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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Quality assessment and improvement in HRPP and IRB

A quality assessment and improvement program is absolutely pivotal to a Human Research Protection Program (HRPP) and Institutional Review Board (IRB). Their absence can destroy the efficiency and consistency of the HRPP and the IRB. Lack of direction can affect not just these, but also the program’s investigators, research participants, and the research program. In short, it affects the entire organization in a number of ways.

The way out of this problem is to implement a targeted quality assessment and quality improvement program for a Human Research Protection Program and IRB, which can go a long way in making the program more efficient, compliant, and consistent. Auditing and quality improvements are a means for doing this. Although these are not regulatory requirements, they are considered best practices. Because of this, auditing and quality improvement are central to any program at an organization.

What are the ways by which a clinical organization can implement these?

Clinical organizations that lack focus or understanding of the quality assessment and improvement program aspects can end up carrying out programs that are expensive, ineffective and futile. HRPP and IRB need to be strengthened and made efficient and effective with a few important steps such as HRPP accreditation and adapting metrics for any IRB function.

The ways of doing this well be the core of the teaching a webinar from MentorHealth, a leading provider of professional trainings, will be imparting. Dr. Peter Vasilenko, who is the President of his HRPP/IRB consulting company, Apex Ethical Services, LLC and is internationally recognized for his leadership and expertise in education and regulations related to human research protections; will be the speaker at this webinar.

To gain the benefit of Dr. Vasilenko’s wealth of experience with HRPP and IRB; Read More

Strategies for implementation

HRPP accreditation programs, which have standards requiring audit and quality improvement; can be useful templates for any HRPP. This webinar will discuss the many examples of potential areas of QA/QI targeted issues. It will also offer a discussion on the development and use of metrics as part of the QA/QI program.

Dr. Vasilenko will offer a strategy for developing metrics for any IRB function. This will include metrics relating to quality, efficiency and compliance. While the Quality assessment and improvement program can help ensure regulatory compliance of IRBs and investigators; its uses go beyond this:

• A QA/QI program in an HRPP/IRB can optimize the use of the organization’s resources
• It can bring about more efficient and standardized reviews, which will benefit researchers
• It can also enable stronger and more consistent protections for research participants.

To enhance IRBs; processes that lead to better committees, better efficiency and more consistency in reviews, decisions making, and approvals need to be put in place.

Dr. Vasilenko will offer understanding of how to accomplish these. He will cover the following areas during this webinar:

• Why quality improvement of an HRPP/IRB is important
• Who should conduct QA/QI activities?
• Areas of quality improvement
  • Periodic evaluation of the HRPP
  • Review times
  • Evaluation of an IRB meeting
  • Evaluation of IRB Members and Staff
  • Non-compliance
  • Documentation
  • Education of Investigators
  • Audit of investigators
• Development and use of metrics
• Strategy to develop metrics for any IRB function,