Research Participant Protections in Rural America

This qualitative study is designed to examine the ethical conduct of clinical research, including the conduct of clinical trials, in rural healthcare settings. This study is of great significance since more than half of the clinical research, including pharmacogenomic studies, conducted in the U.S. takes place in physicians' offices, clinics, and hospitals.(1-8) It is no longer unusual to encounter rural physicians, nurses, research coordinators, and hospital administrators who are engaged, in various capacities, in the clinical research enterprise. Many of the staff recruited in rural areas by pharmaceutical and other biotechnology companies have limited education, training, or experience in the responsible conduct of research, research ethics, and the protection of research participants. In addition, many rural institutions do not have their own Institutional Review Board (IRB) or policies in place to guide their research activities and so rely on oversight provided by central or independent IRBs. As rural healthcare professionals enter the research arena, it is important to ensure that adequate protocols and policies are in place so as to assure adequate protection of the human research participants who live in rural communities. Under the leadership of Multiple PIs Ann Cook, Ph.D., and Hoas, Ph.D., researchers at The University of Montana (UM) propose a qualitative study using key informant interviews to examine how four key stakeholder groups - physicians, nurses, research coordinators, and hospital administrators - who conduct or engage in clinical research in rural healthcare settings address these research ethics issues, especially the adequate protection of research participants. The study has two aims: Specific Aim 1: Identify the ethical issues that face four rural stakeholder groups who engage in clinical research in rural private practices, clinics, and hospitals. Specific Aim 2: Explore how features of the rural environment may influence stakeholders' abilities to maintain research integrity when engaging in clinical research activities. The three year study will be conducted in12 states with large rural populations; 11 of these states meet the criteria for the NIH Institutional Development Award (IDeA) program of the National Center for Research Resources (NCRR). The potential impact on science and the public's health and well-being is twofold. Findings from this proposed study will shed light on whether: (1) existing policies and guidance are sufficient to ensure optimal protection of rural research participants; (2) the safeguards are in place to assure adherence to the principles of research integrity when conducting clinical research in rural healthcare settings. PUBLIC HEALTH RELEVANCE: As rural clinicians, coordinators, nurses, and administrators increasingly participate in the clinical research enterprise, it is important to identify ethical issues that accompany such research when it is conducted in rural settings. The study's potential impact on science and the public's health and well-being is twofold. Findings from this proposed study will shed light on whether: (1) existing policies and guidance are sufficient to ensure optimal protection of rural research participants; (2) the safeguards are in place to assure adherence to the principles of research integrity when conducting clinical research in rural healthcare settings.