IRB Essentials: Live Training Sessions for Research Community

Description: This training session is designed for researchers and research staff involved in the coordination of multi-site research projects. The session covers essential topics such as inter-site communication, data management, and regulatory compliance. Participants will learn best practices for ensuring consistency across research sites, navigating Institutional Review Board (IRB) processes, and effectively managing collaborative teams. By the end of the training, researchers will be equipped with the knowledge and skills to coordinate multi-site projects efficiently and ethically, ensuring high standards of research integrity and participant protection.

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Time: Monday, February 23, 10am*
*NOTE: THIS SESSION IS EXTENDED TO 1.5 HOURS

Description: This training session is tailored for researchers and healthcare providers involved in different categories of expanded access for investigational drugs and devices.

The course will provide an in-depth understanding of the regulatory pathways and ethical considerations associated with providing access to investigational therapies for patients with serious or life-threatening conditions. Participants will learn about the application and approval processes, informed consent requirements, and reporting obligations. By the end of the training, attendees will be equipped with the knowledge to navigate the complexities of these special access programs, ensuring compliance with IRB and FDA regulations while prioritizing patient safety and well-being.

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Time: Monday, March 30, 10am

Description: This training session is designed for researchers and administrative staff involved in the transition of research studies of departing or incoming Principal Investigators (PIs). The session will provide detailed guidance on the procedural and regulatory requirements for transferring oversight of active research studies. Participants will learn about the steps involved in documenting and communicating changes to the IRB, ensuring continuous compliance, and maintaining study integrity.

By the end of this training, attendees will be equipped with the knowledge to smoothly navigate the transfer process, minimizing disruptions and maintaining high standards of ethical and regulatory compliance throughout the transition.

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Time: Monday, April 27, 10am

Description: Please join our team as we review a sample study protocol. During this session, our team will provide details on what the IRB is specifically looking for during their review of protocols so that investigators can design their study protocols with these key points in mind. The presenters will also identify common pitfalls the IRB sees during review of study protocols, and how investigators can avoid those pitfalls, and will share protocols templates and resources that may be useful to our research community.

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Time: Monday, May 18, 10am

Description: Whether you are working with colleagues at another non-Yale/YNHHS university or hospital on collaborative research, or you are conducting Community Based Participatory Research (CBPR) with community members as research collaborators, there are Yale HRPP/IRB policies and procedures that must be followed to ensure all individuals have the proper approvals and experience to conduct the research. During this session, our team will review various scenarios involving research collaboration with external individuals and will provide you with guidance on how to appropriately document the collaboration.

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Time: Monday, June 29, 10am