uconn health

Scholarship and Collaboration in Humanities and Arts Research (SCHARP)

The Office of the Vice President for Research (OVPR) Scholarship and Collaboration in Humanities and Arts Research (SCHARP) Awards aim to support innovative works of scholarship and creative activities in the arts and humanities that have the potential to transform a field of study, impact the common good, or chart a new direction in scholarly, creative, or artistic development.  Proposal reviews will be conducted by a committee composed of representatives from UCHI, the College of Liberal Arts and Sciences, and the School of Fine Arts.

To learn more about the SCHARP Awards, visit the OVPR Storrs site.

UConn Innovations in Quantum STEM Education

Advances in quantum science have the potential to have transformative social and economic impact.  New technologies are poised to revolutionize major industries, creating opportunities for new applications that will fuel economic growth.

Taking full advantage of emerging quantum technologies requires a STEM-educated workforce that is ready to put these new technologies to work.  The Innovations in Quantum STEM Education program seeks to inspire and seed research into quantum-ready STEM education and workforce training that will enable our communities to rise to meet the new employment opportunities that quantum technologies will bring.  We encourage collaborations between UConn and Yale faculty, as well as other academic, workforce development, and corporate/industry partner organizations, to pursue innovative educational research related to quantum.  We particularly encourage collaborations that include faculty from quantum-related fields, STEM Education or curriculum development, and/or digital media and design.

Areas of interest include (but are not limited to): assessing the current state of STEM education approaches in our region and our readiness for quantum, developing/testing new educational approaches to teaching quantum-related STEM concepts, developing training modules and game-based techniques for teaching quantum concepts, developing/implementing quantum-informed curriculum plans for all educational levels, and developing/implementing quantum-informed workforce development approaches for specific industries.

This program is offered as a companion program to the Quantum-CT Regional Innovation Engine project. Quantum-CT, led by UConn and Yale University, is an effort to build an innovation ecosystem of researchers, educators, industry, and state/local stakeholders to harness the economic impact of new quantum-enabled technologies through technology development, innovation and entrepreneurship, and advances in STEM education and workforce development.

To learn more about the program, visit the OVPR Storrs site.

UConn Quantum Innovation Seed Grants

Advances in quantum science have the potential to have transformative social and economic impact.  New technologies are poised to revolutionize major industries, creating opportunities for new applications that will fuel economic growth.

The UConn Quantum Innovation Seed Grant program is designed to encourage and catalyze collaboration among researchers from UConn, Yale University and other regional academic partners, corporate/industry partners, and other stakeholders to explore, develop, and translate innovations and applications related to quantum technologies.  Building on existing strengths at UConn and within partner organizations across the region, this program seeks to support the development of use-inspired applications of quantum technologies relevant to the following research areas and industries:

  • New materials and manufacturing methods for fabricating quantum devices
  • Quantum computing and algorithms; quantum assisted optimization, quantum simulation
  • Advancements in data science, artificial intelligence, and machine learning
  • Quantum information technologies, quantum sensing and cryptography

Quantum science is expected to have direct applications in industries in which Connecticut has a strong presence and workforce:

  • Healthcare and biotechnology
  • Insurance and financial tech
  • Cybersecurity
  • Aerospace
  • Pharmaceuticals
  • Defense
  • Other use sectors

This program is offered as a companion program to the Quantum-CT Regional Innovation Engine project. Quantum-CT, led by UConn and Yale University, is an effort to build an innovation ecosystem of researchers, educators, industry, and state/local stakeholders to harness the economic impact of new quantum-enabled technologies through technology development, innovation and entrepreneurship, and advances in STEM education and workforce development.

To learn more about the program, visit the OVPR Storrs site.

UConn Quantum Startup Awards

Advances in quantum science have the potential to have transformative social and economic impact.  New technologies are poised to revolutionize major industries, creating opportunities for new applications that will fuel economic growth.

To accelerate the translation of quantum technologies, UConn’s Office of the Vice President for Research is creating a new program to support faculty entrepreneurs interested in creating new startups based on quantum-related innovations – the UConn Quantum Startup Awards

This program is offered as a companion program to the Quantum-CT Regional Innovation Engine project. Quantum-CT, led by UConn and Yale University, is an effort to build an innovation ecosystem of researchers, educators, industry, and state/local stakeholders to harness the economic impact of new quantum-enabled technologies through technology development, innovation and entrepreneurship, and advances in STEM education and workforce development.

To learn more about the program, visit OVPR Storrs site.

Guidance on Closure of Human Subject Research Studies

Guidance on Closure of Human Subject Research Studies

A research study should be closed by the Principal Investigator (PI) once all human research activities are completed regardless of whether a study is subject to the continuing review requirement.  To do so, a closure form should be submitted to the IRB through the iRIS submission system for each non-exempt human research study (e.g., studies approved under Expedited review or Full Board review).  The closure form should be submitted before the expiration of IRB approval, however, the PI can also submit a closure form after they have received a notice of lapse of approval.

If the study is an exempt study, the PI may allow the IRB approval to expire. When approval of an exempt study expires, the IRB will administratively close the study, but this does not invalidate the exemption. The research, as proposed to the IRB, may continue; it is not necessary to keep the exemption actively registered with the IRB.

A closure form allows the IRB to have a summary of the following information:

  • the findings of the study
  • the final enrollment data
  • whether the study met the recruitment goals, and
  • whether any of the following events occurred since the last approval (initial or continuing review):
    • subject complaints
    • unanticipated problems involving risk to subjects or others,
    • unexpected profile of adverse events in terms of frequency and/or severity,
    • non-compliance with or deviation from the approved protocol or procedures,
    • audits, inspections or monitoring visits by internal or external personnel.
    • any publications, presentations, trademarks, patents, etc. related to the study.

This guidance explains the circumstances in which a non-exempt human research study may be closed from IRB oversight, as well as ongoing researcher responsibilities that apply to closed studies.

 

Things to Consider before Closing Research Studies

  • Investigators should honor wishes of the sponsor or funding source to keep the study open or to close the study.  Some funding entities require IRB approval for the duration of the funding, even if human research activities are complete, or they may not allow the study to close without the sponsor’s permission. It is the PI’s responsibility to be aware of, and comply with, those requirements.
  • Sponsors, contract research organizations (CROs), or coordinating center personnel may need to verify or monitor individually identifiable study data at a specific site where human subjects activities have been completed. The study team should verify whether these organizations require the studies to be open when conducting their monitoring visits. IRB approval must be maintained while these activities are occurring.
  • Whenever possible, prior to closing a study, data should be permanently de-identified.

When to Close a Study

  • For studies requiring continuing review (e.g., some Expedited studies and all full board studies ) a requests for closure should be submitted at the time the next continuation application is due or within 30 days after the completion of all study activity involving the use of private identifiable information or biospecimens, whichever comes first.
  • Moreover, a closure form should be submitted to the IRB if the if the research study was not conducted or was canceled, or if each of the following conditions exist:
    • The research is permanently closed to the enrollment of subjects
    • The subjects have completed all research-related interventions
    • The research is no longer active for long-term follow up of subjects
    • Data has been de-identified.
  • When a Principal Investigator terminates employment with UConn Health, the PI may submit a closure form to the IRB. Alternatively, the PI may submit a modification form requesting transfer of the study to another eligible Principal Investigator.   Retired investigators with Emeritus status at UConn Health may be permitted to keep the study open and continue as the PI with approval from the HSPP Director.
  • When a student-led project is completed, the study should be closed with the IRB.  This should occur prior to the student’s departure / graduation.

 

IRB Process of Expired studies, Lapsed Studies and Closure Forms

  • Expired studies : If approval for continuation of non-exempt research is not sought, or a request to extend the expected completion date has not been received within a reasonable time frame (e.g., 30 days), IRB staff will administratively close the study and send a written notification to the Principal Investigator of the administrative closure.  The research activity may not continue and a new application may be required to resume research activity.
  • Lapsed studies: If approval of the study has lapsed due to lack of a response to contingencies or a request for continuing approval or to extend the completion date has not been received the study may administratively be closed.  The IRB will send a written notification to the PI. Prior to closure the IRB will issue a final request for response by email to the PI and study contacts and the PI will be given a reasonable period within which to respond (e.g. one or two weeks).
  • Closure forms:  When a closure form is submitted, the IRB will review any new information provided in the closure form and determine whether any additional action is required on the part of the IRB or the investigator. Upon review of the closure form, the status of the study is changed in the iRIS system (e.g., “Closed by PI”) and an outcome letter is issued confirming the closure.

Principal Investigator Responsibilities with Closed Studies

The principal investigator (PI) continues to have responsibilities for a study even when IRB oversight of a study is no longer required. These responsibilities include:

  • Verifying all research activities have been completed. The PI should ensure that all research-related activities, interventions or interactions with human subjects or individually identifiable data have been completed at the site(s) approved under the Principal Investigator’s IRB application at the time a closure form is submitted to the IRB or at the time of approval expiration, whichever occurs first.

If after a study is closed, the PI wishes to engage in an activity such that the criteria for closure listed above would no longer be met, the Principal Investigator must submit a new application for IRB review and approval for the use of the previously collected data.

  • Record Retention Research data from the completed study should be stored and protected in the manner approved by the IRB and consented to by the research participant so as to maintain the privacy and confidentiality of the participants.

Per HSPP Policy 2011-024.0 – File Requirements & Record Retention Requirements, investigators must maintain research records for three years beyond the completion/termination of the study. Investigators should be aware that other laws and requirements (e.g., funding agency) may require a longer record retention period. Per the HIPAA regulation, investigators are to retain documents relating to uses and disclosures, authorization forms for 6 years from the date of creation or the date when it last was in effect, whichever is later.  Per the State of Connecticut records retention schedules, the retention period for signed research authorizations is six years after the study closure date, unless a longer retention period is specified in a contract with a sponsor/funding source in which case, the longer retention period specified in the contract must be followed.

Investigator should be familiar with the record retention format described in the UConn Health HSPP Policy 2015-024.1 – Record Retention Format.

Investigators should ensure that any specific regulatory and/or sponsor requirements are met for record retention or submission of reports.

  • Confidentiality and Data Security. If the PI is maintaining identifiable private data or specimens, the protections described in the IRB application and to subjects must be maintained for the time frame described. The PI must continue to honor any commitments made to participants as part of the approved research (e.g., providing information about study results; payment for research participation).
  • HIPAA authorization. The PI may have obtained HIPAA authorization from subjects to access their medical records, with an expiration date that is far in the future. If the PI still has permission to access medical records at the time they want to close the study that permission expires upon study closure.

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

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

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

Active and Pending Support

General Information/Introduction

UConn researchers should be transparent regarding their other research support, other research activities, and research collaborations when submitting grant proposals to external sponsors. Disclosure of such support, via forms commonly referred to as “Current and Pending” or “Other Support,” allows the identification of potential duplication of funding, assessment of the investigator’s capacity/available effort to complete proposed projects, the evaluation of potential conflicts of interest, and the overall protection of national security and economic interests.

While the format/form being provided to the sponsor may vary, if applicable to a proposal under development, PIs should include ALL support, including grants and contracts from all domestic and non-U.S. sources, including support internal to UConn. Additional guidance is generally available in the specific funding opportunity announcement to which the proposal is responding, and MUST be followed to avoid return without review or other negative consequences.

Federal agencies are increasingly placing additional scrutiny on potential foreign influence and its impact upon the U.S. research enterprise. Efforts at the federal level are currently underway to standardize disclosure requirements, forms, and other requirements, and some agencies have provided additional guidance on completing disclosure documents. For additional assistance, or to report changes to disclosure documents related to existing awards, please contact your department administrator or SPS@uchc.edu.

Active and Pending Support

EpicCare Link at UConn Health for Clinical Trial Studies

EpicCare Link at UConn HealthEpicCare® Link at UConn Health is a secure web portal that offers site monitors easy access to clinical trial study data. There is no cost to access the portal, and there’s no software or hardware to maintain. EpicCare Link is available 24/7 via any computer with an Internet connection and an up-to-date browser. Supported browsers include Chrome version 50 or later, Microsoft Edge version 79 or later, and Internet Explorer version 11.

In order to provide a site monitor with access to EpicCare link and a specific clinical trial, an EpicCare Link Agreement between the sponsor and UConn Health needs to be completed first. Once the agreement is executed, we will add the sponsor to the EpicCare Link. A site monitor can be added once the sponsor is added to EpicCare Link. You can learn more about our process via the following documents:

To start the process, please complete the EpicCare Link Request Form and send it to octrclinicaltrial@uchc.edu.

If you any questions, please contact us at octrclinicaltrial@uchc.edu.

Chemical Safety Data Sheets (SDS)

To access a Safety Data Sheet (SDS), search for it either with a general search engine, such as Google, or use of the specific manufacturer’s or SDS service websites listed below. Specific instructions for each website are listed in the table below.

COMPANY SITE INSTRUCTIONS
Google, Yahoo, MSN, etc. Enter the search criteria: SDS + product name + manufacturer (if known) and SEARCH button to bring up link to SDS.
3M Under Search, down arrow until you find “with Product Name/Number” and under the search (magnifying glass) type in the product you are searching for and on the magnifying glass.
Acros Organics Type in the product name in the “Product Code” box and “Go”.
Avantor Performance Materials, Inc “Certificate/SDS search” and type product name in the “text search” box under SDS and “SDS Search”.
Bio-Rad Laboratories Got to “Literature Library” – Check mark “SDS” and type product name in the search box and press “Search Documents”.
Certol International, LLC Click on whether medical/dental/industrial then on products located in the middle of the page and find the product name and “Safety Data Sheets”.
Eastman Kodak Company Enter product name and search for SDS.
ECOLAB Type in product name and search for SDS.
Fisher Scientific Type in SDS product you are searching for SDS
GC America Inc. Look for product name you are searching for SDS.
Thermo Fisher Scientific Search by typing in product you are looking for and scroll down to find the SDS.
Ivoclar Vivadent Search for product you are looking for. Click on product and to get information.
Lang Dental Manufacturing Company, Inc. Search by product name for SDS.
Promega Search by product name under “Search SDS”.
Pharmco-Aaper Find the product name to get SDS.
Sigma-Aldrich Under “Data Specific Search” search by “Product Name” and under “Search Term” enter product name and click “Search”.  Find the phenol description you are looking for and find “SDS” (next to Pricing) with and click on download arrow.
Sterilex Find product name, “Learn More” and “Resources” to get SDS.
Steris Corporation Search by product name, product number, document title, or key word and “Search SDS”.
Temrex Corporation Click on product name for SDS.