About IBCs

Institutional Biosafety Committees (IBC) are federally mandated in the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH r/s NA Guidelines) for institutions that host r/s NA work (see Section IV, “Roles and Responsibilities”, NIH r/s NA Guidelines).

In recent years, it has been recognized by NIH that the roles and responsibilities of IBCs are growing. IBCs are being given responsibilities for oversight of biohazard materials and emerging technologies like xenotransplantation, nanotechnology and biosecurity.

Contact the UConn Health IBC

At UConn Health, you can contact the IBC through its email at IBC@uchc.edu

Submissions to the UConn Health IBC

The UConn Health IBC meets monthly. See Meeting Dates for details. Submissions are previewed by the Biosafety Program Coordinator for clarification prior to consideration by the IBC reviewers. All submissions should be by email as a word document (please do not send a .pdf). Final submissions should be made two weeks prior to the meeting date, to allow the reviewers time. The BPC will preview submissions on a first-come-first-served basis up to 10 days before IBC meetings. Direct all submissions to the BPC.

Submissions to the IBC consist of Registrations for the use of biohazardous materials and for use of r/s NA. Safety Protocols that bring up biosafety  issues that come to the attention of the BSO from the Institutional Animal Care and Use Committee, the Institutional Review Board, and from researchers themselves are routed to the Institutional Biosafety Committee (IBC).

To find out how recombinant registrations are defined in the NIH r/s NA Guidelines and the two ways recombinant registrations are handled by the IBC relative to approval and the timing beginning of experiments, you can read the first paragraphs of Sections III-D and III-E in the NIH r/s NA Guidelines.

To be compliant, pass everything by the Biosafety Program  prior to beginning an experiment.

About the UConn Health Institutional Biosafety Committee (IBC)

The UConn Health IBC consists of about a dozen members of whom half are researchers with expertise in areas of research that are pertinent to the research that is reviewed. The NIH r/s NA Guidelines require that at least two members are unaffiliated with UConn Health to represent the interest of the surrounding community with respect to health and protection of the environment.

If the membership of the IBC is lacking in expertise concerning a particular registration or issue, the IBC will engage an ad hoc member that has the required expertise. These are usually recruited from the UConn Health faculty.

At times the IBC is looking for additional members, both affiliated with UConn Health and unaffiliated. Please contact the UConn Health BioSafety Program Coordinator if this would interest you.

Times to Contact the BioSafety Program

When you have questions or concerns about:

• Safety and/or compliance around the use of biohazardous materials
• Safety and/or compliance around the use of recombinant or synthetic nucleic acids (r/s NA).
• Safety and/or compliance around the use of viral vectors.
• Using (or ordering – all SA toxin orders must be made through the BSO) an infectious agent or toxin that is on or not on the Select Agent List.
• Experiments involving biohazardous materials such as human, animal or plant pathogens in the laboratory or collecting human samples for research purposes.
• Experiments Involving the Cloning of Toxin Molecules with LD₅₀ of Less than 100 Nanograms per Kilogram Body Weight, including but not limited to: botulinum, tetanus, diphtheria and shigella toxins.
• Experiments involving the deliberate transfer of a drug resistance trait to microorganisms that are not known to acquire the trait naturally, if such acquisition could compromise the ability to control the disease agents in humans, veterinary medicine or agriculture.
• Performing a human gene transfer experiment (you wish to put r/s NA into human subjects).
• Biosafety training.
• Checking anything but ‘no use of r/s NA’  in the recombinant/synthetic materials/compliance section (Section 6) of the IACUC animal application.

Return to the IBC Process

Information for IBC Registration Forms and Determination of Project Exemption

• See the definition of recombinant DNA in the NIH r/s NA Guidelines. Go to the table of contents and click Section I-B. An abbreviated version is: “Molecules which are constructed outside living cells by joining DNA segments to DNA molecules that can replicate in a living cell.” (R. Gilpin, PhD, RBP, CBSP, 2002).
• SOI: Sequence-Of-Interest. One important characteristic of a SOI is its origin – what species it derives from originally. It may also be important to note the actual origin of the fragment of nucleic acid you are using, for instance, a BAC, a lambda phage or other library. NCBI GenBank Accession number, GeneID#, MGI or other database  references are also helpful.
• Host: A temporary or endpoint organism used to replicate or express r/s NA. For instance, E. coli K-12 used to replicate plasmids, HEK 293 cells used to replicate viral vectors,  transgenic organisms.
• Vector: Peripheral NA used to manipulate (deliver, express, replicate, recombine) the SOI. For instance, some plasmids, and viruses have been engineered to allow manipulation of SOIs.
• Host-Vector-SOI Systems (H-V-SOI): A basic “unit” of the NIH r/s NA Guidelines. Certain H-V-SOI have been exempted from the requirement for registration with the IBC. Many projects that involve r/s NA require several H-V-SOI to manipulate the SOI into the environment where its effects can be studied. If you can let the IBC know what H-V-SOI systems you are using in your project, it can tell you which, if any, need to be registered and at what point in the project you need to have IBC approval. Another important part of this process is for the IBC and PI to determine what safety precautions and practices (containment) need to be used in the use of the H-V-SOIs in your project.

Exemption Criteria

• Section III-F of the NIH rDNA Guidelines. In Section III-F-8, Appendix C is referred to, which further defines exempt H-V-SOI systems. Watch out for exceptions to the exemptions!
• Some transgenic rodents are exempt. Contact the IBC Coordinator or IACUC Coordinator.
• Corrections to possible misconceptions about exemption to the NIH r/s NA Guidelines and safety (safe – means more than basic laboratory precautions and/or microbiological practices are not necessary):
  • Biosafety Level 1 (BSL-1 or BL1) experiments are not automatically exempt.
  • All experiments in E. coli are not necessarily exempt or safe.
  • Commercial (kits) or well-worn host-vector systems are not necessarily exempt or safe.
  • Exempt experiments are not necessarily safe, that is, a higher BSL and/or other precautions and/or practices may be required by the IBC.

Return to the IBC Process

Sending and Receiving (or otherwise transporting) Biological Materials: importation, exportation, interstate transfer, intrastate transfer all have laws governing them with serious consequences for non-compliance.

Please contact the Biological Safety Officer far in advance of plans to send or receive biological materials.

You must not send or receive listed Select Agents* (SA*, see * footnote, below) from/at UCONN Health. You must not send or receive risk group 3 or 4 infectious agents* from/at UCONN Health.

When transporting Infectious Agents, Diagnostic Samples, etc:

As an Import: You may need a CDC and/or USDA permit or other customs acceptable certification to get the package through customs; and documented TSCA (EPA) classification is required.

As an Export: Proper shipping, packaging and markings are required according to DOT and IATA (the shipper is responsible for this), and DOT training is required for you to do this yourself. The Department of Commerce disallows exporting certain listed technologies to certain countries. Have the import permit from receiver’s country to go with the package.

When sending biological materials interstate: Proper shipping, packaging and markings are required according to DOT and IATA (the shipper is responsible for this), and DOT training is required for you to do this yourself. The receiver is to have USDA permit(s) for interstate shipment of agricultural pathogens. See the APHIS-USDA Import/Export website. They now have a partial list of regulated pathogens.

Receiving biological materials shipped from another state: Receiver is to have USDA permit(s) for interstate shipment of agricultural pathogens. To get a permit may trigger an inspection of your laboratory by USDA.

Privately transporting infectious biological materials in your car, on your person or in your luggage: This is against UConn Health policy and in today’s social/political/legal climate, we strongly recommend against this practice. EH&S and UConn Health cannot protect you from the FBI, etc., should they decide that your possession of these items is suspicious.

* UConn Health is currently not equipped either physically or legally to host research that involves:

1. the listed Select (biowarfare) Agents, (that are not toxins kept in quantities below the excluded amount). If you are thinking of this, see the Select Agent list and contact the Biological Safety Officer; the federal government imposes prison time and serious fines for unauthorized transfer, use or possession of these materials), and
2. any infectious materials that require Biosafety Level 3 or 4 (BSL-3 or 4) facilities for the work you wish to perform.

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For clinical/research work with human or non-human primate

• blood,
• body fluids,
• tissues, or
• cell cultures – primary/established (even partially tested) lines,
• animals injected with human primary cells or cell lines,

OSHA (under the Bloodborne Pathogen [BBP] Law) and/or UConn Health safety policy require:

• documented initial and then annual refresher training
• documented HBV vaccination and/or adequate HBV antibody titer testing, or a signed declination,
• observing Standard (Universal) Precautions;  or in the lab, BSL-2; or while working with animals, ABSL-2.
• following safe needle/syringe practices (see items 4 and 18),
• following waste requirements (see items 18 and 26),
• following labeling/signage requirements (see the UCH BBP Exposure Control Plan),
• use of a biological safety cabinet that has been certified within the last year per BSL-2 requirements (see above – when aerosols may be generated).

To answer most questions about human materials, review the annual training, read the UConn Health Bloodborne Pathogen Control Plan, call EH&S at 860-679-2723 and/or contact the Biological Safety Officer. Note that the BBP Law does not cover non-human primate (NHP) materials, but it is strongly recommended that for your protection, you follow Standard (Universal) Precautions and/or use BSL-2 containment and practices.

Also, you may view the OSHA law and/or the OSHA interpretation of the law regarding cultures of human primary cells and cell lines.

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If you work with infectious human pathogens (infectious agents) in your laboratory, you need to register your lab with the Connecticut State Department of Public Health. Contact the Biological Safety Officer for questions, forms and checklists. Currently, the highest containment allowed at UConn Health is BSL-2 enhanced. Higher level risk group organisms/procedure combinations requiring higher containment are not allowed. Work with Proliferating Select Agents is not allowed at UConn Health.

Resources About Infectious Agents

• Risk Groups (RG) and Biosafety Levels (abbreviated “BSL” in the BMBL and “BL” in the NIH r/s NA Guidelines): Infectious agents have been classified into Risk Groups (Appendix B, NIH r/s NA Guidelines criteria for these) based on their inherent disease potential in humans. Biosafety Levels (containment) are standardized “combinations of [protective] laboratory practices and techniques, safety equipment and laboratory facilities” (BMBL p. 11). For a good explanation of Risk Groups, Containment Levels and Risk Assessment see sections 2.1 through 2.3 of the Laboratory Biosafety Guidelines 3rd Ed. from the Canadian Minister of Health.
• Determining RGs for a given biological agent usually goes by what information can be found about that agent. Sometimes recommendations are given as BSLs. The US may not have classified an agent but maybe the Canadians have or maybe someone else. We typically choose the best information we can find. Here are some places to look:
  • ABSA risk group lists.
  • CDC/NIH’s Guideline, Biosafety in Microbiological and Biomedical Laboratories (BMBL), 5th Ed., 2007, has Agent Summary Statements with recommended containment precautions in Section VII, beginning on page 88.
  • Appendix B of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, November 2013 (NIH r/s NA Guidelines).
  • Pathogen Safety Data Sheets (PSDS) from Canada’s Office of Laboratory Security. They also have handy apps for iOS, Android & Windows!

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Click on each question below to view the answer:

General Contracts Email: sps@uchc.edu

The use of material transfer agreements (MTAs) is widespread in today’s research and development environment. Biological materials, such as reagents, cell lines, plasmids, and vectors are the most frequently transferred materials, but MTAs may also be used for other types of materials, such as chemical compounds.

Sponsored Program Services reviews and approves all MTAs for incoming materials. We will negotiate the terms if necessary. To initiate this process, please complete an IPAS form and submit along with the MTA to the SPS mailbox.

Technology Commercialization Services creates and processes all MTAs that cover transfers of research materials outside of UConn Health, to both non-profit and for-profit institutions.  Please submit requests and questions to Ana Fidantsef, PhD.

Non-Disclosure Agreements (NDAs) are designed to protect proprietary information that may be exchanged in the course of a research project. You may request the drafting of an NDA to address a situation in which you are either receiving confidential information from the sponsor, or providing such information to the sponsor, or when confidential information is exchanged. Sponsored Program Services prepares, negotiates and executes these NDAs for you. Once finalized, we ask all UConn Health personnel covered under a respective NDA to agree to comply with its terms.