Author: Ellen Ciesielski

Questions about ClinicalTrials.gov?

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ClinicalTrials.gov is an online database of clinical trials. At UConn Health, Principal Investigators are responsible for registering and posting results per the federal regulations as well journal policies. That National Institutes of Health definition of a clinical trial is a research study1  in which one or more human subjects2 are prospectively assigned3 to one or more interventions4 (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.5  

Do you have questions about ClinicalTrials.gov registration or results posting? To schedule a virtual or in-person session with the UConn Health contact for ClinicalTrials.gov, email Ellen Ciesielski, Research Compliance Monitor in Research Integrity & Compliance in the OVPR. To learn more about ClinicalTrials.gov requirements, please see our webpages.

 

 

 

 

 

1See Common Rule definition of research at 45 CFR 46.102(d).
2See Common Rule definition of human subject at 45 CFR 46.102(f).
3The term “prospectively assigned” refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo, or other control) of a clinical trial.
4An intervention is defined as a manipulation of the subject or subject’s environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints.  Examples include:  drugs/small molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment strategies; prevention strategies; and, diagnostic strategies.
5Health-related biomedical or behavioral outcome is defined as the pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects’ biomedical or behavioral status or quality of life.  Examples include:  positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); positive or negative changes to psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and /or information retention); positive or negative changes to disease processes; positive or negative changes to health-related behaviors; and, positive or negative changes to quality of life.

March Remote RCR Training 3/26

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The Responsible Conduct of Research (RCR) Office within Research Integrity & Compliance in the OVPR hosts monthly remote RCR training sessions. For our March remote event, we will be discussing several case studies. This 1-hour event will count towards the 8-hour in person requirement for NIH, however all those who conduct research are strongly encouraged to attend!

For more details about RCR requirements, please visit our RCR Program website.

For questions, please contact Research Compliance Monitor, Ellen Ciesielski or Karen Moré, Director of Research Compliance.

What: March RCR remote training session featuring case study discussions

When: Tuesday, March 26th from 12:00 p.m. to 1:00 p.m.

Where: Remote WebEx Registration Link

March RCR Training

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Calling All Human Subjects Research Staff! Please join the Responsible Conduct of Research (RCR) Office for our March in-person RCR training session with a focus on clinical and social researchers!

 

This month, we will be highlighting the importance of appropriately protecting research participants and avoiding research misconduct. We will meet in the library to view the Office of Research Integrity’s (ORI) interactive movie: “The Research Clinic.” Snacks will be provided!

 

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, but we highly encourage anyone conducting human subjects research to join us!

 

Space is limited so registration is required. To register, please email Research Compliance Monitor, Ellen Ciesielski.

What: March RCR in-person training, “The Research Clinic”

When: Wednesday, March 13th from 12:00 p.m. to 1:30 p.m.

Where: Babbidge Library, Class of ’47 Classroom

 

For questions, please contact Karen Moré, Director of Research Compliance. For more details about RCR requirements, please visit our RCR Office website.

 

2024 Responsible Conduct of Research Training Remote Sessions

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This is the last week of the 2024 Responsible Conduct of Research (RCR) training sessions! Sessions will be presented live via WebEx in a series of hour-long sessions. This week’s sessions include “Managing Mentoring and Peer Relationships” on Monday 2/26, “Research Security/Export Control” on Tuesday 2/27, “Ethics in the Use of Human Subjects in Research” on Thursday 2/29.

 

Who should sign up? All trainees, fellows, participants, and scholars receiving support through any NIH training grant, career development award (individual or institutional), research education grant, or dissertation research grant (specifically, the following programs: D43, D71, F05, F30, F31, F32, F33, F34, F37, F38, K01, K02, K05, K07, K08, K12, K18, K22, K23, K24, K25, K26, K30, K99/R00, KL1, KL2, R25, R36, T15, T32, T34, T35, T36, T37, T90/R90, TL1, TU2, and U2R) are required to complete RCR training per NIH policy. This policy also applies to any other NIH-funded programs supporting research training, career development, or research education that require instruction in responsible conduct of research as stated in the relevant funding opportunity announcements.

 

What kind of training is required? Unlike NSF or USDA NIFA RCR requirements which can be satisfied by online training through the CITI program, NIH requires training to be “face-to-face.” Specifically, 8 hours of unique face-to-face presentation material are required by NIH. The February remote RCR training sessions may be utilized to satisfy this requirement.

 

How do I sign up? Please visit the UConn Health RCR website for a list of the sessions offered along with registration links.

 

To learn more about the NIH RCR requirement or other options to satisfy NIH’s RCR training requirement, please visit the UConn Health RCR website.

 

Questions? Please contact Research Compliance Monitor, Ellen Ciesielski at eciesielski@uchc.edu.

New NSF Responsible Conduct of Research Requirement— Effective 7/31/23

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UConn Health 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 Health 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 Health that fulfill NSF RCR requirements can be found on our UConn Health 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.

 

 

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.