Internal Communications

Recruitment at UConn for External Investigators

Effective March 20, 2024, permission for external researchers to recruit UConn faculty, students, staff, or UConn Health patients, faculty, students, or staff will be managed via a web-based request form located on the Storrs IRB Contacts webpage and the UConn Health IRB Website. This process also applies to cross-campus requests to recruit (i.e., permission for Storrs and Regional Campus researchers to recruit at UConn Health and vice-versa). This form will be routed to the appropriate offices and departments for review. This change in process is the result of efforts for the campuses to harmonize and streamline processes.

 

BRANY IRB Reminder

This is a reminder that certain new studies (as noted below) should be submitted to BRANY IRB instead of the UConn IRB.

  • Externally funded research (including when the award is expected but is pending)
  • Multisite Research/External Investigators: Studies that involve more than 2 external sites or external investigators/staff for which single IRB (by UConn/BRANY) is being requested. PLEASE NOTE: This refers to collaborating researchers/study personnel, not facilities that may be sites where research activities occur.
    • What is meant by “Single IRB (by UConn/BRANY is being requested”?
      • This refers to a situation where the UConn study team is requesting that the external sites/personnel cede IRB review to UConn and that UConn/BRANY serve as the IRB of record for these sites. If the external sites will have their home IRB review the study, then those sites would not satisfy the more than 2 external sites requirement. Please note that single IRB review is required for most federally-funded studies.
    • What should I do if an external IRB is planning to serve as the single IRB of record for a multisite study where I will be engaged in human subjects research?
  • If an external IRB will be the single IRB of record for your multisite study, please complete the External Involvement/Reliance Intake Form for Non-UConn Research Sites (found on the IRB-Reliance – General) webpage and email it to irb-reliance@uconn.edu. The UConn IRB’s reliance team will help you to facilitate a reliance agreement between UConn and the reviewing IRB. If another IRB will be the single IRB of record, the study should not be submitted to BRANY.

Instructions, forms, and templates for submissions to BRANY IRB are available on our website under the tab for IRB Reliance. If you are unsure which IRB to apply to, or have questions about the process, please reach out to the IRB Reliance Team at irb-reliance@uconn.edu.

March Remote RCR Training 3/26

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

March RCR Training

Calling All Human Subjects Research Staff! Please join the Responsible Conduct of Research (RCR) Office TODAY at noon for our March in-person RCR training session with a focus on clinical and social researchers! 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! No registration required. Snacks provided! See you in the library!

 

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

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

Where: Babbidge Library, Class of ’47 Classroom

 

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.” 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. 

 

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

 

IRB Virtual Office Hours for March

Research Integrity & Compliance (RIC) will be hosting virtual office hours via Webex for students and faculty to offer guidance on IRB submissions and human subjects regulations.  Late afternoon/early evening appointments are offered to support availability of students and faculty researchers.

 

RIC staff are available to answer questions for research teams and faculty and student investigators who have questions about submitting to the IRB, human subjects regulations, post approval support, or general guidance on IRB processes.

 

Virtual office hours will be held on the following dates and times:

 

March:

Tuesday March 19, 2024, from 3:00pm-6:30pm

Wednesday March 20, 2024, from 11:30am-2:30pm

 

 

Please use the following Nexus link to sign up for an open meeting slot to schedule an appointment:

 

https://nexus.uconn.edu/secure_per/schedule1.php?stser=4475

 

For questions related to the sessions, please contact Joan Levine at joan.levine@uconn.edu

InfoEd IRB Module Clean Up

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.

Reminder – When New Studies go to 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 now 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.

 

For examples of scenarios when an organization or individual would and would not be engaged and for more information on engagement refer to ”Engagement of Institutions in Human Subjects Research.” If you are uncertain whether an individual, facility, or organization is engaged in research, please contact irb-reliance@uconn.edu.

 

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.

 

Changes to UConn IRB CITI and Other Updates

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.

2024 Responsible Conduct of Research Training Remote Sessions

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

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

Responsible Conduct of Research Training

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

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

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)

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.

 

Research Compliance Quarterly Winter 2023

In This Issue:

  • IACUC inspections

  • ACS personnel updates

  • EHS equipment reminder

  • IRB new forms

  • Research Safety-Economic Espionage

 

 

 

 



IACUC Inspections in April

Spring Semiannual Inspections are coming up during the month of April! The Institutional Animal Care and Use Committee (IACUC) Office will reach out for availability during the first two weeks of April so please be sure that you and any lab staff are available to show the IACUC your lab and to give a brief explanation of what you do and how you do it.

Some helpful tips include:

  • Ensure logs (eye washes, scissor maintenance, surgery, etc.) are up to date.
  • Know what is in your approved IACUC protocol so you can answer any questions the IACUC may have for you. For example, what procedures are done and how is the area prepared beforehand? What happens to the animal before, during, and after the procedure?
  • If you have any drugs or substances, ensure that they are in-date or are properly discarded prior to the inspection.

Do you have a protocol expiring soon? Be sure to lookout for reminder notices from iacuc@uconn.edu and submit as early as possible to facilitate the review process. Please reach out and request any documents or information from the IACUC Office.

Did you just get notified that you’ll be receiving federal funding? Let the IACUC Office know as soon as you can so that we can perform a congruency check and ensure that the information from the grant matches what is in your IACUC protocol. If it doesn’t match, a modification may be needed, so please give yourself plenty of time!

Nick Lacafta, IACUC Specialist

Mark Johnson, IACUC Specialist/Post Approval Monitor

 



Congratulations on the promotion!

Animal Care Services (ACS) would like to announce two recent promotions!

Cassie Leone, RLAT, was promoted from Animal Care Technician to Veterinary Technician (Animal Care Specialist).

Briana Lechkun, LAT, was promoted from Animal Care Specialist to Animal Care Manager.

Job Opening! ACS is currently looking to fill an Animal Care Specialist position.

Looking for more information about ACS? The ACS website offers many helpful tools such as animal/drug ordering, per diem rates, policies/SOPs/Guidelines, and grant information to help principal investigators, lab staff and students successfully and compliantly move their research forward. Also, feel free to reach out with any questions or concerns!

Curtis Schondelmeyer, DVM, CPIA, DACLAM— Director and Attending Veterinarian

 



Purchasing, Acquiring, or Relocating Laboratory Equipment?

Reminder: Please inform Environmental Health Services (EHS) of locations of newly acquired or relocated Biosafety cabinets, x-ray, and laser equipment for registration updates. Contact us at ehs@uconn.edu.

For more information on restricted equipment/materials requiring EHS review or approval, visit https://ehs.uconn.edu/employees/equipment-purchases-and-acquisitions/

Terri Dominguez, University Director

 

 



Institutional Review Board (IRB)

The IRB Office is in the process of developing resources that we hope are of help to our research community. Two of those resources have recently been posted to the IRB Submissions, Forms & Templates webpage. In the “Templates” section, under “Consent Templates” are links to an NIH resource, “Informed Consent for Secondary Research with Data and Biospecimens,” and a Consent Checklist for Investigators document. The NIH resource includes some general points to consider when planning to seek permission for the future research use of data and biospecimens along with some sample language. The Consent Checklist for Investigators mirrors that used by the IRB when evaluating whether a consent document includes all required and “as applicable” elements of consent. We hope that this is helpful as a self QA check prior to submitting consent materials to the IRB.

We also plan to create a section on our website with some resources to help investigators understand NIH’s requirements and recommendations for human participant research subject to the updated Data Management & Sharing Policy. In the meantime, we encourage investigators to review the information the Library has made available on their webpage: NIH Data Management and Sharing Requirements. Please let us know if you have other suggestions for resources: irb@uconn.edu.

And please join us in welcoming our newest IRB Program Specialist, Jeanelle Graham! Jeanelle comes to us with many years of experience as an IRB professional and it is already apparent that she is a great addition to our team!

Questions about human subjects research or IRB? Contact us at irb@uconn.edu.

 



A Message from Research Security

Economic Espionage

Economic espionage is foreign power-sponsored or coordinated intelligence activity directed at the U.S. government or U.S. corporations, establishments, or persons, designed to unlawfully or clandestinely influence sensitive economic policy decisions or to unlawfully obtain sensitive financial, trade, or economic policy information; proprietary economic information; or critical technologies. This theft, through open and clandestine methods, can provide foreign entities with vital proprietary economic information at a fraction of the true cost of its research and development, causing significant economic losses.

Our Nation’s secrets are in jeopardy, the same secrets that make your company profitable. The FBI estimates billions of U.S. dollars are lost to foreign competitors every year. These foreign competitors deliberately target economic intelligence in advanced technologies and flourishing U.S. industries.

Foreign competitors operate under three categories to create an elaborate network of spies:

  • Aggressively target present and former foreign nationals working for U.S. companies and research institutions;
  • Recruit and perform technical operations to include bribery, discreet theft, dumpster diving (in search of discarded trade secrets) and wiretapping; and,
  • Establish seemingly innocent business relationships between foreign companies and U.S. industries to gather economic intelligence including proprietary information.

What Are Trade Secrets?

Trade secrets are all forms and types of financial, business, scientific, technical, economic or engineering information, including patterns, plans, compilations, program devices, formulas, designs, prototypes, methods, techniques, processes, procedures, programs, or codes, whether tangible or intangible, and whether or how stored, complied, or memorialized physically, electronically, graphically, photographically or in writing, (1) which the owner has taken reasonable measures to protect; and (2) which have an independent economic value from not being generally known to the public.

Commonly referred to as proprietary information, economic policy information, trade information, proprietary technology, or critical technology.

What Are Some Methods Of Targeting Or Acquiring Trade Secrets?

  • Steal, conceal, or carry away by fraud, artifice, or deception;
  • Copy, duplicate, sketch, draw, photograph, download, upload, alter, destroy, photocopy, replicate, transmit, deliver, send, mail, communicate, or convey; and,
  • Receive, buy, or possess a trade secret, knowing the same to have been stolen or appropriated, obtained, or converted without authorization.

Know The Signs

  • Working odd hours without authorization
  • Taking proprietary information home without authorization
  • Unnecessarily copying material
  • Disregarding company policies on personal software and hardware
  • Accessing restricted websites
  • Downloading confidential material
  • Conducting unauthorized research

Personal Behaviors

  • Unexplained short trips to foreign countries
  • Engaging in suspicious personal contacts with competitors, business partners or unauthorized individuals
  • Buying items they normally cannot afford
  • Overwhelmed by life crises or career disappointments
  • Showing concern about being investigated

Common Factors

  • Financial need
  • Greed
  • Unhappiness in the workplace
  • Different allegiances to another company or country
  • Drug/Alcohol abuse
  • Vulnerability to blackmail
  • Job offers from other organizations

Targeted Industries Or Sectors

  • Information and communication technology
  • Business information that pertains to supplies of scarce natural resources or that provides global actors an edge in negotiations with U.S. businesses or the U.S. government
  • Military technologies (marine systems, unmanned aerial vehicles, and aerospace/aeronautic technologies)
  • Civilian and dual-use technologies in fast-growing sectors (clean energy, health care and pharmaceuticals, and agricultural technology)
  • Academia

As part of a nationwide campaign to raise awareness of the growing economic espionage threat, the FBI has released a short video, “The Company Man: Protecting America’s Secrets.” Based on an actual case, the video illustrates how one company was targeted by foreign actors and what the FBI did to help.

Contact the UConn Research Security Office at researchsecurity@uconn.edu with any concerns or questions. If you suspect economic espionage is taking place, you can also file an anonymous report at compliance.uconn.edu.



Research Compliance in the News

 

Research Compliance Services
Office of the Vice President for Research
Research Compliance Services
438 Whitney Road Extension
Storrs, CT 06269

Research Integrity & Compliance