Author: Ellen Ciesielski

IRB Virtual & In Person Office Hours

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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, 2nd 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.

     

    IRB InfoEd Updates and Training Sessions

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    IRB InfoEd Updates 

    The UConn 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: 

    1. Enrollment is closed, 
    1. Interactions and Interventions with participants are complete, 
    1. Data collection is complete, and 
    1. Analysis of identifiable information and/or identifiable biospecimens for the purposes of the current research is complete. 
    1. 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. 

    Sign up for an online or in-person training session on our InfoEd Training webpage.

    WHERE CAN I LEARN MORE? 

    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 

     

    IRB Virtual and In-Person Hours in September

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    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, 2nd 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.

     

    IRB Virtual Office Hours 4/22 & 4/23

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    Research Integrity & Compliance (RIC) will hold office hours via Webex extending support to both students and faculty regarding IRB submissions and regulations pertaining to human subjects research. Late afternoon appointments are made available to accommodate the schedules of students and faculty researchers. Evening appointments are available upon request.

     

    Research Integrity & Compliance (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 queries related to IRB procedures.

     

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

     

    April:

    Monday April 22, 2024, from 2:00pm-5:00pm

    Tuesday April 23, 2024, from 10:00am-1:00pm

     

    When reserving a slot, it is helpful to add information under “reason” why you would like to meet with RIC staff. You will receive a confirmation email from Nexus that includes the Webex link. 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

     

    Questions about ClinicalTrials.gov?

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    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

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    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.

     

    Student Involvement in External Human Subjects Research

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    The IRB offices at UConn and UConn Health have developed guidelines to help clarify when student involvement in external human subjects research (i.e., research that is being conducted at or by another organization) requires interaction with the UConn HRPP/IRB office.  These guidelines represent common scenarios that are presented to the office, not all possible scenarios.  When unsure, please reach out to IRB-reliance@uconn.edu. The UConn Storrs and Regional Campuses guidelines can be found on the IRB Reliance – General tab on the IRB website. UConn Health’s companion guidelines can be located within the IRB Frequently Asked Questions section of their website, under the question “Does a student project involving humans require IRB review?” These guidelines can be provided to external organizations’ IRBs if there is a question about whether submission to a UConn IRB is required.

     

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

    Recruitment at UConn for External Investigators

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    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

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    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

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    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

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    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

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    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

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    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

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    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

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    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.