Compliance Key INC - Medical Device Training
Sarah Fowler-Dixon
Sarah Fowler-Dixon, PhD has been working with the Washington University since May 2001. During that time, Dr. Fowler-Dixon has been a member of one or more of the IRB reviewing committees, written and/or revised numerous guidelines and submittal forms, and served on a data safety monitoring board, given hundreds of presentations on the ethics and regulations of human subjects locally and nationally.
Overview
The Federalwide Assurance is required for NIH funded studies. It is a written assurance filed with the Office for Human Research Protections (OHRP) that outlines under which terms a study will be reviewed, approved, and conducted. This document, signed by the Institutional Official, sets forth certain requirements that must be upheld by an institution who has filed such an agreement. One of the terms deals with written agreements for non-affiliated investigators and institutions. When a researcher "engages" a site or individual not currently governed by his/her home institution, the researcher has the option of asking the non-affiliated site or individual to obtain a separate IRB approval or to request that his home institutional review board become the IRB of Record. Once this request is made, the potential IRB of Record must gather certain information and require certain written agreements in order to become the IRB of Record. More often than not, when researchers establish partnerships, little thought is given to regulatory ramifications of that partnership and thus finding themselves frustrated at the thought of having to provide additional information, gather additional signatures, and explain this regulatory requirement to their partners. Attending this webinar will provide you with information that can be passed along to partners to better explain the process.
Why should you attend this webinar?
Most investigators do not think about additional regulatory criteria when designing a study. The current trend is conduct research in private physician offices and other community venues. Although this makes research more accessible to potential participants, it also invokes another set of regulations and requirements. The one that many investigators and their potential research partners struggle with are the written agreements required by the institutional review board (IRB), namely the individual investigator agreement (IIA), IRB authorization agreement (IAA) and the Federalwide Assurance (FWA). The terms of these agreements can appear to be legalistic and intimidate both researchers and potential community partners. What are these? When are the necessary? Why are they necessary? Are all questions that will be answered during this webinar.
Areas Covered in the Session:
- Federalwide Assurance
- Individual Investigator Agreement
- IRB Authorization Agreement
- When these agreements are used.
- Why these agreements are used.
- The process for establishing these agreements
- Are there other types of agreements that institutions may enter into and how those would meet the regulatory framework.
Who can Benefit:
- Principal Investigators /Sub-investigators.
- Clinical Research Scientists (PKs, Biostatisticians,)
- Safety Nurses
- Clinical Research Associates (CRAs) and Coordinators (CRCs)
- Recruiting staff
- QA / QC auditors and staff
- Clinical Research Data managers
- Human Research Protection professionals
Compliance Key INC
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