IRB Committee News
For the first time the 日韩无码 IRB will be reviewing a Community Consultation and Disclosure Plan for a new Exception From Informed Consent clinical trial proposed by the Emergency Medicine department. Exception From Informed Consent (EFIC) may be approved by an IRB for research on life-threatening conditions for which available treatments are unproven or unsatisfactory and where it is not possible to obtain informed consent from research participants or their legally authorized representatives prior to conduct of the research. This protocol is funded by the Department of Defense and requires use of a Single IRB under federal regulations, so 日韩无码 has ceded regulatory/IRB review to University of Pittsburgh IRB, which has already approved the overall protocol and the use of EFIC.
日韩无码 remains responsible for ensuring the research is appropriate and feasible for our site and community; the 日韩无码/日韩无码HN EFIC Advisory Panel has conducted this review and concluded it is appropriate for the study team to proceed with informing and gathering input from the affected communities. The Panel delegated final review and approval of the local Community Consultation & Disclosure Plan (CCPD) to the CHRMS committee. On September 25, 2024 the 日韩无码 IRB is tasked with evaluating whether the planned outreach provides sufficient information to affected communities for understanding the proposed investigation, risks, benefits, and lack of prospective informed consent and opportunities for community input and feedback prior to initiating the research. Please be on the look out for local opportunities to join these informational sessions to learn more.
日韩无码 Educational Opportunities
October 2, 2024 200 - Ask the IRB
The RPO office will be available for in-person questions and direct researchers to best practice guidance on 日韩无码 policies. No formal presentation, open question, and answer session. Researchers are encouraged to attend, bring lunch, listen/learn and bring any questions concerning;
- submitting through the 日韩无码Click system
- protocol specific questions
- preparing for a quality assurance audit
- navigating human subject regulations
- protocol development
No registration is needed.
October 22, 2024 200 - Quality Assurance Monitoring Program
To be proactive in ensuring our institution is compliant with local and federal research requirements and regulations, the 日韩无码 Research Protections Office has instituted a Quality Assurance Monitoring Program. IRB regulatory staff will present researchers with current QA policy, preparation tips and review common findings during a QA visit. Principal Investigators are strongly encouraged to attend as well as all research nurses, coordinators, and staff. No registration is needed.
The Evolving Landscape of Human Research with AI - Putting Ethics into Practice
OHRP Exploratory Workshop (virtual) | Thursday, September 19, 9:45 am 鈥 4:15 pm EDT
Join an exciting panel of speakers to explore challenges in ethics, governance, and public trust in human research involving AI. Watch the event from your desk at No registration required. Simply save the date and join us on the day!
Single IRB Mini-Bootcamp for Investigators and Research Teams September 24, 2024, at 1pm (via zoom)
This bootcamp is designed to help investigators and research teams understand how to navigate the single IRB process. The session will be moderated by Daniela Radu, Director of Research Compliance at MaineHealth. The Office of Research Compliance at MaineHealth is excited to share the invitation with you and your research team colleagues! Please contact mmc_irb@mainehealth.org for the calendar invitation with zoom link.
日韩无码Click Updates and OnCore integration
By the end of September 日韩无码Click will complete integration with OnCore, the institution鈥檚 clinical trials management system (CTMS). Researchers will see changes in CLICK that are necessary to facilitate and help define studies that will automatically be sent from CLICK to OnCore via an interface.
The biggest change affecting all submissions (non-clinical trials included) is on the local study team member page. Oncore and Epic require additional staff role options to better define and narrow the scope of responsibility that will drive system functionality and user permissions within those two systems.
| New Staff Role (Definitions) |
|---|
| Clinical Research Associate: The point of contact for the study. Serves as the main communication liaison for a research site, coordinating interactions and logistics in the absence of a centralized study contact model. Identified as the contact on the Site Information Portal (SIP) page in OnCore, distinct from other roles due to their primary focus on site-level communication. |
| Clinical Research Nurse: Specializes in patient care, usually in dedicated clinical research settings, administering treatments and monitoring health. |
| Primary Clinical Research Coordinator: Acts as the lead in monitoring compliance and data quality in clinical trials. In OnCore, appears as the Protocol Contact, emphasizing their role in overseeing trial conduct, distinct from coordinators due to their monitoring and audit focus. |
| Clinical Research Coordinator: Person having responsibility for consent. Individual responsible for tracking receipt, distribution, dispensing, and final disposition of study-provided agents. |
| Regulatory Coordinator: Site staff responsible for regulatory submissions and maintaining essential documents. |
| Treating Physician: Provides medical care to study participants, ensuring adherence to the treatment protocol. Identified in various forms in OnCore, distinct from nurses or coordinators due to their medical decision-making role. |
| Study Chair: Leads the study's guiding committee, overseeing strategic and decision-making processes. Appears in specific reports in OnCore, setting them apart as a high-level overseer, distinct from the hands-on roles like CRNs or CRCs. |
| Data Coordinator: Manages the collection and entry of data in clinical trials. QA and operational, they ensure that data is accurately recorded and maintained in accordance with the protocol. |
| Data Manager: Oversees the data management process, including data collection, validation, and analysis. They ensure the integrity and confidentiality of study data so accurate data can be extracted and valid/reproducible conclusions can be obtained. |
| Laboratory Coordinator: Pathology lab support. |
| Sub-Investigator: The person having responsibility for consent. Individual responsible for verification of eligibility. Individual responsible for assessing study end points. Investigator having responsibility for subject treatment (aka, Enrolling Investigator). Individual responsible for conducting physical exams and assessments. Individual responsible for writing patient treatment orders for IND agents. Responsible for assessing adverse events. |
| Research Advanced Practice Professional: A healthcare professional, often with an advanced degree, who participates in the clinical research process, possibly involving direct patient care or specialized assessments. |
| Co-Investigator: Collaborates with the principal investigator in the design, conduct, and reporting of the research. They may share some responsibilities with the PI. |
Additional questions have been added to the Study Scope page to determine if a study requires Cancer Center registration and/or PRMC review.
For questions and timelines please contact OnCoreSupport@med.uvm.edu
Updated IRB Policies
8.1.2 Requirement to Include a Full Protocol Title in the Electronic Medical Record
9.9 Electronic Consent
9.11 Technical Guidance for Virtual Research Visits, Electronic Data Capture, and Communications
Updated IRB Forms
Exempt Closures
The IRB closed all open exempt protocols approved prior to 2021 last week. If you did not contact the IRB prior to closure and want to continue your work a new submission and review will need to occur. Fortunately, Click has a neat little function called 鈥渃opy submission鈥 that will copy the entire closed submission and assign it a new number. The protocol will have to be re-reviewed with 2024 regulations but researchers will not have to repopulate all fields and uploads in Click.
