uconn health

Research Involving Cannabis, Hemp, and Marijuana

Cannabis-related research – including research involving marijuana and hemp – must conform to federal and state laws as well as University of Connecticut (“UConn”) policies.

Under the Federal 2018 Agricultural Improvement Act (Farm Bill), hemp is no longer a controlled substance. Hemp is legally defined as Cannabis sativa L. that contains not more than 0.3% delta-9 tetrahydrocannabinol (“THC”) content on a dry-weight basis.  The Farm Bill currently restricts the growing of hemp to states that have established a Hemp Research Pilot Program.

Connecticut recently established such a program with the passing of Public Act 19-3: “An Act Concerning a Pilot Program for Hemp Production.” This act established the state of Connecticut Hemp Research Pilot Program (HRPP) to support research that advances the Department of Agriculture's understanding of hemp agriculture at national, regional, and local levels.  This legislation sets the state requirements for hemp growers, processors, and manufacturers to obtain a license, and establishes requirements for licensing, testing, and inspection.  State requirements apply to the cultivation, processing, and manufacturing of hemp.  State requirements also apply to academic and scientific research, teaching, and testing involving hemp.

UConn researchers who wish to participate in the Connecticut’s HRPP must register through the University and follow University guidelines related to growing, processing, and manufacturing hemp.  For more information on registering through the University, email contact information to HempProgram@uconn.edu.  

Marijuana, including Cannabis sativa L. that contains more than 0.3% delta-9 THC, remains a Schedule I controlled substance, the most restrictive status, under the Controlled Substances Act.  The possession, production, processing, sale, or growth of marijuana remains illegal under Federal law, except under special licensing requirements established by the Drug Enforcement Agency (“DEA”).  Research with marijuana requires the researcher to have both a Federal Schedule I and a Connecticut Schedule II controlled substance license, and s/he may only receive marijuana from other DEA registrants or from the National Institute on Drug Abuse (“NIDA”) approved sources.  UConn researchers must also follow the University’s Controlled Substances Policy or the UConn Health Controlled Substances Policy.  For more information regarding marijuana research, contact HempProgram@uconn.edu.

FAQs

Who is the primary UConn point of contact for external relations issues and requests related to hemp and marijuana?

In the Office of the Vice President for Research, the Associate Vice President for Research Integrity and Regulatory Affairs is the primary UConn point of contact regarding hemp and marijuana. Questions regarding hemp and marijuana should be emailed to <a href="mailto:HempProgram@uconn.edu">HempProgram@uconn.edu</a>.

How do I register through the University in order to participate in the state program?

To register through the University, email contact information to <a href="mailto:HempProgram@uconn.edu">HempProgram@uconn.edu</a>. Registration will involve a criminal background check, designation of the location hemp will be grown or processed, and designation of the source of the hemp.

Can I grow or process hemp, or engage in manufacturing with hemp at UConn without registering?

No. Growing hemp, processing hemp, or engaging in manufacturing with hemp by an individual as part of their University responsibilities or position, as part of a University program, or in University facilities or on University land must register with the Connecticut through the University.

Can I have a personal hemp plant in my dorm room, office, or other location?

No. The University does not allow growing, processing, or use in manufacturing of hemp on any UConn campus or in any UConn facilities unless it has been registered with the state through the University.

Where can I find information regarding the Connecticut Hemp Research Pilot Program?

The <a href="https://portal.ct.gov/DOAG/Regulatory/Regulatory/Hemp-Home-Page" rel="noopener" target="_blank">Connecticut Hemp Research Pilot Program</a> provides information on the state program.

Once the state has issued a license, what am I required to do as the project principle investigator?

Once issued a license, you must comply with the provisions of Public Act 19-3 (the “Public Act”), the federal act (as defined in the Public Act), and the Connecticut Department of Agriculture (“DOAG”) Compliance Policy. As a condition of being granted a grower license, you, as the principle investigator and on-site manager listed on the license, and the University agree to the requirements listed below. Note that submissions and notifications must be made through the University:
1. Comply with instructions from the DOAG and law enforcement agencies;
2. Agree to pay DOAG applicable licensing and inspection fees;
3. Consent to entry onto, and inspection of all buildings, equipment, supplies, vehicles, and records located on this real property where hemp or plants or materials are located, or licensed to be located, by the commissioner, and law enforcement agencies, at any time, with or without cause, and with or without advance notice;
4. Comply with DOAG’s criminal history records check requirements; and
5. Consent to forfeit and destroy, without compensation:
a. Material found to have a THC content in excess of three-tenths percent (0.3%) on a dry weight basis;
b. Hemp plants located in an area that is not licensed by the department; and
c. Hemp plants not accounted for in required reports for the department.
6. Notify the DOAG of all hemp growing, handling, and storage locations, including legal description and GPS coordinates in decimal degrees to the ten-thousandth place, and receive department approval for those locations prior to having hemp on those premises.
7. Submit a Site Modification Request Form, the appropriate fees based on the requested changes, and obtain prior written approval from the commissioner before implementing any change to the plot(s) stated in the grower license application.
8. Not grow, handle, or store hemp in any location(s) other than the location(s) listed in the grower license application.
9. Not interplant hemp with any other crop without express written permission from the DOAG.
10. Not apply and not allow anyone else to apply pesticide to hemp except by person(s) who hold a valid permit or certificate, if required, to apply pesticides in accordance with section 22a-54 of the Connecticut general statutes.
11. Comply with all legal requirements regarding minimum distances from certain structures, and outdoor recreational facilities.
12. Acknowledges that the risk of financial or other loss shall be borne solely by the License Holder.
13. Use a record keeping and product coding system for hemp to facilitate the effective tracking of hemp and hemp products. Such plot system shall be capable of tracing hemp placed into the wholesale or retail distribution chain back to the producing plot. Such records shall be maintained for a period of time that exceeds the expected shelf life of the hemp or five (5) years, whichever is longer. Records of hemp product coding and distribution shall be made available immediately upon request of the department or any law enforcement agency.
14. Ensure that any time hemp is in transit within Connecticut, a copy of the grower license, and certificate of analysis showing the sample to have a THC concentration at or below three-tenths (0.3) percent on a dry weight basis, shall be available for inspection upon the request of the commissioner or any law enforcement agency. In the event the hemp being transported is a hemp sample being transported to a laboratory, then the sample shall be contained in a sealed tamper evident sample package and accompanied by the department approved completed chain of custody form for hemp samples. The hemp sample label shall contain, at a minimum, the date and time the sample was collected, licensee name, licensee number, location where the sample originated, identification of the lot the sample represents and a sample identification number or laboratory accession number.
15. Upon request from the commissioner or a law enforcement agency, immediately produce a copy of his or her grower license for inspection.
16. Submit Planting Reports, Harvest/Destruction Reports, Production Reports, and other reports required by the commissioner, on or before the deadlines established in these regulations. These records shall be maintained for at least three (3) years after harvest or destruction of the hemp. These records shall be made available immediately upon request of the department or any law enforcement agency.
17. Scout and monitor plots for volunteer hemp plants and to destroy those volunteer hemp plants for three (3) years past the last date of planting reported to the department.
18. Not to rent land to cultivate hemp from any person who has a state or federal felony conviction for a controlled substance within 10 (ten) years of the date of this agreement.
19. Notify the department of any interaction with any law enforcement agency immediately by phone and follow-up in writing within three (3) calendar days of the occurrence.
20. Immediately notify the department and applicable law enforcement agency of any theft of hemp materials, whether growing or not.
21. Immediately notify the department and applicable law enforcement agency of any unauthorized cultivation of any plant, within each plot.
22. To destroy any hemp or cannabis that is obligated to be destroyed, only in accordance with state and federal law, and the department’s established procedures.
23. Acknowledge that failure to comply with terms and conditions established in the department’s Compliance Policy and any regulations shall constitute grounds for appropriate action, up to and including termination of the grower license and expulsion from the department’s program.
24. Acknowledge that a person who has been expelled from the program shall not be eligible to reapply to the program for a period of five (5) years from the date of expulsion.
25. Have read and understood the state and federal statutes and the department’s Compliance Policy and any regulations related to the conditional grower license that is being issued.
26. Understand the Commissioner shall revoke or terminate any conditional grower license, if the applicant’s or conditional licensee’s, (including signing authority and on-site manager) results do not meet the federal and state criminal history records check, or the requirements of the federal act, the Public Act and the Compliance Policy.

How should UConn researchers dispose of unwanted industrial hemp materials?

Currently, the only process for destruction of materials is burial or composting. Signed documentation of method of destruction, who destroyed the materials, and when the destruction occurred should be retained.

What is the definition of industrial hemp?

The definition of hemp under Connecticut and federal law is “a plant of the genus Cannabis and any part of the plant, whether growing or not, containing a delta-9 tetrahydrocannabinol (THC) concentration of no more than three-tenths of one percent (0.3%) on a dry weight basis.”

Is hemp different from marijuana?

Yes. Hemp and marijuana are varieties of the cannabis plant that are differentiated based on selective breeding. Hemp is bred for its fiber and seed oil. By both federal and state law, hemp cannot contain more than 0.3% THC on a dry weight basis. THC is delta-9 tetrahydrocannabinol and is the psychoactive component of marijuana. Marijuana is defined as cannabis that contains greater than 0.3% THC on a dry weight basis. Marijuana remains a Schedule I controlled substance. Schedule I controlled substances are subject to the most intense scrutiny by the DEA. In Connecticut, the Connecticut Department of Agriculture regulates hemp cultivation. Under the U.S. Farm Bill and Connecticut’s Pilot Program, institutions of higher education like UConn have latitude to cultivate and research industrial hemp, including its constituent compounds, without a DEA Schedule I license.

Does hemp include extracts that include cannabidiol or other cannabinoids?

The key defining characteristic of hemp is that it is Cannabis sativa L. that does not include THC at a concentration of more than 0.3% on a dry weight basis. If the extract meets that criterion, was lawfully grown in accordance with a state Pilot Program, and was processed in accordance with state law, then it would qualify for treatment as industrial hemp.

Can UConn researchers do hemp research under a DEA Schedule I registration?

No, a researcher may not perform research on hemp with a DEA Schedule I registration because hemp has been removed from the Federal Controlled Substances Schedule.

Can UConn researchers grow industrial hemp for research purposes?

Yes, but this requires registering through the University for a growers’ license from the Connecticut Department of Agriculture.

Where can UConn researchers obtain certified seed to grow hemp for research purposes?

UConn researchers should obtain certified hemp seed only from an agency authorized under the laws of a state, territory, or possession of the United States to officially certify hemp seeds and that has standards and procedures approved by the U.S. Secretary of Agriculture to assure the genetic purity and identity of the hemp seed certified. The seed must have a certificate or other instrument attesting to its genetic purity and identity.

Can UConn researchers obtain CBD (Cannabidiol) for research purposes?

A qualified yes. CBD and other materials derived from Hemp that contain a THC concentration of less than 0.3% on a dry weight basis are not subject to the Controlled Substances Act if the materials are cultivated and processed pursuant to the U.S. Farm Bill and the Pilot Program. In addition, the sourcing party must be properly licensed (for cultivation/processing) with the state’s proper licensing authorities. Please contact HempProgram@uconn.edu before undertaking such research. They can alert researchers to any issues that may exist with sourcing and licensing requirements.

Can UConn researchers obtain hemp products from third parties for research purposes?

A qualified yes. Hemp materials and products (other than viable seeds) that contain a THC concentration of less than 0.3% on a dry weight basis are not subject to the Controlled Substances Act <em>if</em> the materials and products are cultivated pursuant to the U.S. Farm Bill and the Pilot Program. In addition, the third party must be properly licensed with a State Department of Agriculture’s Industrial Hemp Pilot Program, and its activities must have a research purpose. Thus, a researcher is permitted to receive and perform research on such materials and products from parties with which it enters collaborative research-focused agreements.

Can UConn researchers perform hemp research funded by third party industries?

Yes, subject to certain UConn and Connecticut Department of Agriculture approvals. However, accepting funds coming from the marijuana industry or any business related to it is restricted due to current federal banking regulations.

Can UConn researchers perform hemp research in a paid or unpaid sabbatical situation in a foreign country whose laws permit industrial hemp research in any capacity?

Yes.

Can UConn researchers license intellectual property rights resulting from hemp research?

Yes.

Does the Connecticut Hemp Research Pilot Program allow research with marijuana?

No. Marijuana research is defined as research that involves the growth, production, procurement, administration, or use of marijuana. It does not refer to observational research for which the researcher does not grow, produce, procure, or administer marijuana. Marijuana has the same meaning as in the definition provided by Connecticut General Statues § 21a-240(29).

Marijuana is categorized as a Schedule I drug by the DEA under the federal Controlled Substances Act. This means that federal regulations do not permit the use, production, processing, sale, or growth of marijuana, except for medical or research use <strong>conducted under special licensing requirements established by the DEA</strong> and the U.S. Food and Drug Administration (“FDA”) for use with humans or animals. Typically, research conducted under a DEA license also requires sourcing the marijuana from the NIDA. The U.S. Department of Justice’s (“DoJ”) previous guidance indicating that it will not focus its prosecutorial resources on the sale or use of marijuana in states where a well-regulated legal framework has been established was rescinded in 2018. To date, no exemption from the federal regulations has been granted to any state.

UConn is the recipient of considerable federal funding for research, education, capital projects, and healthcare. Accepting this funding obligates UConn to comply with the Drug-Free Schools and Communities Act and the Drug-Free Workplace Act. These federal regulations together prohibit UConn from unlawful manufacture, distribution, dispensing, possession, or use of any controlled substance at the University. Unlike the DoJ’s stance on enforcement of DEA regulations, there has been no statement suggesting that enforcement of the Drug-Free Schools and Communities Act or the Drug-Free Workplace Act has been, or will be, relaxed.

Consequently, despite the state of Connecticut’s legalization of medical marijuana, there is no provision that allows for the legal research of medical marijuana except as already established and involving compliance with DEA, FDA, and NIDA policies and regulations.

Where can I find information about courses or programs at UConn related to hemp?

The UConn College of Agriculture, Health and Natural Resources conducts courses related to hemp cultivation and production. Additional information can be found by searching the <a href="http://cag.uconn.edu/canr/index.php" rel="noopener" target="_blank">College of Agriculture, Health and Natural Resources web site.</a>

Is anyone at UConn involved in testing as part of the state Hemp Research Pilot Program?

The UConn Center for Environmental Sciences and Engineering conducts testing as part of the Hemp Research Pilot Program. Additional information can be found on the <a href="https://cese.uconn.edu/hemp-initiative/" rel="noopener" target="_blank">Center for Environmental Sciences and Engineering web site</a> or by contacting the Center for Environmental Sciences and Engineering Laboratory Director, Christopher Perkins by either email (christopher.perkins@uconn.edu) or phone (860.486.2668).

START Preliminary Proof of Concept Fund

Dear Colleagues,

Through a generous grant provided by the CTNext Higher Education Fund last year, the Office of the Vice President for Research (OVPR) has been administering an early stage translational research funding program called the START Preliminary Proof of Concept (PPOC) Fund. Under the grant, funding is provided to investigators at Central Connecticut State University (CCSU), Southern Connecticut State University (SCSU), University of Bridgeport (UB), and UConn on a competitive basis.

The START program aims to support the preliminary validation of innovative early stage technologies that have possible commercial potential and is designed to advance those technologies to be more attractive for additional funding. Proposals for the START PPOC Fund are welcomed from across all disciplines for early stage projects that may one day result in inventions and technologies that address unmet needs and have potential for commercial application.

As we wrap up the first year on funding, I would like to take a moment to recognize recipients from these institutions and ask that you join me in congratulating them on their efforts to commercialize technologies developed in the course of their academic research. For a full list of recipients and project information, visit the OVPR website.

For more information about the competition, visit the program website.

Thank you for helping to foster the culture of excellence in your schools/colleges, departments, and centers that allows UConn faculty to engage in research, scholarship, and creative activities at the highest levels. 

 

 

Cheers,

Radenka

Celebrating UConn Research, Scholarship, and Creative Activities

As we begin a new semester at UConn, I would like to reflect on our past academic year and share with you the excitement, successes, and progress we made in that time. As a public research university that engages globally in the creation of new knowledge, we measure our success by the impact of our scholarly and educational outcomes, research, innovation, and the creative work of our students and faculty. In the last few years, we have brought people together around shared goals across campuses and disciplines, an accomplishment that is palpable at UConn and has been critical to the success of our land-grant mission.

Our three consecutive years of growth in total awards have borne out the value of our collective efforts.

Thanks to the tireless work of our faculty, postdocs, students, and staff, our new extramural awards for FY19 reached a three-year high of $266.2M. In FY17, our total new awards were $184.5M and in FY18, they were $258M. UConn Health received over $100M in new awards this past fiscal year reaching an all-time high. Our combined efforts represent a 44% increase over three years. We also saw upward trends in our entrepreneurship and innovation ecosystem, with a record 39 high-potential startup companies joining UConn’s Technology Incubation Program, and a ranking of 93rd worldwide in the number of US patents issued for UConn inventions. It is a matter of great satisfaction for me to have helped position entrepreneurship and innovation as an equal mission for our faculty alongside teaching, scholarship, research and creative work.

Our committed focus on seed funding, proof of concept grants, and awards to support the arts and humanities has contributed to STEM and non-STEM excellence. In FY19, our office contributed $2.3M to internal funding programs and an additional $100K to support grant writing workshops and resources. We are thrilled to see engagement, collaboration, and distinction from all areas of the University, whether it be STEM, non-STEM, or a collaborative hybrid, and that these combined efforts are producing growth in research and extramural awards.

I would like to highlight a few new initiatives launched by the OVPR in FY19 that supported faculty success:

  • Convergence Awards for Research in Interdisciplinary Centers (CARIC): Support development of collaborative interdisciplinary teams to bid for major (>$5M) federally funded initiatives, such as research centers.
  • Support of UConn Human Rights Institute with two postdoctoral fellowships in collaboration with the Schools of Engineering and Business.
  • Program in Accelerated Therapeutics for Healthcare (PATH): In partnership with the Schools of Pharmacy and Medicine, aims to accelerate the translational pathway to convert discoveries into new medical therapeutics. The program seeks to quickly develop novel approaches focusing on well validated molecular targets for a specific disease area with an unmet treatment need in the current commercial marketplace.
  • Scholarship and Collaboration in Humanities and Arts Research Program (SCHARP): In partnership with the Humanities Institute, SCHARP supports innovative works in scholarship and creative activities in the arts and humanities that have the potential to transform a field of study, impact the common good, or chart a new direction in scholarly, creative, or artistic direction.
  • STEAM Innovation Grant: In partnership with the School of Fine Arts, STEAM encourages innovative collaborations between the arts and STEM disciplines. Projects funded by this grant may result in publications, exhibitions, performances, academic symposia, or other research outcomes.
  • Stamford Innovate, a new internship program that connects talented UConn students with opportunities in startups in one of the fastest growing regions of the state.

If you want to learn more, click here for a full list of our internal funding programs.

As educators, we all take great pride in our students’ successes, and I wanted to take a moment to recognize some new student projects that are truly remarkable. In collaboration with the Office of the Provost, the OVPR supported a student-led podcast called In Vivo. With regular interviews about science, the arts, current events, and other topics, In Vivo highlights the amazing faculty, students, and staff that give UConn life. The show is conducted out of UConn’s WHUS studio and is run entirely by UConn students. Check it out and consider subscribing for future episodes to learn more about UConn researchers.

Another new initiative is World Poetry Books to support its mission of publishing and vigorously promoting a minimum of six books of exceptional poetry in translation each year. This support offers our students the opportunity to gain hands-on, professional publishing skills, and establishes UConn as home of a preeminent publisher of exceptional world literature.

While sharing accomplishments is important, we also want to increase transparency and continue to maintain open lines of communication as we push to raise UConn’s research profile. In addition to sharing research and tech transfer metrics on the recently revamped UConn Research website, we encourage faculty and staff to reach out with suggestions regarding new opportunities and unmet needs. It is only together – as a team – that we will continue to drive the growth of scholarship, research, and creative pursuits at UConn.

I’d like to conclude with a personal note of gratitude. I cannot thank all of you enough for giving me the opportunity to work with so many talented, hardworking, and committed colleagues. To my staff, I am deeply honored to serve as VPR and grateful for your support, continued improvement, and service to our faculty and students. At the end of a hard day, I find great inspiration in the knowledge that UConn’s faculty and staff – whether they be musicians, chemists, or scholars of law or other disciplines – are some of the world’s most innovative and active researchers. Thank you for making UConn a special place with a vibrant community of caring, collaborative people.

We are opening a new chapter for UConn with a new President who is focused on our excellence, strengths, and new opportunities. I look forward to this journey with all of you, and please remember my door is always open!

Cheers,

Dr. Radenka Maric

Vice President for Research, UConn/UConn Health

Faculty Affiliated Companies / External Entities

What is the purpose of this page?

Assistance with identifying University requirements, policies, guidance, and procedures, including State Code of Ethics laws, related to faculty affiliated companies /external entities

Who should review this information?

 Faculty, staff, and students who hold a financial interest in, or conduct University activities with, a faculty affiliated company /external entity.

Why is this important?

Perceived or real conflicts may arise between University activities and activities of faculty affiliated companies /external entities. The University of Connecticut, its Regional Campuses and UConn Health (the University) are committed to fostering the entrepreneurial activities of its faculty and staff, in addition to its core missions of teaching, research and service. Consistent with its mission, the University encourages translational research, innovation and entrepreneurial activities. The University also is dedicated to ensuring transparency and compliance with University policy and State and Federal regulations.

Is everything I need to know here?

These pages are not an all-encompassing list of requirements, and members of the University community are expected to know and comply with all applicable University policies, and State and Federal regulations. In some cases, federal law and regulation will be stricter than State ethics laws and UConn policy, and such applicable portions of federal law will take precedence, while other aspects of State or University policy will remain in force. The federal and state regulations that govern these areas are complicated and these pages do not cover every situation that may need to be addressed. Therefore, the University recommends faculty, staff and students seek expert guidance in addition to adhering to the provided guidelines.

Who do I contact for more information?

The information available within these pages is also summarized in a Guidelines for Faculty, Staff, and Students who are affiliated with a Company document.  The University strongly encourages any University employee affiliated with a company or acting as a consultant for a faculty affiliated company to seek advice from the Office of the Vice President for Research, the Provost’s Office, the State Ethics Liaison, and the Procurement Services group.  The Office of University Compliance is also available to assist with questions relevant to University policies or State and Federal regulations.

Policies and Regulations

State of Connecticut Ethics Laws

University Guide to the State Code of Ethics

All University faculty and staff are subject to the Connecticut state ethics laws.  Connecticut State ethics laws are designed to prevent a state employee, his/her family, and any associated business(es) from benefiting personally from his/her position as a state employee. The guidance on Consulting Approval, Purchasing Goods or Services, Employment of Students, and Use of University Facilities/Resources, are intended to help the University community comply with state ethics laws and University policy.  While the University has developed its own policy based upon state ethics laws, the University Guide to the State Code of Ethics, the final authority to interpret and enforce these laws rests with the Office of State Ethics, an independent regulatory division of the state.

This policy includes several considerations related to conflicts of interest.

For guidance regarding individual situations, contact the Ethics Liaison.

University Policies

The following University policies are of particular importance for members of the University community who hold a financial interest in, or conduct University activities with, a faculty affiliated company.  Additional guidelines on these topics are available within this site.

Code of Conduct

The Code of Conduct includes campus-wide standards on conflict of interest.

For guidance regarding individual situations, contact the Office of University Compliance.

Faculty Consulting Policy

This policy addresses when a faculty member is working for a faculty affiliated company in a paid or unpaid capacity, including as an employee, consultant, or advisor.

For guidance regarding individual situations, contact the Faculty Consulting Office.

Use of Students in Outside Employment

This policy addresses if a student is to be employed by a faculty affiliated company / external entity.

Financial Conflict of Interest in Research (UConn Health)

Individuals at UConn Health who are involved in University research as an Investigator must make full and timely disclosures of financial interests, including any financial interests with a faculty affiliated company / external entity, according to this policy.

Individual Financial Conflicts of Interest in Clinical Health Care Policy

This Policy on Financial Conflicts of Interest in Clinical Health Care promotes objectivity in clinical health care by establishing standards to reasonably ensure that the planning, support and delivery of clinical health care will not be biased by any conflicting financial interest of a Clinical Practitioner. This Policy applies to all aspects of clinical health care. While UConn Health encourages Clinical Practitioners to engage in appropriate outside relationships, all Clinical Practitioners must in accordance with this Policy disclose any significant financial interest (including those of a spouse or dependent child) that relate to the Clinical Practitioner’s institutional responsibilities and, if applicable, comply with any financial conflict of interest management or mitigation plans.

Use of University Resources

Requests from faculty affiliated companies / external entities for access to, and/or use of, University research lab space or equipment are addressed within the guidance for Use of Research Space or Equipment by External Entities

This guidance provides consistency to the handling of these requests and ensures that the institution is informed and approves of such access.  These steps ensure research space and equipment remains committed to the research mission of the institution.

Questions related to this guidance can be directed to the Associate Deans for Research for School of Medicine or School of Dental Medicine.  Questions can also be directed to the Associate Vice President for Research Integrity and Regulatory Affairs or Assistant Vice President for Research Finance in the Office of the Vice President for Research.

 

Consulting Disclosure and Approval

If a faculty member, or any other University personnel subject to the consulting policy, do any work for a faculty affiliated company, whether or not compensation is received, prior consulting approval from the University is required.  This approval is required even if the faculty affiliated company is not currently paying the faculty member.

For faculty members who have an ownership interest in a start-up company, that ownership must be disclosed when seeking consulting approval.

Faculty members must get consulting approval from the department head, dean, and campus Faculty Consulting Office if working for a faculty affiliated company in a paid or unpaid capacity.

Faculty must seek approval for the Use of University Resources, including University equipment, while consulting.  Faculty members must reimburse the University for using University resources beyond di minimus amounts.

Approval under the University’s Faculty Consulting system is in addition to any other disclosure statements (e.g., for research financial disclosures).

Any consulting activity that is ongoing requires a new request form every fiscal year.

For questions related to the faculty consulting policy, contact the campus Faculty Consulting Office.

Subawards and Subcontracts

Subaward from Faculty Affiliated Company to UConn

The University may accept research subcontracts/subawards from faculty affiliated companies (FAC) in which the FAC is the sponsor. All of the relevant requirements and policies for subcontracting to the University apply regardless of the fact that the subcontracting entity is a FAC. The University Conflict of Interest Committee(s) may place specific requirements on the investigator or others working on the project to manage, reduce or eliminate the conflict.

Subaward from UConn to a Faculty Affiliated Company

If the Principal Investigator (PI) is a faculty member who has an interest in a FAC, the University will not subcontract or issue a subaward to any FAC in which the PI has an interest.

If a Co-PI on the grant has an interest in a FAC, specific rules apply if there is a subcontract or a subaward to any FAC in which the Co-PI has an interest. As a state employee, a Co-PI may be prohibited by state ethics law from having the FAC contract with the University. There is an exception that allows a subcontract or subaward if it is intended to support a collaboration to develop and commercialize an invention or discovery. Many subcontracts and subawards may come within this exception. They are permitted, provided that the following additional requirements are also met:

  1. the PI does not have an ownership or other interest in the FAC receiving the subcontract or subaward
  2. the PI does not receive any financial gain from making the award
  3. the PI has made an independent decision based on the merits to select the FAC and the decision is not based on other factors such as personal or professional relations with the Co-PI
  4. the Co-PI did not participate in the decision to make the award to the FAC
  5. the FAC receiving the subaward or subcontract must be qualified to do the work, and the economic and other terms must be commercially reasonable; and
  6. the evaluation of the work product and the approval of invoices from the company must be done by the PI independently, without the participation of the Co-PI. In addition, in these situations, UConn will inform the sponsor of the potential conflict and confirm that the sponsor has no objections.

The PI cannot receive a payment from the Co-PI or the company receiving the subaward or subcontract. Nor can there be any agreement to funnel subawards or subcontracts to a company in which the PI has an interest.

As noted elsewhere, this does not address any restrictions that may be imposed by the funding source, whether a federal grant or otherwise. The application of those rules needs to be evaluated in the context of the specific situation.

For assistance at UConn Health (Farmington), contact Paul Hudobenko, Director, Sponsored Program Services, at hudobenko@uchc.edu.

SBIR and STTR

Various federal agencies provide funding to small businesses to conduct research and development with the goal of commercializing technology. This federal funding occurs via two different award mechanisms:

  • Small Business Innovation Research (“SBIR”)
  • Small Business Technology Transfer (“STTR”)

Both SBIR and STTR awards are made directly to a small business concern (“SBC”). A SBC is a for-profit company that is the applicant for a SBIR/STTR award. In this section of the guidance, we use the terms SBC and company interchangeably.

STTRs require that the SBC collaborate with a research institution (“RI”) for a certain portion of the award. SBIRs do not require RI involvement, but SBCs often collaborate with RIs on SBIRs. A RI is the research institution partner, such as UConn, that collaborates with an SBC for a SBIR/STTR award through a subcontract/subaward under the SBC.

UConn meets the criteria to serve as a RI for SBIRs and STTRs. UConn’s involvement in either a SBIR or a STTR occurs when it is either included in the proposal or the federal sponsor has provided approval to SBC to engage with the university and is awarded via a subcontract/subaward from the SBC to the university. In cases where there is a collaboration/subcontract/subaward between the SBC and the RI, there is an SBC PI and an RI PI (i.e. a PI for each side of the collaboration).

Requirements for SBIRs and STTRs

SBIR

Applicability Eligibility Requirements
SBC Must be an American-owned business

Must be independently operated

Must be a for-profit business

Must have five hundred or fewer employees

If sub-contract with another party, or with multiple parties: SBC must do at least two-thirds of research during Phase I; SBC must do at least one-half of research during Phase II

SBC PI Must be primarily employed with SBC
RI Involvement of RI not required

If the SBC subcontracts with RI: RI may conduct up to one-third of research during Phase I; RI may do up to one-half of research during Phase II

STTR

Applicability Eligibility Requirements
SBC Must be an American-owned business

Must be independently operated

Must be a for-profit business

Must have five hundred or fewer employees

Not less than 40% of the research/research development must be performed by SBC

SBC PI Must be primarily employed by either the SBC or the collaborating RI
RI Research Institution collaborator required

Must be one of the following: A non-profit college or university; A domestic non-profit research organization; or A federally funded Research and Development Center

RI required to conduct at least 30% of research and development but may conduct up to 60% of research and development

SBC Use of University Space

Small businesses certify in their SBIR and STTR applications and award documents to the federal government that the SBC research and development will occur in SBC facilities using company employees unless otherwise indicated in the SBIR or STTR application and approved in the funding agreement. Therefore, performing the SBC portion of such research in University space using University resources — unless specifically approved by the funding agency and allowed by the University – subjects the company to potential criminal, civil, or administrative sanctions.

Consulting for a Faculty Affiliated Company

As a general rule, if the faculty affiliated company is sponsoring research at UConn under an SBIR or STTR, the faculty member should not be paid as a consultant under the award.

The Same Individual Serving as University PI and SBC PI

For SBIR awards, the SBC PI must be primarily employed by the company. Most faculty members are fully employed by UConn and therefore cannot serve as the PI for an SBC. To serve as PI for a SBC, the faculty member cannot have a University position or appointment of greater than 49%.

For STTR awards, the PI named on the award may be primarily employed by either the company or the University. The exception is for NSF STTR awards, in which the PI named on the award must be primarily employed by the SBC.

For the work conducted for both SBIR and STTR awards, the SBC PI and the RI PI may not be the same individual. While not explicitly stated, the STTR/SBIR policy, instructions, and project percentage requirements make clear that establishing a separation of entities and roles is important. Having the same person on both sides of the collaboration blurs the respective parties’ project roles, responsibilities and effort/time commitments.

Specific sponsor policies or requirements may differ and be more restrictive. For example, the NSF guidance states that no person who is an equity holder, employee, or officer of the proposing small business may (1) be paid as a consultant, or (2) be paid through a subaward budget, in either case, unless recommended and approved by the NSF.

Faculty members that have an interest in an SBC must read all sponsor requirements for SBIR/STTR proposals and awards carefully and note what situations may be prohibited or that may require advance sponsor approval. It is strongly recommended that the SBC engage counsel to review and advice on the grant awards, and hire accountants with specific expertise in SBIRs and STTRs.

Management of Faculty Affiliated Company Grants

The faculty affiliated company/external entity is responsible for all grant administration relating to company grants, including SBIR and STTR grants.  The faculty affiliated company/external entity should seek professional advice on appropriate grant management and administration.

Federal and Sponsor Specific Guidance

 The US Small Business Administration provides guidance to small businesses wishing to pursue SBIR or STTR funding opportunities. Their website includes general information as well as links to individual federal sponsor programs. Sponsors may have additional guidelines or restrictions and those small businesses seeking to pursue a SBIR or STTR project should be careful to thoroughly review guidelines and restrictions.

Disclosure of Financial Interests

Disclosure in Publications, Presentations, and Transactions

Individuals must disclose ownership and consulting relationships, if any, with a faculty affiliated company/external entity in all publications, presentations, and transactions related to the  company’s technology.  Likewise, the faculty affiliated company would disclose its relationship with the faculty member, and the individual’s role with the company, in all publications, presentations, and transactions related to the individual’s work in the development and marketing of its technology.

When an individual files an application for any grant or contract, whether through the University or through a faculty affiliated company/external entity, the individual must disclose their financial interest with the company as required by the granting or contracting entity.

For Investigators who own equity in a faculty affiliated company or start-up company, the ownership must also be disclosed through the University’s financial interest filing process described below.

Financial Conflict of Interest in Research and/or Clinical Care  – Disclosure and Management

Individuals at the University involved in research or clinical care must make full and timely disclosures to the applicable Financial Conflict of Interest Committee of all financial interests meeting the disclosure threshold for Significant Financial Interests (SFIs) within the InfoEd External Interests system.

This includes disclosure of any and all equity or other ownership interests in non publicly-traded entities, such as faculty affiliated companies or other non-public external entities, even if the company has no current value or the value is unknown.

For investigators:  These disclosures are reviewed and, where required, managed, reduced, or eliminated to address potential conflicts in the design, conduct, or reporting of research according to the University’s Financial Conflict of Interest in Research policy.  In some instances, there may be specific sponsor policies or requirements that are more restrictive than State ethics laws and UConn policy, and such applicable portions of sponsor policies or requirements will take precedence, while other aspects of State or University policy will remain in force.  Investigators should review the terms of all awards and must comply with all terms and conditions to be certain there are no additional restrictions pertaining to a company relationship.

Obligation to Update and Provide Information

If there is a change in an individual’s status or responsibilities related to a faculty affiliated company/external entity, the financial disclosure may be required to be updated and other University areas may also need to be notified (e.g., Faculty Consulting Office).  According to University policy, the research financial disclosure is required to be updated within thirty (30) days of the acquisition or discovery of any new significant financial interests.