uconn health

Transport of Biological Materials

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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Human or Non-human Primate Blood, Tissues or Cell Cultures

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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Requirements for Work with Infectious Agents at UConn Health

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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Contracts: Frequently Asked Questions

Click on each question below to view the answer:

The contract can be signed once the study has received contingent approval from the Institutional Review Board (IRB). This guideline also includes expedited studies.
An investigator can accrue subjects to a clinical trial only after the protocol has received final IRB approval. A clinical trial cannot receive final IRB approval until the contract is fully-executed. (Subject accrual is also contingent upon the policies of the sponsor.)
No, OCTR must negotiate all CDA’s for UConn Health and its faculty. However, the principal investigator must review the CDA. Generally, the principal investigator will also be required to sign.

Industry (e.g., pharmaceutical and/or biotech companies and universities) may sponsor or support clinical trials. Cancer cooperative group clinical trials are federally-funded groups that sponsor multi-site clinical trials. Cooperative groups may also be supported by industry/biotech companies.

Federal agencies, foundations, the PI’s institution or department also support investigator-initiated studies.

OCTR negotiates all industry-sponsored and industry-supported clinical trial agreements, including but not limited to industry -sponsored clinical trial agreements, “university to university agreements,” co-operative group contracts, sub-contracts, amendments, investigator agreements, material transfer agreements, letters of indemnification, and agreements for foundation supported clinical trials.

OCTR does not negotiate federally-funded investigator-initiated clinical trials or clinical trials/clinical research in which the Prime Award is in response to a public solicitation (e.g. Request for Information (RFI), Request for Application (RFA), Funding Opportunity Announcement (FOA).

In this instance, the proposals will be negotiated by the staff in Sponsored Programs Services (SPS) .

It is a study that is authored by the principal investigator that purports a clinical trial that was authored by a researcher at the UConn Health or at another academic institution. Generally, these studies are financially supported by industry/biotech companies, foundations, federal agencies, or an academic institution.
If the clinical trial includes John Dempsey Hospital (JDH), University Medical Group (UMG) or Dental charges a Budget Workbook must be done before the protocol is submitted to the IRB. It can be in the midst of budget negotiations at the time of submission. Therefore, a contract for a clinical trial which included such charges cannot be signed without a Budget Workbook being done. If there are no JDH, UMG or Dental charges, a Budget Workbook is not necessary and a memo from OCTR stating such is adequate.
The original is given an InfoEd number stored in the OCTR.
Copies of the contract are retained for the amount of time that is specified in the clinical trial agreement, usually between five (5) and ten (10) years.
If the contract contains “subject injury language” the IRB must review The fully executed contract to compare the subject injury language in the consent and contract before granting final approval.

Material Transfer Agreements

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

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.

Partnering with Industry

The Office of the Vice President for Research (OVPR) is your home for all industry-sponsored research activities.

Contact us.  Bring us in early. We are here to help!

We would like to work with you and your industry partners to ensure that our collaborative research discussions are productive, that negotiations are successful, and that both parties’ needs are met.  We also ensure that agreements are in accordance with University policies and procedures as well as federal regulations and requirements.

We’ve prepared a document that outlines our philosophy and that may be useful to share with your industrial partners.

Sponsored Research Agreements

Research agreements between the University and outside entities come in many forms and serve a wide array of purposes. They cover applied research, evaluation, training, demonstrations, material transfers, confidentiality terms and data use, intellectual property, and more.

Through these agreements, we partner with a wide array of entities, both governmental (local, state and federal) and private (corporate and non-profit).

Sponsored Program Services assists you in creating, negotiating and executing these agreements by facilitating discussion and negotiating terms.

Contact us.   Bring us in early.  We are here to help!

Subawards

A subaward is a portion of an award that is distributed by the University of the original award (pass-through entity or prime) to a third party (subrecipient or subawardee) to facilitate performance of and payment for project work in compliance with project’s terms and conditions.  When the prime award is made to the University and accepted by Sponsored Program Services (SPS), an account number is assigned and the Principal Investigator (PI) is notified.

A subaward may be issued by the University as the recipient of a prime award or as the Subrecipient of another institution’s prime award.  The University now uses the Federal Demonstration Partnership (FDP) subaward template for Research Subaward Agreements (RSA).

Subawards are typically funded on an annual basis, renewable for additional periods as appropriate or based on availability of prime award funding.  Modifications or amendments may be made when circumstances require a change to terms and conditions.

Projects that involve subawards have special requirements both at the proposal and the award stage as well as during the life of the subaward.

» Learn more about initiating a subaward.
» FDP Agreement Request Form.