Harvard Catalyst Colloquium Series: Informed Consent for Research

Research is not treatment. One of the biggest misconceptions of people who volunteer to be experimental subjects in a clinical trial is that the study offers medical therapy in the best interests of the patient.

“There may be components intended to be therapeutic,” said Dan Brock at an April 13 lecture at Harvard Medical School intended to provide an ethical framework for thinking about current issues and controversies in informed consent for research. “Medical therapy benefits the patient. The goal of research is generalizable knowledge. Research and therapy can get confused especially when the investigator is the subject’s physician. And when the subject is also a patient.”

Brock is the Frances Glessner Lee professor of legal medicine in the Department of Global Health and Social Medicine. The lecture was part of the Harvard Catalyst Colloquium Series and is archived at http://catalyst.harvard.edu.

Randomization, placebo controls, protocol restrictions, additional testing, and “washouts” are some of the features of clinical research in conflict with medical care, Brock said. Controversy simmers around such areas as what information goes into the informed consent form, whether or not the subject has understood the possible risks and discomforts, and if an informed consent might be considered coercive in certain contexts, such as a false belief that a person might get worse treatment if he or she does not participate in the trial.

Some of the benefits of the informed consent process include the promotion of individual autonomy and rational decision-making, self-scrutiny by the investigator, avoidance of fraud and duress, reduced civil and criminal liability of the investigator or institution and maintenance of public trust and support for the research enterprise in general.

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