Wednesday, December 15, 2010

Oversight, oversight, oversight

It can’t be repeated often enough: Efficient and competent oversight is of crucial importance when trying to ensure ethically run clinical trials anywhere. Bioethicists were for some time distracted by chasing smaller prizes in their ongoing debates about the ethics of clinical research in developing countries. These smaller prizes were and are important prizes as surely the standards of care provided in a trial matter, and so do our answers to concerns about post-trial benefits and the question of what constitutes a trial related injury that ought to be subject to compensation in prevention trials. And yet, all of these questions seem like skirmishing activities when, after a brief reality check, we realize that next to no trials that are undertaken in developing countries by Western for-profit as well as non-profit sponsors are vetted for ethics compliance by developed country oversight agencies such as the Food and Drug Administration agency in the USA.[1] The reported behaviour of pharmaceutical companies such as Pfizer – a frequent sponsor of bioethics causes – in developing countries is undoubtedly cause for concern and suggests at a minimum that oversight agencies should more rigorously and more vigorously monitor the ethics compliance of research undertaken in developing countries.[2]
The same holds true for trials listing researchers with multiple affiliations on their papers.  When a researcher lists a US American institution among his or her institutional affiliations on a research paper reporting clinical research that was undertaken while he or she was affiliated with that institution, there is no excuse for that institution not to have vetted the trial its staff has undertaken in a developing country.  Unfortunately, the opposite is actually the case.[3]
Perhaps this is as good a time as any to stress the importance of ensuring the enforcement of ethics standards by means of ongoing and efficient oversight. Ethics standards without bite and human power to back them up are not worth the paper they are written on.

Office of Inspector General (DHHS). 2010. Challenges to FDA’s Ability to Monitor and Inspect Foreign Clinical Trials.  DHHS: Washington DC. (OEI-01-08-00510)

[2]  Anonymous. UPDATE 1-WikiLeaks cables: Pfizer took aim at Nigeria AG. The Economist 10 Dec 2010 (accessed 15 December 2010).  A Ballantyne. Benefits to Research Subjects in International Trials: Do They Reduce Exploitation or Increase Undue Inducements? Developing World Bioethics 2008; 8: 178-191.

S Philpott, U Schuklenk. A Trial That Should Not Have Been Done (accessed: 15 December 2010)

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