Is It Ethical to Assign Medically Underserved African Americans to a Usual-Care Control Group in Community-Based Intervention Research?
- Robert M. Anderson, EDD
- Michigan Diabetes Research and Training Center and Department of Medical Education, University of Michigan Medical School, Ann Arbor, Michigan
- Address correspondence and reprint requests to Robert M. Anderson, EdD, G1111 Towsley Center, Box 0201, University of Michigan, Ann Arbor, MI 48109-0201. E-mail: boba{at}umich.edu
The purpose of this commentary is to foster discourse regarding the need to conduct research that is scientifically rigorous while according patients the benefits and protections that they are due as human subjects. These two laudable goals can conflict with one another, leaving researchers, institutional review boards, grant application review groups, and funding agencies with the responsibility of striking an appropriate balance. For the past 14 years, our research (1) has focused on evaluating community-based interventions designed to help urban African Americans in metro Detroit live well with type 2 diabetes. Even if previous research on similar interventions has been promising, it is not possible to know a priori if a particular intervention, with these patients in this setting, will be shown to be effective. Therefore, the ideal design (from a scientific perspective) for many of these studies would be a randomized controlled trial using a usual-care control group. However, we have ethical concerns about assigning the African-American patients recruited in metro Detroit to a true usual-care control group.
Types of control groups used in diabetes-related randomized controlled trials
Best-known care control groups.
A well-known type of control group involves comparing a new medication or procedure with the best medical care known (also known as current standard of care). The Diabetes Control and Complications Trial provides a good example of this type of control group (2). To test the glucose hypothesis, patients were randomized to either an intensive treatment intervention group or a “best-known care” (at the time of the study) control group. This type of control group differs from a usual-care control group in two very important respects. First, usual care in diabetes, particularly for medically underserved populations, is likely to be suboptimal when compared with best-known care (3). Second, in the Diabetes Control and Complications Trial, the diabetes care received by patients in the control group was precisely defined and under the …
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