CTN webinar: Federalwide Assurances (FWA) in the National Drug Abuse Treatment Clinical Trials Network (CTN) – An overview.
An Institutional Review Board (IRB) provides ethical review of proposed and ongoing clinical research to ensure the rights and welfare of research participants are protected, and that both the study and investigative team adhere to pertinent regulations governing the conduct of clinical trials. Clinical sites wishing to engage in human subjects research must be paired with an IRB registered with the Office of Human Research Protections, thereby ensuring adherence to all tenets of Good Clinical Practice. This pledge is provided in the form of a Federalwide Assurance (FWA) and is one of the central pillars of a clinical trial. This presentation from Eric Hardter, PhD, RAC, Regulatory Affairs Specialist at the NDAT Clinical Coordinating Center, Emmes Corporation, provides an overview of the basis of and need for a FWA as well as the roles and expectations of key stakeholders, including IRBs, institutions, and researchers involved in clinical studies.
Learning Objectives:
- Describe FWAs and FWA provisions.
- Discuss who needs to obtain FWAs, when, and who is covered.
- Consider the expectations and roles for IRBs, institutions, investigators, and researchers that provide oversight and/or engage in clinical research.