摘要：Community health centers (CHCs) provide optimal research settings. They serve a high-risk, medically underserved population in the greatest need of intervention. Low socioeconomic status renders this population particularly vulnerable to research misconduct. Traditional principles of research ethics are often applied to participants only. The social-ecological model offers a comprehensive framework for applying these principles across multiple levels (participants, providers, organizations, communities, and policy). Our experience with the Trial Using Motivational Interviewing, Positive Affect and Self-Affirmation in African-Americans with Hypertension, a randomized trial conducted in CHCs, led us to propose a new platform for discussing research ethics; examine the social, community, and political factors surrounding research conducted in CHCs; and recommend how future research should be conducted in such settings. Community health centers (CHCs) serve approximately 20 million people in more than 7500 communities nationwide and function as an important safety net for medically underserved and socioeconomically disadvantaged patients. More than half of those served are racial/ethnic minorities, almost two thirds live at or below the federal poverty level, and approximately 38% are uninsured or rely on Medicaid. 1–3 CHCs provide care for large numbers of patients with multiple comorbid conditions and complex social and economic circumstances. Their focus on serving a high-risk medical population with complex medical and social conditions makes CHCs an ideal setting to develop and conduct public health or health disparities research that focuses on improving the health of underserved racial/ethnic minorities. A survey conducted by the Association of Academic Health Centers reported that 72% of academic health centers conduct research in CHCs. 4 For academic researchers, CHCs offer the potential to reach populations at greatest risk for poor health outcomes; these populations therefore may stand to benefit the most from health behavior interventions. However, the often-precarious health, social, and economic status of some of the patients cared for in this setting renders them vulnerable to being taken advantage or exploited in research studies. 5,6 Interest in CHCs as settings for health disparities research is likely to increase. Under provisions of the Affordable Care Act, CHCs are expected to undergo tremendous expansion and growth. The law will provide additional resources to deliver care to approximately 20 million more people. 1 As the number of CHCs continues to increase, demand for research in these settings may also increase, testing their ability to provide quality care, narrow health disparities, and contain cost. 7 Researchers and policymakers may wish to examine best-practice models of providing service and interventions targeted at improving the health of underserved minority populations and may seek to conduct their studies in CHCs. This calls for a renewed and more nuanced examination of ethical concerns that may arise in the conduct of research in CHCs. When conducting research in large safety net systems of care, researchers must consider the complex interactions among patients as research participants, the providers caring for them, the community settings in which care is rendered, and the organizational policies and practices that govern them. Care must be exercised to avoid placing undue burden on the health care system that operates within CHCs. This requires discussion of research ethics to focus not only on the impact on individual participants but also on the potential impact on the entire system that operates a CHC. 7,8 All public health research requires ethical considerations at multiple levels. However, CHC patients who participate in research deserve special consideration because of the well-documented potential for exploitation, abuse, and other harm among underserved racial/ethnic minority populations. 5 The social-ecological model provides a framework for examining and understanding potential ethical challenges to conducting research in settings that provide care to medically underserved racial/ethnic minority populations. This framework, often used for health behavior change and prevention research, represents a confluence of multiple integrated factors: intrapersonal factors such as the knowledge, attitudes, and behaviors of an individual; interpersonal factors such as the provider–patient interaction and social network involvement; organizational factors that dictate rules and regulations for operation; community factors such as relationships among organizations, institutions, and informal networks; and public or local policies that set standards for how different organizations and constituents operate or interact. 9 The comprehensiveness of this model makes it applicable to understanding ethical challenges to conducting health disparities research at multiple levels. 10,11 Our experience conducting a randomized clinical trial served as a case study to explore the ethical considerations in conducting health disparities research in a CHC. The Trial Using Motivational Interviewing and Positive Affect and Self-Affirmation in African-Americans with Hypertension (TRIUMPH) is a randomized controlled trial among adult African Americans whose blood pressure is above the target range despite their use of medication. 12 TRIUMPH uses the behavioral cognitive approaches of positive-affect induction, motivational interviewing, and self-affirmation to motivate participants to adhere to their hypertension medications and to adopt healthier lifestyles. 13–16 The protocol used in developing TRIUMPH is described elsewhere. 13,17–19 TRIUMPH recruited participants from a large tertiary care urban health center and its affiliate CHCs. Here we focus on our experience of recruiting participants from the primary CHC in TRIUMPH.
