Please join us as we kick off our new monthly in-person Responsible Conduct of Research 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.
Please join us as we kick off our new monthly in-person Responsible Conduct of Research 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 this first 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: December RCR in-person training, The Lab – Avoiding Research Misconduct
When: Tuesday, December 12th from 12:00 p.m. to 1:30 p.m.
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!
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.
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 theevent 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.
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!
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!
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.
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;
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.
Revision Date: March 8, 2021 – revisions in italics
As an applicant organization, UConn/UConn Health has an institutional responsibility to verify the accuracy, validity, conformity, and eligibility of all applications submitted to a sponsor on behalf of the University. We have been exploring how to ensure the best delivery of services, meet sponsor and institutional policy requirements that were highlighted in the recent NSF audit, and to ensure that the University has sufficient time to review and certify proposals and increase the number of successful applications. To that end, we have conducted a survey of all faculty who submitted grant proposals within the last two years, listened to the research community’s comments at town halls, and solicited input from the President, Provost, deans, associate deans for research, the President’s Research Advisory Council, University Senate, and other faculty groups.
This listening process revealed that one of the main challenges for both investigators and staff is the bottleneck that occurs immediately prior to proposal submission. In recent years, nearly two-thirds of proposals submitted (with all components ready) are received by Sponsored Program Services (SPS) within one working day or less of the sponsor deadline.
Numerous proposals are being submitted just barely in time, meaning there is little time for a thorough review. Additionally, proposals that have been submitted to SPS far in advance also routinely lack a timely and thorough review because other proposals with an earlier deadline came in and “cut the line.”
To begin to remedy the proposal submission bottleneck, beginning May 5, 2021, the Office of the Vice President for Research (OVPR) will implement the current policy on internal deadlines for the review and submission of sponsored project proposals. The process change aims to reduce last day proposal submissions and will prioritize proposals as received. Once the policy is implemented, final administrative components of a proposal must be received by SPS Pre-Award at least five full business days in advance of the submission due date (along with a draft of the scientific components). The final submission ready proposal is due to SPS no later than noon the day before the sponsor deadline.
Exceptions include short turnaround RFPs, last minute sponsor requests, or a last minute opportunity to join a proposal under submission by another institution. Also, each UConn investigator will be given one pass to use in the event they are not able to meet the internal five-day deadline. As is the current practice, SPS Pre-Award will make every effort to submit these proposals when possible. Please visit the OVPR website for additional information and FAQs regarding the internal deadline policy.
To increase faculty support related to proposal preparation, the OVPR will be taking the following additional steps:
The OVPR is working to address situations where investigators do not have dedicated administrative support for the preparation of a proposal; we will continue to increase staff training opportunities, extend faculty service offerings, and work to simplify the submission process.
The OVPR will implement a dashboard to increase transparency and provide information on the status and order of review.
The OVPR will provide additional research development services, such as grant editing and proofreading, proposal review, large and complex grant support, and research funding consultation. Further information regarding these services and how to request them is available on the OVPR Research Development section of this website.
The OVPR will continue to work with and incorporate feedback from faculty working groups. Upon recommendation of the University Senate, the President formed a sponsored projects working group to identify impediments to the expeditious review of sponsored project proposals in advance of deadlines. The group’s report is available on the University Senate website.
Development, review, and submission timeline:
Full Business Days Before Submission Deadline
>6 days: PI provides application components to local grants administrator (or Faculty Services)
5 days: Complete application (plus draft scientific components) and IPR submitted to SPS
5-2 days: SPS reviews proposal and provides feedback
2 days:Corrections made and all approvals in place
Noon day before deadline: Final proposal and PI authorization to submit to sponsor provided to SPS
1-0 days before deadline: Proposal submitted
SPS is responsible for ensuring that applications are compliant and that institutional and sponsor guidelines are met including administrative, management, and scientific information. Please contact Paul Hudobenko (hudobenko@uchc.edu/UConn Health) or Mark Reeves (mark.reeves@uconn.edu/Storrs and Regionals) with questions as we move to a consistent and sustainable process.
Thank you for your continued cooperation in our collaborative efforts to advance UConn’s mission through innovative research, scholarship, and creative pursuits.
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”
For more information about ClinicalTrials.gov, including assistance with registration, please contact Research Compliance Monitor, Ellen Ciesielski at eciesielski@uchc.edu.
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 toClinicalTrials.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 trialsinclude interventional studies evaluating atleast one drug, biological, or device product regulated by the FDA.
Formoreinformation about ClinicalTrials.gov, including assistance with registration, please contact Research Compliance Monitor,Ellen Ciesielskiateciesielski@uchc.edu.
The Office of Undergraduate Research and the Office of the Vice President for Research have release guidance on undergraduate participation in on-campus lab/field research during the summer.
Process to request Undergraduate Student participation in research:
The Undergraduate Student should complete and submit the Undergraduate Student Research Request Form. Once submitted, this will be emailed automatically to both the Office of Undergraduate Research and OVPR.
The Office of the Vice President for Research (OVPR) has developed new guidance related to resuming human subjects research. The guidance outlines the minimum safety procedures that must be in place in order for UConn and UConn Health investigators to be approved by the OVPR to reopen or initiate new human subjects research. Principal investigators (PIs) must tailor their safety plans to meet the needs of each individual research situation.
Environmental Health and Safety (EHS) is available to answer safety related questions from PIs. If you have safety related questions, please email ehs@uconn.edu if your human subject research activities are conducted at the Storrs or regional campuses or call (860) 679-2723 if these activities are taking place at UConn Health.
The OVPR has issued new Guidance on UConn Health General Use PPE for Research, which explains the process for UConn Health researchers to obtain general use PPE for the phased reopening of research at UConn Health.
The OVPR’s COVID-19 Resource page has been updated with new guidance on several aspects of ramping up research activity prior to May 20, 2020, including:
The OVPR and Environmental Health and Safety have developed a guide to help researchers safely prepare labs to ramp up research activity after May 20, 2020.
Sponsored Program Services has created guidance for investigators related to submission of NIH Research Performance Progress Reports (RPPRs) during the suspension of research due to COVID-19.
The OVPR’s COVID-19 Resource page has been updated with new guidance on several aspects of ramping up research activity prior to May 20, 2020, including:
Phase 0: Pilot/Limited Research Activity
The Critical Research Infrastructure process is being expanded to allow immediate time-limited access to on-campus research labs in order to generate targeted research to support impending grant deadlines and contract resubmissions, competitive renewals, response to manuscript or other reviewer comments and other similar needs. This is not a ramping up or reopening of the labs and research areas to resume usual research. The process for the Phased reopening of research after May 20th is under development. Submissions must include the following:
Resuming Research Activity form (no longer active)
Returning to Research COVID-19 Safety Training This course was prepared for the University of Connecticut research community (UConn Storrs, regional campuses, and UConn Health) by the Department of Environmental Health and Safety. It is based on current CDC guidelines and UConn procedures. Any updates to these guidelines or procedures will supersede the content in this training. It is mandatory that all individuals complete the online training module before returning to research work. Documentation of completion must be retained by the lab or research area. If you experience any technical difficulties, contact Training and Outreach Program Manager Dr. Shawna Lesseur at shawna.lesseur@uconn.edu.
COVID-19 Safety Plan (no longer active) A COVID-19 Safety Plan must be completed and submitted with the Resuming Research Activity form as part of Phase 0: Pilot/Limited Research Activity. The Faculty Member/Principal Investigator is responsible for ensuring compliance with this Plan. Failing to follow this plan will result in restrictions up to and including immediate shutdown of the offending research lab or area.
Consistent with Governor Lamont’s April 30th Update on Connecticut’s Coronavirus Response Efforts, the OVPR is targeting a phased reopening of UConn and UConn Health research programs to begin on May 20, 2020 (Phase 2 in the posted Ramp-Up: Phased Process for Reopening Research at UConn and UConn Health). This document provides guiding principles and processes for a phased approach to reopening research at UConn and UConn Health while addressing state and federal directives and guidelines related to COVID-19. Instituting a similar process will be established for the Arts and Humanities that reflects the specific needs and concerns of scholarly activity in those areas.
The health and safety of faculty, staff, students, patients, the public, and human research subjects will be protected.
Directives and guidance from local, state, and federal authorities to minimize disease spread and exposure will be followed, such as restrictions related to essential businesses, social distancing, reduced density, stay-at-home, and masks.
Faculty, staff, and students are not required to work in either on-campus research or in field research while stay-at-home directives are in effect, or in a manner contrary to current and applicable directives and guidance from local, state, and federal authorities. Faculty, staff, and students may choose to work either on campus or in field research while stay-at-home directives are in effect, but their choice to do so must be made voluntarily and without undue influence or coercion. Any request to work on campus or in field research can be declined at any time without any fear of retaliation or retribution while work-from-home directives are in place. Any concerns can be reported anonymously through the REPORTLINE by calling a toll-free number at (888) 685-2637, the Office of University Compliance’s website, or the Ombuds Office. The University welcomes and encourages good-faith reporting. As such, individuals who submit a report or participate in a compliance investigation in good faith are provided protection from retaliation per the University’s Non-Retaliation Policy.
On-campus or field research can proceed only to the extent it can be done safely and in compliance with regulatory requirements and University policies. Safety must be rigorously maintained. All University policies and requirements, as well as all local, state, and federal regulatory requirements remain in place and must be followed, unless there is written guidance or documentation that they have been modified or suspended.
Research involving human subjects can proceed only to the extent it can be done safely and in a manner that protects the health of the subjects, researchers, and research staff. Human subjects research must follow current applicable directives and guidance from local, state, and federal authorities to minimize disease spread and exposure. All University policies and requirements, as well as all local, state and federal regulatory requirements remain in place and must be followed, unless there is written guidance or documentation that they have been modified or suspended.
Undergraduate students will not be involved or allowed to participate in on-campus or field research activities until the University opens and these students are allowed to return to campus.
Principal Investigators (PIs) remain responsible for providing direction and oversight of their projects, labs, and/or research sites, and personnel including graduate students, postdoctoral fellows, and staff.
Researchers must maintain plans and be prepared to halt all activities on short notice if this becomes necessary.
The ramp up of research will be through a transparent and phased process.
A publically available working document outlining the phased approach will be maintained and serve as guidance for the ramp up process.
Two groups have been established by the Vice President for Research, Innovation and Entrepreneurship (VPRIE) to provide guidance and oversight for the process:
The Critical Infrastructure Workgroup comprised of five associate research deans. This group reviews and approves projects, and also provides expert guidance on research needs.
Research Ramp up Advisory Group. This group is comprised of senior representatives from various areas, providing a broad range of infrastructure expertise, such as Environmental Health and Safety, Public Safety, Facilities, the Graduate School, Office of the Provost, Core Facilities Directors, Human Resources, and others. This group provides guidance on the support infrastructure that is required to allow research to move forward.
This includes unique reagents, unique cell lines, equipment, liquid nitrogen stocks, and certain long-term experiments where data integrity would be compromised by halting or stopping the projects. The process for review and approval of these projects using the Critical Research Infrastructure Inventory (CRI) form has been in place since March 23rd. This process is also in place to approve the initiation of new projects directly related to COVID-19. Researchers should continue to use this process for applicable projects.
Pilot/Limited Research Activity Approval
The Critical Research Infrastructure process is being expanded to allow immediate time-limited access to on-campus research labs in order to generate targeted research to support impending grant deadlines and contract resubmissions, competitive renewals, response to manuscript or other reviewer comments and other similar needs.
This is not a ramping up or reopening of the labs and research areas to resume usual research. The process for the Phased reopening of research after May 20th is under development.
Project Criteria for Pilot/Limited Research Activity Approval:
Work can be conducted with a limited number of individuals in the lab at any one time
All work can be fully completed within two to four weeks
The work is necessary to produce data in support of an application due within the next 45 days
Returning to Research COVID-19 Safety Training: It is mandatory that all individuals complete the online training module before returning to research work. Documentation of completion must be retained by the lab or research area.
Personnel density increased in a manner that is consistent with federal and state guidelines and directives
Requests for Phase 2 projects are submitted using the Resuming Research Activity form (currently only available for Phase 1) and include a COVID-19 Safety Plan
Identify projects halted or stopped as part of ramp-down not involving chemical or radiological hazards and prioritize for phased restart
Prioritization of groups such as graduate students and postdocs close to completing their degree/term of appointment; grants within three months of their end dates and where the funding agency has not provided flexibility in no cost extensions.
Restart field studies depending on conditions/requirements/restrictions at field sites, such as travel restrictions, stay-at-home directives, and density and social distancing requirements
Humanities, arts, and social science research that requires access to single occupancy spaces (e.g., office, private studio)
Restart human research projects involving direct subject interactions and interventions conducted at UConn Health or University facilities that were halted or stopped as part of ramp-down
Phase 3: Expanded Reopening (To be determined)
Personnel density increased in a manner that is consistent with federal and state guidelines and directives
Requests for Phase 3 Projects are submitted using the Resuming Research Activity form (currently only available for Phase 1) and include a COVID-19 Safety Plan
Identify projects halted or stopped as part of ramp-down involving chemical or radiological hazards and prioritize for phased restart
Restart human research projects involving direct subject interactions and interventions conducted off campus that were halted or stopped as part of ramp-down
Restart humanities, social science, and arts research/scholarship involving direct interpersonal interactions or engagement
Phase 4: Transition to Research as Usual (To be determined)
Begin initiation of new projects
Project submissions no longer required to use the CRI process
