DEFINING AND DEFENDING THE RIGHTS OF HUMAN RESEARCH SUBJECTS
Among human endeavors, clinical research into new drugs and other therapies holds both some of the greatest potential for good and some of the greatest risk for ethical error. That's because no matter how many studies scientists run on cell cultures and laboratory animals, they eventually have to test whether the treatment works—and is safe—in people.
And that raises all kinds of issues, especially in clinical trials of drugs to treat life-threatening diseases. Because patients often enroll in such studies after proven treatments have failed, they may easily mistake the intent of the regimen. Equating “experimental” with “state-of-the-art,” they may assume the medication is being offered as a cure, when in reality the hope of their deriving any personal benefit is slim. For such vulnerable patients, federal regulation of research provides essential protection.
Institute professor Harold Vanderpool helps craft these and other safeguards. He serves as consultant and member of departmental committees in the NIH and FDA, and presently serves as the chair of the Department of Health and Human Services Secretary's Advisory Committee on Xenotransplantation. His expertise is in ethics, but to be effective Vanderpool also must comprehend the biomedical principles that underlie the research. For example, transplanting organs harvested from pigs into humans raises public health concerns about the potential for transmitting diseases across the species barrier. That's why, before he could help develop public policy on xenotransplan-tation, Vanderpool had to come up to speed on the incorporation of endogenous retroviruses in porcine DNA.
“You can't make contributions in ethics in these situations unless you understand the science involved,” he explains. “The FDA, NIH, and DHHS want to do things right—scientifically and ethically.”
The influence of Vanderpool's insights extends well beyond Washington. In 1997 he traveled to Beijing, Dalian and Qingdao, China, where the government and medical schools were struggling with the question of whether regulating research might stifle it. Pointing out that regulation of research in the United States had resulted in an increase in the numbers of people volunteering to be subjects, Vanderpool built his argument meticulously and persuasively: In this case, government controls protect, rather than impinge on, individual rights.
“My theme there was that the regulation of research here has benefited all,” he explains. “Real public good can come from regulation—real good to medicine and to people. That was my message to China.”
Back in Galveston, Harold Vanderpool teaches ethics to medical students and pursues his other major research interest: the human dimensions of cancer care. These include the psychological, social and spiritual well-being of patients, their families and their professional caregivers and the history of how American physicians have dealt with dying patients. Vanderpool also is developing ways to teach active investigators about the ethics of research. But he keeps current airline timetables close at hand. He never knows when he'll be summoned by scientists and agencies eager to expand the boundaries of medical science without violating the boundaries of ethics.
“Invitations will continue to come from agencies and universities that conduct or oversee cutting edge research with ethical hot spots,” he predicts.