Research Protections Office News
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.
The RPO is undergoing an internal redesign process. This process was begun to address recent and future internal and regulatory mandates in our industry. Items such as single IRB, Heath Network research, and potential accreditation require a different infrastructure to remain current, responsive and maintain compliance across the University. RPO is happy to announce the following promotions for IRB staff:
Melanie Locher, B.S., CIP, IRB Director. Melanie has been with the IRB for 16 years and has established relationships with many of you. Her knowledge of ̽̽’s research culture along with her positive work ethic will take the IRB to the next level.
Jen Dulin, MS, DVM, IRB Reliance Administrator and Health Network Liaison. Jen will be the single IRB subject matter expert at ̽̽. This position will fine tune the present policies and procedures that allow for ̽̽ to rely on other institutional IRBs and will develop new policies and procedures that allow reliance on ̽̽’s IRB for the ̽̽HN affiliates.
Nataniel Lester-Coll, M.D., Assistant Professor for Radiation Oncology, has accepted the position as our new medical Associate Chair of the IRB starting July 1, 2022.
Please join me in congratulating these individuals. RPO will be recruiting over the Summer for a new IRB research analyst position, stay tuned for a future new job posting.
̽̽Click
̽̽Click is scheduled for an upgrade from version 8 to version 9 sometime in October. The upgrade will be scheduled to occur over a week-end to limit the amount of disruption to users. There is a new single page view of the entire SmartForm which provides visual indicators for any missing entries. There is an inline document version comparison feature which will assist researchers and staff to ensure they are working from the version intended. Redesigned SmartForm views and overhaul of the external/single IRB reliance submission processes provide an enhanced user experience. RPO staff feel these are all helpful improvements and are excited to move forward.
More information on the upgrade will be released towards the end of the Summer. No new training will be necessary as a result of this upgrade, however, RPO will release revised user guides and FAQ’s.
Click Tips – Tip 1: Click is unable to accept encrypted documents. The system cannot version or add an approval stamp to consents or protocols with embedded encryption. Please remove any protections prior to uploading documents to Click. Tip 2: Please utilize comments to correspond with your analyst. The comments feature is similar to email and your analyst will be alerted to new comments. It is important these exchanges are in the Click system for cross-coverage within RPO and for research teams members.
IRB Policies and Procedures Updates
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.
1.3 Operations of the IRB
1.4 Public Records and Open Meetings (Vermont Law)
14.3 Grant Proposals Lacking Definite Plans for Involvement of Human Subjects
24.2 Prisoners
27. Noncompliance Policy and Procedures
30. Statement of Compliance for the Committees on Human Research
Education Opportunities
The March 15, 2022 IRB presentation, “Navigating IRB Ancillary Reviews” be accessed here
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The April 14th and June 16th “Ask the IRB” open Q&A sessions were well attended, more sessions later this Summer to be announced.
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Upcoming –
July 14 , 2022 - “Quality Assurance Reviews in Research. What they are and what to expect”
Hosted by the IRB and OCTR - 12-1:00 pm in HSRF 200
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̽̽MC Corner
We are taking this opportunity to remind you about the ̽̽ Researcher Credentialing Policy (). This policy is a regulatory requirement to ensure that ̽̽ research faculty and staff have the appropriate orientation, competency, and oversight when accessing ̽̽ Health Network resources.
Please communicate with your ̽̽ research faculty and staff that their current ̽̽ Medical Center research ID badges expire on June 30, 2022.
Clinical research activities include all research projects involving direct patient interaction, retrieving identifiable blood, tissue, or health record data review (including data collected remotely).
The researcher credentialing process is managed through the Office of Clinical Trials Research (OCTR) via REDCap to collect the required credentialing documents. Information can be found on the . Prior to initiating patient contact (or in order to continue if currently credentialed) in a clinical research protocol, or accessing PHI, all ̽̽ employees engaged in and responsible for clinical activities will be required to have a current credentialing record on file with the OCTR.
̽̽ Research Faculty and Staff not currently credentialed will follow the instructions for New Credentialing Procedures for ̽̽ Faculty and Staff.
Please email OCTR, clinicaltrials@med.uvm.edu, with the name and email address of anyone new to the credentialing process. They will then receive an email with the survey information.
̽̽ Research Faculty and Staff who are currently credentialed will follow the instructions for Renewal Procedures for ̽̽ Faculty and Staff.
They will be receiving an email shortly with the survey information.
Failure to comply by June 30, 2022 will result in denied ̽̽ Medical Center IT access and ̽̽ research staff will not be allowed to participate in ̽̽ Medical Center research activities until they have successfully fulfilled the credentialing requirements.
If you have any questions, please call or email the Office of Clinical Trials 656-8990 or clinical.trials@med.uvm.edu.
Fundamentals in the Conduct of Clinical Research Training Program – Upcoming Sessions:
The Larner College of Medicine, in conjunction with The Office of Clinical Trials Research, requires 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.
Next training sessions (via Zoom)
Session 19:
Wednesday, August 03, 2022 (9:30-12:00)
Wednesday, August 10, 2022 (9:30-12:00)
Wednesday, August 17, 2022 (9:30-12:00)
Wednesday, August 24, 2022 (9:30-12:00)
Session 20:
Tuesday, September 20, 2022 (2:00-4:30)
Tuesday, September 27, 2022 (2:00-4:30)
Tuesday, October 04, 2022 (2:00-4:30)
Tuesday, October 11, 2022 (2:00-4:30)
This free comprehensive fundamental clinical research training was created to ensure essential knowledge for staff involved in clinical research at LCOM/̽̽ HN. Comparable trainings would cost hundreds of dollars from an outside source and would not be adapted to LCOM/̽̽ HN processes and policies. We hope you appreciate the value this course is bringing to Researchers and their staff, and that the time investment will elevate the quality and compliance of clinical research at our institutions.
Please use this link for more information and to
Reminder about ̽̽ Health Network COVID-19 Vaccination Policy
̽̽ research employees (faculty/staff/students), who work at ̽̽ Health Network sites (whether full-time or intermittently), must be in compliance with the
̽̽ Medical Center has mandatory and who work at ̽̽ HN sites.
The vaccination policy states that all employees and non-employees who work at ̽̽ HN sites
- Must provide proof of vaccination or approved vaccination waiver using the ̽̽ Health Network non-employee vaccination attestation
- Individuals will not be able to work on-site at ̽̽ Health Network locations if you aren’t in compliance
- Individuals must submit proof of vaccination showing that you have received all required doses
Please complete the and upload a copy of your vaccination card.
To update vaccination records please use the same form to provide updates (second dose, booster, etc.).
Please note that this policy also applies to external vendors such as research monitors and collaborators who are ineligible for an exemption and must be fully vaccinated to provide services on-site.
More information can be found on OCTR Commons