So what does it take to keep medical research a well-oiled enterprise that efficiently and effectively delivers cures? Lots of cooperation–or so I argue, along with co-authors Alex John London and Marina Emborg in a piece appearing in Science[a publicly accessible version of the essay is available at Science Progress]. Unfortunately, we argue, the way or system of drug development currently thinks about the ethics of clinical research does not presently place sufficient emphasis on the conditions necessary to sustain this cooperation.
Right now, oversight of clinical research is focused almost exclusively on protecting the personal interests of human subjects by obtaining valid informed consent and ensuring that risks are reasonable in relation to benefits. We suggest that this ostensibly private transaction between investigators and patient-volunteers has a public dimension in at least three ways. First, such private transactions inevitably draw on public resources. Second, such transactions have externalities- adverse events occurring on one trial have potential to disrupt collaborations elsewhere in the research system. Third, lax oversight of such private transactions creates conditions where consumers have difficulty identifying (and hence rewarding) producers of high quality goods (namely, trials that are well designed).
We suggest that, when considering whether to initiate highly innovative clinical trials that draw on such public goods, proper oversight and analysis must take into consideration factors that lie beyond the personal interests of human volunteers. (photo credit: McKillaboy, Cataglyphis velox 22, 2009)
@Manual{stream2010-65,
title = {Conditions of Collaboration: Protecting the Integrity of the Scientific Enterprise},
journal = {STREAM research},
author = {Jonathan Kimmelman},
address = {Montreal, Canada},
date = 2010,
month = may,
day = 18,
url = {http://www.translationalethics.com/2010/05/18/conditions-of-collaboration-protecting-the-integrity-of-the-scientific-enterprise/}
}
MLA
Jonathan Kimmelman. "Conditions of Collaboration: Protecting the Integrity of the Scientific Enterprise" Web blog post. STREAM research. 18 May 2010. Web. 06 May 2024. <http://www.translationalethics.com/2010/05/18/conditions-of-collaboration-protecting-the-integrity-of-the-scientific-enterprise/>
APA
Jonathan Kimmelman. (2010, May 18). Conditions of Collaboration: Protecting the Integrity of the Scientific Enterprise [Web log post]. Retrieved from http://www.translationalethics.com/2010/05/18/conditions-of-collaboration-protecting-the-integrity-of-the-scientific-enterprise/
Ted Kennedy, who died two days ago, championed many of the issues covered in this blog, among them access to health care, funding for research, and a strong drug regulatory system. To those who care deeply about these issues, his indefatigable advocacy will be missed.
Among the many landmark laws and regulations that owe their origin to Kennedy are U.S. policies on human protections. Way back when, as a freshman Senator, Kennedy chaired Senate hearings that revealed human research abuses like those committed in the Tuskegee Syphilis Study. He went on to introduce some of the first legislation calling for formal regulation of human research. His initial bill would have given the federal government broad authority to regulate both public and private research. However, it was ultimately overtaken by a weaker bill that called for the creation of a National Commission. Ultimately, Kennedy supported the latter bill under the condition that the Department of Health, Education, and Welfare (now HHS) issue regulations. The reports of the National Commission continue to have a towering influence over research ethics, and the regulations following from this law (45 CFR 46) are virtually unchanged today (photo credit: John Mcnab 2007)
Jonathan Kimmelman. "Ted Kennedy: 1932 – 2009" Web blog post. STREAM research. 28 Aug 2009. Web. 06 May 2024. <http://www.translationalethics.com/2009/08/28/ted-kennedy-1932-2009/>
APA
Jonathan Kimmelman. (2009, Aug 28). Ted Kennedy: 1932 – 2009 [Web log post]. Retrieved from http://www.translationalethics.com/2009/08/28/ted-kennedy-1932-2009/
So what does it take to keep medical research a well-oiled enterprise that efficiently and effectively delivers cures? Lots of cooperation–or so I argue, along with co-authors Alex John London and Marina Emborg in a piece appearing in Science [a publicly accessible version of the essay is available at Science Progress]. Unfortunately, we argue, the way or system of drug development currently thinks about the ethics of clinical research does not presently place sufficient emphasis on the conditions necessary to sustain this cooperation.
