ABSTRACT

Multiple sclerosis (MS) trials are challenged by the unpredictable course of the disease, imprecise measures of disease activity, and difficulties in maintaining patient participation in long trials. The three major ethical principles governing such trials and other studies have been summarized as: respect for people (autonomy), beneficence (the obligations to improve well-being and to do no harm), and justice (the risk of research participation must be less than the potential benefits).[1] These three principles have been expanded to seven:[2]

1 Value-enhancements of health or knowledge must be derived from the research (so clinical research with non-generalizable results and lack of publication of the results would each be unacceptable).