uconn health

IBC Forms

Please contact the BioSafety Program Coordinator for all IBC forms.

For Chemical or Biosafety Animal Safety Protocols create a protocol in InfoEd. The forms for this are listed there.

Biosafety Policies, Regulations & Guidelines

Institutions that receive NIH funding for any research involving recombinant or synthetic nucleic acids must comply with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH r/s NA Guidelines). Here at UCH, we commonly abbreviate this title to NIH r/s NA Guidelines.  You can read the full document.

The state of Connecticut has pertinent laws as well. Please see the CT Public Health Code 19a-36-A and the Requirements for Institutions with BSL-3 Facilities for more information.

The Biosafety in Microbiological and Biomedical Laboratories (BMBL), published by the CDC’s Office of Safety, Health, and Environment in conjuction with the NIH, is considered the national standard to promote the safety and health of laboratory workers. It covers the basic principles of biosafety, biocontainment, and provides detailed information on working safely with various pathogens, toxins, and other biohazards. Please take the time to review the BMBL and promote a culture of safety in your laboratory.

For those who may be in contact with human blood, body fluids or tissues, Bloodborne Pathogen training is a legal requirement (OSHA). For those interested in the specifics:

Safe Research & Compliance Training

What training is required for a researcher (anyone who does research in a non-clinical lab) at UConn Health?

All New Employees

  • Attend New Employee Orientation on alternating Fridays. Call Human Resources at 860-679-2426 to answer any questions about the orientation program. This orientation is held remotely and contains several important safety trainings provided by Environmental Health & Safety (EH&S) including especially the Initial Bloodborne Pathogen Training and a basic Safety overview (personal protective equipment, lock-out/tag-out, radiation safety, chemical safety, etc.)
  • Receive free medical evaluation and consultation about their health relative to their new job at Employee Health Services (EHS) in the main building on the ground floor (near the six bank elevator, CG228). It is best if new employees know some details about their duties to make this opportunity most efficient and effective. For example, if you know you will be working with laboratory animals, you will need to have a pre-animal use and respirator medical clearance through EHS. To make an appointment, call 860-679-2893 and leave your contact information. Someone in EHS will return your call. When you go to your appointment, make sure to bring with you your immunization records and TB Skin Test screening results documentation if they are available.

All Research Laboratory Personnel

  • Including PIs, Lab Supervisors, Postdocs, Research Associates and Assistants, Students, Volunteers, Visiting Workers and Trainees, all are required to take Laboratory Safety Training offered by Environmental Health & Safety (EH&S). Contact Liz Pokorski at 860-679-2723 with questions. This training covers an overview of basic lab safety and compliance, chemical safety, waste management, and biosafety.
  • PIs are required to take the NIH r/s NA Guidelines (IBC)/DURC/Biosafety training through the CITI training website every three years. Contact the BSO for instructions on how to do this.

Other trainings may be required (or available) depending on the activities researchers are engaged in…

If you or your supervisee(s) work with:

Infectious Biological Agents or Select Agent Biological Toxins

  • Annual biosafety training for use of Infectious Biological Agents in research is required as part of the Connecticut Department of Public Health (CT DPH) registration that is required for labs that use infectious agents. Some of the refresher computer-based biosafety training is available on this site as PDF files. Refresher training on new topics is required annually. For labs that use viral vectors please contact the BioSafety Program coordinator for training recommendations.
  • Training for work with Select Agent Biological Toxins is required by UConn Health for work with listed toxins at amounts below the regulated limits. You must contact the BSO to place an order for any listed biological toxin. You may contact the BSO at 860-679-3781 although email is preferable.

Human Blood, Body Fluids, Tissues, Primary Cells or Cell Lines in Culture

  • Initial Bloodborne Pathogen Training is offered at New Employee Orientation (see above). For those who may be in contact with human blood, body fluids or tissues, annual refresher training is a legal requirement (OSHA). This may be accomplished by taking the on-line Annual OSHA Bloodborne Disease Refresher Training on the EH&S website (see training) or through SABA. View the OSHA interpretation of how human cells in culture are included in the Bloodborne Pathogen Law, if you work with any human cells in culture. There are also medical surveillance requirements under the Bloodborne Pathogen Law, having to do with Hepatitis B Virus immunizations. Individuals must contact the Employee Health Service (x2893) to find out if their bloodborne pathogen medical surveillance documentation is in order.

Non-human Primate (NHP) Blood, Body Fluids, Tissues, Primary Cells or Cell Lines in Culture

  • Work with NHP materials should be performed using the same precautions as work with human materials. Training for use of Standard (Universal) Precautions and/or BSL-2 procedures with human materials will parallel what needs to be trained for NHP materials.

Chemical Hazards

  • General Chemical Safety Training is offered upon request. The intended target audience is individuals who may be exposed to chemicals in a foreseeable emergency, but who do not actively work with chemicals on a daily basis. This training is not required for anyone who has taken the Laboratory Safety Training.

Lasers (Safety for Class III or Class IV Lasers)

  • Research and Non-Hospital Clinical Laser Use, contact Jim Fomenko at 860-679-2250 or fomenko@uchc.edu for training.

Radioactive Materials or Ionizing Radiation (e.g., X-ray Producing Instruments)

  • Radiation Safety training is required for work with anything that produces ionizing radiation. For questions, contact the Radiation Safety Officer, Jim Fomenko at 860-679-2250, fomenko@uchc.edu.

Respirators

  • Respirator Training is given with the fit testing procedure, the second of two requirements for obtaining the proper respirator. The first requirement is passing a medical evaluation. This is done by filling out a respirator medical evaluation form, available through either Employee Health Services or EH&S. If it has been determined by a healthcare provider that you are physically fit to wear a respirator, a medical approval form will be sent to EH&S and/or given to you. After receiving the medical approval form, EH&S, 860-679-2723, will perform the fit test and training.

Shipping or Receiving Any Hazardous Material (Such as Infectious Substances or Diagnostic Specimens)

  • Department of Transportation (DOT) and International Air Transport Association (IATA) trainings for proper shipping of hazardous materials are required. Contact Jim Fomenko at 860-679-2250 or fomenko@uchc.edu.

  • Contact the BSO for information on USDA or CDC Import permits and the determination of risk groups for organisms.

  • Additional basic information may be found here.

Animal Subjects (Institutional Animal Care and Use Commitee)

Human Subjects (Institutional Review Boards)

  • All personnel involved in the conduct or administration of human subject research are required to complete training in the protection of human subjects before such involvement occurs. Please contact the Human Subjects Protection Office for details.

The fine print – remember: as changes occur in activities and duties in the lab, research personnel may need updated, periodic or new safety/compliance training that covers new or sometimes ongoing work. Legally, PIs are ultimately responsible for training and safety of lab personnel. There should be duty-specific training (presented by the PI or experienced lab staff) that includes safety/compliance information addressing the personnel, the PI and the institution. It is a good idea for PIs to document staff training on lab procedures including safety instruction. Having staff sign that they have read and will follow IBC and IACUC safety protocols that are kept available to staff in the lab is required. Institutionally required trainings are in addition to lab specific training, and the PI is responsible for seeing that their staff attends. When is the last time your lab discussed safety or compliance?

Stem Cell Research Oversight (SCRO) Committee

The role of the UConn/UConn Health 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 pluripotent stem cell lines at all schools, colleges, campuses, and research arms of the University of Connecticut/UConn Health per University policy, regardless of the source of funding. From a legal perspective, the review and approval of human embryonic stem cell research by a SCRO committee or its equivalent is required by the State of Connecticut. At a deeper level, SCRO committees exist to protect both the public interest and the progress of biomedical stem cell research. The ethical mandate of the SCRO Committee is to ensure that appropriate respect is given to the value of human life. 

SCRO approval is required prior to any of the following:

  1. All research involving human embryonic stem cells (hESCs) (SCRO approval is required by the State of Connecticut and University policy.)
  2. 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.)
  3. 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.)
  4. 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.)

 

Export Control

Export control laws are federal regulations that govern how certain information, technologies, and commodities can be transmitted overseas or to a foreign national on U.S. soil. The scope of the regulations is broad: they cover exports in virtually all fields of science, engineering, and technology and apply to research activities regardless of the source of funding. Failure to comply with these laws can have serious consequences, both for the institution and for the individual researcher. Potential penalties include fines and possibly imprisonment. It is thus critical for UConn researchers to understand their obligations under these regulations and to work with Research Integrity and Compliance Services to ensure that the University is in compliance.

The International Traffic in Arms Regulations (ITAR) regulate defense articles, services, and related technical data that are identified on the Munitions Control List. They are administered by the Department of State. The Export Administration Regulations regulate the export of dual use items, i.e. items with both military and commercial applications, identified on the Commerce Control List. They are administered by the Department of Commerce. The Office of Foreign Assets Control Regulations (OFAC Regulations) regulate economic trade with foreign countries and administer the statutory economic trade sanctions imposed against several foreign countries. They are administered by the U.S. Department of the Treasury, through the Office of Foreign Assets Control.

The Export Control Materials are hosted on the UConn Storrs OVPR website.

If you have any questions about Export Control, please email exportcontrol@uconn.edu.

FCOI Electronic Submission System

System Access

Tips

A few tips on using the UConn Health InfoEd financial interests system:

  • You will receive an e-mail invitation to complete a disclosure in InfoEd once the disclosure season opens. The sender is fcoi@uchc.edu – Office of the VP for Res, FCOI.
  • Instructions on how to log-in (and a link to the system) are included in the e-mail invitation.
  • Use your UConn NetID username (e.g., abc12345) and password credentials to login, do no use your UConn Health user credentials. For NetID assistance, visit https://netid.uconn.edu/ for assistance looking up and resetting your UConn NetID password.
  • You will receive an email acknowledgement after submitting your disclosure.

Contacts for questions and assistance:

  • Investigators and IO/COs with questions regarding the form or the disclosure requirements may email fcoi@uchc.edu.  You may also contact an FCOI program Research Compliance Monitor directly.
  • Individuals who are ONLY Clinical Practitioners may email the Clinical Conflict of Interest Committee at CCoI@uchc.edu for questions related to the policy on Individual Financial Conflicts of Interest in Clinical Health Care.
  • If you experience technical issues while completing your disclosure in InfoEd, please contact the eRA Help Desk at era-support@uconn.edu or 860.486.7944 (Mon-Fri, 8:00 AM – 4:30 PM).

Additional information about the roles at UConn Health required to submit a financial disclosure in the system

Individuals in any of the following roles at UConn Health are subject to the Individual, Clinical, and/or Institutional conflict of interest policies, which require these individuals to complete a financial disclosure questionnaire. Roles include:

  • Investigator (i.e., involved in research activity at UConn Health);
  • Institutional Official or Covered Official (IO/CO, as identified by the Office of the Vice President for Research) with authority or responsibility for research programs, research administration or research funding, or a position of authority (direct or indirect) over the conduct of research; or
  • Clinical Practitioner (i.e., responsible for the planning, support or delivery of clinical health care or clinical educational activities at UConn Health).

If you receive an email from us, you have been identified in one of the above roles and are thus required to submit a financial disclosure in the UConn Health InfoEd Financial Conflicts of Interest (FCOI) system at https://uchealth.infoed.uconn.edu.

If you believe you do NOT meet any of the roles above, you will have an opportunity to report this on the Welcome page of the financial disclosure form once you login and you will NOT be required to enter any financial information.

FCOI Contacts

Central email: fcoi@uchc.edu

 

 
Michael Centola, MHS, CIP Associate Vice President-Research Integrity & Compliance 860.679.6568 centola@uchc.edu
Gus Fernandez-Wolff, DVM, CHRC Research Compliance Monitor 860.679.8125 gfernandez@uchc.edu
Kristen Tremblay, MPH, CCRP Research Compliance Monitor 860.679.3276 ktremblay@uchc.edu 
Caroline N. Dealy, PhD. Chair, Financial Conflict of Interest in Research Committees 860.679.1193  dealy@uchc.edu  

For Public Accessibility requests for information regarding FCOIs related to Public Health Service-funded research, please complete the Public Accessibility Request form.

FCOI FAQs

Who is considered 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 considered my Institutional Responsibilities?

Institutional Responsibilities means an investigator’s professional responsibilities on behalf of the institution which may include research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.

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

UConn Health 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. In addition, you must also disclose certain types of intellectual property and appointments to serve in a representative or professional capacity for an entity related to your institutional responsibilities.

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. Once you’ve established there is a possible “related interest,” the threshold for disclosure according to the policy is defined as follows:

  • SFI means a financial interest consisting of one or more of the following interests of the investigator (and those of the investigator’s spouse and dependent children) that reasonably appears to be related to the investigator’s institutional responsibilities:
    • 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 represents more than 5% ownership in any single entity. 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;
    • 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 spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest);
    • Intellectual property rights and interests (e.g., patents, licensing agreements, trademarks, or copyrights) upon receipt of income related to such rights and interests;
    • For PHS-funded investigators, any reimbursed or sponsored travel related to the investigator's institutional responsibilities if the value, when aggregated, exceeds $5,000 from any single entity.

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;
  • PHS or PHS-standard researchers: within 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?

You do not need to disclose the following:

  • 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 you do not directly control the investment decisions made in these vehicles;
  • 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;
  • Travel expenses paid by the University or by a sponsored research award to the University ;
  • 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 research institute that is affiliated with a U.S. institution of higher education.

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 Health 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 Health Policy #2006-01 (Individual 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 submit a financial disclosure in the InfoEd Financial Interests [FCOI] system?

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.

Please note, three roles at UConn Health are subject to UConn Health policies requiring submission of a financial disclosure: research investigators, clinical practitioners, and certain identified Institutional Officials. Individuals who have more than one of these roles at UConn Health are only required to submit one disclosure in the UConn Health InfoEd Financial Interests [FCOI] system. The one disclosure will cover the applicable institutional policy for which the individual is required to submit a financial disclosure.

When was the FCOI policy changed?

The revised FCOI policy was effective on August 24, 2012 and 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.

Who can I contact if I have additional questions?

Researchers, Institutional Officials (IOs), and Covered Officials (COs) responsible for research oversight may contact Gus Fernandez-Wolff in the Office of the Vice President for Research, Research Compliance Services at 860.679.8125 or gfernandez@uchc.edu or fcoi@uchc.edu

Clinical practitioners: Individuals who are not a Researcher or IO/CO and who receive the invitation to complete a financial disclosure have been identified by the Clinical Conflict of Interest Committee as required to submit a financial disclosure under the Individual Financial Conflicts of Interest in Clinical Health Care policy. If you have questions related to this policy, you may email the Clinical Conflict of Interest Committee at CCoI@uchc.edu.