Recent News | Office of the Vice President for Research

October 29, 2024

There are appointments available for virtual or in person meetings with IRB staff scheduled for next Wednesday (virtual) and Thursday (in person)!

IRB Virtual & In Person Office Hours

The Research Integrity & Compliance (RIC) team will be holding virtual (via Webex) and in person office hours to assist students and faculty with IRB submissions and human subjects regulations. To accommodate varying schedules, late afternoon and early evening appointments will be available.

RIC staff will be available to answer any questions regarding IRB submissions, human subjects regulations, post-approval support, and general IRB guidance.

Office hours will be held on the following dates and times:

Wednesday, November 6, 2024: 3:00pm – 6:30pm (virtual)
Thursday, November 7, 2024: 10:00am – 12:00pm and 1:00pm – 2:30pm (in person) Location: Whetten Graduate Center, Giolas Conference Room, 2^nd floor

Follow the link below to schedule an in person or virtual meeting.

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

Education & Training Sessions Offered by RIC

The RIC office provides education, presentations, and training sessions to researchers, research teams, and classes. These sessions cover a range of topics, including best practices for obtaining informed consent, successful IRB submissions, and managing research post-approval. Sessions can also be tailored to requested special topics and subject matter related to human subjects research.

For questions about the office hours or sessions/presentations, please contact Joan Levine at joan.levine@uconn.edu.

October 17, 2024

Info Ed Updates

The IRB Office is EXCITED to announce that the updates to the IRB module of InfoEd will go-live later this Fall. The updated system will help streamline IRB submission and review processes, making it easier to keep track of your protocols and communications with the IRB staff, and streamline the review process.

WHAT WILL BE DIFFERENT?

Consolidated Smart Forms: the application forms have been consolidated into a single Main Application form that uses logic to drive your experience.

Updated Protocol Templates: Comprehensive protocol templates will be introduced with the goal of reducing back and forth during the review process.

Responding to IRB Feedback: System enhancements will make it easier for study teams to respond to IRB feedback.

Routing: Routing will be automated; submitters will not have to add the PI and Department Head to the route for review and sign-off.

Personnel Roles: Personnel roles will drive who on a study team is able to edit, manage, and submit submissions to the IRB and who receives messages.

Amendments: There will be two types of amendments: Personnel Changes and Amendments (for changes to the study itself or study materials). Only one amendment can be in process at any given time.

Ancillary Reviews: Questions are built into the application form that will determine the need for ancillary reviews and automatically inform the responsible office.

Reportable Information/Events: All reports of issues or information that is required to be reported to the IRB will be reported using a single smart form.

Administrative Check-Ins: Studies that do not require continuing review will receive periodic notices to complete an administrative check-in or a study closure.

WHAT DOES THIS MEAN FOR EXISTING STUDIES?

Most existing studies will need to be migrated to the updated application form for the system to work as intended. Migration will be required before continuing review (starting on February 25th 2025) or with the next submission to the IRB (for studies without continuing review).

A study migration guide is forthcoming.

Investigators are encouraged to close studies that are eligible for closure as soon as possible. Studies are eligible for closure when:

Enrollment is closed,

Interactions and Interventions with participants are complete,

Data collection is complete, and

Analysis of identifiable information and/or identifiable biospecimens for the purposes of the current research is complete.

When the UConn IRB is serving as the IRB of record for other sites, the study may be closed when all sites meet the above criteria.

Simply maintaining identifiable data/biospecimens without using, studying, or analyzing the data/biospecimens does not require an open protocol with the IRB.

IS TRAINING AVAILABLE?

Research Integrity & Compliance will offer weekly training opportunities both in-person and online via WebEx or Teams. They are open to all UConn faculty, staff, and students. A recorded session will be made available for those unable to attend in person.

WHERE CAN I LEARN MORE?

Visit our dedicated InfoEd Update webpages for more information in the future. The IRB Office (irb@uconn.edu) is always available to answer any questions you may have.

How-To Guides with step-by-step instructions will also be made available including:

InfoEd Guide for Researchers

InfoEd Guide for Ancillary Reviewers

InfoEd Guide for Department Reviewers

InfoEd Guide for IRB Members

September 3, 2024

IRB Virtual and In-Person Office Hours

The Research Integrity & Compliance (RIC) team will be holding office hours via Microsoft Teams to assist students and faculty with IRB submissions and human subjects regulations. To accommodate varying schedules, late afternoon and early evening appointments will be available.

RIC staff will be on hand to answer any questions regarding IRB submissions, human subjects regulations, post-approval support, and general IRB guidance.

Office hours will be held on the following dates and times:

Wednesday, September 25, 2024: 3:00pm – 6:30pm

Location: Whetten Graduate Center, Giolas Conference Room, 2^nd floor.

Thursday, September 26, 2024: 10:00am – 1:00pm

Follow the link below to schedule an in person or virtual meeting.

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

Education & Training Sessions Offered by RIC

The RIC office provides educational and training sessions to researchers, research teams, and classes. These sessions cover a range of topics, including best practices for obtaining informed consent, successful IRB submissions, managing research post-approval, and other aspects of human subjects research.

For questions about the office hours or educational sessions, please contact Joan Levine at joan.levine@uconn.edu.

February 12, 2024

IRB Virtual Office Hours

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:

February:

Monday February 19, 2024, from 3:00pm-6:30pm

Wednesday February 21, 2024, from 1:00pm-4:00pm

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

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.