IRB Essentials: Live Training Sessions for Research Community

    ‘IRB Essentials’ is a series of monthly sessions aimed at specific topics related to human subjects research and IRB review. During these one-hour long live Zoom sessions, Yale HRPP and Institutional Review Board (IRB) team members will provide attendees with tangible education and guidance on the Yale IRB and HRPP processes. Each month will focus on a unique topic, and we will offer opportunities for researchers to attend these sessions monthly.

    We look forward to providing these pertinent educational sessions to our Yale and Yale New Haven Health System (YNHHS) researchers!

    Please review our 6-month training schedule below for “IRB Essentials” (first half of 2025) and register using the unique links.

    Additional training sessions for the second half of 2025 will be posted to our web section soon.

    Month Topic Description and Learning Objectives
    February Continuing Reviews and Modifications

    Description: Once research projects are approved by the Yale HRPP/IRB via IRES IRB, there are ongoing responsibilities for the Principal Investigator (PI) and the study team. This session will provide guidance to investigators on submitting Modification (MOD) and Continuing Review (CR) applications in IRES IRB.

    Learning Objectives: Upon completion of this course, learners will be informed of IRES IRB system requirements for MODs and CRs, distinguish when MODs may/may not require full board review, and what the IRB is looking for when reviewing MODs and CRs.
    March Exemptions

    Description: This presentation will provide our Yale/YNHHS research community with an overview of exempt research categories, special considerations for exempt research, and caveats for exemption determinations for chart reviews and Social Behavioral and Education (SBE) research. Case studies will be presented to promote discussion.

    Learning Objectives: Upon completion of this course, learners will be informed of when research can be exempt, requirements for charts reviews, and caveats for exemption determinations for SBE research.

    Register for Learning Objectives: March 31, 10am
    April How to complete the IRB Submission Form

    Description: This session will introduce investigators to Yale’s “IRB Submission Form”, which is a required document for all expedited and full board Yale IRB applications.

    Learning Objectives: Upon completion of this course, learners will be informed of how to navigate and properly complete the IRB Submission Form from a Yale HRPP/IRB team member, including helpful tips and guidance.

    Register for how to complete the IRB submission form: Monday, April 28, 10am
    May Basics of Informed Consent: Form, Process, E-Consent, Re-Consent

    Description: Informed consent is one of the most important requirements in human subject research and directly tied to the Belmont Report pillar of “Respect for Persons.” During this session, attendees will learn about required and additional elements of consent, when re-consent of participants may be required, requirements related to properly documenting consent, and e-consent considerations and guidance.

    Learning Objectives: Upon completion of this course, learners will be informed of required and additional elements of consent, re-consent requirements, requirements related to properly documenting consent, and e-consent considerations.

    Register for basics of informed content: Monday, May 19, 10am
    June Noncompliance and RNIs

    Description: This training session will provide a comprehensive overview regarding Unanticipated Problems (UAPs), Noncompliance (NC), Adverse Events (AEs), Serious Adverse Events (SAEs), protocol deviations, and other events that occur in the context of human subjects research. The session will end with learning exercises designed to complement session concepts.

    Learning Objectives: Upon completion of this course, learners will be informed of key definitions related to untoward research events and how to submit Reportable New Information (RNI) applications in IRES IRB related to these events.

    Register for noncompliance and RNIs: Time: Monday, June 30, 10am
    July Use of External IRBs

    Description: Yale and Yale New Haven Health System (YNHHS) investigators may use an external Institutional Review Board (IRB) in lieu of the Yale IRB to oversee a research study. The Principal Investigator (PI) must work with the Yale Human Research Protection Program (HRPP) to submit an external IRB application via the electronic submission system IRES IRB.

    Learning Objectives: Upon completion of this course, learners will be informed of the process of requesting use of a non-Yale IRB, local requirements, and ongoing responsibilities toward the Yale HRPP.

    Register for use of external IRBs: Monday, July 28, 10am