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Federalwide Assurances: What Are They? Why and When Do I Need Them?

4445
Duration : 60 Minutes

Sarah Fowler-Dixon, Clinical Research

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 pr Read more


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 find 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.

Course Objectives:

• Discuss the Federal Wide Assurance, Individual Agreement and IRB authorization.
• Explore the terms of the Federal Wide assurance so that researchers can better explain this to their partners.
• Explain when and why these agreements are used.
• Describe a process for establishing agreements.
• Discuss other types of agreements that are being used to bring community partners and organizations under the same IRB umbrella.

Course Outline:

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.

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

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

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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Subject : Federalwide Assurances: What Are They? Why and When Do I Need Them?


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