�պ�����

�պ����� IRB Educational Opportunities

Federal and state regulations, institutional policy, good clinical and research practices require investigators to maintain documents related to human subjects research. This document was developed to assist researchers in organizing research-related documents. It details what documents may be stored in each section of a study-specific regulatory binder. Refer to the Regulatory Essential Documents Binder: Set-up and Maintenance tool to ensure your study binder is up to date.

“Special Protections for Children as Research Subjects”

January 17, 2023 from 12:00PM  - 1:00PM Location: HSRF 200

When a proposed research study involves children, �պ�����’s Institutional Review Board must take into consideration the special federal regulatory requirements that provide additional protection for the underage participants involved in the research.  Learn about the required protections for this vulnerable population that both researchers and IRB’s must adhere to.

Presented by Melanie Locher, IRB Director

“Single IRB at �պ�����: What We’ve Learned and Where We Are Now?”

Updates and changes to regulations, what we’ve learned since implementation and current scenarios for reliance at �պ����� was presented November 2.  If you were unable to attend the session, slides can be found here.

IRB Updated Policies

• 1.3.1 Safety Subcommittee Review of Unanticipated Problems, Protocol Deviations and Noncompliance
• 1.3.2 Guidelines for Continuing Review of Research
• 1.3.5 Institutional Review Board Minutes
• 6. Conflict of Interest
• 8.1.4 Participant Compensation
• 24.1 Pregnant Women, Fetuses, Neonates of Uncertain Viability and Non-Viable Neonates 45 CFR 46 Subpart B
• 27. Noncompliance Policy and Procedures
• 29. Regulatory Definitions

�պ�����Click

• �պ�����Click completed an upgrade from version 8 to version 9 December 2, 2022.  New user guides and �󴡲�’s have been developed to help researchers navigate the new software.
• If you experience problems with logging into �պ�����Click, it is likely that your password has expired. Please go to page for directions on how to reset your password.

Meet the Research Protections staff!

Working from home and never met your dedicated IRB regulatory analyst in person? Find all contact information, office location and pictures of staff here.

�պ����� Medical Center News

Fundamentals in the Conduct of Clinical Research Training Program

January Fundamentals in the Conduct of Clinical Research Training Program Dates:

Wednesday, January 4, 2023, 2:00-4:30pm
Wednesday, January 11, 2023, 2:00-4:30pm
Wednesday, January 25, 2023, 2:00-4:30pm
Wednesday, February 1, 2023, 2:00-4:30pm

More information about the fundamentals program can be found on the OCTR Commons/SharePoint site

Research Professionals Network Educational Opportunity

Join us for the January Workshop, on Tuesday, January 31st 3:00-4:30pm.

�պ����� HN HIM Upload Process Change

�պ����� Medical Center has a new process that allows study teams to upload signed consent forms directly into Epic via

Incorporating signed consent forms into a patient’s medical record is required per Emailing consent forms to HIM for upload will no longer be an option after January 2023.

The PowerPoint instructions detailing the new process along with the link to the video tutorial can be f

These materials are also available on the LCOM OCTR Commons/SharePoint site

If you have any questions regarding this requirement, or the new process, please email research.navigator@med.uvm.edu.