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Rethinking Human Research Protections

While voluntary informed consent to participate in research has long been an “axiom of bioethics,” in reality there has been a “process of erosion and retreat” from this principle, said Alexander Capron in the Beecher Award Lecture on December 2 in New York. Capron noted the relevance of this trend in light of President Obama’s request last month that his bioethics commission examine the ethics of human subjects research.

Alexander Capron delivers the Beecher Award lecture

Capron is the 2009 recipient of the Henry Knowles Beecher Award, which recognizes individuals who have made a lifetime contribution to ethics and the life sciences and whose careers have been devoted to excellence in scholarship, research, and ethical inquiry. A founding Fellow of The Hastings Center, Capron is University Professor and Scott H. Bice Chair in Healthcare Law, Policy and Ethics at the University of Southern California. The lecture was the centerpiece of a celebration of the 80th birthday of Daniel Callahan, cofounder of The Hastings Center.

Capron cited numerous violations of informed consent over the decades, including the revelation in October that doctors from the U.S. Public Health Service deliberately infected Guatemalan prisoners, mental patients, and soldiers with syphilis to test the effectiveness of penicillin. He also noted that federal rules allow institutional review boards to grant waivers to informed consent in several circumstances, including studies that involve minimal risk.

Capron said that the problems with informed consent today are inherent in the way the federal government regulates research – specifically, placing the responsibility of protecting human subjects with ethics committees and not with the researchers themselves. In addition to informed consent, the need for researchers to take responsibility for the ethical integrity of their experiments was called for nearly half a century ago by Henry Knowles Beecher, a distinguished physician who exposed questionable practices in human subjects research. “I now see the centrality of placing this responsibility on each and every investigator,” Capron said. “Indeed, I hold little hope that we can make progress without it.