RPO Office Staffing News
RPO welcomes Coralee Tye, PhD as an IRB Research Review Analyst. She comes to us from the Department of Biochemistry with research experience in biosafety oversight, animals and grant writing. Please welcome Coralee when you have an opportunity. Ryann Guayasamin, PhD is back from maternity leave and is getting back up to speed with her departments while juggling a new baby girl. Congratulations, Ryann!
RPO is utilizing a new hybrid staffing model. Staff members will be in the Waterman office 2-3 days a week and work remotely on alternate days. Staff can be reached via Microsoft Teams Monday-Friday 8:00 am – 4:30 pm. Teams is the quickest and most efficient way to connect with us. The office will be staffed 8:00 am – 4:30 pm Monday – Thursday and limitedly on Fridays.
Holiday Schedule
̽̽ offices are closed on November 25 and 26 for the Thanksgiving break and December 24 through Monday January 3, 2022 for the Christmas and New Year holidays. We are back on Tuesday, January 4.
Single IRB
Reminder Any collaborative domestic NIH project requires use of a single IRB. Please remember to identify any costs of using the Western IRB, if ̽̽ is the lead, and include those in your grant application. The excerpt below is from our website /rpo/western-irb and you can find additional information in the IRB policy and procedures /rpo/irb-policies-and-procedures#westernirb. “̽̽ Principal Investigator (PI) is Lead on a Grant
Prior to Grant Application (as early in the process as possible)
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̽̽ PI needs to identify the project as a domestic multicenter trial with two or more sites.
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̽̽ PI determines, with other sites, who they wish to be the IRB of record.
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If ̽̽ takes on that responsibility, ̽̽ PI contacts Charles Eibeler (email link), phone 919-244-9887, to assist with budget development. A complimentary, detailed, quote will be provided for the submission.
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̽̽ PI should contact their assigned SPA Research Administrator to assist with the proposal development and submission process.”
IRB Policies and Procedures Update
This is the quarterly summary update of the IRB Policy and Procedure document. The following sections have been altered with minor changes, unless otherwise noted.
5.0 Eligibility to Perform Research at ̽̽/̽̽MC
8.11 International Research (new)
10.5 NIH Genomic Data Sharing Policy (new)
13.9 Collaborative Research Between ̽̽ and the VT Agency of Human Services (AHS) (new)
27.0 Noncompliance Policy and Procedures
Compliance with Human Subjects Training and Good Clinical Practices Training Requirements
Completion of the CITI human subjects refresher training is required of all PIs and research personnel listed on non-exempt protocols and CITI Good Clinical Practice is required for anyone conducting clinical trials as well as those individuals who are in the College of Medicine. More information can be found and .
Regulations and guidance can be fluid. The refresher courses are necessary to ensure that researchers are up-to-date with the most current human subjects in research environment. The requirement to complete refresher trainings is once every 3 years. All researchers receive multiple advanced email reminders directly from the CITI system to help you remember this requirement. It is your responsibility to track and complete the training. When your IRB Analyst becomes aware of training expirations, protocol submissions will not be reviewed until the requirement has been met. A lapse in training is considered noncompliance and may be reportable.
Tips to avoid expiration:
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Heed the email reminders from the CITI system (90, 60, 30, and 7 days prior to expiration);
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Ensure that you are able to see emails sent to your uvm.edu address as that is where the reminders are sent;
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If you are unsure of when you last completed this training you may look here;
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PI/designee keeps a secondary calendar of expirations for each of the study team members and reminds personnel to complete training;
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PI/designee checks the team’s training records in the Click system prior to submitting anything in Click and works with the expired individual to complete the training as soon as possible.
̽̽MC Corner
From the Office of Clinical Trials Research
Dear LCOM REDCap Users/ Researchers and Research Staff, The REDCap system will be unavailable on Monday, Nov. 22 from 6 to 8 am while we upgrade to version 11.3.4. Please plan accordingly. We will let you know when the upgrade has been completed and the system is again available. If you have any questions, please contact REDCap.Administrator@med.uvm.edu
From the ̽̽ Health Network
The ̽̽ Health Network, in collaboration with the RPO, is implementing new procedures that will improve the review process for studies involving secondary use or disclosure of enterprise data from the ̽̽ Health Network. Beginning December 1st, studies involving data requested from the Data Management Office (DMO) for secondary data analysis using the Category Exemption 4iii Protocol will be reviewed by a new IRB Member from the DMO, instead of using the Ancillary Review process. This change will streamline the review process by providing the DMO IRB Member the opportunity to coordinate the review of the data request and the IRB study while working with the investigator directly through Service now and the ̽̽Click system. Future procedural enhancements will be phased in as they are developed and communicated to the research community through the IRB Newsletter, as well as on the Research Protections Office and Data Management Office websites.
Educational Opportunities
The September 30th IRB presentation, “Keys to Successful IRB Submissions” An overview of the most common pitfalls and misunderstandings in research and how to ensure a smooth protocol submission to the IRB. The slide deck can be accessed here.
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The December 2, 2021 IRB presentation, “Allowable Strategies for Successful Research Recruitment, Screening & Retention at ̽̽ and ̽̽MC” will be held from 12-1pm in HSRF 200.
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RPO Drop-In Hours
The office is staffed with rotating Research Analysts Monday-Thursday. Researchers may make prior arrangements with their assigned research analyst to meet in-person in Waterman 213 or via Microsoft Teams any time for remote assistance. Staff members will be available to answer your questions and discuss issues which may arise during protocol development. Please note that these consultations are advisory in nature and do not take the place of a formal IRB review. If applicable, you will still need to submit your final application to the IRB for review.
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January 2022 Fundamentals –
The Larner College of Medicine, in conjunction with The Office of Clinical Trials Research, is requiring that all research staff engaged in at LCOM and the ̽̽ Health Network complete LCOM Research Professionals Training, Fundamentals in the Conduct of Clinical Research Training Program, including, but not limited to; Research Coordinators, Research Nurses, Research Health Care Professionals, and Regulatory Staff, or individuals fulfilling these roles. This requirement applies to all research staff who are involved in the conduct of research involving human subjects, irrespective of funding source supporting the research activity.
Wednesday, January 05, 2022, 9:30am-12:00pm
Wednesday, January 12, 2022, 9:30am-12:00pm
Wednesday, January 19, 2022, 9:30am-12:00pm
Wednesday, January 26, 2022, 9:30am-12:00pm
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December Research Professionals Network
Title: When Novel turns Normal: Social Media Recruitment in an Ever-Evolving Research Landscape
Tuesday, December 14, 2021 from 3-4:15 pm Presenters:
- Elizabeth Flood-Grady, PhD, Visiting Assistant Professor, STEM Translational Communication Center and Manager, Clinical Translational Science Institute Recruitment Center, University of Florida
- Tara Pittman, MA, CCRP Recruitment Manager, SUCCESS Center South Carolina Clinical & Translational Research (SCTR) Institute Medical University of South Carolina
Level: Fundamental
Joint Taskforce Competency: , 5, 8
IRB Quality Assessment Reviews (Monitoring)
The IRB will begin in-person quality assessment reviews this November. Research Protections staff will conduct periodic protocol reviews to ensure that human subject research activities are conducted in accordance with federal regulations, state laws and institutional policies regarding the protection of human subjects in research. Monitoring for compliance and quality is necessary to meet the terms of ̽̽’s and ̽̽MC’s Federal wide Assurances. The IRB is committed to administering a process that is educational for the personnel involved in human subjects research, with the goal of fostering a collegial environment, and thus contributing to a culture of compliance. Our protocol review program covers a sampling of all studies, both medical and behavioral, that are currently active. Highest priority is given to high-risk protocols, investigator-initiated protocols with no sponsored oversight, protocols that involve the collection of sensitive personal information, and protocols that are approved for the use of a legally authorized representative. However, all types of research, including exempt, expedited, and research overseen by an external IRB, are subject to quality assurance reviews.
̽̽Click Updates
Please utilize the comment functionality within the ̽̽Click system to communicate with your Research Analyst. Emails outside of the sytem are not captured within the protocol record and could therefore result in missing information/documentation a regulator would be interested in reviewing during a site visit. It also helps cross covering personnel to recreate what has occurred with a specific submission.