Exploring the Potential for Moral Hazard When Clinical Trial Research is Conducted in Rural Communities: Do Traditional Ethics Concepts Apply?

Over the past 20 years, clinical research has migrated from academic medical centers to community-based settings, including rural settings. This evolving research environment may present some moral hazards or challenges that could undermine traditionally accepted standards for the protection of human subjects. The study described in this article was designed to explore the influence of motives driving the decisions to conduct clinical trial research in rural community settings. The researchers conducted semi-structured interviews with 80 participants who conducted clinical trials with rural subjects. The interviews provided a way to examine the influence of budgetary factors when deciding to conduct a clinical study, how information about the budget and the purpose of the study is conveyed to research participants, and the potential willingness of clinicians and coordinators to enroll in the kinds of studies they offer. The findings suggest that clinical trial research in rural communities may challenge clinicians' abilities to balance the needs of the patient with the needs of the research enterprise. Few respondents seemed to recognize the traditionally recognized hazards of a dual relationship, specifically the moral risks of trying to attend to the interests of both patient and industry. It seems important to re-examine how we protect human subjects and what such protection should look like as research becomes part of the way medical care is provided, even in very rural areas.

Challenges with Healthcare in the Rural and Prairie Environment.

This symposium includes thirteen personal narratives from individuals who have learned, first-hand, what it means to provide healthcare services in rural or frontier communities in the United States. This meaning is uncovered as the authors describe an array of personal and professional challenges and rewards-the careful balancing of one's soul, psyche, family, and profession-with the constraints that accompany care in less populated areas. This symposium also includes three commentaries by authors who have expertise in the areas of bioethics, patient advocacy, health policy, and healthcare decision making. We hope that readers of these stories will gain greater understanding and respect for the work entailed in providing healthcare in rural settings and for some of the more unique issues that can accompany healthcare delivery in places where resources and expertise may be limited, where relationships among patients and families may be more continuous and intertwined, and where medicine becomes a job and a lifestyle.

Exploring the Practical Meaning of Clinical Ethics When Providing Healthcare in Rural and Frontier Settings: Appreciating What Matters.

This article provides an opportunity to ponder the ethics of rural healthcare via a rural or frontier lens. The authors juxtapose the insights, offered in the narratives, with the lessons learned from their more than twenty years of empirical bioethics research in rural communities.

Ethics and rural healthcare: what really happens? What might help?

Relatively few articles discuss the ethical issues that accompany healthcare in rural areas. This article presents and discusses the key findings obtained from multi-method research studies conducted over a 9-year period of time in a multi-state rural area. It challenges the efficacy of current models for bioethics, shows what kinds of ethical issues develop in rural communities, and offers a framework for envisioning resources and approaches that may be more appropriate.

An error by any other name.

Recent reports from the Institute of Medicine and other sources have shown that far too many avoidable medical errors occur; other research has shown a strong association between patient outcomes and characteristics of nursing staff. The authors of this paper present findings from multimethod research conducted over three years in 29 small rural hospitals in nine Western states. They examined the organizational processes used to recognize medical errors and assign responsibility for them to resolve patient-safety issues. The research comprises seven substudies that used surveys, questionnaires, interviews, and case studies to gather data from nurses, physicians, administrators, pharmacists, and other health care workers.Generally, participants responded positively to questions about an institution's receptivity to communicating about errors and agreed on the most common kinds of errors that occur. But other data suggest that providers' understanding of patient safety is heavily conditioned by preconceived notions of what constitutes an error and of professional roles. Participants' analyses of case studies showed that they don't agree on what constitutes error or what kinds of events should be reported. And in one substudy, even when there was overwhelming agreement among participants (97%) that an error had occurred, only 64% would disclose the error to the patient affected. Physicians, administrators, and nurses tended to perceive patient safety as primarily a nursing responsibility. Only 22% of respondents to one survey said that physicians, nurses, pharmacists, and administrators should share responsibility equally for patient safety. The research was not designed to answer specific questions about the recruitment and retention of nurses, but the data collected suggest that institutional processes used to identify errors, assign responsibility for them, and resolve patient-safety issues may have unintended, harmful effects on nurse recruitment and retention. The authors propose that "a systems approach to patient safety" be adopted, one in which responsibility for safety is shared by all members of the health care team.

The protectors and the protected: what regulators and researchers can learn from IRB members and subjects.

Clinical research is increasingly conducted in settings that include private physicians' offices, clinics, community hospitals, local institutes, and independent research centers. The migration of such research into this new, non-academic environment has brought new cadres of researchers into the clinical research enterprise and also broadened the pool of potential research participants. Regulatory approaches for protecting human subjects who participate in research have also evolved. Some institutions retain their own Institutional Review Boards (IRBs), but Independent IRBs, community hospital IRBs and community-based IRBs also fulfill oversight responsibilities. This article sheds light on this evolving world by discussing the findings gleaned from two studies: a study of the decision making processes used by members who serve on different kinds of IRBs and a study of the decision making processes employed by research participants. The article then discusses how the key findings may inform proposed revisions to the Common Rule.