ABSTRACT: Although IRBs are supposed to promote
participant rights and welfare, they can overlook relevant research
participants, information sources, or subjects, especially when the
participants are clinicians, consumers, or students rather than patients. Kate
Saylor will briefly describe how the research ethics literature and regulations
evolved to have these blind spots. She will describe various groups who are
often overlooked by current research regulations and IRBs, and types of
research (e.g., clinical chart review studies) that don’t fit the typical
participant-researcher framework. For illustration, Ken Richman will present
evidence that chart review studies of clinician behavior often falsely identify
patients as the participants. We will present strategies to ensure that the
rights and welfare of all groups involved in research are protected, such as
community deliberation or posted flyers. Kathy Zaiken will share insights
into whether these strategies are practical in real research settings. With
members of the audience, we will discuss what it would take to shift our
thinking and implement these strategies without creating excessive
administrative burden or undermining existing safeguards for patients.
Kate
Saylor earned
an MS in Neuroscience from Oregon Health & Sciences University, and a PhD
in Public Policy from the University of North Carolina, Chapel Hill. Her work
integrates ethics, simulation modeling and quantitative analysis to examine and
advance health equity. She has written about the ethical values embedded in
quantitative methods and developed arguments to support fair inclusion in
medical research and equitable access to genomic medicine.