Coming Soon! Re-launch of RCR app & new training options

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Research Integrity & Compliance within the OVPR is launching a new Responsible Conduct of Research (RCR) Program, including new training opportunities to fulfill your funder-required RCR requirements. In January, if you work on a National Science Foundation (NSF), National Institutes of Health (NIH), and National Institute of Food and Agriculture (NIFA) project, you will receive an automated email from our updated RCR training tracking app. The tracking app will show your current training status and direct you to a list of our RCR Program training options, including online CITI training, monthly in-person trainings, and our February blitz month of remote trainings that can be utilized to satisfy NIH’s requirement for 8 face-to-face training hours. Please consider visiting our RCR Program website now to view your opportunities to get a head start on fulfilling this requirement.

RCR training offerings are continuously being developed and we encourage you to consider how existing departmental events, seminars, or workshops could be leveraged to incorporate RCR-specific learnings to meet the requirements as well. Please contact the RCR Program office (contacts below) to discuss or further brainstorm on how your department may wish to partner with the OVPR in developing content for this effort.

 

Karen Moré, Director of Research Compliance, karen.more@uconn.edu

Ellen Ciesielski, Research Compliance Monitor, eciesielski@uchc.edu

Responsible Conduct of Research Training

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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.

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.

 

Important Notice on Proposal Submission Policy

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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 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.

Undergraduate Participation in On-Campus Summer 2020 Lab/Field Research

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  • 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 faculty member wanting to add one or more undergraduate students to an approved safety plan should complete and submit the Request to Include Undergraduate Students Form.
    • Once BOTH forms are received, the OVPR will respond with an Approval to both the student and faculty member.
    • For questions or concerns contact the OVPR at ovpr@uconn.edu or Office of Undergraduate Research at our@uconn.edu.

    For more information on safely conducting research during the COVID-19 pandemic, visit the OVPR’s COVID-19 Resource page.

Guidance for Reopening Research Involving Human Subjects

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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.

For more information, visit the OVPR’s COVID-19 Resource page.

Lab Preparedness Guide & Guidance on Submitting NIH RPPRs

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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:

UConn Research Lab Ramp-Up Preparedness Guide

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.

Guidance on the Preparation of NIH Research Performance Progress Report (RPPRs) and COVID-19 Impacts

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.

Contact ovpr@uconn.edu with questions.

Safety Training & Safety Plan for Phased Research Ramp Up

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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.

Contact ovpr@uconn.edu with questions.

Message from the Office of the Vice President for Research – COVID-19 Update

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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.

Important Documents

 

Principles

  • 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.

Phased Ramp Up

Phase 0: Maintain Critical Research Infrastructure (March 13, 2020 – Present)

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
Submission Process:

Questions should be sent to ovpr@uconn.edu

Phase 1: Prepare to Resume Research (Present – May 19, 2020)

  • Activities conducted by a limited number of people, with time limited access to minimize personnel density
  • Develop and require training on COVID-19 related to University, state, and federal guidelines, directives, and requirements
  • Begin re-breeding, expansion of cell lines, plant propagation, etc.
  • Limited, reopening of work areas and labs to assess readiness and needs to restart, check, and restart equipment, and identify needed supplies
  • Allow reordering of supplies, materials, animals, chemicals, biologicals, etc. needed to restart projects
  • Coordinate with other units such as facilities, purchasing, and finance to identify and address cross unit impact of ramp up
  • Re-open core research facilities

Related Guidance

Phase 2: Limited Reopening (Begins May 20, 2020)

  • 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
  • Open all research facilities

Associate VP, Innovation and Entrepreneurship

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Dear Colleagues,

I am pleased to announce that, after a national search, Dr. Abhijit (Jit) Banerjee will join UConn’s Office of the Vice President for Research as Associate Vice President, Innovation and Entrepreneurship on May 22, 2020.

Prior to joining the UConn team, Dr. Banerjee served as Senior Director of Business Development at the Office of Technology Transfer & Business Development at Oregon Health & Science University (OHSU), where he oversaw a team of business development professionals. During his tenure at OHSU, Dr. Banerjee led several major commercialization initiatives, including implementing strategies for academic-industry partnerships and long-term growth, guiding startup formation and life cycle management of new companies, and building a strong entrepreneurial ecosystem to encourage the translation of research to the market. He also has extensive experience supporting university spinoff companies, specifically in the life sciences, healthcare, and digital health sectors. Dr. Banerjee holds a Ph.D. from the Indian Institute of Chemical Biology at the University of Calcutta and an MBA from Suffolk University.

In this newly created role, Dr. Banerjee will be responsible for all aspects of the University’s technology commercialization activities, including patenting, licensing, venture development, and UConn’s business incubator, the Technology Incubation Program (TIP). Reporting to the Vice President for Research, Innovation and Entrepreneurship, Dr. Banerjee will support UConn’s continued growth as an economic driver for the state of Connecticut by helping to set an agenda that defines the University’s program in technology commercialization. I believe that Jit is a leader who is not afraid to take risks, has a clear purpose, and a high level of enthusiasm. He will work with a team to get the most out of the university and stay abreast of an ever-changing world.

I would also like to thank the search committee for their time in this comprehensive national search.

 

Cheers,

Radenka

 

Dr. Radenka Maric

Vice President for Research, Innovation and Entrepreneurship
UConn/UConn Health
Professor in Sustainable Energy
438 Whitney Road Ext., Unit 1006
Storrs, CT 06269
Storrs: 860.486.3621
UCH: 860.679.2230
research.uconn.edu