Adrift in the Gray Zone: IRB Perspectives on Research in the Learning Health System.

ABSTRACT:

Background

Human subjects protection in healthcare contexts rests on the premise that a principled boundary distinguishes clinical research and clinical practice. However, growing use of evidence-based clinical practices by health systems makes it increasingly difficult to disentangle research from a wide range of clinical activities that are sometimes called "research on medical practice" (ROMP), including quality improvement activities and comparative effectiveness research. The recent growth of ROMP activities has created an ethical and regulatory gray zone with significant implications for the oversight of human subjects research.

Methods

We conducted six semi-structured, open-ended focus group discussions with IRB members to understand their experiences and perspectives

SUBMITTER: Lee SS 

PROVIDER: S-EPMC5130156 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature