Abstract

In the United States 46 million people are uninsured and it is from within this population that many ‘normal, healthy’ research participants are selected. Research institutions and sponsors are not required to compensate or provide free treatment to participants when they incur research-related harm, and most studies do not stipulate the provision of free medical care to treat research-related adverse events. The consequence for uninsured participants is that they must assume these medical costs unless they successfully sue the study sponsor or research institution. This article discusses the matter of healthy volunteers becoming ‘the sick’ as a result of research participation, and proposes guidance for the informed consent process in order to optimize awareness about injury potential and injury compensation. Guidance regarding health screening for these volunteers is also presented.