Research Protections Office News

Renee Stapleton, M.D., Ph.D. Professor of Medicine, Pulmonary and Critical Care Medicine has accepted the position as our new Chair of the IRB for medical sciences starting July 1, 2023.

Alexandra Potter, Ph.D. Professor of Psychiatry, has accepted the position as our new Associate Chair of the IRB for medical sciences starting July 1, 2023. 

Research Educational Opportunities

Find all past IRB newsletters here

- Old Trips, New destinations: Exploring the Ethical and Practical Considerations of Psychedelics in Research, will be livestreamed on Thursday, 9:45-4:15, Sept 14th

Psychedelics are powerful psychoactive substances that alter perception and mood and affect numerous cognitive processes. Their origins predate written history, and early cultures used them in many sociocultural and ritual contexts. The name 'psychedelics' was coined by Humphrey Osmond in 1957, suggesting that they have a mind-manifesting capability that may reveal useful or beneficial properties of the mind. For decades, psychedelics have been classified as illegal drugs. Recent research suggests that these substances may provide a potential breakthrough in the treatment of a myriad of mental health conditions. This exploratory workshop will examine the ethical and practical considerations for psychedelics research with the goal of promoting an open and grounded discourse on how to conduct research that is inclusive and protective of participants.

 

The Regulatory Guidance for Academic Research of Drugs and Devices () provides academic researchers with the regulatory tools and resources necessary to successfully navigate the pathway from discovery to clinical implementation of new drugs, biologics and medical devices.

These free training modules/videos cover the responsibilities associated with maintaining an IND or IDE and are intended for academic investigators who will hold an IND or IDE.

Responsibilities of the Faculty Sponsor for student research

It is that time of the year again!  The Faculty Sponsor (FS) is the responsible investigator for all research involving human subjects which is designed and conducted by non-faculty. The FS will guide the non-faculty researcher in the development of the protocol, thus assuring that the content, quality, and timing of the submission meets the requirements of the IRB Committee. As the responsible investigator, the faculty sponsor is required to complete the required human subjects training. Protocol approvals will not be released until that requirement has been met.

Furthermore, the FS is accountable for ensuring that non-faculty researchers are aware of their responsibilities as investigators, and the FS is ultimately responsible for the appropriate implementation of the IRB approved research protocol.  The FS will ensure that the IRB is immediately notified in the event of research-related, unanticipated events or findings during the study that would affect the risks or benefits of participation.

All research conducted by students/trainees, including postdoctoral fellows, must include a FS as a member of the study team. The FS is expected to provide active mentorship and oversight during the conduct of the research, and the FS is responsible for ensuring the ethical conduct of the research and is institutionally accountable for the study.

In our experience, when a FS does not participate in a thoughtful pre-review of a student's protocol materials, the submission is incomplete.  An incomplete submission is often returned for significant additions and or clarifications in the proposed procedures.  We understand students are typically on a tight timeline for completion of their research requirement.  Your initial review and guidance prior to submission will help alleviate delays in IRB approval of these student projects.  Please review the 2023 Summer Faculty Sponsor Newsletter.

Updated IRB Forms

  1. Repository Consent Template (version 8/14/23)
  2. Request to Rely on an External IRB (version 3/23/23)
  3. Human Research Protocol (version 6/21/23)
  4. Grant Proposals Lacking Definite Plan for Involvement of Human Subjects (version 6/21/23)
  5. Qualitative Research Protocol (version 7/25/2023)
  6. Consent process documentation template (8/31/2023)
  7. Consent process documentation for LAR (8/31/2023)

ÈÕº«ÎÞÂëClick

All modules are preparing for an upgrade to version 10 in the next year.  IRB effort starts in late August.  Once the upgrade is done, we will be collaborating with ÈÕº«ÎÞÂë HN on integrations with the new Clinical Trials Management system OnCore. 

V10 provides you with opportunities to personalize your Dashboard. This new feature will be a welcome addition to assist researchers with managing workload.

From your Dashboard, you will see:

  • My Inbox: Items that require you to take action.
  • My Reviews: Items assigned to you to review if you are a reviewer. These are a subset of the items in My Inbox.
  • Recently Viewed:
    • Recent: The last several items you viewed. Scroll through this list to find an item you worked on recently.
    • Pinned: You can pin the items in the Recently Viewed section for quick and easy access. This is where those pinned items are listed.
  • Personalize Table: You can alter the tables displayed on the dashboard by using the Personalize Table gear icon.

ÈÕº«ÎÞÂë Medical Center News

 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 at LCOM and the ÈÕº«ÎÞÂë 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.

October 2023 Session
Tuesday, October 03, 2023, 10:00am-12:30am
Tuesday, October 10, 2023, 10:00am-12:30am
Tuesday, October 17, 2023, 10:00am-12:30am
Tuesday, October 24, 2023, 10:00am-12:30am

January 2024 Session
Wednesday, January 10, 2024, 2:00pm-4:30pm
Wednesday, January 17, 2024, 2:00pm-4:30pm
Wednesday, January 24, 2024, 2:00pm-4:30pm
Wednesday, January 31, 2024, 2:00pm-4:30pm

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

Research Professionals Network Workshop - Educational Opportunity

Join us for the following Research Professionals Network Workshops Tuesday, September 19, 2023, 3:00pm-4:30pm:

This workshop will discuss important considerations for representative and culturally sensitive research recruitment and study design. Presenters will highlight community engagement principles and how research coordinators can apply this to study recruitment and holistic study design.