Impediments to “T2” research: Is research ethics really to blame?

Abstract

Ever since the emergence of the field of research ethics, concerns have existed about the possibility that regulation of research might “cripple”, if not eliminate, research in important fields (Beecher 1959). In recent years research ethics review has been accused of impeding basic and translational research and of being responsible for driving medical research from the industrialised West to “less heavily regulated” regions (e.g. Russia, Africa, China, India, Latin America and Brazil) (Asprey 2010). Indeed, while research ethics committees are sometimes criticized for existing primarily to serve the interests of research scientists and academic and commercial organizations, these committees and other regulatory structures have also been characterized as “regimes of ethical control” which seriously threaten both scientific progress and academic freedom (Boden, Epstein, and Latimer 2009). Sofaer and Eyal join this chorus, arguing that post-approval (“T2”) translational research is particularly affected by excessive regulation and overly bureaucratic ethics review. This is an interesting question, as T2 research has not typically been the focus of complaints about ethics review (which have tended to focus on more on regulatory impediments to research on “vulnerable” populations” such as children and the mentally ill, on restrictions to the use particular research technologies or resources such as human tissue collections and on the bureaucratic impediments to collaborative (including multi-site and multi-national) research (Boden, Epstein, and Latimer 2009; Asprey 2010)). Unfortunately, Sofaer and Eyal provide little empirical data to support their