By Alan Wertheimer, author, senior research scholar in the department of bioethics, clinical center at the US National Institutes of Health, and PRIM&R member

Oxford University Press has just published my most recent, and probably my last, book, Rethinking the Ethics of Clinical Research: Widening the Lens. This is the first extended work of my second career. After teaching political philosophy at the University of Vermont for 37 years, I joined the Department of Bioethics in the Clinical Center at the National Institutes of Health (NIH) in 2005.
My philosophical work had focused on the moral status of dyadic relations: when is one coerced in a way that compromises one’s responsibility for one’s actions? When does someone exploit another? When does a person give valid consent to sexual relations? When I arrived at NIH, I waded into the literature on the ethics of research with human subjects, only to find that the concepts about which I had been obsessing for many years were central to that discourse. Can offers of financial payments to participate in research be coercive? Are researchers exploiting subjects in less developed countries? Do research subjects give valid consent when they do not fully understand or appreciate that they will not be receiving personalized medical care? So, I started working along lines with which I was familiar, but in a context that was entirely new to me, and which has led me to extend and revise my views. My book is not a systematic treatise on research ethics. Rather, it consists of philosophical reflections on a variety of issues such as the unacknowledged prevalence of paternalism in research ethics, exploitation in international research, the ethics of paying research subjects, and whether researchers have special obligations to those who already benefit from and consent to participate in research.

As a quasi-outsider, I have been struck by the extent to which research ethics adopts a type of “research exceptionalism,” which is the view that participation in research is a distinctive activity that requires moral principles that we do not adopt or reject in other social contexts. For example, research ethics often proceeds as if it is obvious that valid consent must be preceded by an elaborate disclosure of information. Yet, we make no such assumption in many other areas of life, such as marriage, sexual relations, employment, and most commercial transactions.

It is also universally said that subjects have a right to withdraw at virtually any point without penalty, but in some areas of life, people make binding commitments in exchange for benefits. Why not here?

Additionally, it is often said that it is morally problematic to pay subjects to accept risks to their life or health that they would not otherwise accept. On the other hand, we pay people to accept risks all the time, be it as coal miners (I write just after 33 miners in Chile have been rescued), soldiers, loggers, fishermen, fire fighters, structural steel workers, or pizza deliverers. Is there something morally distinct about the risks of research? If so, what is it? Another issue lies in the “off-shoring” of medical research. Some think that “off-shoring” of manufacturing and services is a net good for countries and workers abroad, and for those who consume those products and services (at lower prices) here. This may mean people believe it is unproblematic to employ those “off-shore” to answer telephones, but morally troublesome to employ them as research subjects for testing drugs. That may be so, but, if so, why is that so?

That is not clear.

The book’s sub-title—widening the lens—reflects my commitment to viewing the principles of research ethics from a broader perspective, and my hope to persuade readers that it is worth looking at the ethics of research from a wider philosophical angle.

To hear more from Alan, please join us at the 2010 AER Conference, where he will be one of the many expert faculty leading over 175 keynotes, panels, and breakout sessions.