How Much Is Enough?

Abstract

This chapter provides key takeaways for investigators and clinical researchers in healthcare settings doing minimal-risk research and quality improvement. Following an in-depth overview of the current regulations for informed consent (IC) with a focus on the 2018 regulatory revisions, it then describes the current state of IC in quality improvement activities commonly employed in learning healthcare systems and the ethical challenges they present. This chapter does not address the complexities of IC in clinical trials or in research with greater than minimal risk because the IC processes in such activities are well established. Instead, the focus is on what the regulations state regarding the requirements of informed consent; when and how consent can be waived; how research and quality improvement activities differ from the viewpoint of IC; and what information potential research subjects need to make decisions about participating in minimal-risk research and quality improvement in healthcare settings.