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.
Using human subjects in trials means making sure of 'informed consent.'
That wasn't always the case. The stories of questionable practices by scientists are legendary. The Frankenstein monster was a hit among the public because it was plausible. Tesla electrocuted dogs and even as recently as the 1960s researchers were conducting experiments on unaware humans.
Less educated people are less capable of making what we consider informed consent, as are desperate people with live-threatening illnesses. Yet without including all people, including minorities that elites have termed more 'vulnerable' to exploitation by science, we could be creating treatments primarily for western white men. Increasingly, minority groups don't see themselves as vulnerable, they are demanding access to the benefits of research and want successful inclusion in developing treatments. In the modern age, what does 'vulnerability' even mean? Is it just relative mumbo-jumbo or can it be defined?
"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, Deputy Director for Public Health at the Johns Hopkins Berman Institute of Bioethics.
In an editorial, Kass and co-authors Sandra Quinn and Stephen Thomas 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.
According to Thomas, "It is impressive how several of the articles call for the re-imagination of human subjects protections for vulnerable populations and a re-engineering of the research enterprise to elevate the 'community' to be as important as the 'individual' when it comes to improving the informed consent process."
Citation: Sandra C. Quinn, Nancy E. Kass, and Stephen B. Thomas, 'Building Trust for Engagement of Minorities in Human Subjects Research: Is the Glass Half Full, Half Empty, or the Wrong Size?' American Journal of Public Health December 2013: Vol. 103, No. 12, pp. 2119-2121. doi: 10.2105/AJPH.2013.301685
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