François Lemaire1. 1. Henri Mondor Hospital, MICU, Paris XII University, Paris, France. francois.lemaire@hmn.ap-hop-paris.fr
Abstract
PURPOSE OF THE REVIEW: Historically, clinical research and patient care have long been intertwined. Until the mid-1970s, physicians in both North America and Europe considered that research on their patients was an integral part of the care that they delivered to them. In the United States, it was after the recommendations of the Belmont report, in 1979, that both medical activities were clearly separated. But, in Europe, the concept of "individual direct benefit from research" is still prevailing in some national legislation. RECENT FINDINGS: The revision of the Declaration of Helsinki and the implementation of a European directive (in 2001) on clinical research in Member States' national laws have prompted a reappraisal of the distinction of research with and without individual benefit. Several recent articles have shown that this concept is flawed for several reasons: first, the commitment of a physician to his patient is inherently different in these two situations; second, it masks the possible conflict of interest, which can be financial or not; third, it perpetuates the "therapeutic conception" and reduces the obligation for a physician-investigator to implement supplemental procedures aimed at enhancing the safety of study patients. SUMMARY: The European directive on clinical research, voted on in 2001 and still in the process of being implemented in national laws of the European Union Member States, mandates clarification of these issues. All European investigators are concerned because the framework of regulations governing clinical research will be markedly altered. The replacement of the distinction between research with and without direct benefit by the evaluation of the risk/benefit ratio by ethics committees is one of the most important changes that is due to happen soon.
PURPOSE OF THE REVIEW: Historically, clinical research and patient care have long been intertwined. Until the mid-1970s, physicians in both North America and Europe considered that research on their patients was an integral part of the care that they delivered to them. In the United States, it was after the recommendations of the Belmont report, in 1979, that both medical activities were clearly separated. But, in Europe, the concept of "individual direct benefit from research" is still prevailing in some national legislation. RECENT FINDINGS: The revision of the Declaration of Helsinki and the implementation of a European directive (in 2001) on clinical research in Member States' national laws have prompted a reappraisal of the distinction of research with and without individual benefit. Several recent articles have shown that this concept is flawed for several reasons: first, the commitment of a physician to his patient is inherently different in these two situations; second, it masks the possible conflict of interest, which can be financial or not; third, it perpetuates the "therapeutic conception" and reduces the obligation for a physician-investigator to implement supplemental procedures aimed at enhancing the safety of study patients. SUMMARY: The European directive on clinical research, voted on in 2001 and still in the process of being implemented in national laws of the European Union Member States, mandates clarification of these issues. All European investigators are concerned because the framework of regulations governing clinical research will be markedly altered. The replacement of the distinction between research with and without direct benefit by the evaluation of the risk/benefit ratio by ethics committees is one of the most important changes that is due to happen soon.
Authors: F Lemaire; J Bion; J Blanco; P Damas; C Druml; K Falke; J Kesecioglu; A Larsson; J Mancebo; D Matamis; A Pesenti; J Pimentel; M Ranieri Journal: Intensive Care Med Date: 2005-02-15 Impact factor: 17.440