Research Compliance Services News

January RCR Training

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Please join us to kick off our new monthly in-person RCR training offerings!

 

The Responsible Conduct of Research (RCR) Program within Research Integrity & Compliance in the OVPR is developing a series of monthly in-person RCR training sessions. For our January event, we will meet to view the Office of Research Integrity’s (ORI) interactive movie: “The Lab – Avoiding Research Misconduct.” The movie is designed as a “choose your own adventure”-type experience to allow participants to work through some common pitfalls and challenges in a low-risk environment. This 1.5-hour event will count towards the 8-hour in person requirement for NIH. For more details about RCR requirements, please visit our RCR Program website.

 

Space is limited so registration is required. To register, please email Research Compliance Monitor, Ellen Ciesielski. For questions, please contact Karen Moré, Director of Research Compliance.

 

What: January RCR in-person training, The Lab – Avoiding Research Misconduct

When: Monday, January 22nd from 12:00 p.m. to 1:30 p.m.

Where: Babbidge Library, Class of ’47 Classroom

New NSF Responsible Conduct of Research Requirement— Effective 7/31/23

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UConn is committed to maintaining the highest ethical standards in the performance, reporting, reviewing and proposing of research and scholarly activity. In support of this commitment and to fulfill funder requirements, UConn offers Responsible Conduct of Research (RCR) training and education with the goal of engaging researchers in the exploration of best ethical practices.

A recent National Science Foundation (NSF) requirement expansion includes RCR training for faculty and other senior personnel, and will require that the training address mentor training and mentorship. These new requirements apply to NSF proposals submitted on or after July 31, 2023.

A list of RCR trainings at UConn that fulfill NSF RCR requirements can be found on our UConn RCR webpage. Be on the lookout for additions to the RCR offerings in the coming months!

 

ClinicalTrials.gov Modernization Efforts

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Let your voice be heard! ClinicalTrials.gov is getting a facelift and the National Library of Medicine wants your feedback.

 

The National Library of Medicine (NLM) is holding a virtual public meeting to discuss the ongoing modernization efforts for ClinicalTrials.gov on April 25th, 2023, from 12:30 – 3:00 p.m. They will provide a detailed look at the current beta websites– both the public-facing ClinicalTrials.gov site as well as the entry system site for researchers, known as the Protocol Registration and Results System or PRS. They will provide progress updates and ask for feedback from stakeholders. For the meeting agenda and a link to register, visit the NLM website.

For questions regarding ClinicalTrials.gov at UConn and UConn Health, please contact local PRS Administrator, Ellen Ciesielski.

NIH Plan to Enhance Public Access to the Results of NIH-Supported Research (NIH Public Access Plan)

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The Office of the Vice President for Research would like to share some information with researchers who may be affected.

The National Institutes of Health (NIH) is hosting a virtual, public listening session next Wednesday, April 12, 2023, from 1:00 – 3:00 pm for feedback on the NIH Plan to Enhance Public Access to the Results of NIH-Supported Research (NIH Public Access Plan). The virtual listening session will be viewable through NIH Videocast. Further information about the listening session, including the agenda and how to sign up to make oral comments, can be found on the event page of the Office of Science Policy (OSP) website. The slots for oral comments will be provided in the order they are received until all slots have been filled, and must be received by April 10, 2023.

Written Request for Information (RFI) responses on the NIH Public Access Plan will continue to be accepted until April 24, 2023.

For questions, you can contact OSP at SciencePolicy@od.nih.gov.

 

Research Compliance Quarterly Winter 2023

In This Issue:

  • IACUC inspections

  • ACS personnel updates

  • EHS equipment reminder

  • IRB new forms

  • Research Safety-Economic Espionage

 

 

 

 

IACUC Inspections in April

Spring Semiannual Inspections are coming up during the month of April! The Institutional Animal Care and Use Committee (IACUC) Office will reach out for availability during the first two weeks of April so please be sure that you and any lab staff are available to show the IACUC your lab and to give a brief explanation of what you do and how you do it.

Some helpful tips include:

  • Ensure logs (eye washes, scissor maintenance, surgery, etc.) are up to date.
  • Know what is in your approved IACUC protocol so you can answer any questions the IACUC may have for you. For example, what procedures are done and how is the area prepared beforehand? What happens to the animal before, during, and after the procedure?
  • If you have any drugs or substances, ensure that they are in-date or are properly discarded prior to the inspection.

Do you have a protocol expiring soon? Be sure to lookout for reminder notices from iacuc@uconn.edu and submit as early as possible to facilitate the review process. Please reach out and request any documents or information from the IACUC Office.

Did you just get notified that you’ll be receiving federal funding? Let the IACUC Office know as soon as you can so that we can perform a congruency check and ensure that the information from the grant matches what is in your IACUC protocol. If it doesn’t match, a modification may be needed, so please give yourself plenty of time!

Nick Lacafta, IACUC Specialist

Mark Johnson, IACUC Specialist/Post Approval Monitor

 

Congratulations on the promotion!

Animal Care Services (ACS) would like to announce two recent promotions!

Cassie Leone, RLAT, was promoted from Animal Care Technician to Veterinary Technician (Animal Care Specialist).

Briana Lechkun, LAT, was promoted from Animal Care Specialist to Animal Care Manager.

Job Opening! ACS is currently looking to fill an Animal Care Specialist position.

Looking for more information about ACS? The ACS website offers many helpful tools such as animal/drug ordering, per diem rates, policies/SOPs/Guidelines, and grant information to help principal investigators, lab staff and students successfully and compliantly move their research forward. Also, feel free to reach out with any questions or concerns!

Curtis Schondelmeyer, DVM, CPIA, DACLAM— Director and Attending Veterinarian

 

Purchasing, Acquiring, or Relocating Laboratory Equipment?

Reminder: Please inform Environmental Health Services (EHS) of locations of newly acquired or relocated Biosafety cabinets, x-ray, and laser equipment for registration updates. Contact us at ehs@uconn.edu.

For more information on restricted equipment/materials requiring EHS review or approval, visit https://ehs.uconn.edu/employees/equipment-purchases-and-acquisitions/

Terri Dominguez, University Director

 

 

Institutional Review Board (IRB)

The IRB Office is in the process of developing resources that we hope are of help to our research community. Two of those resources have recently been posted to the IRB Submissions, Forms & Templates webpage. In the “Templates” section, under “Consent Templates” are links to an NIH resource, “Informed Consent for Secondary Research with Data and Biospecimens,” and a Consent Checklist for Investigators document. The NIH resource includes some general points to consider when planning to seek permission for the future research use of data and biospecimens along with some sample language. The Consent Checklist for Investigators mirrors that used by the IRB when evaluating whether a consent document includes all required and “as applicable” elements of consent. We hope that this is helpful as a self QA check prior to submitting consent materials to the IRB.

We also plan to create a section on our website with some resources to help investigators understand NIH’s requirements and recommendations for human participant research subject to the updated Data Management & Sharing Policy. In the meantime, we encourage investigators to review the information the Library has made available on their webpage: NIH Data Management and Sharing Requirements. Please let us know if you have other suggestions for resources: irb@uconn.edu.

And please join us in welcoming our newest IRB Program Specialist, Jeanelle Graham! Jeanelle comes to us with many years of experience as an IRB professional and it is already apparent that she is a great addition to our team!

Questions about human subjects research or IRB? Contact us at irb@uconn.edu.

 

A Message from Research Security

Economic Espionage

Economic espionage is foreign power-sponsored or coordinated intelligence activity directed at the U.S. government or U.S. corporations, establishments, or persons, designed to unlawfully or clandestinely influence sensitive economic policy decisions or to unlawfully obtain sensitive financial, trade, or economic policy information; proprietary economic information; or critical technologies. This theft, through open and clandestine methods, can provide foreign entities with vital proprietary economic information at a fraction of the true cost of its research and development, causing significant economic losses.

Our Nation’s secrets are in jeopardy, the same secrets that make your company profitable. The FBI estimates billions of U.S. dollars are lost to foreign competitors every year. These foreign competitors deliberately target economic intelligence in advanced technologies and flourishing U.S. industries.

Foreign competitors operate under three categories to create an elaborate network of spies:

  • Aggressively target present and former foreign nationals working for U.S. companies and research institutions;
  • Recruit and perform technical operations to include bribery, discreet theft, dumpster diving (in search of discarded trade secrets) and wiretapping; and,
  • Establish seemingly innocent business relationships between foreign companies and U.S. industries to gather economic intelligence including proprietary information.

What Are Trade Secrets?

Trade secrets are all forms and types of financial, business, scientific, technical, economic or engineering information, including patterns, plans, compilations, program devices, formulas, designs, prototypes, methods, techniques, processes, procedures, programs, or codes, whether tangible or intangible, and whether or how stored, complied, or memorialized physically, electronically, graphically, photographically or in writing, (1) which the owner has taken reasonable measures to protect; and (2) which have an independent economic value from not being generally known to the public.

Commonly referred to as proprietary information, economic policy information, trade information, proprietary technology, or critical technology.

What Are Some Methods Of Targeting Or Acquiring Trade Secrets?

  • Steal, conceal, or carry away by fraud, artifice, or deception;
  • Copy, duplicate, sketch, draw, photograph, download, upload, alter, destroy, photocopy, replicate, transmit, deliver, send, mail, communicate, or convey; and,
  • Receive, buy, or possess a trade secret, knowing the same to have been stolen or appropriated, obtained, or converted without authorization.

Know The Signs

  • Working odd hours without authorization
  • Taking proprietary information home without authorization
  • Unnecessarily copying material
  • Disregarding company policies on personal software and hardware
  • Accessing restricted websites
  • Downloading confidential material
  • Conducting unauthorized research

Personal Behaviors

  • Unexplained short trips to foreign countries
  • Engaging in suspicious personal contacts with competitors, business partners or unauthorized individuals
  • Buying items they normally cannot afford
  • Overwhelmed by life crises or career disappointments
  • Showing concern about being investigated

Common Factors

  • Financial need
  • Greed
  • Unhappiness in the workplace
  • Different allegiances to another company or country
  • Drug/Alcohol abuse
  • Vulnerability to blackmail
  • Job offers from other organizations

Targeted Industries Or Sectors

  • Information and communication technology
  • Business information that pertains to supplies of scarce natural resources or that provides global actors an edge in negotiations with U.S. businesses or the U.S. government
  • Military technologies (marine systems, unmanned aerial vehicles, and aerospace/aeronautic technologies)
  • Civilian and dual-use technologies in fast-growing sectors (clean energy, health care and pharmaceuticals, and agricultural technology)
  • Academia

As part of a nationwide campaign to raise awareness of the growing economic espionage threat, the FBI has released a short video, “The Company Man: Protecting America’s Secrets.” Based on an actual case, the video illustrates how one company was targeted by foreign actors and what the FBI did to help.

Contact the UConn Research Security Office at researchsecurity@uconn.edu with any concerns or questions. If you suspect economic espionage is taking place, you can also file an anonymous report at compliance.uconn.edu.

Research Compliance in the News

 

Research Compliance Services
Office of the Vice President for Research
Research Compliance Services
438 Whitney Road Extension
Storrs, CT 06269

Research Integrity & Compliance

NIH policy on registration/results posting of Basic Experimental Studies with Humans (BESH)

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NIH’s clinical trial definition includes prospective basic science studies involving human participants. Basic Experimental Studies with Humans (BESH) use an intervention to understand fundamental aspects of a phenomena without specific application towards processes or products in mind. NIH published clinical trial case studies with examples of BESH (cases 9, 14, 40 & 41).

 

NIH funded clinical trials, including BESH, are required to register and post results in ClinicalTrials.gov. On Monday, December 7th from 3:00-4:00 pm, Rebecca Williams, Acting Director of ClinicalTrials.gov, and Elisa Golfinopoulos will present the results of the National Library of Medicine analysis of challenges and considerations for registration and results information reporting of BESH in ClinicalTrials.gov. You may send questions before or during the event to SciencePolicy@od.nih.gov with the Subject “BESH Webinar”

 

Webinar: Monday, December 7, 2020 3:00-4:00 PM https://videocast.nih.gov/watch=40141

 

For more information about ClinicalTrials.gov, including assistance with registration, please contact Research Compliance Monitor, Ellen Ciesielski at eciesielski@uchc.edu.

 

 

 

 

New FDA Guidance for Civil Money Penalties for ClinicalTrials.gov Non-Compliance

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On August 12, 2020, the Food and Drug Administration (FDA) issued a final guidance document titled “Civil Money Penalties relating to the Clinical Trials.gov Data Bank.” The guidance clarifies how the FDA identifies whether responsible parties have failed to submit required clinical trial registrations or results to ClinicalTrials.gov, or knowingly submitted false or misleading information, and details the applicable fines, including “$10,000 for each day that the violation continues” and potential civil or criminal penalties. Applicable clinical trials include interventional studies evaluating at least one drug, biological, or device product regulated by the FDA.

For more information about ClinicalTrials.gov, including assistance with registration, please contact Research Compliance Monitor, Ellen Ciesielski at eciesielski@uchc.edu.

NIH Asks For Your Feedback

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The Office of the Vice President for Research would like to share some information regarding data sharing with researchers who may be affected.

The National Institutes of Health (NIH) is requesting comments on the draft NIH Policy for Data Management and Sharing and Supplemental Draft Guidance.

NIH will be hosting an informational webinar on the draft NIH policy and guidance on Monday, December 16th from 12:30-2:00 PM ET. The purpose of the webinar is to provide information on the draft policy and answer questions about the public comment process.

Submit your comments to NIH by January 10, 2020. Additional information can be found in this NIH blog post. Questions about the draft may be sent to the NIH Office of Science Policy at SciencePolicy@od.nih.gov.

For questions, please contact Research Compliance Monitor, Ellen Ciesielski at 860.679.6004.

Important Information from the NIH and NSF

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Dear Investigator,

On July 10th, the National Institutes of Health (NIH) published a reminder on NIH Policies on Other Support and on Policies related to Financial Conflicts of Interest and Foreign Components.  This was followed on July 11th by a Dear Colleague Letter on protecting research funded by the National Science Foundation (NSF) from NSF Director, Dr. France Córdova. These notices relate to the ongoing concerns regarding foreign influence in federally funded research.

In response to these publications, the OVPR recommends that any collaborations with foreign entities or individuals, or appointments with foreign entities (including foreign talent or similar programs) be disclosed to the NIH or NSF program officer, your Dean, and the OVPR (contacts and additional information listed below).

The OVPR has posted additional guidance on our site regarding Active and Pending Support and Foreign Collaborations. For any questions or for guidance on this and other related matters, please contact:

Thank you for your cooperation,

Radenka Maric, PhD
Vice President for Research
UConn/UConn Health

 

 

Important Information from the NIH and NSF for UConn/UConn Health Investigators

The NSF Letter references the draft NSF Proposal and Award Policies & Procedures Guide published in May 2019.  Clarifications in the draft Guide related to current and pending support and biographical sketches include:

  • Providing information for all current and pending support irrespective of whether such support is provided through the proposing organization or directly to the individual.
  • Expanding examples of current and pending support to include non-profit organizations and consulting agreements.
  • Reporting all projects and activities requiring a time commitment (no minimum has been established), even if the support received is only in-kind.
  • Appointments should include any titled academic, professional, or institutional position whether or not remuneration is received.

The Dear Colleague Letter also states the NSF will be issuing a policy that NSF personnel and Intergovernmental Personnel Act (IPA) assigned personnel cannot participate in foreign government talent-recruitment programs.

The NIH Notice reminds applicants that in regards to Other Support, they must:

  • List all positions and scientific appointments, both domestic and foreign, held by senior/key personnel which are relevant to an application including affiliations with foreign entities or governments such as titled academic, professional, or institutional appointments whether or not remuneration is received, and whether full-time, part-time, or voluntary (including adjunct, visiting, or honorary).
  • Report all resources and other support for all individuals designated in an application as senior/key personnel – including the program director/principal investigator and other individuals who contribute to the scientific development or execution of a project in a substantive, measurable way, whether or not they request salaries or compensation. All current support for ongoing projects must be included, irrespective of whether such support is provided through the applicant organization, through another domestic or foreign organization, or is provided directly to an individual who supports the senior/key personnel’s research efforts.
  • Report all current projects and activities involving senior/key personnel, even if the support received is only in-kind (e.g. office/laboratory space, equipment, supplies, employees), including, but not limited to, foreign financial support, research or laboratory personnel, lab space, scientific materials, selection to a foreign “talents” or similar-type program, or other foreign or domestic support.
  • Provide the total award amount for the entire award period covered (including facilities and administrative costs), as well as the number of person-months (or partial person-months) per year to be devoted to the project by the senior/key personnel.

 

The Notice also reminds applicants of the need to determine whether projects include a foreign component, defined as the existence of any “significant scientific element or segment of a project” outside of the United States including:

  • Performance of work by a researcher or recipient in a foreign location, whether or not NIH grant funds are expended and/or
  • Performance of work by a researcher in a foreign location employed or paid for by a foreign organization, whether or not NIH grant funds are expended.

 

If a significant portion of a project will be conducted outside the United States, then there is a foreign component and NIH prior approval is required.  If all project activity is conducted within the United States, but there is a non-U.S. resource supporting the project, it must be reported as other support.

Interim Director of Research Compliance Services

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Dear Colleagues,

Ms. Karen Moré, who currently serves as the Executive Program Director in support of the IACUC in the Office of the Vice President for Research for UConn’s Storrs and Regional Campuses, has agreed to serve as the Interim Director of Research Compliance Services (RCS).

As Interim Director, Karen will direct the day-to-day operations of RCS and provide leadership on University-wide programs and services for the research and teaching community. She will serve as a liaison to faculty, staff, students, and University leadership regarding matters related to research compliance issues.

For the past 8 years, Karen has managed the IACUC at UConn and has been an invaluable resource for faculty, students, and staff. Since joining the University in 1999, Karen has been an integral part of UConn’s program for the humane care and use of animals in research and teaching, and has been crucial to the University’s efforts to achieve and maintain AAALAC accreditation.

Karen brings extensive experience, expertise, and a history of collaboration and engagement with colleagues to this appointment. Please join me in thanking her for her continued service to UConn’s research community, and in congratulating her on this new position.
Regards,

Wesley G. Byerly, Pharm.D.
Associate Vice President

Office of the Vice President for Research
Research Integrity and Regulatory Affairs
University of Connecticut and UConn Health
263 FARMINGTON AVENUE, MC 1524
FARMINGTON, CT 06030
860.679.2230 Administrative Assistant
860.422.3978 Mobile Phone

NIH Asks for Your Feedback on a Future Draft Data Management and Sharing Policy

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The Office of the Vice President for Research would like to share some information regarding data sharing with researchers who may be affected.

 

The National Institutes of Health (NIH) issued a Request for Information (RFI) seeking feedback on proposed key provisions to help inform the development of a draft NIH policy for data management and sharing. Submit your comments to NIH by December 10, 2018. Additional information can be found in this NIH blog post, and questions about the proposed provisions may be sent to the NIH Office of Science Policy at SciencePolicy@od.nih.gov

 

NIH will also be hosting a webinar on the proposed key provisions on November 7, 2018, from 11:30 a.m. – 1:00 p.m. ET.

 

For questions, please contact Research Compliance Monitor, Ellen Ciesielski at 860.679.6004.

 

Are You Liable for ClinicalTrials.gov Civil Money Penalties?

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The Office of the Vice President for Research would like to share some information regarding ClinicalTrials.gov with researchers who may be affected.

 

On September 18, 2018, the Food and Drug Administration (FDA) announced a draft guidance titled Civil Money Penalties relating to the Clinical Trials.gov Data Bank. The guidance addresses how the FDA Centers (Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health, for drug, biological, and device products, respectively) identify whether parties have failed to submit required clinical trial registrations, results, or certifications, or knowingly submitted false or misleading information.

The guidance explains that when a responsible party has potentially failed to comply with its disclosure obligations, the FDA will send a Preliminary Notice of Noncompliance Letter, and allow the responsible party 30 days to make corrections. If the FDA determines that the responsible party has still failed to comply, the FDA may issue a Notice of Noncompliance, assess civil monetary penalties, or seek an injunction and/or criminal prosecution. The statutory maximum for civil penalties is “not more than $10,000 for all violations adjudicated in a single proceeding,” plus “not more than $10,000 for each day that the violation continues” past the 30-day notification period.

The deadline to submit your comments to the FDA on this draft is November 20, 2018.

 

  • To check if your trial meets the criteria for ClinicalTrials.gov registration and results posting set forth by the FDA, review this checklist. Applicable clinical trials include those evaluating at least one drug, biological, or device product regulated by the FDA.

 

  • If your NIH-funded study involves human subjects, review this checklist to see if it meets the NIH’s broad definition of a clinical trial and will require registration and results posting. NIH defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

 

For questions about ClinicalTrials.gov, please contact Research Compliance Monitor, Ellen Ciesielski at 860.679.6004.

 

 

 

Will NIH require you to register your basic science research in ClinicalTrials.gov?

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The Office of the Vice President for Research would like to share some information regarding ClinicalTrials.gov with researchers who may be affected.

 

NIH has released a Request for Information (RFI), Registration and Results Reporting Standards for Prospective Basic Science Studies Involving Human Participants. This RFI seeks input from the scientific research community and the general public regarding how best to implement the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information (NOT-OD-16-149) for prospective basic science studies involving human participants. NIH is specifically interested in learning more about studies that meet the NIH definition of a clinical trial (NOT-OD-15-015) but are not defined as applicable clinical trials (42 CFR Part 11), and also meet the definition of fundamental research. You can submit your comments to NIH by November 12, 2018.

 

For questions about ClinicalTrials.gov, please contact Research Compliance Monitor, Ellen Ciesielski at 860.679.6004.

 

ResearchMatch Training

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ResearchMatch.org is a national online recruitment tool, funded by the National Institutes of Health and maintained at Vanderbilt University. ResearchMatch connects researchers with individuals interested in participating in research studies, through its secure, online matching tool. There is no cost to UConn researchers to use ResearchMatch.

To learn more about using ResearchMatch for your studies, register for the free ResearchMatch Researcher Webinar Training/Live Demo on Thursday, July 12, 2018 from 3:00 p.m. – 4:00 p.m. The training is open to all research staff. After registering, you will receive a confirmation email with instructions on joining the training.

The team at ResearchMatch will show you how to register your studies, create a cohort of potential volunteers and send out contact messages and surveys. They will also cover how to send a pre-screening (eligibility) survey, contact the volunteers that replied ‘yes’ to your initial message, and manage your enrollment continuum.

To register for the training, click here:

https://attendee.gototraining.com/r/9112903382698216193

For additional information, contact Ellen Ciesielski at eciesielski@uchc.edu or 860.679.6004.

Revised & New University-Wide Research Policies

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The Office of the Vice President for Research (OVPR) Research Compliance Services would like to share some important updates regarding university policies for animal use, human subjects, and stem cell research. These policies were revised to be consistent with federal requirements and are now in effect for all campuses, including UConn Health.  A new university-wide policy to address FDA, NIH, and CMS requirements for registration of applicable trials to ClinicalTrials.gov has also been published.

 

Please see links to published policies below.

 

ClinicalTrials.gov: https://policy.uconn.edu/?p=7310

Animal Use in Research, Teaching and Testing: https://policy.uconn.edu/?p=113

Human Stem Cell Research Approval: https://policy.uconn.edu/?p=2453

Human Subjects Research: https://policy.uconn.edu/?p=406

 

For additional information, contact Ellen Ciesielski at eciesielski@uchc.edu or 860.679.6004.