Internal Communications

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

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?

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On September 18, 2018, the Food and Drug Administration (FDA) announced a draft guidance titled Civil Money Penalties relating to the Clinical Trials.gov Data Bank.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 FDAreview 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?

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.

 

Innovation Partnership Building Officially Open

A view of the Innovation Partnership Building onAug. 6, 2018. (Peter Morenus/UConn Photo)

UConn is home to some of the most active and innovative researchers in the world. Across all of the University’s campuses, scholars, artists, and scientists are working on projects that will help our state, society, economy, and the world.

That global commitment was demonstrated at a ribbon-cutting ceremony for UConn’s Innovation Partnership Building (IPB) on Discovery Drive in Storrs September 20, 2018.

UConn President Susan Herbst, U.S. Sen. Richard Blumenthal, U.S. Rep. Joe Courtney, various state legislators, and faculty, staff, and students took part in the morning event.

To read more and see photos from the event, visit UConn Today.

New OVPR Website

The Office of the Vice President for Research is pleased to present a new and improved website. The new site is still home to all of the important information you need to take care of the day-to-day of your research projects, just in a prettier package. There is some new information as well, including:

  • Cross Campus Collaboration resource page
  • Training page related to all types of research-related trainings

Please note that the OVPR’s new sites for information pertaining to Storrs, the regional campuses, and UConn Health have new URLs. If you have bookmarked pages, you will need to update to the new URLs.

If you are having trouble locating something you need, please don’t hesitate to contact the relevant service unit. Visit the OVPR Contacts page to find the office or OVPR team you need.

Exec. Director, Innovation, External Engagement & Industry Relations

Dear Colleagues,

I am pleased to announce that Dr. Mark Aindow will serve as Executive Director for Innovation, External Engagement, and Industry Relations beginning this coming fall. In addition to introducing Dr. Aindow, I would like to take this opportunity to thank the search committee and the other members of the university community who assisted during the search process.

In this role, Dr. Aindow will serve as a catalyst for new interactions between faculty, potential commercial partners, and other research organizations to support and articulate UConn’s technology innovation and research capacity. He is tasked with identifying and promoting initiatives that provide growth opportunities for applied research through technology transfer and industry partnerships. We will also look to Dr. Aindow to develop large-scale interdisciplinary, center-level initiatives, and proposals involving multiple researchers, and to coordinate with the OVPR and Government Relations to keep state agencies and congressional offices informed as appropriate, as we seek to gain support for new federal initiatives that align with UConn’s strategic priorities.

Dr. Aindow brings with him 27 years of experience in collaborative, interdisciplinary research with industry, academic, and other partners. He understands that in order for UConn to expand our research funding portfolio, it is essential that we look beyond the boundaries of traditional opportunities and that we increase outreach in emerging areas of strength for the University.

Dr. Aindow’s research, which is often interdisciplinary and invariably includes an industrial partner or sponsor, involves the study of microstructural development in engineering materials using, primarily, electron microscopy techniques. These projects include work with companies like GE Energy, Thermo Fisher Scientific (formerly FEI), and UTC Aerospace Systems, and all are associated with broader industry partnerships with UConn including: the GE/UConn partnership, the UConn/FEI Center for Advanced Microscopy and Materials Analysis (CAMMA), and the UConn/UTAS Center for Advanced Materials.

Dr. Aindow received a BEng in Metallurgy and Materials Science in 1985 and a PhD in Materials Science and Engineering in 1988 from the University of Liverpool. He joined the faculty at the University of Connecticut in 1999 and is currently a Professor of Materials Science and Engineering (MSE). While at UConn, Dr. Aindow served as Director of the MSE Program from 2006-2009 and as Associate Director for the Institute of Materials Science from 2013-2017. He has published over 350 peer-reviewed papers in journals and conference proceedings, and has graduated 29 PhDs.

We are thrilled to have someone with Dr. Aindow’s extensive experience as both an internationally recognized scientist and collaborator to lead these efforts. Please join me in congratulating Dr. Aindow on his new role!

 

Sincerely,

Dr. Radenka Maric
Vice President for Research
UConn/UConn Health

ResearchMatch Training

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.mThe 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

 

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.

Attending Veterinarian and Director of Animal Care Services

Dear Colleagues,

I am pleased to announce that following a national search, we have selected Dr. Curtis Schondelmeyer, DVM, DACLAM to serve as Attending Veterinarian and Director of Animal Care Services for UConn’s Storrs and regional campuses, effective June 22, 2018. I would like to take this opportunity to thank the search committee and other members of the university community who assisted in conducting the search, met with candidates, and provided feedback.

I would also like to thank Attending Veterinarian and Director of the Center for Comparative Medicine at UConn Health, Dr. Ramaswamy (Ramy) Chidambaram, DVM, PhD, DACLAM. During the national search, Ramy served as Attending Vet for UConn Health as well as Storrs/regionals, which allowed programs at all campuses to be maintained and for research to continue uninterrupted. Ramy will return to his prior roles as AV and Director of CCM at UConn Health upon Curtis’ arrival. Thank you, Ramy!

In his role as institutional attending veterinarian, Curtis will have oversight and direction of all animal facilities at the Storrs and regional campuses; maintain a veterinary care program that ensures compliance with federal, state, and local regulations, laws, policies, accreditation agency standards, and guidelines for the ethical care and use of animals; develop and maintain a collaborative relationship with faculty, staff, and students; and lead the administrative, management, technical, and operational functions of ACS.

Prior to UConn, Curtis served as Senior Scientist and Veterinarian at Biogen, a multinational biotechnology company based in Cambridge, Massachusetts, specializing in the discovery, development, and delivery of therapies for the treatment of neurodegenerative, hematologic, and autoimmune diseases to patients worldwide. He also has extensive previous experience working in an academic setting and held various positions in animal care services at Delaware Valley University, Emory University School of Medicine and The Yerkes National Primate Research Center, and Harvard Medical School’s Center for Animal Resources and Comparative Medicine. He earned his BS in Small Animal Science from Delaware Valley University in 2001, his Doctorate of Veterinary Medicine from Ohio State University College of Veterinary Medicine in 2004, and held a postdoctoral appointment at Emory University School of Medicine and The Yerkes National Primate Research Center beginning in 2006. He is also a Certified Professional in IACUC Administration (CPIA) and a Diplomate, American College of Laboratory Animal Medicine.

Curtis brings extensive experience, expertise, and a history of collaboration and engagement with colleagues from the private sector and academia to this appointment. Please join me in welcoming him to UConn and congratulating him on this new position.

 

Sincerely,
Radenka Maric

New Research Initiatives Supported by the Office of the Vice President for Research

Dear Colleagues,

In the current climate of declining federal funding and impending reductions in state support, the Office of the Vice President for Research (OVPR) is taking measures to provide faculty with critical additional assistance to guarantee that UConn proposals have the best chances of success. I wanted to share a few new initiatives with you as you prepare to submit new grant proposals.

Reduction of Overhead Costs

In order to provide faculty with more buying power on proposals, reduced overhead costs will be charged to grants of up to $50,000 where total costs are inclusive (i.e., direct and indirect costs capped at $50,000). This policy will be in place at UConn and UConn Health. The effective overhead rate for such grants will be capped at 20% instead of the standard 59%. This reduced rate will apply to future grant proposals, and is not applicable retroactively. Existing grants will continue to be charged the standard 59% rate. In the case where agencies, such as NSF, view a reduced F&A rate as cost share, faculty should apply the full rate and the OVPR will return the F&A back to the PI. Additional guidelines will be forthcoming on how to incorporate this lower rate on new proposals.

Faculty Grant Mentorship Incentive Program

Faculty members with a history of grant success have valuable expertise that can benefit faculty colleagues. Through this program, experienced PIs will be eligible to serve as mentors for three untenured faculty in return for a stipend of $10,000. Faculty mentors will provide untenured faculty with strategic insight and guidance to more successfully navigate the grant submission process. Activities will include introductions to program managers, review of proposals, guidance and support, help to establish individualized goals and professional development plans for each mentee, and insight on how to learn about grant solicitations that may not be announced through standard methods. In the coming weeks, we will announce an open call for senior faculty to nominate their colleagues or themselves to serve as mentors. The selection process will include an evaluation of nominees’ previous experience as a mentor for untenured faculty, as well as a review of their success winning extramural funding. Additional guidelines, mentor/mentee applications, and program requirements will be forthcoming and available on the OVPR website.

SBIR/STTR Funding

Funding through the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs encourage domestic small businesses to engage in federal research and development that has the potential for commercialization. Each year, Federal agencies with extramural research and development budgets that exceed $100 million are required to allocate 3.2 percent (FY 2017) of their R&D budget to these programs, and agencies with research budgets over $1 billion are required to set aside a portion of these funds for STTR. SBIR/STTR grants range from $300,000 to $1 million each and can be a valuable source of non-dilutive funding for startups and eligible small companies. Under SBIR, the PI must be primarily employed with the small business at the time of award and for the duration of the project period, but subcontracts often occur with collaborating research institutions. Under the STTR program, primary employment is not stipulated, so the PI may be primarily employed by a collaborating institution.

These programs can be an effective tool for entrepreneurial faculty and the university’s efforts to boost our industry sponsored research portfolio. The OVPR is initiating several support programs to increase the number of successful SBIR/STTR awards submitted with UConn/UConn Health PIs or co-PIs.

First, we will host a series of workshops to expose faculty to the programs and how to successfully apply. The first workshop is sponsored by CTNext and will be held on November 29 & 30 at 400 Farmington Ave on the UConn Health campus. For more information and to register, visit the CTNext site.

The OVPR is also piloting an effort to connect faculty to SBIR/STTR program managers, as well as existing companies seeking R&D partnerships to support SBIR/STTR proposals. In order to do this we are developing a team able to offer assistance directly to faculty, their startups, and outside industry partners that are eligible for SBIR/STTR support. If you are interested in learning more about these support services, please contact ovpr@uconn.edu.

Collaboration with the UConn Foundation

Finally, in partnership with the UConn Foundation, we will continue to seek creative solutions and establish innovative programs and initiatives to increase philanthropic dollars for student and faculty research.

For existing and new initiatives to support research, we will establish metrics and methods to track success to ensure that our investments result in returns for our faculty and the university.

We will be in touch again soon to share additional information and more specific details about these new programs and initiatives as soon as they become available. In the meantime, this message serves to reassure faculty and students that we are dedicated to helping UConn’s world-class researchers succeed despite the fiscal challenges we are currently facing. We are committed to supporting UConn’s vibrant research community, and we thank you for your invaluable contribution to the university, the state of Connecticut, and the global scientific community.

 

Sincerely,

Dr. Radenka Maric
Vice President for Research
UConn/UConn Health