Navigating federalwide assurance requirements when conducting research in community-based care settings.

Abstract

There is an urgent need for research on quality of life and healthcare delivery for older adults living in community-based care settings, yet implementing current federalwide assurance (FWA) requirements can be a challenge in these settings. This paper discusses FWA requirements for engagement in federally funded research as the requirements pertain to community-based care settings. Factors that impede community facilities in achieving FWA approval include lack of organizational structure to provide oversight for the ethical conduct of research, administrator concerns regarding potential liability associated with obtaining the FWA, lack of resources to complete required paperwork, and lack of staff knowledge about human subjects protection and federal requirements for participating in research. Effects of the FWA process on investigators include the burden of extra time needed to support community-based facilities to acquire a FWA and concerns that studies may be limited to only those community facilities with the resources to complete the FWA process. Investigator-initiated strategies for conducting research in community-based settings include considering study designs that are exempt from the FWA process and proactively assisting community-based facilities to acquire FWA status. Investigators need to work with potential research sites and the office for human research protections to ensure that subjects are protected without shifting the burden of protection to ill-prepared community administrators.