Internal Communications

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

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

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.

Informational Session/Q&A on Research at UConn During & After the Pandemic

SAVE THE DATE: The Office of the Vice President for Research will join President Thomas Katsouleas in hosting a virtual informational session for UConn & UConn Health researchers on Monday, April 20 from 11:00am to 12:30pm. The purpose of the session is to update the UConn research community on critical information related to research on campus during and after the COVID-19 pandemic, as well as answer questions from UConn faculty and staff. A number of questions have already been submitted via the University Senate. If you would like to pose a question regarding our research activities or share a comment, please send it to ovpr@uconn.edu before Monday, April 20.

While the world is still in the midst of the ongoing crisis, there are a great many unknowns when it comes to research and our other operations, but participants will endeavor to answer every question they are able to and discuss what is known with respect to research as of April 20.

A communication with a web address on how to watch and participate in the town hall will be sent later this week.

OVPR Internal Funding Announcement

Dear Colleagues,

I hope this message finds you well, as we have all been facing many challenges related to the COVID-19 epidemic over the last several weeks. While our focus has been on rapidly shifting to new methods for teaching and conducting research, the Office of the Vice President for Research (OVPR) is pleased to announce that decisions for several of our internal funding programs have been finalized. These programs support a variety of high impact research, scholarship, and artistic pursuits across UConn and UConn Health’s departments. The OVPR is thrilled to support these diverse projects, which will lead to additional extramural funding and increase the reputation of UConn amongst peers. Funding for the following recipients will be made available now for projects that can be conducted remotely, and will be on hold for other recipients until the University resumes normal operations after the COVID-19 pandemic. Decisions regarding other internal funding programs including the Research Excellence Program (REP) and Scholarship and Collaboration in Humanities and Arts Research (SCHARP) are expected to be announced in May.

 

Please join me in congratulating winners for the following funding programs and visit the OVPR’s Internal Funding website to learn more about these programs:

Convergence Awards for Research in Interdisciplinary Centers (CARIC)

CARIC is an initiative of the Office of the Vice President for Research (OVPR) that provides support of up to $150,000 for the development of collaborative interdisciplinary teams to bid for major (>$5M) federally funded initiatives, such as research centers. CARIC provides funding for planning, outreach to strategic partners, and proof-of-concept research activities that will prepare the team to bid competitively for these prestigious federal awards.

Puxian Gao, Material Science and Engineering
Mapping Catalytic Energy Transformations: Convergence of Nanoarray Catalysis, In Situ Microscopy, and Data Science

Jeffrey Hoch, Molecular Biology and Biophysics
Biomolecular Digital Commons

Cato Laurencin, Connecticut Convergence Institute
Convergence Center for Regenerative Engineering- A Science and Technology Center

Mark Urban, Ecology and Evolutionary Biology
241: Reintegrating Biology & Harnessing the Data Revolution to Predict and Prevent Global Ecosystem Change

 

Microbiome Seed Fund Recipients
Through this program, the OVPR is able to provide up to $50,000 to UConn faculty to support innovative and collaborative research projects that will lead to new proposals for extramural funding in microbiome research.

Jonathan Klassen, Molecular and Cell Biology
Metal-Binding Antimicrobial Peptide Mediation of a Fungus-Growing Ant Symbiosis

Co-PIs: Alfredo Angeles-Boza

Mark Peczuh, Chemistry
Characterizing the Role of Siderophores in the Euprymna Scolopes – Vibrio Fischeri Symbiosis
Co-PIs: Spencer Nyholm

J Evan Ward, Marine Sciences
The Effect of a Common Anthropogenic Pollutant on the Microbiome of an Ecologically and Commercially Important Bivalve
Co-PIs: Penny Vlahos, Lisa Nigro

Wing Ki Mok, Molecular Biology and Biophysics
Friend or Foe? Impact of Chronic Infection Microbiome Constituents on Persistence of Staphylococcus Aureus toward Antifolate Antibiotics
Co-PIs: Dennis Wright, Maria Rocha Granados, Debjani Si

 

Spring 2020 Scholarship Facilitation Fund Program

Through this program, the OVPR is able to provide up to $2,000 to UConn faculty across all disciplines, on a competitive basis, to foster, support, and enhance research, scholarship, and creative endeavors. (Please visit the site for the full list of recipients.)

 

START Preliminary Proof-of-Concept Q1-3

Through this program, the OVPR is able to provide up to $10,000 to Central Connecticut State University, Southern Connecticut State University, University of Bridgeport, and UConn faculty to foster and bolster the initial validation of innovative early stage technologies that have possible commercial potential. The program is designed to bring these promising technologies to a stage that may be more attractive for additional later stage translational funding support. (Please visit the site for the full list of recipients.)

Cheers,

Radenka

COVID-19: NSF RAPID Program Opportunities

Dear Colleagues,

While we all face turmoil caused by the global coronavirus pandemic, I wanted to make sure that all faculty are aware of unique funding opportunities through the National Science Foundation with the specific aim of helping address COVID-19. Specifically NSF’s RAPID funding mechanism allows for a drastically reduced submission/award timeline to address this urgent need. Please see the Dear Colleague letter below from NSF Director, Dr. France A. Córdova for more information and consider applying through this mechanism if you are conducting applicable research.

Thank you, as always, for your continued support of UConn and our research community.

Sincerely,
Radenka

NSF 20-052

Dear Colleague Letter on the Coronavirus Disease 2019 (COVID-19)

March 4, 2020

Dear Colleague,

In light of the emergence and spread of the coronavirus disease 2019 (COVID-19) in the United States and abroad, the National Science Foundation (NSF) is accepting proposals to conduct non-medical, non-clinical-care research that can be used immediately to explore how to model and understand the spread of COVID-19, to inform and educate about the science of virus transmission and prevention, and to encourage the development of processes and actions to address this global challenge.

NSF encourages the research community to respond to this challenge through existing funding opportunities. In addition, we invite researchers to use the Rapid Response Research (RAPID) funding mechanism, which allows NSF to receive and review proposals having a severe urgency with regard to availability of or access to data, facilities or specialized equipment as well as quick-response research on natural or anthropogenic disasters and similar unanticipated events. Requests for RAPID proposals may be for up to $200K and up to one year in duration. Well-justified proposals that exceed these limits may be entertained. All questions should be directed either to a program officer managing an NSF program with which the research would be aligned or to rapid-covid19@nsf.gov.

Complete guidance on submitting a RAPID proposal may be found in Chapter II.E.1 of the NSF Proposal and Award Policies and Procedures Guide.

We ask that all investigators and organizations maintain awareness of the dynamic nature of this event through regular monitoring of official communications from the Centers for Disease Control and World Health Organization.

NSF has also provided Frequently Asked Questions that address questions associated with NSF proposal submission and award management relevant to research proposals relating to COVID-19 as well as possible impacts of COVID-19 on activities under existing awards and on participation in NSF’s merit review panels; that website will be updated as appropriate.

Sincerely,

Dr. France A. Córdova
Director

Research Shut Down Notice March 23, 2020

With Governor Lamont’s order for all non-essential businesses to suspend operations, the president, provost and vice president for research have determined that all on-campus research activities on ALL CAMPUSES – UConn, regional and UConn Health – must stop and labs must
close by 8 p.m. on Monday March 23.

In addition to faculty, this includes research being conducted by undergraduates, graduate students, and postdoctoral scholars. The only exceptions to this are human subjects clinical trials, research where continued in-person interaction or intervention is needed for the safety and welfare of enrolled subjects, research that is directly connected to addressing the COVID-19 crisis, and research that can be conducted remotely by faculty, staff, and/or students without in-person intervention or interaction with research subjects.

We understand the enormous impact this decision will have on faculty and students. But as we deal with the challenges of a global pandemic as well as the uncertainty of its impact on all aspects of the University and surrounding communities, we must make difficult decisions guided
by the principles of health and safety.

  • Faculty and research staff should follow the Laboratory Ramp-Down Checklist: Procedures for Safely Vacating a Laboratory (updated March 22, 2020) to close down their research and labs.
  • Research related to COVID-19 can continue, but faculty must submit a Critical Research Infrastructure Inventory form indicating they need to begin or continue this work and describe the work (see last question on the form).
  • Faculty with animals must contact the attending veterinarian for their campus regarding steps to immediately reduce animal numbers and number of cages. Breeding must be reduced to the minimum possible; no increases in cage counts will be permitted and plans should be in place for reductions of cage counts in the future. Labs using aquatic, avian, or other species that are housed outside the vivarium must contact the attending veterinarian regarding how animal care and husbandry operations will be maintained.
  • Any faculty with critical research infrastructure, such as unique reagents, unique cell lines, equipment, liquid nitrogen stocks, and certain long-term experiments should complete the Critical Research Infrastructure Inventory form (updated March 22, 2020). These will be reviewed and the faculty
    member will then be advised on how to proceed based on their individual situation.
  • Any researcher or faculty member who is unable to halt their research by Monday’s deadline or who has a unique situation that needs to be considered should email ovpr@uconn.edu with a description of the situation or need and their recommendation for how it can best be met or addressed. The email should include a phone number(s) where the faculty member can be reached.
  • Any student or employee who feels they have been asked unreasonably to continue on campus research beyond Monday’s deadline should contact the dean of their school or college and the OVPR without fear of retaliation.

For now, the shut-down of labs will be in effect until April 22, 2020. We will assess and monitor the status as events change daily. However, you should plan for a remote-work research operation and lab closure that could last for several weeks or months.

Important NIH teleconference on Covid-19 Monday, March 16, 2020

Dear UConn Community,

Research!America is hosting a conference call on Monday, March 16th from 1:30 to 2:30 PM with NIH Deputy Director Lawrence Tabak. Dr. Tabak will discuss NIH’s efforts to ensure research institutions and scientists are accorded the flexibility needed as they confront COVID-19-related research disruptions. No need to RSVP for the call (call number below). To dial in:

What: Teleconference with Dr. Larry Tabak
When: 1:30-2:30 p.m. ET, Monday, March 16, 2020
Call-In: 866-876-6756 (toll-free) or 704-288-1165 (U.S.)
Passcode: 737857

The following are additional updates and guidance from the NIH and NSF

o   Frequently Asked Questions (FAQs) about COVID-19 for the National Science Foundation

o   NSF website for the research community with detailed guidance on the Coronavirus (COVID-19)

o   Frequently Asked Questions (FAQs) about COVID-19 for the National Institutes of Health

o   Flexibilities Available to Applicants and Recipients of Federal Financial Assistance Affected by COVID-19

Cheers,
Radenka

Attention- UConn Health Human Subjects Research Community:

The UConn Health Institutional Review Board (IRB) would like to remind Principal Investigators (PI) and study personnel of existing IRB policies and procedures that are in place and that may be relevant given the potential impact of COVID-19 on research. Because every research protocol is different, the IRB is not issuing a single standard. Principal Investigators are responsible for the oversight of their research, for knowing the nature of their research, and for determining what action, if any, is needed for ensuring appropriate policies and procedures are followed. The following policies may be of particular relevance during this time. Principal Investigators and study personnel should review these policies and determine which actions, if any, are appropriate.

Policy 2011-009.1 – Institutional Review Board – Submission of Materials: In accordance with this policy, if a Principal Investigator determines that a change to the implementation of the protocol is necessary, a request for modification is to be submitted to the IRB. For example, if the PI determines that all subject interviews will be conducted by phone vs. in person, a request for modification should be submitted to the IRB. As with any modification, the change should be clearly described to the IRB. For example, changes that will only occur for a limited timeframe should be described accordingly (e.g. “while the COVID-19 pandemic is ongoing, subject interviews will be conducted by phone whenever possible”). When possible, approval for such changes is to be received prior to the change being implemented.  However, if a change in protocol is required to eliminate apparent immediate hazards to subjects, the PI may implement that change and report it to the IRB within five business days. In this type of situation, the change to protocol would be anticipated to be a lasting change and not particular to one subject ,which would be reported per one of the following policies.

Policy 2009-002.0 – Reporting Non-Compliance to the Institutional Review Board: In accordance with this policy, protocol deviations within the control of the research team are to be reported to the IRB within five business days. Non-compliance that is not within the control of the research team and that does not pose risks to subjects is to be reported to the IRB at the time of continuation or study closure, whichever comes first. For example, if a subject declines to come to a study visit due to general concerns about COVID-19, and missing that visit will not place the subject at risk, this would be tracked by the study team and reported to the IRB at study continuation or closure. Likewise, if the institution makes a policy decision that prevents the study team from fully implementing the approved protocol, the deviations would be tracked and reported at study continuation or closure, provided the subjects were not put at risk. For example, if the institution limited access to only those providing or needing clinical care, subjects would not be able to come on site for interview/survey procedures. It is anticipated that the tracking of protocol deviations will be the most prevalent course of action during the COVID-19 pandemic.

Policy 2009-001.0 – Reporting Unanticipated Problems to the Institutional Review Board: An unanticipated problem is any unforeseen occurrence that involves risk to the subject or others, and that is related to or is possibly related to either a research intervention or interaction, or the conduct of the study in general. If a protocol is not able to be implemented and that inability places the subject at risk (e.g. subjects prevented from coming to institution to receive clinical research intervention and the lack of intervention puts the subject at risk), the PI should report this to the IRB. This may be a single missed visit; or it may become a concern after a certain number of visits are missed.

In summary, it is the responsibility of the Principal Investigator to oversee the implementation of the research protocol within the framework of existing IRB policies and procedures. If you have any questions, you may contact one of the IRB Regulatory Specialists.

  • Steven MacKinnon for IRB numbers ending in -1 or .1  (mackinnon@uchc.edu, 860-679-8729)
  • Patricia Gneiting for IRB numbers ending in -2 or .2   (gneiting@uchc.edu, 860-679-4849)

NSF 2026 Idea Machine

Dear Colleagues,

In the summer of 2018, the National Science Foundation (NSF) launched an innovative competition, the NSF 2026 Idea Machine, to crowdsource big challenges and big ideas that could help tackle them. The Idea Machine aimed to set the stage for breakthrough research in science, technology, engineering, and mathematics (STEM) and STEM education through the nation’s 250th anniversary in 2026 and beyond. NSF received around 800 entries from established researchers, students, teachers, and even high school and middle school students from all across the country. Those 800 big ideas have now been narrowed down to seven finalists, which were announced last week.

As we continue to work towards fulfilling President Katsouleas’ bold vision to boost research, scholarship, and creative works at UConn, I encourage you to visit the NSF 2026 Idea Machine site and learn about the program’s goals and the recently selected finalists. This provides UConn’s research community with an opportunity to see what is next for the NSF’s long-term agenda and align our activities based on our existing and emerging strengths.

Thank you for your continued commitment to grow UConn’s profile in research, scholarship, and the arts.

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

Export of Research Materials Abroad

To the UConn/UConn Health research community:

The Council on Government Relations (COGR) has issued an alert regarding recent situations where researchers have attempted to export research materials abroad. The FBI and other federal law enforcement agencies have increased their surveillance efforts to identify transport of research materials and verify that those exports comply with federal laws. These efforts are believed to be part of a nation-wide enforcement action to control the transport of biological materials that may present a threat to our national security and/or reduce the theft of intellectual property developed in the US, much of it with federal funds.

Transporting certain materials may require import/export permits or other documentation from federal agencies, including US Customs and Border Protection (CBP), the FDA, USDA, Fish and Wildlife, and the CDC.

Anyone with questions should contact the applicable federal agency or the UConn Export Control Office (exportcontrol@uconn.edu) for assistance.

Related news:
– https://www.universalhub.com/2019/chinese-cancer-researcher-not-allowed-leave
– https://www.universalhub.com/2019/chinese-researcher-nabbed-liquid-filled-vials

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