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.

A few weeks ago, a rural hospital administrator phoned with a question posed by his management team. “If you were going to give us some ethics resources,” he queried, “just exactly what would they...

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. (shrink)

Hospital ethics committees have evolved as a response to complicated legal, ethical, and social dilemmas that accompany modern medicine. In the United States, their growth has been augmented by Joint Commission for the Accreditation of Healthcare Organizations standards and the Patient Self-Determination Act. There appears to be an implicit presumption that all clinical ethics consultation practices are relatively similar. Finally, there is heightened awareness of the needs for quality standards and assessment of the outcomes of ethics consultations.

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. (shrink)

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.

The ramifications of including genetic components in the clinical studies conducted in non-academic settings create unique ethical challenges. We used a qualitative research design consisting of semi-structured interviews that took place between October 2010 and September 2012. The sample consisted of 80 participants − 38 physicians and 42 coordinators − who worked across a number of different settings, including clinics, private practices, small hospitals, free standing research centers, and blended hospital-institutes in both rural and urban communities in 13 states across (...) the United States. The respondents primarily conducted industry sponsored trials and recruited their own patients as research participants. A majority of the respondents (65%) reported that most of the studies they conducted included an additional genetics component, and so participants were asked to donate specimens for genomics or biobanking. While genomics association studies were perceived as being of benefit, awareness of ethical implications associated with such studies was limited. The rapid advances in genetic technologies make it hard for clinicians and coordinators to help patients make informed decisions about participating in clinical research, and underscore the need to ensure that the regulations governing research on human subjects keep pace with the social and technological changes. It seems essential to discern legitimate ethical concerns and find ways to convey what is going on, what is possible and what might not be possible in terms of protecting privacy, anonymity, and confidentiality. (shrink)