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High incarceration rates among black men enrolled in clinical studies may compromise ability to identify disparities.
Pubmed ID: 24799583
Pubmed Central ID: PMC4065793
Journal: Health affairs (Project Hope)
Publication Date: May 1, 2014
MeSH Terms: Humans, Male, Adult, Aged, United States, Cohort Studies, Adolescent, Middle Aged, Clinical Trials as Topic, Young Adult, Prospective Studies, Follow-Up Studies, Patient Selection, National Heart, Lung, and Blood Institute (U.S.), Ethics, Research, Healthcare Disparities, Patient Dropouts, Prisoners, Bias, Black People
Grants: UL1 TR000142, 1U01HL105270-03, K08 AG032886, K23 HL103720, P30 MH062294, U01 HL105270
Authors: Krumholz HM, Wang EA, Aminawung JA, Wildeman C, Ross JS
Cite As: Wang EA, Aminawung JA, Wildeman C, Ross JS, Krumholz HM. High incarceration rates among black men enrolled in clinical studies may compromise ability to identify disparities. Health Aff (Millwood) 2014 May;33(5):848-55.
Studies:
- A Case Controlled Etiologic Study of Sarcoidosis (ACCESS)
- Activity Counseling Trial (ACT)
- Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)
- Aspirin-Myocardial Infarction Study (AMIS)
- Atherosclerosis Risk in Communities Study (ARIC)
- Beta-Blocker Heart Attack Trial (BHAT)
- Coronary Artery Risk Development in Young Adults (CARDIA)
- Digitalis Investigation Group (DIG)
- Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD)
- Multi-Ethnic Study of Atherosclerosis (MESA)
- Multicenter Study of Hydroxyurea (MSH)
- Multiple Risk Factor Intervention Trial for the Prevention of Coronary Heart Disease (MRFIT)
- Prevention and Treatment of Hypertension Study (PATHS)
- The Jackson Heart Study (JHS)
Abstract
In 1978 the federal government restricted research on prison and jail inmates in medical studies, the result of decades of unethical research in correctional institutions. We evaluated the impact this policy has had on studies of health outcomes in minority populations, particularly studies involving black men, who are disproportionately incarcerated. Specifically, we explored the effect of incarceration on follow-up rates of fourteen prospective clinical studies funded by the National Heart, Lung, and Blood Institute. We estimated that during the past three decades high rates of incarceration of black men may have accounted for up to 65 percent of the loss to follow-up among black men in these studies. The impact of incarceration was far less among white men, black women, and white women. These estimates suggest that the ability of those studies to examine racial disparities in health outcomes, as well as to understand the experience of this group, could be compromised. We believe that community-recruited subjects who are incarcerated should be allowed to continue participating in observational clinical research that poses minimal risk to participants.