Clinical Trials, Cancer, and the Emergence of Human Research Ethics in Canada, 1921-1980

Abstract

Clinical cancer trials in the 21st century take place only with the ethics review committee’s approval and the written informed consent of human subjects. How and why professionals reached these standards of a modern regulatory framework for clinical research by the late 1970s is the subject matter of this dissertation. An historical examination of burgeoning cancer care and clinical trial programs in Canada offers insight into socio-cultural factors that enabled the transformation of experimental treatment into clinical research. This dissertation is a history of the creation, coordination, and contestation of new practices in Canadian clinical settings wherein surgical, radio- and chemo-therapeutic procedures were devised, evaluated, and eventually regulated. Using historical epistemology and the constructivist methodology of science studies, this dissertation demonstrates that medical research ethics emerged through clinical investigation rather than philosophical speculation. Since ethically questionable clinical trials usually provoked professional disapproval, public outcry, and official condemnation from the judiciary, clinicians continually modified their research protocols based on empirical evidence and ethical imperatives. Over the decades, new protocols induced changes in the ethical acceptability of human subject research (HSR) and in its regulation. This process culminated with randomized controlled clinical trials (RCTs) in the 1950-1960s, when their ethical rationalization became more problematic. As this dissertation shows, clinical investigators first raised these concerns in the late 1950s, which later resonated among medical professionals, patients, judges, philosophers and others, all of whom contributed to reshaping the ethics of HSR. Renegotiation and reinterpretation of the meaning of ethical HSR occurred through a series of critical junctures: institution-building, technological innovation, inter-professional struggle, exploitation of cancer patients, litigation, and challenges to the culture of clinical experimentation. This dissertation concludes that both scientific and cultural factors interacted to produce a parallel development of clinical cancer investigation and its ethics, which became embodied in the RCT protocol. Facilitating both the conduct of RCTs and their ethical regulation, protocols generated a feedback loop between the RCT content and the codification of HSR ethics. Ultimately, RCT protocols made possible an increasing professionalization in oncology and an enhanced administrative oversight of clinical research.