Obtaining voluntary consent for research in desperately ill patients.

Voluntary informed consent is a hard problem--one that inheres in the domain of research. The standard definition requires four criteria for consent to be morally valid: disclosure, understanding, voluntariness, and competence. These standards apply across the continuum of activities that comprise research. This paper concentrates on consent for the desperately sick, for whom enrollment in a research trial represents the last best hope of rescue. The literature indicates that many of these subjects enroll in research on the basis of feelings of hope or trust. This finding bypasses the careful weighing of risks and benefits that the model of informed consent is based upon. This paper explores how the requirements of candor need to be balanced with those of kindness.