Reducing rule-breaking in clinical trials

The way that most scientific reports are presented seems to suggest that clinical trials have controlled for flaws or deviations, but some test subjects secretly break study rules that conflict with their own personal interests. These “subversive subjects” undermine the research endeavor.


Rebecca Dresser, JD, biomedical ethics expert and professor of law and of medicine at Washington University in St. Louis, describes the existence of subversive subjects and ways in which to address the problem in the latest issue of the Journal of Law, Medicine & Ethics.

“No one, including members of the research community, should be shocked that many — perhaps most — subjects care more about their personal needs and circumstances than about the knowledge-seeking objectives of research,” Dresser writes.

From lying about medical histories to drug-sharing in placebo trials to deviating from set drug administration times to sneaking food and drinks not allowed by study protocols, Dresser lists several reported instances of subversive subject behavior. Some study participants exaggerate their compliance in order to please the researchers.

That said, Dresser also acknowledges that the research model can contribute to this subversion. Sometimes, subjects will break the rules of a study due to mistreatment by the research team. Substandard research unit conditions, dishonest researchers or the need to rebel against perceived authority all contribute to subjects’ noncompliance with the rules.

Dresser describes three general approaches researchers can adopt to combat the problem of subversive subjects: “more vigilant policing of subjects’ behavior; intensified efforts to guide subjects towards compliance; and increased collaboration with subjects to develop mutually acceptable research conditions.”

Of these approaches, only the collaboration method treats subjects as full partners in research. “Policing and guidance strategies can be conducted in ethical ways, but constant surveillance and patronizing communication are demeaning to research subjects,” she said.

Dresser asserts that our best chance at reducing subversive behavior is for researchers to work with subjects to create “subject-friendly studies.”