Robust technology infrastructure is needed to enable learning health care systems to improve quality, access, and cost. Such infrastructure relies on the trust and confidence of individuals to share their health data for healthcare and research. Few studies have addressed consumers’ views on electronic data sharing and fewer still have explored the dual purposes of healthcare and research together. The objective of the study is to explore factors that affect consumers’ willingness to share electronic health information for healthcare and research. (...) This study involved a random-digit dial telephone survey of 800 adult Californians conducted in English and Spanish. Logistic regression was performed using backward selection to test for significant associations of each explanatory variable with the outcome variable. The odds of consent for electronic data sharing for healthcare decreased as Likert scale ratings for EHR impact on privacy worsened, odds ratio = 0.74, 95% CI [0.60, 0.90]; security, OR = 0.80, 95% CI [0.66, 0.98]; and quality, OR = 0.59, 95% CI [0.46–0.75]. The odds of consent for sharing for research was greater for those who think EHR will improve research quality, OR = 11.26, 95% CI [4.13, 30.73]; those who value research benefit over privacy OR = 2.72, 95% CI [1.55, 4.78]; and those who value control over research benefit OR = 0.49, 95% CI [0.26, 0.94]. Consumers’ choices about electronically sharing health information are affected by their attitudes toward EHRs as well as beliefs about research benefit and individual control. Design of person-centered interventions utilizing electronically collected health information, and policies regarding data sharing should address these values of importance to people. Understanding of these perspectives is critical for leveraging health data to support learning health care systems. (shrink)

In this paper, we argue that there are important ethical questions about healthcare improvement which are underexplored. We start by drawing on two existing literatures: first, the prevailing, primarily governance-oriented, application of ethics to healthcare ‘quality improvement’ (QI), and second, the application of QI to healthcare ethics. We show that these are insufficient for ethical analysis of healthcare improvement. In pursuit of a broader agenda for an ethics of healthcare improvement, we note that QI and ethics can, in some respects, (...) be treated as closely related concerns and not simply as externally related agendas. To support our argument, we explore the gap between ‘quality’ and ‘ethics’ discourses and ask about the possible differences between ‘good quality healthcare’ and ‘good healthcare’. We suggest that the word ‘quality’ both adds to and subtracts from the idea of ‘good healthcare’, and in particular that the technicist inflection of quality discourses needs to be set in the context of broader conceptualisations of healthcare improvement. We introduce the distinction between quality as a measurable property and quality as an evaluative judgement, suggesting that a core, but neglected, question for an ethics of healthcare improvement is striking the balance between these two conceptions of quality. (shrink)

In this editorial essay I explore the possibilities of ‘improvement scholarship’ in order to set the scene for the theme of, and the other papers in, this issue. I contrast a narrow conception of quality improvement research with a much broader and more inclusive conception, arguing that we should greatly extend the existing dialogue between ‘problem-solving’ and ‘critical’ currents in improvement research. I have in mind the potential for building a much larger conversation between those people in ‘improvement science’ who (...) are expressly concerned with tackling the problems facing healthcare and the wider group of colleagues who are engaged in health-related scholarship but who do not see themselves as particularly interested in quality improvement, indeed who may be critical of the language or concerns of QI. As one contribution to that conversation I suggest that that the increasing emphasis on theory and rigour in improvement research should include more focus on normative theory and rigour. The remaining papers in the issue are introduced including the various ways in which they handle the ‘implicit normativity’ of QI research and practice, and the linked theme of combining relatively ‘tidy’ and potentially ‘unruly’ forms of knowledge. (shrink)

Under the Common Rule, federally-supported activities involving human participants are presumptively required to undergo prospective ethics review if they are “designed to develop or contribute to generalizable knowledge.” However, the “generalizable knowledge” standard is inherently ambiguous; moreover, it is both over- and under-inclusive of the type of activities that warrant prospective ethical oversight. Rather than conditioning prospective ethics review on an ethically irrelevant criterion like the generalizable knowledge standard, this article proposes that prior ethics review should be required when some (...) individuals are exposed to greater-than-minimal risks for the potential benefit of others, at least when the activity in question is conducted or supported by federal agencies. Under such an approach, the fact that an activity constitutes research would be neither necessary nor sufficient to trigger prospective ethical oversight. (shrink)