OVPR Email Messages

Questions about ClinicalTrials.gov?

Posted on by

ClinicalTrials.gov is an online database of clinical trials. At UConn, 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 contact for ClinicalTrials.gov, email Ellen Ciesielski, Research Compliance Monitor in Research Integrity & Compliance in the OVPR. For details 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.

April In-Person Responsible Conduct of Research Training

Posted on by

The UConn/UConn Health RCR Office offers monthly Responsible Conduct of Research trainings to provide an opportunity to discuss and explore RCR topics, as well as count toward fulfilling funder requirements.  

 

This month’s RCR Offering

Who: April’s session focuses on clinical research but we highly encourage anyone conducting human subjects research to join us! 

What: We will meet in the library to view a live broadcast from UConn Health titled “Regulatory Compliance in Clinical Research,” sponsored by UConn Health’s Clinical Research Center (CRC). The presentation is being given by Research Integrity & Compliance AVP for UConn/UConn Health, Michael Centola.

Following the 1-hour broadcast, we will have a group discussion to wrap up our session. This is an informal gathering. Snacks and drinks will be provided! Also please feel free to bring your lunch!

When: Tomorrow, Tuesday, April 16th from 12:00 p.m. to 1:30 p.m.

Where: Babbidge Library, Class of ’47 Classroom

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

 

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

 

March Remote RCR Training 3/26

Posted on by

The Responsible Conduct of Research (RCR) Program 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

InfoEd IRB Module Clean Up

Posted on by

In preparation for the implementation of improvements to the InfoEd IRB module, the UConn IRB office has initiated a project to identify and administratively close out studies that are no longer active and those for which IRB approval has expired. Study teams may receive notifications as we go through this process. Most of the correspondence will be notification of an administrative closure which should be retained with your study records. However, please review the correspondence because we will be asking investigators who have a study with a recent lapse in approval to reply and indicate whether they intend to continue/submit a continuation.

The IRB office is actively working on improvements to our forms, templates, and guidance. Please visit our IRB Submissions, Forms & Templates page prior to creating a submission to ensure that you are using the most current versions of our forms and templates.

Additional messages about the InfoEd IRB module updates will be forthcoming.

If you have any questions, please contact irb@uconn.edu.

Changes to UConn IRB CITI and Other Updates

Posted on by

The UConn IRB office is pleased to announce the following changes to UConn’s CITI training requirements and our related processes.  Our intent is to reduce the number of times that submissions are returned for changes, streamline review cycles, and reduce burden. These changes were effective Monday, November 20, 2023, for new submissions to the IRB and for those that have not yet undergone Intake review.

  • Ideally CITI human subjects training should be complete and current at the time of IRB submission for all study personnel so that missing or expired trainings do not hold up the approval.  However, the IRB Office will no longer return a submission at the Intake review if the only issue is missing or expired training(s). An email will instead be sent to the PI informing them of who has missing/expired training(s) and noting that the training(s) must be completed before the study can be approved. Investigators will also be given the option to remove any non-essential personnel from the submission and to add them back on via a personnel amendment once the research is approved and training is complete.

 

  • When personnel have completed CITI training elsewhere, but the individual has not yet affiliated with UConn -Storrs and Regional Campuses in their CITI profile, investigators will be given the options of either having them affiliate in CITI so that their training becomes visible to the IRB Office (preferred) or uploading a copy of their CITI Completion Report (not a CITI Training Certificate) into the InfoEd study record. The Completion Report lists the modules that were completed and when. The IRB Office will review the Completion Report and determine whether the training is current (within 3 years) and meets UConn’s requirements or is substantially equivalent (meaning that at least 70% of the modules align).

 

  • For studies that are subject to NIH’s Good Clinical Practice (GCP) Training policy, the UConn IRB Office will no longer require proof of CITI GCP training with IRB submissions.  Instead, Principal Investigators will be responsible for ensuring that study personnel have completed the training, that it is refreshed at least every three years, and for maintaining the proof of training. If a study that is subject to the policy has a Post Approval Monitoring (PAM) visit, the PI may be asked to provide the documentation of GCP training for verification. Proof of training should also be provided to other appropriate parties upon request (e.g., other IRBs, SPS, NIH).

 

We are in the process of updating our webpages and other materials to reflect these changes.  Questions about training requirements can be directed to irb@uconn.edu.

 

Improvements to InfoEd: The project to make improvements to InfoEd is progressing well with all forms undergoing basic testing and revisions to ensure that the logic is functioning properly, and that content appears as expected. Work is also being done on the workflow within the system and other aspects of system set-up. We expect to soon be able to do some more advanced testing and will be reaching out to Investigators and IRB Members to assist with the testing and to provide feedback from their perspectives. Announcements will be forthcoming as we continue to make progress.

 

BRANY IRB: The UConn IRB office would like to remind study teams that new externally funded studies and studies with more than 2 collaborating sites or investigators/study personnel should be submitted to BRANY IRB after an administrative review by the IRB Office to validate consistency with UConn requirements. Please note that this includes both faculty and student research. For more information, including a process overview and BRANY-specific protocol and consent templates, please visit the following IRB webpage: https://ovpr.uconn.edu/brany-irb/.

 

We would also like to clarify that collaborating sites refers to universities and other organizations who are engaged in the research. The term “Collaborating sites” is not intended to encompass external facilities (e.g., K-12 schools) or spaces (e.g., lab space) who have agreed to provide access to their facilities/space for research activities but are not engaged in the research itself.

 

Feedback from investigators thus far has been largely positive, but we are working on a few improvements related to feedback we have received. If you have feedback to share, please reach out to the interim IRB Manager, Karen Christianson, or to the IRB Reliance Team. Feedback is always welcome and appreciated. Questions/feedback can also be sent directly to the BRANY IRB Point of Contact, Vanessa Rodriguez, at vrodrguez@brany.com or 516.514.2445.

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.

 

NE Underwater Research, Technology & Education Center Closure

Posted on by

UConn’s Northeast Underwater Research, Technology and Education Center Closes

Exploration and Research that Made a Difference

 

The University of Connecticut’s Northeast Underwater Research, Technology and Education Center (NURTEC) officially closed on December 31, 2017 after 34 years of activities across the global ocean and large lakes of the world.  Reduced funding and retirement of key personnel necessitated this action.  The Center was established at UConn in 1983 with funding from the National Oceanic and Atmospheric Administration’s (NOAA) National Undersea Research Program (NURP) and began fieldwork with research submersibles, remotely operated vehicles (ROVs) and advanced wet diving technologies in 1984.  Over the next three decades the Center compiled a remarkable record of scientific accomplishment, technological advancement, and operational safety along with developing unique education and outreach programs.  Using the scientific results generated by this work, the Center also influenced ocean policy and management.  A brief retrospective of the Center recognizes that it was guided both by the mandates and mission of NOAA, focused on conservation and sustainable use of ocean and large lake resources and by the spirit of innovation and exploration that runs deep at UConn.

For the first 25 years NURTEC operated as one of six regional National Undersea Research Centers (NURC’s), soliciting, reviewing and funding undersea research projects that required placing scientists directly, or virtually, underwater.  After federal budget priorities shifted and NURP was eliminated, NURTEC operated as a University cost center for 11 more years, based on a diversity of grants and contracts.  Over time, the Center used 9 different occupied submersibles, ten different remotely operated vehicles, and multiple approaches for wet diving systems including surface supplied, mixed gas and rebreather technologies.  The Center’s annual request for proposals was based upon NOAA’s national and related regional research priorities and was distributed to over 2,500 scientists across the nation.  Over this period the Center brought in over $43 million of federal funds that supported 246 peer-reviewed undersea research and education projects.  While research was focused primarily off the northeast and U.S. Great Lakes, projects also spanned the globe including Antarctica and U.S. Arctic waters, South China Sea, Eastern Tropical Pacific, African Rift Valley Lakes, Lake Baikal in Russia, Gulf of California, Mediterranean, Red Sea, and the northeast Atlantic off Portugal.  Scientists supported by the Center produced 213 peer reviewed publications with data collected from over 8,750 dives.

Location of NURTEC supported dives

Staff scientists at the Center and those supported at other institutions, often working with NOAA partners, made direct contributions to improve management and conservation of ocean resources.  Center scientists took results from their underwater studies to State governments, regional Fishery Management Councils, the U.S. Congress, the United Nations, and even the White House.  Some notable examples include the use of research results to significantly influence the development of essential fish habitat and deep sea coral provisions in national fisheries legislation, implementation of fisheries closed areas off the northeast US to enhance sustainable fisheries, identification of management plan alternatives for National Marine Sanctuaries, development of measures to protect vulnerable ecosystems on the high seas through the United Nations, and designation of the first Marine National Monument in the U.S. North Atlantic by President Obama. Such research also aided decisions about Long Island Sound in regards to assessing impacts of a proposed liquid natural gas terminal and impacts of the disposal of harbor dredge material on seafloor habitats.

Studies with other partners focused on the use of underwater technologies to explore our nation’s rich maritime history.  ROVs were used to identify and survey the remains of the steamship Portland, a sidewheel passenger steamer that sank in 1898 in a surprise storm with loss of 192 lives including crew and passengers.  Called the “Titanic of the Gulf of Maine,” the exploration was featured on Discovery’s Science Channel. Thirty-five additional shipwrecks were surveyed while working with NOAA’s National Marine Sanctuary program, four of which have been provided additional protection by placement on the National Register of Historic Places.  Further, the Center surveyed the wreck of the Lightship LV-51 that sank at the mouth of the Connecticut River, resulting in its being designated as Connecticut’s second submerged heritage site.

Since its inception the Center played a leading role in developing underwater sampling tools to meet the needs of sponsored researchers working on a variety of diving technologies.  In 1987 the Center initiated its remotely operated vehicle (ROV) program with the purchase of the first commercially available low-cost vehicle, the MiniRover, capable of diving to 1,000 feet and collecting samples using a simple manipulator arm. Over the next thirty years the Center acquired, operated and upgraded a number of ROVs to better serve the research community, culminating with the development of the 1,000-meter Kraken2 (K2). The K2 is widely recognized as one of the most capable and affordable “science class” ROV’s in the country and conducted a wide range of missions in support of ocean science and infrastructure.  Over the past decade the K2 has provided subsea maintenance to help keep the NSF Ocean Observatories Initiative’s Pioneer Array, located on the continental shelf south of Martha’s Vineyard, operational; recovered NOAA’s $500K HabCam towed imaging system that was lost on the wreck of the Bow Mariner; supported numerous projects focused on deep sea corals in the Gulf of Maine, Atlantic seaboard, Gulf of Mexico and National Marine Sanctuaries off the coasts of Oregon and California; and surveyed over 65 nautical miles of subsea cables for the U.S. Navy operating from the Research Vessel Connecticut.

Recovering the K2 ROV onto the RV Connecticut following a dive in the Gulf of Maine

Ocean science education was an enduring mission of the Center with a focus on the unique contribution that underwater technologies make to the advancement of science and the engagement of students and teachers.  The High School Aquanaut Program, conducted over the course of 20 years, engaged students and teachers in hands-on field science using submersibles, remotely operated vehicles and acoustic technologies.  The NSF-funded Classroom of the Sea program developed innovative ocean science education approaches for deaf and hard of hearing students.  Most recently, the Center led one of the 14 Centers for Ocean Sciences Education Excellence (COSEE) funded by the NSF – COSEE-TEK – Technology and Engineering for Knowledge that utilized ocean science and technology to provide professional development for high school teachers, and engage and expose students to ocean sciences and engineering career opportunities, including dozens of undergraduate students from the New England Louis Stokes Alliance for Minority Participation.

While NURTEC has ceased to operate, the legacy of excellence and innovation will continue within the Department of Marine Sciences.  Former Center Director Ivar Babb is now a Research Scientist within the Department with a focus on science education and the broader impacts of ocean research.  Research Professor Emeritus and former NURTEC Science Director Peter Auster, who has had a faculty appointment with the Department since 2002, continues his studies on the ecology and conservation of marine fishes, human impacts on the sea, and the use of marine protected areas as conservation tools.  The Underwater Vehicles Laboratory and ROV operations, led by Kevin Joy, will now be directed by the Department’s marine operations program.

 

Announcement Regarding Prisoner Research Protocols

Posted on by

Dear Investigators,

This is advance notice that the IRB will not be able to review protocols involving research with prisoners at its October 27, 2016 IRB meeting.  This includes submissions of new protocols, amendments and requests for continuation that involve research with prisoners.  The IRB prisoner representative member will not be able to attend this meeting.

Protocols involving research with prisoners may be submitted on Thursday, September 22, 2016 for review at the October 6, 2016 IRB meeting or submitted on Thursday, October 27, 2016 for review at the November 10, 2016 IRB meeting.  Click here for additional IRB meeting dates and submission deadlines.

If you have any questions, contact Doug Bradway at 6-0986 or by email at doug.bradway@uconn.edu.

Fair Labor Standards Act (FLSA)

Posted on by and

August 17, 2016

Dear Colleagues,

I am writing today about the recently announced changes to federal overtime regulations that will affect the compensation of postdoctoral associates as of December 1, 2016.

The Fair Labor Standards Act (FLSA) is a federal law regulated by the Wage and Hour Division of the United States Department of Labor (DOL).  This law regulates wage and hour standards such as minimum wage, overtime, equal pay, and time reporting requirements.  On May 18, 2016, President Obama and Secretary Perez announced the publication of the DOL’s final rule updating overtime regulations.  The University is required to comply with the changes to this law, effective December 1, 2016.

The regulations mandate that the standard salary level to qualify for exemption from the FLSA minimum wage and overtime requirements will increase from $455 per week ($23,660 per year) to $913 per week ($47,476 per year). In practice, employees who do not meet the revised salary threshold and other requirements, or who fail to qualify for other specific exemptions as outlined in the regulations, must be treated as hourly employees and be paid for each hour worked.

In order to comply with this new regulation, Human Resources at both Storrs and UCH has determined that postdoctoral associates will remain exempt and (where requisite), their salaries will be increased to the new threshold of $47,476.

Given this decision, all submitted proposals must include budgets that reflect the new minimum salary requirements for research staff. Information regarding these salaries is available on the OVPR website for UConn Health and the Storrs and regional campuses. Please contact OVPR Preaward Services staff with any questions at 860.486.3007 (Storrs/regional) or 860.679.4040 (UConn Health).

With regard to the added burden of increased postdoctoral associate salaries on existing projects after December 1, 2016, Central Administration at both Storrs and UCH will provide one-time financial support in FY2017 for postdoctoral associates whose salaries will increase to the new federally regulated threshold. This support will allow projects already underway in Storrs and UCH to maintain their budgeted buying power and complete the research or scholarship activities they set out to do. The Office of the Vice President for Research will work closely with Principal Investigators (PIs) to transfer these funds into the appropriate accounts.

PIs with awards from the National Science Foundation are encouraged to contact their program officer to discuss requesting additional funding to cover the increased cost of postdoctoral associate salaries, per a recently released notice from the NSF.

Thank you for your cooperation. We look forward to continuing to support your research and scholarship in every way that we can.

Sincerely,
Dr. Jeff Seemann
Vice President for Research
UConn/UConn Health

Fair Labor Standards Act (FLSA)

Posted on by

August 17, 2016

Dear Colleagues,

I am writing today about the recently announced changes to federal overtime regulations that will affect the compensation of postdoctoral associates as of December 1, 2016.

The Fair Labor Standards Act (FLSA) is a federal law regulated by the Wage and Hour Division of the United States Department of Labor (DOL).  This law regulates wage and hour standards such as minimum wage, overtime, equal pay, and time reporting requirements.  On May 18, 2016, President Obama and Secretary Perez announced the publication of the DOL’s final rule updating overtime regulations.  The University is required to comply with the changes to this law, effective December 1, 2016.

The regulations mandate that the standard salary level to qualify for exemption from the FLSA minimum wage and overtime requirements will increase from $455 per week ($23,660 per year) to $913 per week ($47,476 per year). In practice, employees who do not meet the revised salary threshold and other requirements, or who fail to qualify for other specific exemptions as outlined in the regulations, must be treated as hourly employees and be paid for each hour worked.

In order to comply with this new regulation, Human Resources at both Storrs and UCH has determined that postdoctoral associates will remain exempt and (where requisite), their salaries will be increased to the new threshold of $47,476.

Given this decision, all submitted proposals must include budgets that reflect the new minimum salary requirements for research staff. Information regarding these salaries is available on the OVPR website for UConn Health and the Storrs and regional campuses. Please contact OVPR Preaward Services staff with any questions at 860.486.3007 (Storrs/regional) or 860.679.4040 (UConn Health).

With regard to the added burden of increased postdoctoral associate salaries on existing projects after December 1, 2016, Central Administration at both Storrs and UCH will provide one-time financial support in FY2017 for postdoctoral associates whose salaries will increase to the new federally regulated threshold. This support will allow projects already underway in Storrs and UCH to maintain their budgeted buying power and complete the research or scholarship activities they set out to do. The Office of the Vice President for Research will work closely with Principal Investigators (PIs) to transfer these funds into the appropriate accounts.

PIs with awards from the National Science Foundation are encouraged to contact their program officer to discuss requesting additional funding to cover the increased cost of postdoctoral associate salaries, per a recently released notice from the NSF.

Thank you for your cooperation. We look forward to continuing to support your research and scholarship in every way that we can.

 

Sincerely,
Dr. Jeff Seemann
Vice President for Research
UConn/UConn Health

University Intellectual Property & Commercialization Policy Update

Posted on by

October 22, 2015

 

Dear Colleagues,

I am pleased to announce that an updated version of the University’s Intellectual Property and Commercialization Policy was approved by the Board of Trustees in early October and is now available online. This comes as the result of a substantive collaboration between the Office of the Vice President for Research, the Provost’s Office, the Office of the General Counsel and faculty and staff at both UConn-Storrs and UConn Health.

Although most of the substantive elements remain the same, the policy now provides a more comprehensive, consistent, and clear explanation of relevant issues, such as the use of University resources by a faculty-affiliated company, conflict of interest disclosures, and the hiring of students to work in faculty-affiliated companies, among others.

We are confident that this streamlined policy document, which applies to faculty, staff, and students at all UConn campuses, more accurately reflects the University’s belief that teaching, research, and economic development are enhanced by the intellectual property generated at UConn.

Should you have any questions related to the updated Intellectual Property and Commercialization Policy, please contact:

 

Gregory Gallo, PhD
Director
Technology Commercialization Services
Office of the Vice President for Research
Tel. 860.679.3992
gregory.gallo@uconn.edu

 

Sincerely,

 

Dr. Jeff Seemann
Vice President for Research
UConn/UConn Health