Remarkable improvements in the quality of life, prevention and treatment of disease have been made possible through advancements in biomedical research, including clinical trials involving human subjects. Future progress will depend in large measure on the inclusion of women and racial and ethnic minority populations into the research enterprise. Unfortunately, research abuses in the past have contributed to fear and mistrust among these populations resulting in regulatory measures designed to protect them due to their real or perceived "vulnerability."
Increasingly groups seen as vulnerable are demanding access to the benefits of research and investigators are making progress in successful inclusion of women and minorities. This question of vulnerability is just one of many ethically relevant concepts raised in the current theme issue of the American Journal of Public Health, titled "The Ethics of Human Subjects Research on Minorities".
"While there is growing attention to the participation of minority populations in research, there has been far less attention on the ethical issues raised through research recruitment, enrollment and engagement; our goal was to shine a spotlight on those issues in particular," says Nancy E. Kass, ScD, one of three guest editors of the issue and the Deputy Director for Public Health at the Johns Hopkins Berman Institute of Bioethics.
The theme issue opens with an editorial by Kass and her co-guest editors Sandra C. Quinn, PhD, and Stephen B. Thomas, PhD, of the Maryland Center for Health Equity (M-CHE) at the University of Maryland School of Public Health. In their editorial, "Building Trust for Engagement of Minorities in Human Subjects Research: Is the Glass Half Full, Half Empty or the Wrong Size?" The editors contextualize the history of human subjects protections for "vulnerable persons," recognizing that the protections themselves, while critically important and very successful, may also have limited the benefits of research among the populations that were "protected". They discuss the progress we've made, the challenges still to be tackled, and propose a shift in the way researchers approach minority communities.
Other topics explored in the issue include recruitment of minority populations, community engagement, and training of researchers and health professionals in ethics and working with minority populations. Articles in the volume focus on specific populations including Native American and Alaskan Native populations, persons with disabilities, populations at risk of contracting HIV, and racial and ethnic minority populations.
The theme issue is one of the scholarly products made possible by the National Bioethics Research Infrastructure Initiative grant from the NIH-NIMHD, "Building Trust Between Minorities and Researchers " awarded to the University of Maryland Center for Health Equity. The issue assembles a collection of peer-reviewed papers that explore the complexities involved in the ethical inclusion of minority populations in research and the challenges facing the nation in having a research enterprise that is both protective and inclusive of vulnerable groups. Additionally, contemporary research operates in the long shadow cast by the abuse of human subjects in research, Kass says.
Drs. Quinn, Kass, and Thomas are uniquely suited to guest editing this theme issue. Kass holds a joint appointment in Johns Hopkins' Berman Institute of Bioethics and Bloomberg School of Public Health as the Phoebe R. Berman Professor of Bioethics and Public Health; she is a globally recognized public health expert and has served on international and national ethics committees, in addition to leading the Johns Hopkins-Fogarty African Bioethics Training Program for the last 13 years.
Quinn has extensive experience investigating the impact of disasters on preparedness of minority communities and the willingness of these groups to accept seasonal flu and other vaccines. Thomas is Professor and Founding Director of the Maryland Center for Health Equity at the University of Maryland School of Public Health and a recognized national expert on community engaged research. His work with Quinn on the legacy of the US Public Health Service Syphilis Study done at Tuskegee contributed to the 1997 Presidential Apology to survivors. Together Thomas and Quinn are principal investigators of the Building Trust project at M-CHE.
According to Dr. Thomas, "It is impressive how several of the articles call for the re-imagination of human subjects protections for vulnerable populations and a reengineering of the research enterprise to elevate the 'community' to be as important as the 'individual' when it comes to improving the informed consent process" he said.
The full theme issue is available online now at http://ajph.
The print version will be available December 2013.
Funding for the theme issue was provided the by Award Number 7RC2MD004766 (Quinn & Thomas, Principal Investigators) from the National Institute on Minority Health and Health Disparities (NIMHD) and the Office of the Director, National Institutes of Health (NIH).