Are special ethical guidelines needed for palliative care research?

Recent studies have made it clear that there are substantial opportunities to improve end-of-life care. Doing so will,require solid evidence on which to base clinical and polity decisions and this, in turn, will require a focused research effort. However, research that involves patients near the end of life creates numerous ethical challenges. Moreover the inclusion of dying patients in research may make many providers uncomfortable. In short, there seems to he something ethically unique, and uniquely challenging, about palliative care research. This paper considers 4 arguments for this unique status: 1) dying patients are eapecially vulnerable; 2) adequate informed consent may be difficult to obtain; 3) balancing research and clinical roles is particularly difficult; and 4) the risks and benefits of palliative research are difficult to assess. We conclude that the first three of these arguments are weak;, and that special guidelines are not needed. We suggest, however that the fourth argument may have some merit, and should be the focus of discussion among investigators, providers, and patients. (C) U.S. Cancer Pain Relief Committee, 2000.