uconn health

Policies & Compliance

Experience indicates that there is no uniform approach that will meet the needs of our diverse industry partners. The University is committed to working with its partners to provide leases for incubation space, contact terms and IP rights necessary to meet company goals. Faculty working with industry partners should contact the Technology Commercialization Services (TCS) about specific requests; our policies provide an ability to offer industry research partners options that serve their unique needs.

Licensing Policies

Royalty Sharing Policy

The University of Connecticut policy provides that our faculty inventors share in revenue generated by their discoveries as follows:

33 1/3% to the Inventor(s) as personal income (Multiple Inventors share the income).
33 1/3%to be further subdivided as follows: (a) 50% to the Inventor(s)’ research program to be administered through an account set up by the Office of the Vice President (OVPR). (This allocation is only available to Inventor(s) having an active research program at the university); 30% to the Inventor(s)’ primary academic unit (department) or other administrative unit to be administered by the Director or Department Head; and (c) 20% to the Inventor(s)’ school or college to be administered by the Dean.
33 1/3% to the University of Connecticut.

If a faculty member is no longer at UConn, the portion of the revenue that would have gone to the inventor’s research program (50% of the 33 1/3%) will be shared equally between the appropriate dean and the university.

License Back Policy

If the University does not believe that it can successfully commercialize a University Invention, and if the faculty member is not interested in founding a Startup, the University will offer the inventor a license of the University Invention (such license referred to as a “license back”). In addition, the inventor may request a license back from OVPR at any time. OVPR is not required to grant a license back but will respond to any request within three months. If the University elects to license back the University Invention to the inventor, the inventor, as licensee, will assume obligations related to patent expenses and commercialization and will agree to pay a portion of the gross revenue that the inventor receives through his or her commercialization efforts. In addition, the inventor will not be entitled to the net revenue payments described in Section 3 of this policy.

As stated in the UConn IP and Commercialization Policy

Other Policies

Guidelines for Faculty, Staff, and Students who are affiliated with a company: Guidelines for FACs and SBIR-STTR

Student Employment: https://policy.uconn.edu/2011/06/02/use-of-students-in-outside-employment/

Faculty Consulting: https://consulting.uconn.edu/

Financial Conflict of Interest: https://research.uconn.edu/fcoi-home/

CT Code of Ethics: https://policy.uconn.edu/2011/05/24/guide-to-the-state-code-of-ethics/

UConn Code of Conduct: https://policy.uconn.edu/2011/05/17/employee-code-of-conduct/

Intellectual Property and Commercialization: https://policy.uconn.edu/2015/10/08/intellectual-property-and-commercialization-policy/

Starting a Company

A startup is a new business entity formed to commercialize one or more related intellectual properties. Forming a startup business is an alternative to licensing the IP to an established business. There are several factors you should consider to determine if a startup is viable path. Examples include:

Idea-Team-Plan Trifecta. A successful start-up evolves around three key ingredients: (1) a new idea, supported by initial data, (2) an experienced team to develop and deliver technical and business goals, and (3) a business plan that serves as a road map.
Not every great idea needs to be a company. Consider alternative paths, such as partnership, co-development, licensing, and more.
Execution Risk. While having a new idea is necessary for creating a startup, it is not sufficient for its success. It requires focused team-work, and willingness to take in advice and to pivot when necessary.
Competition and Collaboration. Two key elements to be fully aware of and respond to with a dynamic approach.
Funding. How much capital is required to deliver various milestones, what sources to pursue, and Return on Investment (ROI)?
Market Size and Dynamic. Is the market large enough and is it a stable, shrinking or expanding market?
Revenue and Exit. What is the revenue projection and potential key opportunities for exit?

TCS Venture Development can help to determine if a startup company is viable, and will advise on other key issues relating to starting a company. The choice to establish a new company for commercializing intellectual property is a joint decision made by TCS and the inventors. If a new business startup is chosen as the preferred commercialization path, TCS can assist you and the other founders in meeting investors, consultants and entrepreneurs and accessing other resources at UConn to advise you in founding the company. It is advisable for inventors to have agreements regarding their roles with the startup reviewed by their own counsel to ensure that all personal ramifications – including taxation and liabilities – are clearly understood.

The general process for the selection of potential technologies for a university startup includes a review of inventions based on criteria such as:

Technology novelty, supported with initial data
The market size
The technology can be adequately protected through patents, copyright or trademark to create barriers that make market entry difficult for competitors.
The technology is scalable.
The estimate of the net present value of the return (less the costs of getting the business going) is much greater than the value that can be obtained by executing a typical license with an existing company.
Is a prototype/proof of concept available?
Do the inventors have a reasonable understanding of what is required to build a business, and what their roles may be?
Does the business model have a visible path to profitability?
Are the initial management and financing needs reasonably clear?

TCS Assistance:

Early stage involvement. TCS Venture Development staff is actively involved in the early stages of the company formation and work with their network of professionals to develop a business plan and find initial management, space and other critical elements. In some cases, the advisors and Executives In Residence (EIRs) may take on interim management roles to facilitate the accomplishments of key milestones, such as drafting a business plan, meeting with venture capital firms or angel investors to obtain funding and assisting with a liquidity event.
Business/financing assistance. TCS Venture Development staff can provide business help and/or financing advice. We have several programs for assisting in market research, business planning and the set-up of new companies including a business incubator that offers space and business services and the Business School’s Innovation Accelerator where MBA students and faculty undertake semester-long projects.
Connections with industry partners. TCS Venture Development helps to connect researchers and industry partners. We strive to connect external entrepreneurs and businesses with collaborators within a university or to identify resources that will help them advance their technologies and business interests. Many opportunities to create mutually beneficial projects between university researchers and regional tech entrepreneurs can be initiated thanks to this ability to efficiently connect.
- TCS serves in a liaison role. External businesses and entrepreneurs are invited to contact TCS Venture Development staff and discuss their initiatives, needs, goals and objectives. TCS works with these clients to understand the key issues and to determine if there are opportunities to develop mutually beneficial working relationships and projects. Venture Development staff can provide business help and/or financing advice.
- Establishes projects that advance businesses toward commercial success. These projects are selected to align with UConn research interests, such that as early-stage companies achieve success, they are well positioned to strengthen their collaborations with UConn researchers. These projects are also selected based on the ability to generate positive economic development outcomes in the region. Typical engagements include market research projects on behalf of small firms who are applying for SBIR grants that, if successful, will lead to opportunities to engage UConn researchers and their graduate students on larger development programs. UConn faculty who are interested in reaching out to small technology businesses in the state are encouraged to contact TCS.
Incubator program. UConn’s Technology Incubation Program (“TIP”) is part of TCS. TIP offers new companies that have a technology linkage or synergistic relationship with UConn the ability to be located on campus and access resources that could be otherwise unattainable for a fledgling company. TCS supports the incubation process offering lab and office facilities on campus, business-planning resources, and access to faculty experts, expensive instrumentation and specialized equipment. In some cases TCS clients are working with UConn technology and others have their own intellectual property. TIP provides the following services to startup companies:
- Investment Network – Access to various sources of capital available within CT and other locations, through direct introduction, office-hours with investors and public and private events.
- Library and Computer Network – Access to UConn Libraries, the largest public research collection in the state. The University of Connecticut Libraries provide users with intellectual content that fulfills their academic and research needs through electronic and physical access.
- Equipment/Instrumentation – Some of the departments and faculty have large and expensive specialized items of equipment. TCS’s incubator helps negotiate agreements between the relevant faculty and the company, given that time is available on the instrument and client employees have been properly trained.
- Business Support – Through a network of service providers and advisors, TIP provides a variety of business consultants including accountants, lawyers and subject matter experts to help with issues important to startup companies. TCS staff can support business plan development and financial planning. TCS organizes educational and networking events to promote collaboration among faculty and company scientists, to provide exposure to experienced entrepreneurs and entrepreneurial resources, and to assist through connections with advisors and mentors. Through the School of Business, TIP can arrange access to knowledgeable faculty and students able to conduct business development projects for emerging companies. Learn about our TIP program.

For additional resources to help you start your business, see our Startup Guidebook.

Licensing

Once a faculty discovery has been patented, that’s not the end of the line! The next step is to find an industry partner who would like to license the technology.

Marketing a technology:

TCS uses many sources and strategies to identify potential licensees and market inventions. Sometimes existing relationships of the inventors, TCS and other researchers are useful in marketing an invention. Market research can also assist in identifying prospective licensees. In addition, we also examine other complimentary technologies and agreements to assist our efforts. Faculty publications and presentations are often excellent marketing tools as well.

Licensees can be identified in many ways. First, the inventors are often aware of the commercial companies who would be interested in the work. Industry-specific marketing efforts, including trade show participation, affiliations and market research carried out by TCS, also seek to identify potential licensees. Additionally, issued patents listed by the USPTO can provide names of companies who currently have patents similar in nature; often these can prove to be potential licensees.

How you can help:

Your active involvement can dramatically improve the chances of matching an invention to an outside company. Studies have shown that 70% of licensees were known to the inventors. Thus research and consulting relationships are often a valuable source for licensees. Your research and consulting relationships are often helpful in both identifying potential licensees and technology champions within companies. Once interested companies are identified, the inventor is the best person to describe the details of the invention and its technical advantages. The most successful technology transfer results are obtained when the inventor and TCS Licensing Director work together as a team to market and promote use of the technology.

Working with industry:

Marketing technology to a potential licensee will usually require that a Confidentiality Agreement be established. The OVPR can negotiate these agreements for you and has the legal authority from the University to do so. Confidentiality Agreements, named Non-Disclosure Agreements (NDAs) or Confidential Disclosure Agreements (CDAs), are agreements between UConn and an outside entity (company, person). These are used to facilitate discussions of information that the parties wish to keep out of the public view. For companies, sharing of their business needs can lead to developing solutions with UConn personnel; however, they may not want such needs to be known to their competitors. For UConn, maintaining confidentiality can preserve patent rights to inventions. Many university offices and the programs of OVPR can provide NDAs/CDAs and can ensure proper agreements are put in place.

Once their evaluation is completed, the potential partner may want to discuss the terms of a license. TCS will negotiate the terms of the license with input from the inventor regarding valuation, and other obligations, that occur in such legally binding agreements. Other terms that are included in a license include exclusivity versus non-exclusivity, world-wide rights versus rights in only some territories, all fields of use versus restricted fields of use, and many other considerations. On occasion, we will sign an option agreement, which gives a company the right to evaluate the technology for a limited time prior to making a decision about licensing (usually 6 months – 1 year). The TCS is experienced in negotiating contracts and is the designated legal authority from the University to do so. If a potential partner asks what kinds of terms the University would want in a license, please refer them to TCS.

Agreement Management:

TCS tracks the progress of the licensee towards milestones and goals established in the signed agreement. Licenses usually state that technology progress reports must be submitted regularly until a product hits the market. Some companies will fund research and development of the technology at UConn in the inventor’s lab. Others may offer a consulting position to the inventor as they develop a product at the licensee’s facilities. TCS usually continues to manage the patents, if there are any, and will sometimes need to handle patent interferences, patent infringement or deal with arbitration or litigation surrounding a technology or a license. Once a product is offered for sale, then TCS requires quarterly reports and royalty payments from the licensee, although specific terms vary from license to license. Payouts are made according to the royalty sharing policy after UConn has recouped its out-of-pocket expenses, primarily the cost of obtaining patent protection.

License Back Policy:

If TCS decides not to pursue a patent on a technology, the inventors have the option to license back the technology. The license back is a legal agreement that enables the Inventor(s) to patent and commercialize technology developed at the University.

Royalty Sharing Policy:

Inventor contribution percentages refer to the share of net royalty income that is split amongst the inventors; the standard disposition is equal sharing. However, it is up to the inventors to propose and agree on a different formula and communicate that agreement to TCS. This is accomplished by filling out the back of the Invention Disclosure Form. Invention-related income is allocated based on the university’s Royalty Sharing Policy.

If you have any questions please contact us!

Protecting Your IP

As researchers uncover new knowledge, often times they develop novel techniques or demonstrate new and valuable applications of their results. New ideas that can be applied in useful ways can be considered new inventions, and inventions are intellectual property (IP) that can be considered for patent protection. IP includes inventions and other creative works and/or materials that may be protected under the patent, trademark and/or copyright laws.

Understanding and being mindful of intellectual property is so crucial in a research environment because:

in the course of pure research, you may be creating inventions to solve problems and not realize it
technologies created in faculty labs belong to the University and need to be disclosed
inventions can be commercialized, which can lead to income and research support for the inventor(s)

There is a logical order to ideas as they take shape, coalesce into inventions and move forward to commercialization. TCS guides this process and is often the first stop for inventors and industries seeking to advance new ideas and products. TCS manages all intellectual property created at the university.

TCS will assess the invention for its commercial potential by evaluating its technical strength, market potential, patentability and strength as if issued as a patent. We will also take into consideration whether a prototype exists or proof of principle experiments are complete, as well as whether a potential commercial partner has already been identified or has expressed interest. If the invention is considered to be a reasonable risk, a patent application will be filed.

Patenting is a legal and technical process, which is overseen by TCS, but which very much involves the inventor(s) and the University’s outside patent attorneys. Specifically, the inventor(s) may be asked by the attorney to: clarify details of their invention, describe all its possible uses, differentiate the invention from related technology and describe its potential advantages, and help define what each potential inventor contributed to the creation of the invention. The inventor(s) will also be asked to review patent applications and to help respond to questions raised by the Patent Office. To be granted a patent, an invention must be novel, non-obvious, and useful.

Faculty Invention Ownership

UConn owns all inventions made by its employees while working under a grant or contract to UConn, or while using UConn resources.

U.S. patent law specifies that all inventions are owned by the inventor(s) unless the inventor(s) has transferred ownership or title to another entity. This applies to UConn. Under Connecticut law (C.G.S., Sec. 10a-110b), UConn has the right to own title to any invention conceived by university employees (including but not limited to full-time and part-time faculty, post-doctoral fellows, student employees, research assistants, visiting scientists and emeritus professors) in the performance of customary or assigned duties or which emerges from any research or other program of the university, or which is conceived or developed wholly, or partly, with the use of university funds, facilities, equipment or materials.

That is, by virtue of employment, employees of UConn are required to assign their right, title and interest in inventions to the university. Click here to review an invention ownership flowchart.

Student Contribution to an Invention

A student can even be the sole contributor or inventor. The policy for ownership of an invention developed with or by a student is the same as for any other member of UConn in circumstances where a student is participating in sponsored research at the university and the research contract addresses ownership. Procedurally, a student who believes he or she should have clear title to an invention, which is developed at the university, should contact TCS. Upon disclosure of the invention and examination of the details surrounding its development, the university may execute a waiver of rights regarding the invention to the student, or ask the student to assign his or her rights to UConn.

Disclosing Your Invention

An invention is “the discovery or creation of a new material (either a new manufactured product or a new composition of matter), a new process, a new use for an existing material or any improvements of any of these.” Computer software may also be classified as an “invention.”

All researchers are required to disclose to UConn all intellectual property that could constitute inventions or copyrighted works. This is especially important where any portion of the funding comes from the federal government, private foundation or commercial sponsor. Federal law requires prompt disclosure for federally funded inventions. If not, UConn, inventors and involved companies could lose very significant rights if disclosures are not promptly made.

You have an invention. Now what?

Contact TCS when you believe you have a scientific or technical observation with potential commercial or research value.
Complete and submit the UConn Invention Disclosure Form or the UConn Software/App Invention Disclosure Form to TCS in sufficient time to file a patent application before publicly disclosing your technology or publishing a manuscript – preferably before submitting the manuscript for publication. Public disclosure includes journal publications, website publications, and presentations at conferences, posters, dissertations, master theses or abstract publications. More generally, it is when the intellectual property is made publicly available and accessible to those skilled in the art to which the invention relates.
To avoid risking your patent rights and possibly hindering the opportunity to market your invention, contact TCS before holding any discussions with people outside the UConn community. If a patent application has not yet been filed, TCS will give you a Non-Disclosure Agreement for the parties to sign before you describe your invention to them.
On the UConn Invention Disclosure Form, include companies and contacts you believe might be interested in your intellectual property (IP) or who may have already contacted you about your invention. Studies have shown that over 70% of all licenses are executed with commercial entities known by the inventor, so your contacts can be extremely useful.
Respond to TCS and outside patent counsel requests. While some aspects of the patent and licensing process will require significant participation on your part, we will strive to make efficient use of your valuable time.
Keep TCS informed of upcoming publications or interactions with companies related to your intellectual property.

The Invention Disclosure Form must be completed as described in the following steps:

Complete the Invention Disclosure Form (Word document).doc or the UConn Software/App Invention Disclosure Form, as appropriate.
Submit the form to the TCS group by e-mailing the disclosure to mccluskey@uchc.edu
or mailing a hard copy to:

Christine McCluskey
Technology Commercialization Services
University of Connecticut MC6400
400 Farmington Avenue
Farmington, CT 06032

*In all cases a hard copy of the original signature page must be submitted.

Upon receipt, the Invention Disclosure will be assigned a case number for tracking purposes and an acknowledgement will be sent to you via email.
You will be contacted by the Licensing Director assigned to your invention disclosure within a few weeks after the submission.
The Licensing Director will meet with you to learn more about your invention and begin to evaluate the technology for commercial potential.
The invention will be presented to the TCS committee and will be considered for patenting based on technical merit, patentability, and marketability.
You will be notified of the TCS committee’s assessment of the invention.

If you have any questions please contact us!

Gregory Gallo, Director, Technology Transfer

Donna Cyr, Director of Licensing, Physical Sciences & Engineering

Lindsay Sanford, Director of Licensing, Engineering

or call us at 860-679-3992

Commercialization Process

Our job is to help your commercialize your technology. The easiest way to get started is to contact us so we can better understand what you are working on. We encourage you to contact us during your early research activities to be aware of the options that will best leverage the commercial potential of your research.

The staff is trained to assist you with questions related to marketability, funding sources, commercial partners, patenting and other protection methods, new business startup considerations, university policies and procedures and much more. Our team approach provides you with access to specialized support such as a new business development specialist.

The typical steps in the commercialization process include:

Research

The commercialization process begins when a discovery emerges from research. We offer assistance both prior to and after the research discovery.

Invention Disclosure

Submitting an Invention Disclosure to TCS is the first step to formally document your invention with our office. This is a confidential document which fully details your invention so that we can evaluate options for commercialization.

Assessment

TCS will assess your invention for its commercial potential by evaluating its technical strength, market potential, and patentability. We will also consider whether a prototype exists or proof of principle experiments are complete, as well as whether a potential commercial partner has already been identified or has expressed interest.

Protection

We want to protect the rights of those who create IP. Based on a thorough assessment, we will determine if patent protection is possible and appropriate. If we believe your invention has commercial potential, we will file a patent application with the U.S. Patent Office.

Marketing

TCS will work with you to determine whether to try to license the invention to an existing company or help start a new venture to commercialize the technology. If we seek a licensing partner, TCS will work with you to identify and contact potential commercial partners and market the technology.

Licensing

A licensee is chosen based on its ability to commercialize the technology for the benefit of the general public. Sometimes an established company with experience in similar technologies and markets is the best choice. In other cases, the focus and intensity of a startup company is a better option. Once a licensee has been identified, TCS will negotiate any necessary agreements with third parties.

Commercialization

The licensee continues the advancement of the technology and often makes business investments to further develop the product or service. This could include further development, obtaining regulatory approvals, additional sales and marketing support, training, or other activities.

Reinvestment

Licensing revenues received by UConn are distributed to inventors as well as their academic units. These revenues fund additional research and education and encourage further participation in the technology commercialization process.

For Faculty

The mission of TCS is to expedite and facilitate the transformation of UConn discoveries into products and services that benefit patients, industry and society.

TCS and its network collaborate to support technology transfer and venture development based on student and faculty innovation. We provide services for entrepreneurial training, intellectual property protection, technology licensing, mentorship, business startup, and connections to the investment community. UConn’s Technology Incubation Program, the University’s business incubator, is part of TCS.

Working throughout UConn’s 14 schools and colleges, and participating in the state’s ecosystem, TCS is a focal point for the University’s innovation-based activities, particularly for faculty and external entrepreneurs and companies seeking technology partnerships at UConn. TCS can provide access to university-wide programs supporting innovation and entrepreneurship.

Tech Transfer Basics – Videos

Request System Access Changes

Basic InfoEd Access

The UConn Health InfoEd eRA portal is secured with the UConn NetID single sign-on. All users are required to have a valid UConn NetID. UConn faculty and staff including UConn Health faculty and staff are automatically set up with an account. External users (e.g. UConn affiliates) should request access after obtaining an UConn NetID through University Information Technology Services (UITS) or UConn Health IT domain account.

If you are trying to access the UConn Health instance of InfoEd please login at https://uchealth.infoed.uconn.edu.
If you cannot login, make sure you are using your correct NetID and password combination or your correct username and password. Consult the https://netid.uconn.edu website tools to verify your NetID and password credentials or contact the eRA Help Desk at 860-486-7944.

If you still cannot access the InfoEd eRA portal after verifying your correct credentials and attempting to login, contact the eRA Help Desk at 860-486-7944 to verify that you have an account on the particular system. If you do not have an account or you need additional permissions, you can request access by completing the eRA Access Request Form. Faculty may also add undergraduate students to InfoEd using a new automated process.

Account Access Request Form

This form is also used if you are requesting additional security permissions for InfoEd (e.g. a Department Administrator requesting view access to proposals in his/her department or school) or another system. You may type directly on the form and print it. The form must be signed by the applicant/requester and the applicant’s/requester’s supervisor.

Account Request Form – A fillable PDF file

Cross Campus Collaboration

Enhancing interdisciplinary research is a strategic goal for the University. An important component of this is the strengthening the inter-campus collaborations between Storrs and the Health Center. We can assist faculty in preparing and submitting externally funded inter-campus proposals and awards.

Because UConn (Storrs) and UConn Health (UCH) are two separate fiscal entities, proposals seeking extramural funds are administered similar to sponsored activity involving any other inter-institutional collaborations – where one institution serves as the lead applicant and the other consortium partner acts as the subawardee.

This section of the website provides educational information and support including tutorials, manuals, job aides, videos, and other reference guides to help and support faculty, staff, and students.

FCOI Webpage

FCOI Contacts

Question: How is the financial conflict of interest disclosure requirement on a proposal handled when there is a cross-campus collaboration involving a faculty member with a dual appointment at UConn Health and UConn (Storrs, Regionals, School of Law, School of Social Work)?

Answer: A faculty member may be considered compliant with the financial disclosure requirement as long as the faculty member has a current financial disclosure on record at the campus of their primary department/school. FCOI training is incorporated into the disclosure forms at both campuses.

Question: How is the financial conflict of interest disclosure requirement on a proposal handled when there is a cross-campus collaboration involving a faculty with dual appointment at UConn Health or UConn and another local institution (e.g., JAX, CCMC)?

Answer: The University FCOI policy applies to faculty members involved in research activities at the University. Thus, they must have a current financial disclosure on file within the University’s electronic disclosure submission system at the campus of their department/school.

Question: How are reviews of potential financial conflicts of interests for cross-campus research handled?

Answer: All University faculty investigators responsible for research activities on a cross-campus research project would have a current financial disclosure on record. The Financial Conflict of Interest in Research Committee (FCOIRC) at the campus of the faculty members’ department/school would review any disclosed significant financial interests when the project involves research activity at that campus.

IACUC Webpage

IACUC Contacts

Cener for Comparative Medicine Webpage

Center for Comparative Medicine Contacts

Question: If there’s a collaboration using animals, who needs to hold the protocol?

Answer: There should be an animal protocol in place at the campus where the work will be performed. Personnel from the collaborating campus can be listed on that protocol.

Question: If the collaboration requires an animal to be used at both institutions as part of the study, who needs to hold the protocol and who owns the animal?

Answer: A protocol should be in place at each institution to describe the work that is specific to that site. The overarching collaboration should also be described in both protocols, and animal ownership should be transferred when an animal is moved to the secondary institution.

Question: If I will be listed on a protocol at my collaborator’s institution, will my home campus training be valid at the collaborating institution?

Answer: It depends. The general IACUC training and Occupational Health and Safety Program enrollment is portable, but training specific to the institution where the animal work will be performed may also be necessary (e.g. facility orientation).

Question: If there is a PHS funded grant describing a collaboration between the two campuses, who is responsible for assuring congruency between the grant and the animal protocol?

Answer: The “Prime” institution has the responsibility of assuring congruency.

IBC Website

IBC Contacts

Question: I am a PI at UCH, but have some research that is conducted at UConn (Storrs and/or regionals). Does my UCH IBC registration cover my research at UConn?

Answer: No. UConn and UCH have separate IBCs, with different requirements. Therefore IBC registration processes are different between the two campuses. If research is being conducted at UConn by a UCH PI, please contact ibc@uconn.edu, for additional information and assistance in completing the appropriate registration forms. If you are a UConn PI, contact rwallace@uchc.edu .

Question: I have samples coming from UCH, and my personnel are conducting the analysis at UConn. Which IBC do I need to contact to complete a registration?

Answer: If the samples are being analyzed at UConn, an IBC registration will need to be completed through the UConn IBC. If there are any analyses being conducted at UCH, the UCH IBC should be contacted to determine if an IBC registration is necessary.

Question: I am a PI at UCH, but I teach a course at UConn which includes lab teaching activities that involve biological materials. Do I need an IBC registration with the UConn IBC or UCH IBC?

Answer: A UConn IBC registration is required for these activities. At UConn, all experimental or teaching activities involving biological materials must be registered with the UConn IBC. It should be noted that biological materials includes but is 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. Teaching activities being conducted at UCH may require an IBC registration. The UCH IBC should be contacted to determine if an IBC registration with them is necessary.

Question: I have already taken Biosafety and Bloodborne Pathogens Training at UCH. Do I have to take these trainings at UConn as well?

Answer: Yes, if you are working at UConn and also at UCH, applicable EHS trainings must be completed for each. Though Biosafety and Bloodborne Pathogens Training is similar between the two, they incorporate site specific information that is distinct to each. Therefore, applicable trainings do not count for both.

Question: I am a researcher using human embryonic stem cells (hESC) and/or human induced pluripotent stem cells (hiPSC). Do I need to register both with the Stem Cell Research Oversight committee (SCRO) and the IBC?

Answer: It depends. For work at UConn, you need to register with both the SCRO and IBC. At UCH for hESC, you need to register with the SCRO but not the IBC if your experiment is exempt under the NIH Guidelines. If you will be using animals or viral vectors with the cells it is definitely not exempt and you will need to register with the respective (UConn or UCH) IBC. For other experiments with rsNA, it’s always a good idea to consult with the respective IBC. As with any human cells, you need to work at BSL-2 containment and have fulfilled Bloodborne Pathogen (BBP) training and HBV immunization requirements (documented titer or declination). For hiPSC it’s the same as hESC except for certain uses no SCRO is required. Also, if the cells were reprogrammed with a HIV-based lentiviral vector that was not removed, the cell line will have remaining HIV sequences from the vector which are Risk Group 3 (RG-3) sequences. There is no exemption for working with (even just culturing) cells containing RG-3 rsNA sequences. hiPSC reprogrammed with Sendai vectors or plasmid vectors eventually contain no rsNA and are technically not recombinant, though they remain human and fall under the BBP rules. hiPSC reprogrammed with retroviral vectors have residual viral sequences (not RG-3). They are recombinant and fall under the exemption for culturing, but certain other experiments, such as transfer into animals require an IBC registration.

Human Subjects Research Website

Human Subjects Research Contacts

Question: My non-exempt research study (i.e. a study for which review by the full board or review by expedited procedures will occur) will involve key personnel (e.g. investigators, study coordinators, persons obtaining informed consent) from UConn Health and UConn Storrs. Do I need IRB approval from both places?

Answer: One IRB must grant formal approval and the other IRB must agree to rely upon that approval. UConn Health and UConn Storrs have entered into an IRB Reliance Agreement (also referred to as a Cooperative Agreement) whereby only one of the IRBs has to conduct a formal review and the other IRB conducts a one-time facilitated review. The IRB conducting the formal review is referred to as the IRB of Record and the IRB conducting the one-time facilitated review is referred to as the Relying IRB. Once a facilitated review has been completed, the investigator then only deals with the IRB of Record.

Question: How is it determined which IRB is the IRB of Record and which IRB is the Relying IRB?

Answer: In most cases the IRB of Record will be the IRB of the institution at which the majority of subject enrollment will occur. Other factors such as the place of employment of the Principal Investigator or which institution is the recipient of a grant award may also be considered. For example, if subject recruitment will occur primarily at UConn Health and involve UConn Health patients, the UConn Health IRB is likely the more appropriate IRB to request as the IRB of Record. Conversely, if recruitment will occur primarily at Storrs and a UConn Health person will assist in data analysis, the IRB at UConn Storrs is likely the more appropriate IRB to request as the IRB of Record. Within the IRB application form, the PI may indicate which IRB s/he prefers to be the IRB of Record but the decision is ultimately made by the IRBs.

Question: What is facilitated review, how is it requested, and why is it necessary?

Answer: Facilitated review is the process through which one IRB officially agrees to rely upon the oversight of another IRB (e.g. UConn Health IRB relying upon UConn Storrs IRB or vice versa). While there is an IRB Reliance Agreement in place between the two institutions, the decision to defer IRB oversight for non-exempt research must still be made on a case-by-case basis. Once the initial determination is made by the Relying IRB to defer oversight, the investigator only deals with the IRB of Record from that point forward. Before the research begins, the Principal Investigator must obtain approval from the IRB of Record and confirmation that the Relying IRB has deferred oversight to the IRB of Record.

Once formal IRB approval has been obtained from one IRB (i.e. the proposed IRB of Record), a request for facilitated review is submitted to the other IRB. A request for facilitated review typically requires completion of an abbreviated application form and attachment of the documents that have been approved by the IRB of Record. When UConn Storrs is the requested IRB of Record, the UConn Storrs IRB will submit the request for facilitated review through iRIS to the UConn Health IRB on behalf of the Storrs faculty. When UConn Health is the requested IRB of Record, UConn Health personnel are responsible for submitting a request for facilitated review to the UConn Storrs IRB by attaching the approved material to an email to irb@uconn.edu

Facilitated review is necessary because each institution is still responsible for knowing about and reporting on all research with which it is involved. Once the facilitated review has been completed, the IRB of Record will communicate directly with the Relying IRB about the status of the study. For example, the IRB of Record may copy the Relying IRB on correspondence that informs the Principal Investigator that a study has been approved for continuation.

Question: Does my research have to comply with HIPAA because UConn Health is involved?

Answer: It depends. While the majority of the UConn Storrs campus is not a covered entity under the HIPAA regulation, the entire UConn Health campus is a covered entity under the HIPAA regulation. Therefore any use or disclosure of protected health information for a research purpose requires that the study be in compliance with HIPAA. However it is possible to have a cross-campus collaboration that does not involve the use of protected health information (e.g. research about educational activities) in which case HIPAA would not be applicable.

Question: I have completed the training for protection of human subjects as required by my IRB (e.g. the UConn Storrs IRB). Do I have to complete this training again if I request that the UConn Health IRB be the IRB of Record (or vice versa)?

Answer: Typically no, satisfying the training requirement on one campus will serve to satisfy the requirement for either IRB. However, when your home institution is not the IRB of Record, it is recommended that evidence of completion of that training be included in the submission made to the requested IRB of Record. Also, each IRB reserves the right to require additional training if it deems it appropriate. For example, if a study proposes to include prisoners as subjects the IRB has the right to require completion of a training module specific to the additional protections for the inclusion of prisoners as subjects.

Question: My cross-campus collaborative research project was determined to be exempt by the UConn Storrs IRB, do I need to obtain an exemption from the UConn Health IRB as well (or vice versa)?

Answer: Yes, when UConn Health is engaged in exempt research the UConn Health IRB must also grant an exemption (or vice versa). The IRB Reliance agreement pertains to non-exempt research so a request for exemption should be made to each campus. It is recommended that the determination be obtained from one campus and then the approved documents and exemption letter be included in the submission to the other campus.

Question: Where do I find instructions about making IRB submissions and who do I contact for help?

Answer: Information, instructions and contacts for the UConn Health IRB are available from the web at https://ovpr.uchc.edu/services/rics/hspp/ Information, instructions and contacts for the UConn Storrs IRB are available from the web at https://ovpr.uconn.edu/services/rics/irb/

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