Research Compliance Services News

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.

 

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

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

 

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

 

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

 

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

 

 

 

 

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

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

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

NIH Asks For Your Feedback

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

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

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

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

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

Important Information from the NIH and NSF

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Dear Investigator,

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

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

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

Thank you for your cooperation,

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

 

 

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

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

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

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

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

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

 

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

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

 

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

Interim Director of Research Compliance Services

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Dear Colleagues,

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

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

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

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

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

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

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

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

 

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

 

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

 

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

 

Are You Liable for ClinicalTrials.gov Civil Money Penalties?

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

 

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

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

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

 

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

 

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

 

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

 

 

 

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

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

 

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

 

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

 

ResearchMatch Training

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

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

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

To register for the training, click here:

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

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

Revised & New University-Wide Research Policies

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

 

Please see links to published policies below.

 

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

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

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

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

 

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

Attending Veterinarian and Director of Animal Care Services

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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

CITI Program Website Now Secured by UConn NetID

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The Office of the Vice President for Research (OVPR) is pleased to announce that training offered through the CITI Program website is now secured by the UConn Single Sign-On NetID. Faculty, staff, and students at the Storrs and regional campuses will now be able to access the CITI Program website using their UConn NetID and password, instead of/in addition to a specific CITI Program website username and password.

The CITI Program is used by OVPR Research Compliance Services and UConn faculty, staff, students, and affiliates for online training related to animal care and use, biosafety, research with human subjects, NIH Good Clinical Practice, and Responsible Conduct of Research. Since partnering with CITI, over 20,000 UConn learners have used the CITI Program website to fulfill their regulatory training requirements.

Utilizing the UConn Single Sign-On makes it easier for faculty, staff, graduate and undergraduate students to access the CITI Program training courses with their existing UConn NetID and eliminates a unique username or password specifically for the CITI Program. It also assures faculty, staff, and student learners using CITI are correctly identified in training reports, making it easier to tell if the appropriate coursework has been completed.

To take advantage of this new feature, simply log in through our institution on the CITI Program website at https://www.citiprogram.org instead of using your existing CITI login credentials. Further information about CITI Training requirements for the UConn IRB can be found on our website at https://ovpr.uconn.edu/irb/citi-training/.

 

If you have any questions, please contact Matthew Cook at 860.486.1698 or matthew.cook@uconn.edu.

ResearchMatch now available to UConn researchers

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Research Match

The Office of the Vice President for Research (OVPR) is pleased to announce that UConn is now part of the ResearchMatch Network. ResearchMatch.org is a national online recruitment tool, funded by the National Institutes of Health and maintained at Vanderbilt University. ResearchMatch connects interested participants with research studies that might be a good “match” for them through its secure, online matching tool. There is no cost to UConn researchers who use ResearchMatch to conduct recruitment feasibility analysis or participant recruitment.

For more information, including the process for using ResearchMatch as a recruitment tool, please contact Ellen Ciesielski in the OVPR Research Compliance Services at 860.679.6004 or email researchmatch@uchc.edu.