Académie royale de Médecine de Belgique


Mark Siegler (USA)

(Séance du 28 octobre 2000)


par Mark SIEGLER (Centre MacLean pour l’Ethique médicale de l’Université de Chicago – USA).

Dr Mark Siegler serves as Director of the Policy and Ethics Committee (PEC) of the Immune Tolerance Network (ITN), a $170 million, 7 year contract funded by the National Institute of Health. The central goal of the ITN is to conduct translational research designed to extend basic science work to the clinical arena.  The ITN has identified four initial target areas for this work : 1) Kidney and islet cell transplantation; 2) autoimmune diseases (multiple sclerosis, Type I Diabetes Mellitus, rheumatoid arthritis, lupus); 3) asthma; and 4) allergy.  The PEC is the central ethics advisory board for the ITN.  In this capacity, the PEC has three primary functions: 1) policy development; 2) ethics review of both proposed clinical trials and ongoing clinical trials; and 3) teaching/training seminars for ITN leaders and funded investigators in clinical research ethics/human subject protection.

Recently, government-funded clinical research has been increasingly scrutinized by external oversight organizations.  (Food and Drug A  dministration, National Institutes of Health, Department of Health and Human Services) for deviations from acceptable ethical standars; Institutions have been penalized for violations, including failure to adequately protect human subjects, inadequate informed consent protocols, failure to report adverse events, and failure to have an acceptable ethics review process.  This brief talk will focus on the PEC’S role in protecting human subjects by reviewing the ethical issues raised by proposals for clinical trials.  Time permitting, several case examples will be discussed.  Each case will show the framework the PEC uses when evaluating the ethical acceptability and risk-benefit ratio for a proposed clinical trial.