2024 Responsible Conduct of Research Training Remote Sessions

Posted on by

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 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 RCR website.

 

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

January Responsible Conduct of Research Training

Posted on by

Please join us as we kick off our new monthly in-person Responsible Conduct of Research training offerings! 

 

The Responsible Conduct of Research (RCR) Program within Research Integrity & Compliance in the OVPR is developing a series of monthly in-person RCR training sessions. For our January event, we will meet to view the Office of Research Integrity’s (ORI) interactive movie: “The Lab – Avoiding Research Misconduct.” 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. For more details about RCR requirements, please visit our RCR Program website.

 

Space is limited so registration is required. To register, please email Research Compliance Monitor, Ellen Ciesielski. For questions, please contact Karen Moré, Director of Research Compliance.

 

What: January RCR in-person training, The Lab – Avoiding Research Misconduct

When: Monday, January 22nd from 12:00 p.m. to 1:30 p.m.

Where: Babbidge Library, Class of ’47 Classroom

January RCR Training

Posted on by

Please join us to kick off our new monthly in-person RCR training offerings!

 

The Responsible Conduct of Research (RCR) Program within Research Integrity & Compliance in the OVPR is developing a series of monthly in-person RCR training sessions. For our January event, we will meet to view the Office of Research Integrity’s (ORI) interactive movie: “The Lab – Avoiding Research Misconduct.” 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. For more details about RCR requirements, please visit our RCR Program website.

 

Space is limited so registration is required. To register, please email Research Compliance Monitor, Ellen Ciesielski. For questions, please contact Karen Moré, Director of Research Compliance.

 

What: January RCR in-person training, The Lab – Avoiding Research Misconduct

When: Monday, January 22nd from 12:00 p.m. to 1:30 p.m.

Where: Babbidge Library, Class of ’47 Classroom

Coming Soon! Re-launch of RCR app & new training options

Posted on by

Research Integrity & Compliance within the OVPR is launching a new Responsible Conduct of Research (RCR) Program, including new training opportunities to fulfill your funder-required RCR requirements. In January, if you work on a National Science Foundation (NSF), National Institutes of Health (NIH), and National Institute of Food and Agriculture (NIFA) project, you will receive an automated email from our updated RCR training tracking app. The tracking app will show your current training status and direct you to a list of our RCR Program training options, including online CITI training, monthly in-person trainings, and our February blitz month of remote trainings that can be utilized to satisfy NIH’s requirement for 8 face-to-face training hours. Please consider visiting our RCR Program website now to view your opportunities to get a head start on fulfilling this requirement.

RCR training offerings are continuously being developed and we encourage you to consider how existing departmental events, seminars, or workshops could be leveraged to incorporate RCR-specific learnings to meet the requirements as well. Please contact the RCR Program office (contacts below) to discuss or further brainstorm on how your department may wish to partner with the OVPR in developing content for this effort.

 

Karen Moré, Director of Research Compliance, karen.more@uconn.edu

Ellen Ciesielski, Research Compliance Monitor, eciesielski@uchc.edu

Responsible Conduct of Research Training

Posted on by

Please join us as we kick off our new monthly in-person Responsible Conduct of Research training offerings! 

 

The Responsible Conduct of Research (RCR) Program within Research Integrity & Compliance in the OVPR is developing a series of monthly in-person RCR training sessions. For this first event, we will meet to view the Office of Research Integrity’s (ORI) interactive movie: “The Lab – Avoiding Research Misconduct.” 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. For more details about RCR requirements, please visit our RCR Program website.

 

Space is limited so registration is required. To register, please email Research Compliance Monitor, Ellen Ciesielski. For questions, please contact Karen Moré, Director of Research Compliance.

 

What: December RCR in-person training, The Lab – Avoiding Research Misconduct

When: Tuesday, December 12th from 12:00 p.m. to 1:30 p.m.

Where: Babbidge Library, Class of ’47 Classroom

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

Posted on by

UConn 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 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 that fulfill NSF RCR requirements can be found on our UConn RCR webpage. Be on the lookout for additions to the RCR offerings in the coming months!

 

ClinicalTrials.gov Modernization Efforts

Posted on by

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)

Posted on by

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.

 

Important Notice on Proposal Submission Policy

Posted on by

Revision Date: March 8, 2021 – revisions in italics

As an applicant organization, UConn/UConn Health has an institutional responsibility to verify the accuracy, validity, conformity, and eligibility of all applications submitted to a sponsor on behalf of the University. We have been exploring how to ensure the best delivery of services, meet sponsor and institutional policy requirements that were highlighted in the recent NSF audit, and to ensure that the University has sufficient time to review and certify proposals and increase the number of successful applications. To that end, we have conducted a survey of all faculty who submitted grant proposals within the last two years, listened to the research community’s comments at town halls, and solicited input from the President, Provost, deans, associate deans for research, the President’s Research Advisory Council, University Senate, and other faculty groups.

This listening process revealed that one of the main challenges for both investigators and staff is the bottleneck that occurs immediately prior to proposal submission. In recent years, nearly two-thirds of proposals submitted (with all components ready) are received by Sponsored Program Services (SPS) within one working day or less of the sponsor deadline.

Numerous proposals are being submitted just barely in time, meaning there is little time for a thorough review. Additionally, proposals that have been submitted to SPS far in advance also routinely lack a timely and thorough review because other proposals with an earlier deadline came in and “cut the line.”

To begin to remedy the proposal submission bottleneck, beginning May 5, 2021, the Office of the Vice President for Research (OVPR) will implement the current policy on internal deadlines for the review and submission of sponsored project proposals. The process change aims to reduce last day proposal submissions and will prioritize proposals as received. Once the policy is implemented, final administrative components of a proposal must be received by SPS Pre-Award at least five full business days in advance of the submission due date (along with a draft of the scientific components). The final submission ready proposal is due to SPS no later than noon the day before the sponsor deadline.

Exceptions include short turnaround RFPs, last minute sponsor requests, or a last minute opportunity to join a proposal under submission by another institution. Also, each UConn investigator will be given one pass to use in the event they are not able to meet the internal five-day deadline. As is the current practice, SPS Pre-Award will make every effort to submit these proposals when possible. Please visit the OVPR website for additional information and FAQs regarding the internal deadline policy.

To increase faculty support related to proposal preparation, the OVPR will be taking the following additional steps:

  • The OVPR is working to address situations where investigators do not have dedicated administrative support for the preparation of a proposal; we will continue to increase staff training opportunities, extend faculty service offerings, and work to simplify the submission process.
  • The OVPR will implement a dashboard to increase transparency and provide information on the status and order of review.
  • The OVPR will provide additional research development services, such as grant editing and proofreading, proposal review, large and complex grant support, and research funding consultation. Further information regarding these services and how to request them is available on the OVPR Research Development section of this website.
  • The OVPR will continue to work with and incorporate feedback from faculty working groups.  Upon recommendation of the University Senate, the President formed a sponsored projects working group to identify impediments to the expeditious review of sponsored project proposals in advance of deadlines.  The group’s report is available on the University Senate website.

 

Development, review, and submission timeline:

Full Business Days Before Submission Deadline

>6 days: PI provides application components to local grants administrator (or Faculty Services)

5 days: Complete application (plus draft scientific components) and IPR submitted to SPS

5-2 days: SPS reviews proposal and provides feedback

2 days: Corrections made and all approvals in place

Noon day before deadline: Final proposal and PI authorization to submit to sponsor provided to SPS

1-0 days before deadline: Proposal submitted

SPS is responsible for ensuring that applications are compliant and that institutional and sponsor guidelines are met including administrative, management, and scientific information. Please contact Paul Hudobenko (hudobenko@uchc.edu/UConn Health) or Mark Reeves (mark.reeves@uconn.edu/Storrs and Regionals) with questions as we move to a consistent and sustainable process.

Thank you for your continued cooperation in our collaborative efforts to advance UConn’s mission through innovative research, scholarship, and creative pursuits.

 

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

Posted on by

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

Posted on by

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.

Undergraduate Participation in On-Campus Summer 2020 Lab/Field Research

Posted on by

  • The Office of Undergraduate Research and the Office of the Vice President for Research have release guidance on undergraduate participation in on-campus lab/field research during the summer.

    Process to request Undergraduate Student participation in research:

    • The Undergraduate Student should complete and submit the Undergraduate Student Research Request Form. Once submitted, this will be emailed automatically to both the Office of Undergraduate Research and OVPR.
    • The faculty member wanting to add one or more undergraduate students to an approved safety plan should complete and submit the Request to Include Undergraduate Students Form.
    • Once BOTH forms are received, the OVPR will respond with an Approval to both the student and faculty member.
    • For questions or concerns contact the OVPR at ovpr@uconn.edu or Office of Undergraduate Research at our@uconn.edu.

    For more information on safely conducting research during the COVID-19 pandemic, visit the OVPR’s COVID-19 Resource page.

Guidance for Reopening Research Involving Human Subjects

Posted on by

The Office of the Vice President for Research (OVPR) has developed new guidance related to resuming human subjects research. The guidance outlines the minimum safety procedures that must be in place in order for UConn and UConn Health investigators to be approved by the OVPR to reopen or initiate new human subjects research. Principal investigators (PIs) must tailor their safety plans to meet the needs of each individual research situation.

Environmental Health and Safety (EHS) is available to answer safety related questions from PIs. If you have safety related questions, please email ehs@uconn.edu if your human subject research activities are conducted at the Storrs or regional campuses or call (860) 679-2723 if these activities are taking place at UConn Health.

For more information, visit the OVPR’s COVID-19 Resource page.

Lab Preparedness Guide & Guidance on Submitting NIH RPPRs

Posted on by

The OVPR’s COVID-19 Resource page has been updated with new guidance on several aspects of ramping up research activity prior to May 20, 2020, including:

UConn Research Lab Ramp-Up Preparedness Guide

The OVPR and Environmental Health and Safety have developed a guide to help researchers safely prepare labs to ramp up research activity after May 20, 2020.

Guidance on the Preparation of NIH Research Performance Progress Report (RPPRs) and COVID-19 Impacts

Sponsored Program Services has created guidance for investigators related to submission of NIH Research Performance Progress Reports (RPPRs) during the suspension of research due to COVID-19.

Contact ovpr@uconn.edu with questions.