ABSTRACT
In our time of genome-based personalized medicine, clinical research and clinical medicine are accelerating at a quick pace. Faster and cheaper DNA sequencing and protein profiling, microfluidic devices for capturing blood biomarkers, nanoparticles for precise drug delivery and enhanced imaging, rapid computational analysis of massive data inputs, and other technological wonders coalesce to create a kind of Moore's Law for medicine. Needs are obvious, knowledge grows, capital becomes available, but these factors are not entirely sufficient to make health more achievable. Personalized medicine also requires social acceptability, not only for accuracy and efficacy but also because medicine is a moral domain. This chapter deals with medical ethics that determine the choices a society makes regarding healthcare; and it has not always been a steady, morally correct course of progress. Indeed, medical ethics has largely derived from socio-scientific calamities in the past. Personalized medicine, with its enhanced capacity to access the individuality of illness, must have a continuously evolving feedback mechanism-the most important element being the physician-patient relationship-which is its ethical footing.
Subject(s)
Ethics, Medical , Precision Medicine/ethics , Humans , Physician-Patient RelationsABSTRACT
Modern ethical codes in medicine were developed following World War II to provide respect for persons, beneficence, and justice in clinical research. Clinical trial medicine involves greater scrutiny than most research activities. In every instance, clinical trials have institutional review boards to ensure the medical procedure under study complies with regulatory requirements, privacy, informed consent, good practices, safety monitoring, adverse events reporting, and is free of conflicting interests. Mandatory training in medical ethics for all clinical staff is becoming more common, and at some institutions, knowledgeable patient advocates play a watchdog role. In personalized medicine, each patient becomes a clinical trial of one, based on the uniqueness of the person's illness and the relatively tailored treatment. These features imply a shared responsibility between the patient and the researchers because uncertainty exists over the outcome for each individual patient. This chapter introduces ethical considerations using case studies, with historical context, and describes general ethical guidelines for initiating a clinical trial.
