integrity of the scientific enterprise

Conditions of Collaboration: Protecting the Integrity of the Scientific Enterprise

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)

2010 May 18 | Leave a comment | Tags: first in human trials human protections integrity of the scientific enterprise preclinical studies translational trials

BibTeX

@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. 24 Apr 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/

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