Assurances: What are they, Why and When do I need them - Webinar By MentorHealth February 28, 2013

Overview: The Federal wide 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: 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:
Federal wide 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 Will 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
Sarah Fowler-Dixon, PhD, CIP is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with state and federal authorities.

She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fundamentals of research management to graduate and undergraduate students. More recently, she lead a task force in the development of the Community Engaged Research Program at Washington University. Dr. Fowler-Dixon has simultaneously served as an Independent Consultant, providing expertise and creating supplemental educational materials, including a copyrighted workbook.

Prior to joining Washington University, Dr. Fowler-Dixon was the Educational Development and Learning Specialist for Saint Louis University serving on various committees to improve research, procedures, community outreach, and retention.
For more info please visit the site http://alturl.com/eaovb