Research Compliance Services News

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On September 18, 2018, the Food and Drug Administration (FDA) announced a draft guidance titled Civil Money Penalties relating to the Clinical Trials.gov Data Bank.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

 

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 (eciesielski@uchc.edu; 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 (eciesielski@uchc.edu, 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

CITI Program Website Now Secured by UConn NetID

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

Research MatchThe 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.

New Export Control Policy

The Office of the Vice President for Research (OVPR) would like to announce a new policy related to Export Control compliance, effective 12/14/2015. Intended to protect national security and support foreign policy, export controls are federal laws that regulate how certain controlled information, technology, software, services and goods can be shipped, transferred or transmitted to individuals or organizations overseas.  They also regulate the release of certain information to foreign nationals who are in the U.S. and their ability to work with or have access to certain technologies and software while in the U.S.  This policy has been put in to place to ensure that the University and its employees remain in full compliance with federal regulations, has been approved for all UConn campuses, and can be found at the University’s Policies & Procedures page.

The OVPR has developed resources related to Export Controls to assist faculty and other members of the University community that are available on the Research Compliance Services page.

If you have any questions relating to Export Control and/or this policy, please contact:

Dr. Wesley Byerly
Associate Vice President for Research, Research Compliance Services
Office of the Vice President for Research
(860) 679-2230
byerly@uchc.edu

IRB Policy Change: Review of Research Methods Courses

The UConn Storrs Institutional Review Board (IRB) previously required that a protocol application be submitted to the IRB for any study for which human subjects research is the intent and the researcher proposes to use or involve human subjects student research projects conducted as part of Research Methods Courses.

As of July 1, 2015, that policy has been revised as follows:

A protocol application must be submitted to the IRB for any Research Methods Course where student human subjects research projects meet the regulatory definition of research: “Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” Examples of this include: whole class projects where students are assisting the faculty member to collect data for the faculty’s own research purposes, those classes where each research project is designed to support a Master’s Thesis or a Dissertation, research projects intended to generate data that will be directly used for publication or presentation, or research projects designed to support further research (e.g., having students collect pilot data to support a future grant application or larger research project). Currently approved Research Methods Course protocols that meet the definition of research must be submitted for re-approval.

Any Research Methods Course where the goal of the student human subjects research projects is solely to provide an educational experience for the students that does not meet the regulatory definition of research will no longer require submission of a protocol application to the IRB.  Presentations of the data in the context of the class does not meet the definition of research.  Any individual or group projects within this course that do meet the definition of research must be submitted to the IRB as stand-alone protocols for review and approval.  Note that any currently approved Research Methods Course that does not meet the definition of research does not require submission to the IRB for re-approval.

Course instructors are encouraged to contact Doug Bradway at 860-486-0986 or by email at doug.bradway@uconn.edu with any questions.