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An understanding of Federal-Wide Assurances

The Federal-Wide Assurance (FWA) is an assurance given by an institution that is carrying out NIH-funded studies. Through this written assurance, which is required to be filed with the Office for Human Research Protections (OHRP); the institution commits itself to compliance with the terms of requirements set out in the HHS Protection of Human Subjects regulations at 45 CFR part 46. It is the only type of assurance that the OHRP accepts and approves.

The FWA must clearly outline the terms for reviewing, approving, and conducting a study. The FWA, which is to be signed by the Institutional Official, details the requirements that the institution that has filed such an agreement must uphold.

An essential element of the terms relates to written agreements for non-affiliated investigators and institutions. When a researcher works in a site or with an individual that is not currently governed by her home institution; the researcher is given the option of asking the non-affiliated site or individual to obtain a separate IRB approval or to request that her home institutional review board become the IRB of Record.

Grey areas of FWA's

This, however, is a term that most investigators overlook. Almost invariably, when designing a study, investigators, who are too busy forming partnerships, gloss over important additional regulatory criteria such as these. At present, the trend is of conducting research in private physician offices and other community locations. This trend has come about mainly because of the advantage it brings: it makes research more accessible to potential participants. Yet, it calls for its own set of regulations and requirements.

There are many other grey areas that are particularly prominent and those that cause nagging problems to many investigators and their potential research partners. These include the written agreements required by the institutional review board (IRB), namely the Individual Investigator Agreement (IIA), IRB Authorization Agreement (IAA), and the Federal-Wide Assurance (FWA).

Since the terms of these agreements appear to be legalistic, they can intimidate both researchers and potential community partners. What are these? When are they necessary? Why are they necessary?

Proper learning on the unclear areas of FWA's

It is to vital questions such as these that Sarah Fowler-Dixon, Education Specialist and instructor with Washington University School of Medicine, who has developed a comprehensive education program for human subject research which has served as a model for other institutions, will provide answers at a highly engaging webinar.

Being organized by MentorHealth, a leading provider of professional trainings for the healthcare industry; this highly informative webinar will clarify on the meaning and interpretation of FWA's, what they are, and when they are needed.

Pleas register for this webinar and gain a proper understanding of Federal-Wide Assurances.

Sarah will offer insights into the regulatory ramifications of partnerships that overlook vital details, which will cause them frustration and could require them to carry out many actions such as providing additional information, gathering additional signatures, and explaining this regulatory requirement to their partners. Sarah will explain how to better explain the process to partners and thus save themselves these nagging issues.

Sarah will cover the following areas at this webinar:

  • 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?

This session is of high value to those involved in any important aspects of clinical research, such as 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, and Human Research Protection professionals.

 

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