Protecting the uninsured human research subject.

Currently, research institutions are not mandated to provide free medical care or compensation to research participants for research-induced injuries. Research studies offering financial compensation or the possibility of treatment often attract more of the working poor who are less likely to have health insurance. Thus uninsured or underinsured participants face a heavier burden and greater risk than those with insurance. Based on a theoretical examination of the Belmont principles of beneficence and justice, the authors' IRB analysis, and an analysis of the changing health care and research arenas, the authors provide reasons to amend the Federal Code of Regulations.