Regulation of therapeutic research is compromising the interests of patients

In this paper, I consider the impact of research regulation on the duty of doctors to help to resolve uncertainties about the effects of treatments; in particular, treatments already in use within 'normal' or 'usual' clinical practice. After providing examples of ways in which current research regulation is obstructing this professional duty, I consider the influence of "a confused ethical analysis", the double-standard in informed consent to treatment within and outside of controlled trials, and the failure of research regulators to use their powers to reduce unnecessary research and promote full publication of necessary research. I suggest that these problems should be addressed by more thoughtful ethical analyses, more effective protection of the interests of patients by research regulators and empirical research to inform the future development of research regulation. Because ethicists and research regulators have paid insufficient attention to these issues, I conclude that they have contributed to the avoidable suffering and deaths of millions of people, the vast majority of whom have not been participants in clinical research. © 2007 Adis Data Information BV. All rights reserved.