The Justification of the Benefit to Others

Awareness of the morally significant distinction between research and innovative therapy reveals serious gaps in the legal provision for compensation in the UKfor injured subjects of medical research. Major problems are limitations inherent in negligence actions and a culture that emphasises indemnifying researchers before compensating victims. Medical research morally requires compensation on a no-fault basis even where there is proper consent on the part of the research subject. In particular, for drug research, there is insufficient provision in the current patient guidelines of the Association of the British Pharmaceutical Industry, since they make "no legal commitment" to paying compensation for injury to patient subjects. There is a needfor the provision of both adequate insurance and contractual arrangements for making payments. The solution is for Local Research Ethics Committees (LRECs) to make use of their power to withhold approval of medical research where compensation is not legally enforceable. Definition of research and the general principles THE DEFINITION OF RESEARCH We might begin with the Oxford English Dictionary's definition. "Research" is there defined as "An investigation directed to the discovery of some fact by careful study of a subject; a course of critical or scientific discovery". The important point is that it is accompanied by an intention to further knowledge, irrespective of benefit to the subject. This essentially captures the idea of research used by the Royal College of Physicians (RCP).' The crucial component is the intention with which the research is done since there are clearly novel ways in which techniques (or drugs) may be used, especially in cases where there is a high risk in any case that a patient will die, and