Читать книгу The SAGE Encyclopedia of Stem Cell Research - Группа авторов - Страница 363

All clinical trials present ethical concerns that must be balanced against research value. Patient safety is paramount; however, there is always risk and the acceptable amount is often determined by how devastating the illness to be treated is. Patients must be presented with the full facts about risk and benefit (both to themselves and others) in order to make an “informed consent” of participation.

To ensure study viability, placebo groups are often used, which, in and of itself, introduces ethical concerns as patients must decide if the potential benefits of the experimental treatment are outweighed by the possibility of being in the placebo group and receiving no treatment at all. In the case of severe illnesses, the placebo group is often replaced by a comparison of the trial results against traditional treatments. Risk/benefit analysis and informed consent are of special concern with iASC studies due to an ongoing controversy surrounding cancer studies in the 1990s.

Human integrity and provider conflicts of interest are real concerns, but difficult to quantify. In this discussion human integrity refers to protecting the patient’s rights and dignity throughout the course of the trial, including property rights and the use of an individual’s tissues for purposes outside the study. These concerns can frequently lead to conflicts of interest within the medical and research communities.

Of particular concern with technologies such as iASC, which show high profit potential, is the dual role held by doctors as care providers and researchers. Patients with serious illness are a vulnerable population and depend heavily on the guidance of their caregiver. Even the best-intentioned professionals can find themselves swayed by their personal enthusiasm for a project, as well as other pressures, to place candidates into a study when they might objectively be better served by traditional treatments.

Studies for “last chance” therapies are especially susceptible to human integrity violations by both physicians and patients. These studies involve patients suffering life-threatening illnesses who have not responded (or not responded well) to traditional treatments. The temptation of “new hope” can be coercing to patients and providers alike when palliative end-of-life care may realistically offer the greatest dignity and quality of life. An important factor in these cases is how much legitimate promise the treatment offers, versus the cost in human suffering. Again, potential systemic failures during early research into iASC has led some to be concerned that the efficacy of stem cell therapy may be overstated and improperly coercive to patients facing terminal illnesses.