RPO 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.
Annual Self Review Checklists
The start of a new year is a perfect time for researchers to complete the Annual Self Review Checklists (Medical or Behavioral). These review forms have been developed for PIs with protocols that no longer require annual continuing review. The tool is meant to assist researchers in remaining compliant with federal regulations and local ̽̽ policies. Completed checklists DO NOT need to be submitted to the IRB but it is strongly recommended that you complete the checklist and file in your regulatory binder. If you find because of your self-review that you need to submit materials to the IRB, please be sure to do so via ̽̽Click. If you have any questions while completing your annual review, please contact your RPO research analyst.
IRB Policies and Procedures Update
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.
1.3.2 Guidelines for Continuing Review of Research
Educational Opportunities
The December 2, 2022 IRB presentation, “Allowable Strategies for Successful Research Recruitment, Screening & Retention at ̽̽ and ̽̽MC” slide deck can be accessed here.
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The January 26, 2022 Research Professional Network’s presentation, “Cede Review: Navigating the World of Single IRB” slide deck can be accessed .
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Upcoming – March 15, 2022
“Navigating IRB Ancillary Reviews” 12-1:00 pm in HSRF 200
IRB Quality Assessment Reviews (Monitoring)
The IRB and the Office of Clinical Trials has begun in-person quality assessment reviews. Research Protections staff will conduct periodic protocol reviews to ensure that human subject research activities are conducted in accordance with federal regulations, state laws and institutional policies regarding the protection of human subjects in research. Monitoring for compliance and quality is necessary to meet the terms of ̽̽’s and ̽̽MC’s Federal wide Assurances. The IRB is committed to administering a process that is educational for the personnel involved in human subjects research, with the goal of fostering a collegial environment, and thus contributing to a culture of compliance. Our protocol review program covers a sampling of all studies, both medical and behavioral, that are currently active. Highest priority is given to high-risk protocols, investigator-initiated protocols with no sponsored oversight, protocols that involve the collection of sensitive personal information, and protocols that are approved for the use of a legally authorized representatives. However, all types of research, including exempt, expedited, and research overseen by an external IRB, are subject to quality assurance reviews.
̽̽MC Corner
March 2022 Fundamentals –
The Larner College of Medicine, in conjunction with The Office of Clinical Trials Research, is requiring 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.
March 2022
Thursday, March 10, 2022, 2:00-4:30pm
Thursday, March 17, 2022, 2:00-4:30pm
Thursday, March 24, 2022, 2:00-4:30pm
Thursday, March 31, 2022, 2:00-4:30pm
̽̽ Medical Center has a new mandatory COVID-19 vaccination policy
Applicable for all employees and non-employees who work at ̽̽ Health Network sites.
̽̽Click Reminders
If you are a new researcher or support staff to researchers needing to submit through ̽̽Click, the RPO has a website dedicated using the ̽̽Click software. You can access step by step user guides, read tip sheets, and review our FAQ’s.
Closing Expedited and Exempt Protocols
If you have completed your research project it is important to close your study with the IRB. Directions for closing a study within ̽̽Click can be found here.
Determine if your Project Requires IRB Review
Prior to beginning a ̽̽Click protocol submission, please ensure your project requires IRB review under the federal regulations. The two categories listed below do not require IRB review. You may be able to make a determination independently about your project using our tools (links below) and if so, would not need to submit your study in ̽̽Click for IRB review.
Research Not Requiring IRB Review Tool
The IRB does not review projects that do not meet OHRP's definition of research.
Research: Research is defined as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
Research that Does Not Require IRB Review: Quality improvement projects or program evaluation projects systematically collect data for administrative, clerical, or reporting purposes. Program implementation and public health surveillance also do not require IRB review.