animals.

Reference Books

• The National Research Council publishes animal care guidelines and standards in The Guide for the Care and Use of Laboratory Animals.
• The National Research Council publishes occupational health and safety guidelines in Occupational Health and Safety in the Care and Use of Research Animals.
• The National Research Council publishes guidelines in Occupational Health and Safety in the Care and Use of Nonhuman Primates.
• The Centers for Disease Control and Prevention also publishes guidelines for Biosafety in Microbiological and Biomedical Laboratories.
• The National Research Council publishes guidelines in Emerging Animal Diseases.
• The National Institutes of Health publishes the PHS Policy on Humane Care and Use of Laboratory Animals.

The Office of Clinical and Translational Research (OCTR) website has been compiled to assist the principal investigator (PI), research staff and sponsors to navigate the intricacies of budget and contract negotiations as well as the complexities of research financial compliance.

Our mission is to ensure that investigators who carry out clinical trials/research at UConn Health adhere to federal and state laws/regulations and institutional policies that govern clinical trials/research contract negotiations and define research financial compliance.

Staff in the OCTR provides researchers the fiscal and contractual administrative support necessary to conduct clinical trials/research within the institution and community. The goals of the OCTR are to:

• Work collaboratively with researchers to develop viable clinical trial/research budgets for all protocols opened at UConn Health
• Create a Budget Workbook for each clinical trial or clinical research study done at UConn Health that accrues John Dempsey Hospital (JDH) and/or UConn Medical Group (UMG) and/or dental medicine charges
• Negotiate clinical trial or clinical research budgets with the sponsor
• Negotiate all contracts for:
  • Non-federal investigator initiated industry supported clinical trials
  • Industry sponsored clinical trials
  • University to university clinical trials
  • Co-operative group clinical trials
  • Foundation supported clinical trials
• Establish Banner research accounts and reconcile these accounts to actual charges
• Audit ongoing clinical trials or clinical research to assure research financial compliance with institutional policies and state and federal laws/regulations

If you have any questions regarding the services provided by the staff in the OCTR, or you would like to set up an appointment to discuss services, please call us at 860-679-4040.

The Financial Conflict of Interest in Research program supports the UConn Health research community with understanding and complying with University requirements related to financial conflicts of interest (FCOIs) in research.

Who is an Investigator?

• Investigator means the project director or Principal Investigator (PI) and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research (regardless of sponsor or funding source), which may include, for example, collaborators or consultants.

What are my responsibilities as a UConn Health investigator?

• Review and be knowledgeable of the UConn Health policy on financial conflicts of interest in research, including the definition of Significant Financial Interest (SFI) and how it applies to you.
• Promptly and fully disclose all SFIs, including those of a spouse and/or dependent child, that reasonably relate to your institutional responsibilities; and, if applicable, comply with FCOI management or mitigation plans.
• Submit a financial disclosure in the UConn Health InfoEd Financial Interests [FCOI] system: https://uchealth.infoed.uconn.edu.
  • Annually
  • Within 30 days of acquiring or discovering a new SFI
  • Investigators on PHS awards or other sponsored projects requiring adherence to PHS FCOI regulations: Within 30 days of any applicable reimbursed or sponsored travel
• Understand that completion and submission of the financial disclosure form also satisfies the FCOI training requirement, as required under federal regulations and UConn Health policy.
• Investigators, coordinators, and persons obtaining consent must also disclose any project-specific SFIs pursuant to UConn Health Human Subject Protection Program (HSPP) policies.

What other resources are available to help investigators?

• Contact our team members by visiting the FCOI contacts page or e-mailing the FCOI mailbox: fcoi@uchc.edu
• Review step-by-step instructions on how to submit an electronic financial disclosure: How-to Guides and Materials
• For Faculty, Staff, and Students who are affiliated with a Company, review the guideline document

To get a general idea of compliance requirements for different areas of research, here is a Regulatory Overview for researchers.

The goal of UConn Health Biosafety website is to make understanding the requirements more convenient and to provide information and resources to help our community members perform their work in safe and healthy ways that promote productive, legal science with as little/ few fuss, fines or imprisonment (FFI) as possible on anyone’s part.

The UConn Health Biosafety Program has safety and regulatory requirements involving the following research situations:

• Work with infectious organisms or viruses. “Select Agents” are not currently authorized at UConn Health. Laboratories that use Risk Group 2 pathogens must register with CT Department of Public Health (CT DPH).
• Work with biological toxins, including those that are listed as “Select Agents.”
• Work with exempt or non-exempt recombinant or synthetic nucleic acids.
• Work with human or non-human primate blood, fluids, tissues or cell strain/line cultures. Note: Contact the SCRO and the Biological Safety Officer about work with any human embryonic stem cells.
• Work with humans or the Institutional Review Board (IRB). Note: contact the Biological Safety Officer about Human Gene Transfer studies or biological Risk Assessment Reports.
• Work with animals or the Institutional Animal Care & Use Committee (IACUC). Note: contact the Biological Safety Officer after reading occupational (human) hazards in Animal Care Protocols and about developing safety protocols for these (forms for safety protocols are on Topaz).
• Shipping, receiving, importing, or exporting biological materials.

If you have questions, suggestions or concerns about the Biosafety Program or this website please contact:

Biological Safety Officer: TBD

Biosafety Program Coordinator: Victoria Scranton, vscranton@uchc.edu 860.679.7533

or email to ibc@uchc.edu.