uconn

Institutional Biosafety Committee (IBC)

Mission Statement:

The Institutional Biosafety Committee (IBC) of the University of Connecticut (UConn) is committed to promoting the advancement of research and teaching activities, by ensuring that all experiments involving biological materials are conducted in full compliance with local, state, and federal regulations and guidelines. As required by the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), all institutions that conduct research with recombinant/synthetic nucleic acids (rsNA) and receive NIH funding, must maintain an active IBC. With the cooperative effort of Principal Investigators (PIs), the IBC conducts risk assessments for hazards associated with the use of biological materials, and promotes the safe use of such materials by enhancing lab personnel’s understanding of biosafety practices and procedures, as defined in the Biosafety in Microbiological and Biomedical Laboratories (BMBL) issued by the Centers for Disease Control and Prevention (CDC).

Overview:

The IBC was established to review research and teaching activities that involve biological materials including but not limited to: recombinant or synthetic nucleic acid molecules (rsNA), bacteria and their phages and plasmids, viruses, biological toxins, fungi, mycoplasmas, prions, and parasites; human and non-human primate tissues, body fluids, blood, blood byproducts, and cell lines, transgenic and wild type animals and plants, animal remains and insects that may harbor zoonotic pathogens.

Institutional policy requires that all biological research is registered, reviewed, and approved by the IBC every three years. The IBC review and approval process is based on the completion and submission of a biological summary in the HuskySMS database. If your lab requires an IBC registration, and you do not see a “Bio” tab in your HuskySMS dashboard, please contact the IBC Office for additional assistance.

The IBC provides guidance on research related safety issues as described in the NIH Guidelines (Section IV-B-2-b). For example, the IBC will assess facilities, incidents, procedures, practices, training and expertise of personnel involved with biological research. The IBC will ensure compliance with all necessary health surveillance, data reporting, and adverse event reporting requirements. The IBC also works with UConn Biosafety to ensure compliance with other relevant federal and state regulations (e.g. Connecticut Department of Public Health (DPH), Centers for Disease Control and Prevention (CDC), Animal Plant Health Inspection Service (APHIS), etc.).

ClinicalTrials.gov

ClinicalTrials.govOver the past ten years, government agencies and the International Committee of Medical Journal Editors (ICMJE) have issued laws and directives on the subject of trial registration. All parties have consistently agreed that the purpose of trial registration is to promote the public good by ensuring that the existence and design of clinical trials are publicly available. The registration effort began with the development of a publicly available website, ClinicalTrials.gov, a service of the National Institutes of Health (NIH), developed by the National Library of Congress.

In 1997, the Food and Drug Administration (FDA)/NIH began requiring registration for only a limited number of trials. Then in September 2007, the FDA Amendments Act (Title VIII. Sec. 801) significantly expanded the scope of clinical trials that must be registered and set civil monetary penalties for failing to register “applicable trials.” In 2004, the ICMJE defined trials that must be registered in order to be considered for publication in journals that adhere to ICMJE standards. In 2007, the ICMJE expanded the definition of trials that must be registered. Scores of journals (not limited to medical journals) have adopted the registration policy. In 2016, the final rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11), which clarifies and expands the requirements in FDAAA 801, was released, and the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information was published.

The bottom line:
The FDA, NIH and the ICMJE each have their own requirements for registration, and while some of the requirements overlap, there are some differences. In order to comply with the law and preserve the ability to publish in many journals, all sets of requirements must be met. UConn is committed to compliance with the regulations of the FDA, NIH and ICMJE in supporting Principal Investigators (PIs) with meeting the requirements concerning the public availability of clinical trial data in ClinicalTrials.gov, as outlined in our University ClincalTrials.gov policy.

How is “clinical trial” defined and what are the registration deadlines?

According to NIH:

A clinical trial is a research study1  in which one or more human subjects2 are prospectively assigned3 to one or more interventions4 (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.5  All clinical trials must be registered within 21 days of enrollment of the first participant.

1See Common Rule definition of research at 45 CFR 46.102(d).

2See Common Rule definition of human subject at 45 CFR 46.102(f).

3The term “prospectively assigned” refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo, or other control) of a clinical trial.

4An intervention is defined as a manipulation of the subject or subject’s environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints.  Examples include:  drugs/small molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment strategies; prevention strategies; and, diagnostic strategies.

5Health-related biomedical or behavioral outcome is defined as the pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects’ biomedical or behavioral status or quality of life.  Examples include:  positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); positive or negative changes to psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and /or information retention); positive or negative changes to disease processes; positive or negative changes to health-related behaviors; and, positive or negative changes to quality of life.

Registration Deadline: The NIH Policy on Dissemination of NIH-funded Clinical Trial Information applies to applications for funding submitted to NIH on or after 1/18/17. Registration is required no later than 21 days after the first patient is enrolled. The consent form for the trial is required to include the following language: “A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law.  This Website will not include information that can identify you.  At most, the Website will include a summary of the results.  You can search this Website at any time.”

According to the ICMJE:

A clinical trial is any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the cause-and-effect relationship between a health-related intervention and a health outcome. Health-related interventions are those used to modify a biomedical or health-related outcome; examples include drugs, surgical procedures, devices, behavioral treatments, educational programs, dietary interventions, quality improvement interventions, and process-of-care changes. Health outcomes are any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events. Those who are uncertain whether their trial meets the expanded ICMJE definition should err on the side of registration if they wish to seek publication in an ICMJE journal.

Registration Deadline: Registration at or before the time of first patient enrollment is as a condition of consideration for publication in an ICMJE journal.

According to the FDA:

The U.S. Department of Health and Human Services in September 2016 issued a final rule that specifies requirements for registering certain clinical trials and submitting summary results information to ClinicalTrials.gov. The new rule expands the legal requirements for submitting registration and results information for clinical trials involving U.S. Food and Drug Administration-regulated drug, biological, and device products. The FDA Amendments Act (Title VIII. Sec. 801) requires registration for all “applicable clinical trials,” including Federal, industry-sponsored, and investigator-initiated that are:

  1. Trials of drugs and biologics: Controlled, clinical investigations, other than Phase I investigations, of a product subject to FDA regulation, and
  2. Trials of devices: Prospective clinical studies of health outcomes comparing an intervention with a device against a control in human subjects (other than small clinical trials to determine the feasibility of a device, or clinical trials to test prototype devices where the primary outcome measure relates to feasibility and not to health outcomes); and pediatric postmarket surveillance studies, as required under the Federal Food, Drug and Cosmetic Act.

Registration Deadline: The FDA Amendments Act of 2007 requires that all trials, regardless of sponsor, must be registered in full no later than 21 days after the first patient was enrolled.

Who is responsible for registering a trial?

The Principal Investigator (PI) is ultimately responsible for determining that registration requirements are met. Although some industry sponsors will do the actual registration work, it is still the PI’s responsibility to ensure that the registration has been accomplished and is accurate.

What are the penalties for failing to register?

According to the ICMJE:

Unregistered trials will not be considered for publication in journals that adhere to ICMJE standards. Questions about policies of a specific journal should be addressed to that journal directly. A list of journals whose editors or publishers have signed on to the ICMJE Uniform Requirements for Manuscripts Submitted to Biomedical Journals may be found at http://www.icmje.org/journals.html.

According to the FDA/NIH:

Penalties may include civil monetary penalties up to $13,237 fine for failing to submit or for submitting fraudulent information to ClinicalTrials.gov. After notification of noncompliance, the fine may go up to $13,237 per day until resolved. For federally funded grants, penalties may include the withholding or recovery of grant funds.

Who can help with questions about meeting the requirements?

Please contact the local Protocol Registration and Results System (PRS) Administrator for UConn/UConn Health, Ellen Ciesielski, Office of the Vice President for Research, Research Integrity & Compliance at 860.679.6004 for any questions related to ClinicalTrials.gov. The PRS Administrator serves as a point of contact for resolving requests by ClinicalTrials.gov and regularly monitors to promote compliance with the requirements.

Research Integrity & Compliance

The University of Connecticut is committed to the highest standards of integrity in fulfilling its mission to expand human knowledge and benefit society through research. All research activities undertaken by faculty, staff, and students at UConn will be conducted in accordance with strict ethical principles and in compliance with federal, state, and institutional regulations and policies. Research Integrity & Compliance (RIC) reports to the Vice President for Research, Innovation and Entrepreneurship. RIC is responsible for providing support and training to faculty, students and staff in order to meet these requirements and maintain a robust research compliance program at UConn.

RIC works with the faculty oversight committees to promote the ethical and responsible conduct of research and to ensure compliance with regulatory requirements relating to research involving human participants, vertebrate animal subjects, biological materials, recombinant/synthetic nucleic acids, biohazards, radiation hazards, chemical hazards, and stem cells. The committees supported by this office include the Institutional Animal Care and Use Committee (IACUC), the Institutional Review Board (IRB), the Institutional Biosafety Committee (IBC), the Financial Conflict of Interest in Research Committee (FCOI), the Stem Cell Research Oversight Committee (SCRO) the Radiation Safety Committee, the Laser Safety Committee, and the Chemical Hygiene Committee. RIC also has responsibilities relating to ClinicalTrials.gov and Responsible Conduct of Research.

Responsible Conduct of Research

To promote the responsible conduct of research, Research Integrity & Compliance is developing a Responsible Conduct of Research Program. The program’s mission will be to educate and participate in an ongoing dialogue to create an environment of robust, ethical performance of all research activities, including conflict of interest, mentor/mentee relationships, safety in research and research environments, collaborative research, peer review, data acquisition and analysis, secure data use and confidentiality, and responsible authorship and and publication. In support of this commitment and to fulfill funder requirements, UConn offers Responsible Conduct of Research (RCR) training and education with the goal of engaging researchers in the exploration of best ethical practices. Projects funded by the National Science Foundation (NSF), National Institutes of Health (NIH), and National Institute of Food and Agriculture (NIFA) have specific requirements regarding training in RCR.

Faculty Consulting

facultyconsultingConsulting is a time honored and frequent activity of faculty throughout U.S. research universities.  The ability to consult is important in promoting recruitment and retention of faculty of the highest quality. Often, such consulting activities provide a range of benefits including fostering economic development, enhancing the reputation of the University, promoting faculty development and enhancing the faculty’s ability to bring to the classroom current and relevant “real world” experiences, among others.

Consulting is an activity performed by a faculty member for compensation as a result of his/her expertise or prominence in his/her field while not acting in his/her official capacity as a State employee (i.e. in his/her own time.) The University’s Laws and Bylaws prohibit faculty from consulting on “time due to the University.”

Visit the UConn Faculty Consulting Website for faculty consulting requests and other resources.

Key Definitions

Who is an investigator?

Per the U.S. Public Health Service (PHS) definition, an “investigator” is the principal investigator (PI) and any other person (regardless of title or position) identified by the PI as someone responsible for the design, conduct or reporting of research or educational activities. This may include faculty and research staff (research associates and assistants, postdoctoral fellows, graduate students, visiting scientists engaged in research conducted at the University) as well as consultants.

How has the UConn FCOI policy changed?

UConn’s revised FCOI policy was effective on August 24, 2012 and corresponds with the 2011 Public Health Service revised financial conflict of interest (FCOI) regulations (42 CFR 50). These regulations apply to any institution receiving funds from a PHS entity.

Significant Financial Interest (SFI) – PHS funding:

  • With regard to any publicly traded entity, an SFI exists if the value of any remuneration* received from the entity in the twelve months preceding the disclosure and the value of any equity interest* in the entity as of the date of disclosure, when aggregated, exceeds $5,000; or
  • With regard to any non-publicly traded entity, an SFI exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s Immediate Family) holds any equity interest (e.g., stock, stock option, or other ownership interest); or
  • Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
  • Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their Institutional Responsibilities.

*For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value

Significant Financial Interest (SFI) – Non-PHS funding:

  • An equity interest that when aggregated for the Investigator and the Investigator’s Immediate Family exceeded $5,000 over the last 12 months, and/or is expected to exceed $5,000 in value over the next 12 months as determined through reference to public prices or other reasonable measures of fair market value; or when the Investigator (or the Investigator’s Immediate Family) holds a 5% or greater equity interest (e.g., partnership, ownership, stock, stock option, or other ownership interest) in a single publicly traded entity or holds any equity interest in a non-publicly traded entity; or
  • Salary, royalties or other payments not from the University for services (e.g., consulting fees or honoraria) that when aggregated for the Investigator and the Immediate Family over the last 12 months exceeded $5,000 or are expected to exceed $5,000 over the next 12 months.

 

Investigators governed by FDA regulations would also have a Significant Financial Interest if one or more of the following apply:

  • Compensation made to the investigator in which the value of compensation could be affected by the outcome of the study/research project.
  • A proprietary interest in the tested product, including but not limited to, a patent, trademark, copyright or licensing agreement.
  • Significant payments of other sorts, which are payments that have a cumulative monetary value of $25,000 or more made by the sponsor of a covered study to the investigator or the investigators’ institution to support activities of the investigator exclusive of the costs of conducting the clinical study or other clinical studies, (e.g., a grant to fund ongoing research, compensation in the form of equipment or retainers for ongoing consultation or honoraria) during the time the clinical investigator is carrying out the study and for one year following completion of the study.

 

The term Significant Financial Interest does not include the following types of financial interests:

  • Salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the University, including intellectual property rights assigned to the University and agreements to share in royalties related to such rights;
  • Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles;
  • Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education; or
  • Income from service on advisory committees or review panels for a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.
  • Travel that is reimbursed or sponsored by a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.

Related University Policies

Policy Title

Department

Effective
Administrative Review and Approval of Proposals for External Support Office of the Vice President for Research, Sponsored Program Services 06/24/2015
Code of Conduct Office of the President 02/22/2011
Consulting Policy Office of the Provost 03/25/2015
Extra Compensation for Full-time Faculty in AAUP Human Resources & Office of the Provost 09/26/2006
Faculty Professional Responsibilities, Policy on Office of the Provost 03/29/2011
Financial Aid Code of Conduct Board of Trustees 01/22/2008
General Rules of Conduct Office of Faculty & Staff Labor Relations 01/02/2004
Guide to the State Code of Ethics Office of University Compliance 01/26/2014
Use of Students in Outside Employment Office of University Compliance 07/14/2015

FCOI FAQs

Who is an Investigator?

Investigator is defined as “The principal investigator and any other person (regardless of title or position) who is responsible for the design, conduct or reporting of research or educational activities*. This may include faculty and research staff (research associates and assistants, postdoctoral fellows, graduate students, visiting scientists engaged in research conducted at the University) as well as consultants.” *For DOE funded projects, the definition states that the Principal Investigator or any other person, regardless of title or position, who is responsible for the purpose, design, conduct, or reporting of a project.

What are considered my institutional responsibilities?

Institutional Responsibilities are your professional responsibilities conducted on behalf of the University. These include activities such as clinical health care, research, teaching, professional practice, and membership or service on UConn Health or University committees, boards or panels (such as Institutional Review Boards or Data Safety Monitoring Boards), including but not limited to, those that influence direct or indirect vendor selection or purchasing.

How do I know what Significant Financial Interests (SFIs) to disclose?

UConn FCOI in Research policy requires disclosure of Significant Financial Interests (SFIs) with entities that are related to your institutional responsibilities and that meet a certain threshold.

As noted above, “institutional responsibilities” are your professional responsibilities on behalf of the University (e.g., research, teaching, etc.). An SFI is considered “related” to your institutional responsibilities if the financial interest is with an entity related to your field of expertise and/or your role as a University employee or for which you have consulting approval. Once you’ve established there is a possible “related interest,” the threshold for disclosure on the eform is defined as follows:

SFI means a financial interest consisting of one or more of the following interests/relationships of the investigator (or those of the investigator’s spouse and dependent children) in or with an entity that reasonably appears to be related to the investigator’s institutional responsibilities (e.g., with an entity related to the investigator's field of expertise and/or role as a University employee) or for which the investigator has consulting approval and that meet the following thresholds:

  • Remuneration of $5,000 or greater when aggregated from any entity;
  • Equity interest in a publicly-traded entity that is $5,000 or greater when aggregated from any entity;
  • Any equity interest in a publicly-traded entity; or a greater than 5% equity interest in a publicly-traded entity;
  • Any intellectual property rights and interests possibly related to an investigator's institutional responsibilities;
  • An appointment to serve in either a personal or representative capacity with an entity;
  • Reimbursed or sponsored travel worth $5,000 or more from a single entity or if value unknown.

When do I need to submit or update a financial disclosure?

Investigators submit or update their financial disclosure:

  • Annually (at the time of the annual disclosure, the investigator must disclose the current aggregated value of the SFIs received over the previous year);
  • Within thirty (30) days of the acquisition or discovery of a new reportable SFI;
  • Within thirty (30) days of reimbursed or sponsored travel in excess of $5,000 from a single entity possibly related to your institutional responsibilities.

What does not need to be disclosed?

Investigators do not need to disclose the following:

  • Salary received from UConn or UConn Health;
  • Salary support from a UConn or UConn Health administered sponsored awards;
  • Income from investment vehicles, such as mutual funds and retirement accounts, as long as you do not directly control the investment decisions made in these vehicles;
  • Travel expenses paid by UConn or UConn Health or by a sponsored research award to UConn or UConn Health;
  • Travel reimbursed or sponsored by a U.S. federal, state, or local government agency, a U.S. institution of higher education, a U.S. academic teaching hospital, a U.S. medical center or a research institute that is affiliated with a U.S. institution of higher education.†
  • Income from seminars, lectures and teaching engagements sponsored by U.S. Federal, state or local government agencies; U.S. institutions of higher education or U.S. research institutes; U.S. academic teaching hospitals or U.S. medical centers that are affiliated with U.S. Institutions of higher education;†
  • Income from service on advisory committees or review panels for U.S. Federal, state or local government agencies; U.S. Institutions of higher education or U.S. research institutes; U.S. academic teaching hospitals or U.S. medical centers that are affiliated with U.S. Institutions of higher education;†
  • †Note: The Department of Energy Interim Conflict of Interest Policy doesn't exclude academic teaching hospitals or medical centers.

What is a Financial Conflict of Interest?

  • Investigators are obligated to submit a financial disclosure and to disclose any financial interests as requested on the form. The University then determines whether a financial conflict of interest (FCOI) exists.
  • An FCOI is a situation in which an investigator’s significant financial interest in an entity may compromise, or have the appearance of compromising, an investigator's professional judgment in conducting or reporting research, the results of which could affect the aforementioned entity, either directly or indirectly.
  • In summary, FCOI means a significant financial interest (SFI) that could directly and significantly affect the design, conduct or reporting of research.
  • An FCOI exists when the University, through its designated official(s), reasonably determines that an investigator's SFI is related to a research project and could directly and significantly affect the design, conduct or reporting of the research.
  • The UConn Financial Conflict of Interest in Research Committee (FCOIRC) meets regularly to review financial disclosures, identify FCOIs in the conduct of research, and to assign appropriate management or mitigation plans for identified FCOIs.
  • The UConn Policy on Financial Conflicts of Interest in Research promotes objectivity in research by establishing standards to ensure there is no reasonable expectation that the design, conduct, or reporting of research will be biased by any conflicting financial interest of an investigator.

Why do I need to fill out a disclosure?

In order for the University to maintain public trust and support in carrying out its research mission, the University must demonstrate that it subjects itself to the highest standards of ethical behavior. Situations in which financial consideration may compromise, or have the appearance of compromising, an investigator’s professional judgement in the design, conduct, or reporting of research must be managed or mitigated when they occur.

The University’s policy on Financial Conflicts of Interest (FCOI) in Research promotes objectivity in research by establishing standards to ensure the design, conduct, or reporting of research will not be biased by any conflicting financial interest of an investigator.

While the University encourages investigators to engage in appropriate outside relationships, all investigators must, in accordance with University policy, disclose any significant financial interests (including those of a spouse and/or dependent child) that relate to the investigator’s institutional responsibilities and, if applicable, comply with financial conflict of interest management or mitigation plans.

What is the University’s Conflict of Interest in Research Policy?

The University FCOI in Research policy corresponds with the 2011 Public Health Service (PHS) revised Financial Conflict of Interest (FCOI) regulations (42 CFR 50). These regulations apply to any institution receiving funds from a PHS entity.  The Policy applies to all investigators responsible for the design, conduct or reporting of research.  You can see the Policy in its entirety at http://policy.uconn.edu/?p=382.

Who do I call for more information?

You may contact Kristen Tremblay, Committee Staff for the Financial Conflict of Interest in Research Committee, with any questions at 860.679.3276 (or send an email to fcoi@uconn.edu).

Financial Conflict of Interest in Research Committee

Appointed by the Vice President for Research, the UConn Financial Conflicts of Interest in Research Committee (FCOIRC) is a faculty committee with responsibility for the identification and management of financial conflicts of interest as relates to the conduct of research at the University.  The FCOIRC includes broad representation of the campus community.

All UConn investigators must submit a financial disclosure electronically within the UConn InfoEd External Interests module (https://www.infoed.uconn.edu).

The FCOIRC meets regularly to review financial disclosures, identify financial conflicts of interest (FCOIs) in the conduct of research, and to assign appropriate management or mitigation plans for identified FCOIs.

 

FCOI Training

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

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

  1. When the University’s FCOI policy changes such that investigator requirements are affected (within 60 days).
  2. When an investigator is new to the University (prior to engaging in PHS or DOE-funded research).
  3. When the University finds that an investigator is not in compliance with the Policy or a management plan, as applicable.

Financial Conflict of Interest

The Financial Conflict of Interest in Research program supports the UConn (Storrs campus, four regional campuses, the School of Social Work, and the School of Law) research community with understanding and complying with University requirements related to financial conflicts of interest (FCOIs) in research.

Who is an Investigator?

  • Investigator is defined as “The principal investigator and any other person (regardless of title or position) who is responsible for the design, conduct or reporting of research or educational activities*. This may include faculty and research staff (research associates and assistants, postdoctoral fellows, graduate students, visiting scientists engaged in research conducted at the University) as well as consultants.” *For DOE funded projects, the definition states that the Principal Investigator or any other person, regardless of title or position, who is responsible for the purpose, design, conduct, or reporting of a project.

What are my responsibilities as a UConn investigator?

  • Review and be knowledgeable of the UConn 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 or dependent child, that reasonably relate to your institutional responsibilities; and, if applicable, comply with FCOI management or mitigation plans.
  • Submit a financial disclosure within the UConn InfoEd External Interests / FCOI system: https://www.infoed.uconn.edu/
    • Annually while engaged in research activities;
    • Within 30 days of acquiring or discovering a new SFI;
    • At the time of submission of a new research proposal for funding (a new disclosure is required unless a current disclosure has previously been made);
    • Prior to expending research funds (a new disclosure is required unless a current disclosure has previously been made).
  • Understand that completion and submission of the financial disclosure form also satisfies the FCOI training requirement, as required under federal regulations and UConn policy.
  • Investigators, coordinators, and persons obtaining consent must also disclose any project-specific SFIs pursuant to UConn Human Subjects Protection Program Institutional Review Board (IRB) policies.

What other resources are available to help Investigators?

Stem Cell Research Oversight Committee (SCRO)

The role of the UConn/UConn Health’s Stem Cell Research Oversight (SCRO) Committee is to ensure that human embryonic stem cell (hESC) and human induced pluripotent stem cell (iPSC) research is well-justified and that inappropriate and/or unethical research is not conducted. Its mandate is to provide oversight of ethical issues related to the derivation and research use of human stem cell lines at all schools, colleges, campuses, and research arms of the UConn/UConn Health regardless of the source of funding, and to review all proposals from UConn/UConn Health investigators funded by the State of Connecticut’s Regenerative Medicine Research Fund. Review by the SCRO committee supplements but does not replace the usual reviews for compliance with federal, state, and local regulations (e.g., reviews by Institutional Animal Care and Use Committees (IACUC), Institutional Review Boards (IRB), Institutional Biological Safety Committees (IBC), etc.).

SCRO approval is required prior to any of the following:

  • All research involving human embryonic stem cells (hESCs) (SCRO approval is required by the State of Connecticut and University policy.)
  • In vitro human induced pluripotent stem cell (hiPSC) research involving the generation of gametes, embryos, or other totipotent cells (SCRO approval is required by University policy.)
  • In vivo research involving introduction of human induced pluripotent stem cells (hiPSC) directly into prenatal animals or into the central nervous system of post-natal animals or elsewhere in the animal where cells could potentially enter the central nervous system (SCRO approval is required by University policy.)
  • Stem cell research project funded by the State of Connecticut through the Connecticut Bioscience Innovation Fund, including those that do not use human embryonic stem cells (SCRO approval is required by the State of Connecticut.)

 

 

IACUC Training

Initial IACUC Training is a requirement for everyone working with live vertebrate animals at the University of Connecticut in accordance with the policies and guidelines set forth in the “Public Health Service Policy on Humane Care and Use of Laboratory Animals” (PHS 1986), the “Guide for the Care and Use of Laboratory Animals” (ILAR 2011), the USDA Animal Welfare Regulations (CFR 1985) and the “Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching.”

Retraining is required for faculty PIs on a triennial basis (once every three years). All other animal users (staff, post-doctoral fellows, graduate students and undergraduates) must complete IACUC retraining on an annual basis.

Initial IACUC Training

The University’s Institutional Animal Care and Use Committee (IACUC) requires that all faculty, staff and students who work with live vertebrate animals attend an initial IACUC training session.   This will provide an overview of federal, state and University regulations, policies and procedures as well as general information related to the care and use of animals at the University.

ALL INITIAL IACUC TRAINING IS PROVIDED ONLINE VIA SYNCHRONOUS WEBEX EVENTS. Please navigate through the links provided below to sign up for an IACUC training session. When using the sign-up link, please use the Register link on the associated page.  You should receive an “Approval” email after signing up.  If you have any questions or concerns regarding sign-up, please contact nicholas.lacafta@uconn.edu.

Presentation Dates and Times:

Please note: Sessions start promptly. Latecomers risk not receiving credit.

Day Time Session Name Presenter Sign-Up Link
Wednesday, May 15, 2024 10:00 AM IACUC Initial Training Megan Hiller, IACUC Specialist WebEx
Thursday, June 13, 2024 10:00 AM IACUC Initial Training Megan Hiller, IACUC Specialist WebEx
Tuesday, July 16, 2024 11:00 AM IACUC Initial Training Megan Hiller, IACUC Specialist WebEx
Thursday, August 8, 2024 10:00 AM IACUC Initial Training Megan Hiller, IACUC Specialist WebEx
Tuesday, August 20, 2024 11:00 AM IACUC Initial Training Megan Hiller, IACUC Specialist WebEx
Thursday, September 12, 2024 10:00 AM IACUC Initial Training Megan Hiller, IACUC Specialist WebEx
Tuesday, September 24, 2024 11:00 AM IACUC Initial Training Megan Hiller, IACUC Specialist WebEx
Thursday, October 3, 2024 10:00 AM IACUC Initial Training Megan Hiller, IACUC Specialist WebEx
Thursday, October 17, 2024 10:00 AM IACUC Initial Training Megan Hiller, IACUC Specialist WebEx
Friday, November 15, 2024 11:00 AM IACUC Initial Training Megan Hiller, IACUC Specialist WebEx
Tuesday, November 26, 2024 10:30 AM IACUC Initial Training Megan Hiller, IACUC Specialist WebEx
Tuesday, December 10, 2024 11:00 AM IACUC Initial Training Megan Hiller, IACUC Specialist WebEx

Retraining Options

The IACUC requires retraining for all animal users.  Within a year (for Faculty who are Principal Investigators, three years) after the initial classroom training session, animal users must complete one of the following retraining options in order to receive approval for continued animal use:

  1. Completion of an animal subjects web-based exam on the Collaborative Institutional Training Initiative (CITI) Program website (www.citiprogram.org). Please login to the CITI Program site using your Institutional Login credentials (Log In Through My Institution) and selecting University of Connecticut – Storrs & Regional Campuses so that you can enter your UConn NetID username and password to access the CITI Program website. Depending on the course one selects, it may take approximately 1-6 hours to complete.  Please note that completion of any of the web-based courses can be spread over a period of time.  They do not have to be completed in a single session.  Currently, the course modules available include:
    • UConn IACUC, A Review
    • Working with the IACUC
    • Essentials for IACUC Members
    • Post-Procedure Care of Mice and Rats in Research
    • Working with Amphibians in Research Settings
    • Working with Fish in Research Settings
    • Working with Mice in Research Settings
    • Working with Rats in Research Settings
    • Working with Gerbils in Research Settings
    • Working with Hamsters in Research Settings
    • Working with Guinea Pigs in Research Settings
    • Working with Rabbits in Research Settings
    • Working with Cats in Research Settings
    • Working with Dogs in Research Settings
    • Working with Swine in Research Settings
    • Working with Non-Human Primates in Research Settings
    • Working with Zebrafish (Danio rerio) in Research
    • Wildlife Research
    • Working with Reptiles in a Research Setting
  2. Documented attendance at or participation in one of the sessions offered by the Biological Health & Safety section of Environmental Health & Safety. This training is designed for laboratory personnel who work with research animals.  Topics include principles/concepts of biosafety, agent classes and safety levels, engineering controls, personal protection equipment, work practices, biological agent use and transport information and biological waste management issues.
  3. Documented repeat attendance at the in-house classroom session presented by ACS/IACUC.  The session lasts approximately 1.5  hrs.
  4. Documented attendance at any special seminar session that may be specifically offered by Research Compliance Services or Animal Care Services in the future to fulfill this training requirement.
  5. Documented attendance at a training session offered by a recognized scientific society or organization that addresses animal use in research and/or animal welfare concerns.  Please consult with Research Compliance Services in advance to determine whether the session you would like to attend meets this retraining requirement.

IACUC Resources