Medical Research and Intangible Harm

Abstract:     
Although conventional wisdom assumes that human subjects participating in medical research face significant risk of pain, disability, and death, evidence suggests that, in the aggregate, research subjects fare as well therapeutically as patients with similar conditions not participating in clinical trials. Research subjects do, however, face unappreciated risk of intangible harm, even if not physically injured, such as affronts to dignitary interests. This Article considers whether the intangible hazards faced by subjects should be cognizable under the law to a greater degree. A more flexible approach has considerable advantages, including helping to police opportunistic conduct in the investigator-subject relationship, but also raises difficult drawbacks, such as pragmatic problems in defining boundaries for intangible harm claims and possible over-deterrence. This Article balances the competing considerations and suggests a limited, incremental approach to recognizing intangible harm claims in medical research. In particular, this Article contends that intangible harm remedies are best used to address abandonment hazards, such as when investigators and sponsors readily frustrate and potentially exploit subjects' assumptions regarding study terminations and continued access to experimental technology. Similarly, subjects may be wrongfully abandoned, even if not physically injured, when the study fails to contribute to general medical knowledge through the public dissemination of research results. Because such abandonment conduct disgregards subjects' reasonable expectations and considerable personal investments in clinical trials, and raises serious concerns for the research enterprise generally, it warrants sanction as legally cognizable harm.

Keywords: medical research, medicine, experimentation, clinical trials, intangible harm, research subject

Accepted Paper Series