uconn health

SCRO Policies, Regulations & Guidance

For a detailed description of UConn/UConn Health SCRO Committee policies, please consult the SCRO Policy Manual document.

For additional resources, please check out the following links:

Training for Users of Stem Cells

University policy requires all researchers and research staff, including students, post-docs, visitors, and faculty, to pass the Human Stem Cell Compliance tutorial quiz with 100% accuracy prior to engaging in research. The tutorial is intended to educate researchers on ethical issues associated with hESC and hiPSC research and inform them of relevant institutional, state, and federal policies and procedures.

 

The tutorial is not required for those conducting in vitro human induced pluripotent stem cell (hiPSC) research involving the generation of gametes, embryos, or other totipotent cells. The tutorial is also not required for research that requires SCRO review to secure State of Connecticut funding but otherwise would not fall under SCRO’s jurisdiction (i.e., non-human stem cells, etc.). All other research requires that research staff complete the tutorial prior to beginning work on approved SCRO projects.

 

To access the tutorial, quiz, and the sheet to record your answers, click on the links below. Return your answer sheet to SCRO Coordinator, Ellen Ciesielski, eciesielski@uchc.edu.

Institutional Biosafety Committee Meeting Dates

The UConn Health Institutional Biosafety Committee (IBC) is federally mandated to review work with recombinant or synthetic nucleic acids.

This committee meets monthly, usually on the second Thursday of the month. Exceptions are noted (*). Receive forms from and submit to ibc@uchc.edu by the submission deadline.

Upcoming meetings 2023:

Date Time Location Submission Deadline
October 10, 2024 3:10 pm WebEx October 1, 2024
November 14, 2024 3:10 pm WebEx November 5, 2024
December 12, 2024 3:10 pm WebEx December 3, 2024
January 9, 2025 3:10 pm WebEx December 31, 2024
February 13, 2025 3:10 pm WebEx February 4, 2025
March 13, 2025 3:10 pm WebEx March 4, 2025
April 10, 2025 3:10 pm WebEx April 1, 2025
May 8, 2025 3:10 pm WebEx April 29, 2025
June 12, 2025 3:10 pm WebEx June 3, 2025
July 10, 2025 3:10 pm WebEx July 1, 2025
August 14, 2025 3:10 pm WebEx August 5, 2025
September 11, 2025 3:10 pm WebEx September 2, 2025
October 9, 2025 3:10 pm WebEx September 30, 2025

 

If you are a person interested in or concerned about this type of research, you are invited to attend a meeting of the UCONN Health IBC. Meetings will be held virtually for the foreseeable future. Please contact IBC@uchc.edu for more information.

WCG Institutional Biosafety Committee Services periodically convenes open meetings regarding a human gene transfer study at UCONN Health. Announcements about these meetings will appear below when they are scheduled.

 

 

 

What If I’m Doing Exempt or Non-exempt Recombinant or Synthetic Nucleic Acids (r/s NA) Experiments?

This page gives you some facts and a strategy for what you need to do about compliance when working with rDNA.

FACTS
  • If you will be working with rDNA and funded by NIH or working at an Institution where work involving rDNA is funded by NIH (like it is at UConn Health), you are working under the NIH Guidelines for Research Involving Recombinant or Synthetic DNA Molecules (NIH r/s NA Guidelines). Compliance to these guidelines is required as a condition of NIH funding (and that of many other agencies) for research involving rDNA at the whole institution.
  • Institutions (UConn Health), Institutional Biosafety Committees (IBCs) and Principal Investigators (PIs) are all responsible for compliance under the NIH rDNA Guidelines.
  • All faculty are required to take the IBC/DURC/Biosafety training available at the CITI training site every three years. Contact the BioSafety Program Coordinator to get instructions how to do this.
  • Many rDNA experiments are exempt to the NIH r/s NA Guidelines, but some that you might think are exempt may not be. Experiments that are not exempt need to be registered with the IBC before they are started. In some cases the application needs only to be submitted and accepted by the IBC before work may start.
  • Viral Vector rDNA experiments need to be registered with the IBC.
STRATEGY (What to Do and Not Do)
  • Determine if your experiment or set of experiments is exempt or not exempt.
  • If you know your experiment(s) is not exempt, contact the BioSafety Program Coordinator to begin the registration process.
  • Even if you believe your experiment(s) is exempt (or safe or used elsewhere), please contact the BioSafety Program Coordinator. The only way for a PI to be sure they have done all they can to ensure their compliance with the NIH r/s NA Guidelines, is for the IBC to determine that the PI’s experiment is exempt and document it. Fortunately, the BSO may serve as the IBC’s proxy to make this determination and perform the documentation. This makes the decision about whether an experiment needs to be registered or not, quicker and not too hard.
  • Do not begin any rDNA work without UCH IBC authorization or determination that the work is exempt by the BSO.

 

 Additional information regarding the IBC and r/s NA experiments

IBC Contacts

Please direct all submissions to the BioSafety Program Coordinator.

Name Title Phone Email
TBD Biological Safety Officer
Victoria Scranton BioSafety Program Coordinator 860.679.7533 vscranton@uchc.edu
TBD Director of Research Compliance–Animal Research & Safety

 

 

 

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 UCH 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

    Laboratory Safety Training: 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.

    OSHA Bloodborne Disease Training

    Initial Training is required for everyone potentially exposed to human blood and other potentially infectious material (as described by the UConn Health’s Exposure Control Plan) must complete this training prior to accomplishing any task presenting such a potential exposure risk. This training is included as part of the Laboratory Safety Training.

    Annual Refresher Training: completion of an annual Refresher Session (part of SABA) is mandatory. If you are not assigned Refresher BBP training in SABA, researchers may opt to take the Annual Bloodborne Pathogen Refresher Training PowerPoint Presentation  (http://content.research.uconn.edu/pdf/uch/rcs/ehs/BBPRefresher.ppsx) on our website.  On the last slide, please click on the Annual Bloodborne Pathogen Refresher Training Confirmation Form to get credit (may have to right click on link and “Open Hyperlink” with certain web browsers for input form).

    WARNING: Employees must not perform tasks with potential exposures to human blood and other potentially infectious materials until they have completed the initial training. Contact the Environmental Health and Safety Office (x2723) if assistance is needed.

    PI Specific Biosafety/Biosecurity Training

    • In addition to Laboratory Safety Training, PIs are required to take the NIH r/s NA Guidelines (IBC)/DURC/Biosafety training through the CITI training website every three years.
      • We have a contract with CITI Program for online compliance training (https://about.citiprogram.org/en/homepage/ ). To access it you need to register (upper right of homepage) as an affiliate of “University of Connecticut Health Center” (and no other). Once you register and promise not to divulge the material in the trainings to others, you will need to navigate to the courses:
        • When you come to “CITI Course Enrollment Procedure”
        • Scroll all the way to the bottom under “question 8”
        • Click the checkbox next to “PI” under Biosafety/Biosecurity
        • Click the “Complete Registration” box
        • Click the “Finalize Registration” box
        • Click “view courses” in the upper part;  Note: If you do not see courses, scroll down to “Learner Tools for University of Connecticut Health Center” and click “Add a course”. This will take you to the Select Curriculum page where you scroll all the way to the bottom where it says “Question 8”. Choose your learner group –PI
        • Click “Start Now”, agree to the Assurance statement, and take all modules in the course. There are quizzes.

    If you have any questions, email IBC@uchc.edu.

    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: 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 EH&S for (x2723) 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. (https://ovpr.uchc.edu/services/rics/ehs/safety-training-sessions/schedule/)
    • Contact the Biosafety Program 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?