© 2006 Nature Publishing Group

Ethics Watch

DESPERATE TIMES CALL FOR DESPERATE MEASURES

Today, it might not be wise to disclose being an ethicist when attending a meeting among scientists. Ethics has lost a great deal of credibility and ethicists do not have an aura of trustworthiness. Ethics is seen as impeding research and inhibiting its initiation. For example, the impracticable requirements for ethics approval have been blamed for the lack of randomized clinical research during the 2003 SARS outbreak1. Even if this might not have been the only reason, the allegation should be taken seriously. The regulation and practice of ethics review have been established with the dual aim of protecting individual research participants from harm and facilitating biomedical research to the benefit of humankind. What has gone wrong that ethics now seems to be so dysfunctional? It is time for the ethics’ profession to assess the complaints, make a diagnosis and suggest a cure.

There are two dimensions to the problem. First, the traditional content of medical ethics and its guiding principles might not be sufficiently applicable anymore to the questions that are raised by current research, especially in genomics. The ‘protection model’, which is intended to safeguard individual rights and interests and features ‘autonomy’ as the core concept, is not equipped for the assessment of genetic population studies with its focus on groups and communities, and using data and samples that have different levels of identifiability. Also, the data that are collected in pharmacogenetic studies have an information content that is different from that of genetic data that are collected in research on rare hereditary disorders. The possible effect on study participants is not comparable. Therefore, rights and interests must be redefined accordingly. The same holds for the ethical principles that are to be applied. First attempts to develop new normative frameworks have been made. Notably, the set of principles as proposed by Knoppers and Chadwick2 that includes reciprocity, solidarity and citizenry could offer guidance in the ethics review of population-based genetics research.

The second part of the problem with dysfunctional ethics review is caused by its procedural outgrowths. The establishment of procedures for ethics review in the past two decades is reflected in laws and in hierarchies of committees and review boards. Often approval must be sought from national, regional, local and in-house ‘authorities’3. Studies of the approval procedures for this type of research show the shocking cost in terms of time, money and personnel resources4, as well as in terms of study delay, withdrawal from international multicentre studies and abandonment of planned research projects1. The European Union Directive for Good Clinical Practice is soon to be implemented, but it looks as if its practical consequences will not be favourable for promoting Europe-wide multicentre clinical research5.

It seems that current ethics review is impeding both biomedical research and ethics itself. Is there a cure? Desperate times call for desperate measures and in this case the ethics’ profession should take the lead by the further development of new normative frameworks and innovative streamlined procedures. Pruning the procedural outgrowths will be difficult, but we should at least try not to let them grow into an impenetrable thicket.

Jeantine E. LunshofVU university medical center, Amsterdam, The Netherlands.

e-mail: je.lunshof@vumc.nl

REFERENCES 1Glasziou, P. & Chalmers, I. Ethics review roulette: what can we learn? BMJ 328, 121–122 (2004) | 2Knoppers, B. M. & Chadwick, R. Human genetic research: emerging trends in ethics. Nature Rev. Genet. 6, 75–79 (2005) | 3Hearnshaw, H. Comparison of requirements of research ethics committees in 11 European countries for a non-invasive interventional study. BMJ 328, 140–141 (2004) | 4Wald, D. S. Bureaucracy of ethics applications. BMJ 329, 282–284 (2004) | 5Bosch, X. Europe’s restrictive rules strangling clinical research. Nature Med. 11, 1260 (2005)

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2 | MONTH 2006 | VOLUME 7 www.nature.com/reviews/genetics