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�պ����� IRB Educational Opportunities

New free CITI webinars available!  The VPR’s office has provided resources to add an all-access pass to view educational webinars produced by the CITI program.  There are currently 100 webinars that cross all domains, and they are all available to �պ����� and �պ�����MC researchers.  Go to review the available series along with brief descriptions. Attached are directions on how to access the content.

Did you miss the May IRB Education? 

“Steps to Rely on an External IRB”
Jen Dulin, MS, DVM
IRB Reliance Administrator and Health Network Liaison

“Are you Following your IRB Approved Protocol? Emerging from COVID Restrictions”
Melanie Locher, B.S., CIP, IRB Director

NIH 2023 Data Management and Sharing (DMS) Policy

NIH has issued the Data Management and Sharing (DMS) policy (effective January 25, 2023) to promote the sharing of scientific data.

Under the DMS policy, NIH expects that investigators and institutions:

  • Plan and budget for the managing and sharing of data
  • Submit a DMS plan for review when applying for funding
  • Comply with the approved DMS plan

�պ����� libraries has complied material for researchers to adhere to this new requirement. 

Researchers must include in their IRB protocol the data sharing plans to NIH via the Data Management and Security Plan.

When writing your consent refer to or use our updated medical consent template for more info.

IRB Updated Policies

1.2 Committee Membership

1.3.1 Medical Safety Subcommittee Review

3.1 Full Review

3.2 Expedited Review

3.4 Exemption Determinations

3.6 Projects Not requiring IRB Review

13. - 13.10 – Single IRB

16.0 Continuing Review Requirements

17.0 Closing a Protocol by the PI

18.0 Reportable New Information

27.0 Research Non-Compliance Policy

27.1 Non-Compliance Review Procedures

27.2 Definitions, Guidance, and Examples Referenced as Part of Non-Compliance Reviews

27.3 Non-Compliance Policy on external IRB Studies

Changes We Wish to Call to Your Attention

5.4 CITI Training Requirements – IRB CITI training is now required for exempt 2(iii), 3(i)(c) and 4(iii) protocols.  As these protocols include sensitive information or identifiable PHI, study personnel should be trained in basic human subject protections including privacy and HIPAA regulations, informed consent and history and ethics of research in the US.

17.1 Closure of Protocol by Committee – This policy outlines criteria used by the IRB to discard submissions that have not yet been approved.All protocol submission types may be removed from committee consideration under the following circumstances:

• PI fails to respond to the IRB’s initial request for revisions and/or clarifications within 60 days while in �պ�����Click clarification requested (pre-review) state, prior to Committee or Designated review. 
• PI fails to respond to the IRB’s request for revisions and/or clarifications within 60 days while in the modifications required state, after Committee or Designated review.
• Ancillary reviewer(s) fail to respond to the IRB’s request for review within 10 months while in post review.

18.1 Reportable New Information on External IRB Studies – When relying on an External IRB (Reviewing IRB, IRB of Record, Single IRB) it is important to always follow that IRB’s reporting requirements for submission of reportable new information.  The �պ����� IRB requires RNI reporting of UAP’s, termination, complaints, and serious or continuing noncompliance reports only after receiving the External IRB’s determination.

26.1 Human Subject QA Reviews on External IRB Studies - The �պ����� IRB may conduct post-approval monitoring in addition to, or in cooperation with, the External IRB for protocols relying on an External IRB. Research Projections Office staff may conduct for-cause audits or routine post-approval monitoring assessments of research ceded to External IRBs as part of the human subject quality assurance review activities.

Consolidation of Self-Determination Tools

We have consolidated our two self-determination tools, Not Human Subjects and Research Not Requiring IRB review, into one tool that addresses both scenarios.  Click here -

Research Protections Office Metrics Project

The RPO has been updating and creating new metrics for the IRB, IACUC and IBC committees.  Metrics are currently in development for measuring IRB Regulatory Analysts, researcher and member workloads, timelines, and expectations. The RPO will use these metrics to spot trends in performance (good and bad), predict performance and create reasonable expectations. New policies will be developed based on the findings and the RPO will share both internal and external metrics with the �պ����� community in the upcoming year.

Updated IRB Forms

1. Biological Specimens/Data Repository Protocol, version 5/8/2023
2. Medical Consent Template, version 4/3/2023 revised to include NIH data sharing links and language
3. Exemption 2 Form, version 5/12/2023
4. Research Data Management and Security Plan, Version 6/6/2023

�պ����� Click

Leaving �պ�����/�պ�����MC? Don’t forget to close your protocols! 

of all the studies you are currently listed on as PI or key personnel.

You can close a study or submit a modification to remove yourself as a key personnel.

�պ����� Medical Center News

The �պ����� Health Network and the �պ����� Larner College of Medicine are excited to announce the launching of TriNetX to our Research Community. What is TriNetX?

is a global health research network containing data for 250M+ patient records from around the world. TriNetX provides researchers the ability to explore datasets from the �պ����� Medical Center since 2010, as well as from established collaborative networks, and national and global networks.

This self-service analytics platform combines real time access to longitudinal clinical data with state-of-the-art analytics to optimize study protocol design and feasibility, facilitate site selection and patient recruitment, and enable discoveries through the generation of real-world evidence.

Who can have access?   

�պ�����HN employees or �պ����� faculty, staff, or students with an �պ����� NetID may request access to

To learn more about TriNetX, please visit any of the following websites:

Have questions or need assistance?

Email:  trinetxadmin@med.uvm.edu

Office of Clinical Trials Research

FY24 �պ����� Research Credentialing Deadline Approaching:
We are taking this opportunity to remind you about the �պ����� Researcher Credentialing Policy ().  This policy is a regulatory requirement to ensure that �պ����� research faculty and staff have the appropriate orientation, competency, and oversight when accessing �պ����� Health Network resources.

Please communicate with your �պ����� research faculty and staff that their current �պ����� Medical Center research ID badges expire on June 30, 2023. 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 to continue if currently credentialed) in a clinical research protocol, or accessing PHI, all �պ����� employees engaged in and responsible for clinical activities will be required to have a current credentialing record on file with the OCTR.

�պ����� Research Faculty and Staff not currently credentialed will follow the instructions for New Credentialing Procedures for �պ����� 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.

�պ����� Research Faculty and Staff who are currently credentialed will follow the instructions for Renewal Procedures for �պ����� Faculty and Staff.

They received an email on 06/01/2023 with the survey information.

Failure to comply by June 30, 2023, will result in denied �պ����� Medical Center IT access and �պ����� research staff will not be allowed to participate in �պ����� 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*:

*Please note that the CITI CRC Foundations Module (prerequisite to the classroom training) needs to be completed every 3 years. The classroom sessions only need to be completed once.

The Larner College of Medicine, in conjunction with The Office of Clinical Trials Research, requires that all research staff engaged in h at LCOM and the �պ����� 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 regardless of job title.  Investigators are welcome (but not required) to attend.

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 24:

Thursday, August 04, 2023, 9:00am-11:30am

Thursday, August 11, 2023, 9:00am-11:30am

Thursday, August 18, 2023, 9:00am-11:30am

Thursday, August 25, 2023, 9:00am-11:30am 

This free comprehensive fundamental clinical research training was created to ensure essential knowledge for staff involved in clinical research at LCOM/�պ����� HN. Comparable trainings would cost hundreds of dollars from an outside source and would not be adapted to LCOM/�պ����� 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