Maximizing benefits and minimizing risks in health services research near the end of life.

This article explores the ethical issues specific to Health Services Research (HSR) in palliative care, with particular attention to similarities and differences between HSR and institutional quality improvement (QI) initiatives. We focus on the challenges of determining what level of protection is warranted by investigations of health services and programs of care, in contrast to the traditional randomized clinical trial design, and how best to assure subject protection. A decision algorithm regarding the requirements for full IRB review and informed consent is proposed as a mechanism to assure that the level of protection is commensurate with the level of risk.