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�պ����� Educational Opportunities

Thursday, December 12, 2024 HSRF 400 - �պ����� Health Network Research Documents and Resources

The IRB office will be hosting staff from the �պ�����MC Data Management and �պ�����NH Compliance and Privacy Offices.

The   and  forms will be reviewed.

No registration is needed.

Did you miss the October IRB Education?

 - The slides can be accessed on our Education page. 

Updated IRB Forms

Updated IRB Policies

• 2.0 Institutional Ancillary Reviews
• 3.1 Full Committee Review
• 8.11 International Research
• 10.3 European Union General Data Protections (GDPR)
• 13.7 Collaborations with External Investigators (External Study Team Members)
• 14.6 Fees for Committee Review

Changes in IRB Fee Process

We are moving our IRB Fee invoicing and collection activities from the Office of Clinical Trials and the Financial Edge system to a shared resource, IMFLabs, under the Vice President for Research as of January 1, 2025.  Moving these IRB fee activities to Peoplesoft will help us prepare for and provide consistency when we roll out single IRB direct charge processes. 

IMFLabs will receive billing information from the IRB and in turn manage invoice distribution to the sponsors, collections and reporting.  The distribution of the invoices will be by email only.  We will use the sponsor contact email that is provided in Click.  As this may change over the life of the protocol, it is very important that you amend this information if you become aware of a change.  Initial approvals will continue to be held until payment is received and annual review payments, if not received within 60 days of the first invoice, will accrue at an interest of 1% per month.

IRB fees initiated through the Office of Clinical Trials, prior to January 1, will stay with the Office of Clinical Trials until they are paid.  New billable protocols received in January and/or annual reviews will be invoiced at the beginning of the month going forward. Clinical trial payments that are not IRB Fees, will continue to be managed through OCTR and the Financial Edge system.   Please refer to revised section 14.6 Fees for Committee Review.

Collaborations with External Investigators

We have updated our guidance Section 13.7 Collaborations with External Investigators (External Study Team Members).  An external investigator is a study team member who is not affiliated with �պ����� or �պ�����HN sites but is engaged in �պ����� human subjects research. Examples may include but are not limited to former �պ����� students and community collaborators. These external individuals’ activities should be covered under a Federalwide Assurance, but they do not have one in place.  This category does not include collaborators who are covered under their own Federal wide Assurance and have an IRB. For questions about that scenario please reach out to the

With tighter restrictions on access and protection of human subject data, gone are the days you can add a community partner or keep a �պ����� student who has graduated on your protocol.  If there is no relationship between the two entities other than the collaboration, there are things you as the PI need to do to ensure you are compliant with involving this external investigator.  

Retirees Are Allowed to Continue in PI or Key Personnel Roles

Emeritus faculty members may remain Principal Investigators if they have obtained approval from the Provost’s Office following the Research Requirement process located on the �պ����� Retirement website.  Non-Emeriti faculty are not eligible to be Principal Investigators post-retirement, however, can be listed as a study team member.

Non-Emeritus faculty members wishing to continue as a study team member on a protocol must obtain a Research Affiliate appointment from the Provost’s office.   See Section 5.0 Eligibility to Perform Research at �պ�����/�պ�����HN for guidance.

­­­New Ancillary Review for Trainees in LCOM

The IRB, in collaboration with the Senior Associate Dean for Research in LCOM, will as of January 1, 2025, begin to assign ancillary protocol reviews to Departmental Research Vice Chairs and/or Department Chairs.  This new process will apply to all trainee research protocols that require a faculty mentor within the College of Medicine.  To help improve IRB submissions from our trainees, the Research Vice Chairs and/or Chairs are being provided an opportunity to review and discuss with faculty mentors and/or the trainee directly.  IRB review will not begin until confirmation from the department through the ancillary review that:

• the assigned faculty mentor has applicable experience to support the trainee;
• the proposed project is appropriate for where the trainee is in his/her training;
• the proposed project has scientific validity;
• the proposed level of risk to subjects or others is appropriate to someone in training (e.g. not a clinical trial, does not include vulnerable populations (e.g. children, prisoners);
• protocol conduct and completion is feasible (good plan for active support from faculty mentor, access to necessary tools/data are in place, and the required timeframe can be met); and 
• the protocol/consents follow the IRB requirements and are well written.

�պ�����Click user guide on how to complete a review can be found .

Research Professionals Network (RPN)

(you do not have to be a member to participate in the workshops)

December Workshop: - “” (Click on title to register)           12/16/2024, 2:30-4:00pm - Zoom

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 �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. 

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.

January 2025 Session

• Tuesday, January 07, 10:30am - 1:00pm
• Tuesday, January 14, 10:30am - 1:00pm
• Tuesday, January 21, 10:30am - 1:00pm
• Tuesday, January 28, 10:30am - 1:00pm

March 2025 Session

• Wednesday, March 05, 1:00pm - 3:30pm
• Wednesday, March 12, 1:00pm - 3:30pm
• Wednesday, March 19, 1:00pm - 3:30pm
• Wednesday, March 26, 1:00pm - 3:30pm

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.

Research Navigator Program

The Research Navigator program is a free resource to help Faculty and Staff navigate the clinical research process at �պ����� Larner College of Medicine and �պ����� Health Network.

• Learn about the Clinical Research Process
• Ask Questions regarding the Clinical Research Process
• Clarify your Research Pathway
• Connect with a Collaborator/Mentor
• Learn about Education and Training Resources
• Stay up to date with our Event Calendar

NNE-CTR Research ECHO

The Clinical Research ECHO is a knowledge-sharing forum via monthly Zoom sessions. This is a great networking opportunity that features didactic and case presentations by colleagues sharing their research and engaging in lively problem-solving discussions. See past presentations . To register for future sessions, click . 

REDCap Resources

Visit the for new features, training resources, and templates.

REDCap Training: Basic course – 12/04/2024 (12:00-1:15pm)

REDCap Training: Advanced – 12/11/2024 (12:00-1:30pm)

�պ�����MC Corner