Consent to clinical research

Every year, millions of people are enrolled into research. The studies in which they participate range from simple surveys of consumer preferences to the experimental insertion of electrodes into patients’ brains and the intravenous administration of potentially toxic drugs. The involvement of human subjects in scientific research, especially medical experiments, has provoked considerable ethical concern among lay people and academics. This ethical concern has two primary sources. One is historical. In the words of bioethicist Carol Levine, research ethics was “born in scandal.” 1 A long history of egregious experimentation on unsuspecting and vulnerable people has led to awareness of the potential dangers of leaving researchers to their own devices. The other source of concern has to do with the goals of research. While the primary goal of clinical care is to benefit the patient being treated, the primary goal of clinical research is to generate information that will ultimately benefit other people in the future. Benefiting research participants is, at best, a secondary goal. Clinical research consequently provokes particular ethical concern because of the potential for conflict between the interests of participants and the goal of acquiring knowledge.