The goal of Single IRB review is to enhance and streamline the IRB review process for multi-site research so that research can proceed without compromising ethical principles and protections for human research participants. This presentation will help provide education to WCM investigators, study teams, and research administrators on the concept of a Single IRB model in multi-site research.
After this educational session, you will be able to: (1) Understand what Single IRB review is; (2) Recognize what types of studies must comply; (3) Explain the overall process for obtaining Single IRB review; (4) Plan for Single IRB review for a multi-site research study.
Building on our sIRB 101 session, this follow-up focuses on what happens after initial IRB approval under the Single IRB model. This session is designed to help WCM investigators, study teams, and research administrators understand their responsibilities and best practices for ongoing submissions, including amendments, continuing reviews, reportable events, and study closures in the context of sIRB oversight.
After this session, you’ll be able to:
This session is ideal for teams currently engaged in sIRB studies or preparing for future multi-site research submissions.
In this session we present a brief history of the evolution of human subjects protections in research and the general ethical principles guiding research regulations. We also provide an overview of the various regulations that govern the responsible conduct of human subjects research and when they apply. This is an excellent opportunity for research team members to learn about the role of the IRB in ensuring that all human subjects research conducted within an organization meets the applicable guidelines and regulations governing the research.
In this session we provide an overview of the regulatory requirements underlying one of the most important documents in human subjects research, the Informed Consent Form (ICF). We will review the essential elements of the ICF, when a waiver is warranted and how to address the criteria for waiver or documentation and waiver of consent, and tips for creating an ICF that the IRB can approve. This presentation will provide essential information for the responsible conduct of research and is recommended for all study team members.
The goal of this presentation is to provide WCM investigators with an understanding of FDA regulatory requirements when conducting research involving drugs and/or medical devices. This is an excellent opportunity for clinical research team members to learn about the sometimes hard-to-navigate requirements set forth by the FDA, and to receive answers to any questions you may have about the applicable guidelines and regulations governing your research.
In this session, we review the IRB’s role as Privacy Board by exploring the different regulatory pathways to utilizing Protected Health Information (PHI) in research according to the Health Insurance Portability & Accountability Act (HIPAA) of 1996. Discussion will include how to determine when your research needs a full or partial HIPAA waiver as opposed to prospective HIPAA Authorization from subjects, and other scenarios. We’ll also discuss what you can do to protect research subjects’ PHI when transmitting it via email and how to report to the IRB in the event of an accidental disclosure.
Please join us for our next METS session presented by our very own Sr. Research Navigator, Yefrenia Henriquez Taveras. The goal of this presentation is to provide researchers with effective tips for completing a successful IRB application. This presentation will help provide education to WCM investigators, study teams, and research administrators on describing basic requirements for successful submissions to the IRB and minimizing common errors that may delay submission progression.
