Compulsory Research in Learning Health Care: Against a Minimal Risk Limit.

Abstract

Existing calls to implement learning health care systems have tended to stipulate a minimal or near-minimal risk limit for compulsory learning activities. I argue to the contrary that such a limit cannot be defended. So long as the way in which patients are compelled to participate in learning activities is solely through the withholding of nonresearch options for receiving care, compelling participation does not violate any individual's rights and can be both efficient and adequately fair. Because the decision to compel participation in this way is relevantly similar to the decision to ration care, theories of justice in cost-effectiveness rationing can be used to further specify when it is appropriate to use this method to compel research participation. When applied, these theories will not support a minimal risk limit for compulsory research.