March 7, 2011 — University of Virginia bioethics professor John Arras has been named to a new International Research Panel created by the Presidential Commission for the Study of Bioethical Issues to consider the standards for protecting human subjects in scientific studies.
The announcement comes in direct response to a request from President Obama, explained Arras, the Porterfield Professor of Biomedical Ethics and Professor of Philosophy in the College of Arts & Sciences, a member of the presidential commission and one of the 15 experts from around the world named to the new panel.
The president asked the commission to report on the effectiveness of current U.S. rules and international standards for the protection of human subjects in scientific studies supported by the federal government and to assure him that "the current rules for research participants protect people from harm or unethical treatment, domestically as well as internationally."
This request arose in the wake of revelations last October about U.S. Public Health Service-supported research on sexually transmitted diseases in Guatemala from 1946 to 1948, which involved the intentional infection of people.
"We don't have to think of hypotheticals in bioethics," Arras said. "There's always something real that comes along and often outstrips our imagination. This is that."
The Guatemalan research was uncovered by Susan Reverby, a professor at Wellesley College, while conducting historical research on the Tuskegee Study of Untreated Syphilis among the archived papers of the late Dr. John Cutler, a U.S. Public Health Service medical officer and a Tuskegee investigator.
To consider the effectiveness of current federal rules and international standards governing research involving human subjects, the International Research Panel will convene in a series of meetings that will examine:
• The dominant norms, and competing alternatives, driving the ethics of medical research in different global regions outside of the U.S.;
• The conflicts, if any, between U.S. norms and international standards;
• The challenges facing researchers conducting U.S.-funded research in global settings; and
• How best to address any major differences in regional norms for medical research.
The group plans to meet three times, with at least one of the meetings taking place outside the United States. Public comments will be solicited before the commission submits its final report to the president.
In addition, the Presidential Commission for the Study of Bioethical Issues will conduct a thorough fact-finding investigation into the 1946-48 research.
Some news reports have cited sources warning that an episode similar to the one in Guatemala could happen today, but Arras disagrees.
"The chance of something as morally egregious as the Guatemala study happening today as are pretty slim, given the system of controls that we now have in place – the whole institutional review board system was set up to guard against just this type of abuse," he said. "Bad things are happening and will happen. But probably not on this type of scale."
Many thorny issues remain, however. Arras said that most privately financed medical research, and an increasing share of government-financed research, is done outside the United States to reduce costs by avoiding U.S. regulations.
"With a lot of what goes on now, we are targeting certain populations not for a scientific reason, but simply because it's cheaper, because their legal and regulatory systems are more lax," Arras said. "That's not a healthy situation."
However, in countries with weak public health infrastructure, drug trials often offer the only access to certain types of medical care, creating some difficult ethical questions.
What "standard of care" is expected of researchers, one equivalent to that offered in industrialized nations or equivalent to the local standard? Do researchers and sponsors owe participants continuing care after a trial is over? When a patient in a drug trial becomes sick with an unrelated issue, what is the duty of the researcher?
"To what extent are you just a researcher versus a caregiver responding to problems on the ground there?" Arras asks. "That's a very deep conflict, and nobody quite seems to know how to solve it. That's why this area is so important, but also ethically, intellectually challenging."
The announcement comes in direct response to a request from President Obama, explained Arras, the Porterfield Professor of Biomedical Ethics and Professor of Philosophy in the College of Arts & Sciences, a member of the presidential commission and one of the 15 experts from around the world named to the new panel.
The president asked the commission to report on the effectiveness of current U.S. rules and international standards for the protection of human subjects in scientific studies supported by the federal government and to assure him that "the current rules for research participants protect people from harm or unethical treatment, domestically as well as internationally."
This request arose in the wake of revelations last October about U.S. Public Health Service-supported research on sexually transmitted diseases in Guatemala from 1946 to 1948, which involved the intentional infection of people.
"We don't have to think of hypotheticals in bioethics," Arras said. "There's always something real that comes along and often outstrips our imagination. This is that."
The Guatemalan research was uncovered by Susan Reverby, a professor at Wellesley College, while conducting historical research on the Tuskegee Study of Untreated Syphilis among the archived papers of the late Dr. John Cutler, a U.S. Public Health Service medical officer and a Tuskegee investigator.
To consider the effectiveness of current federal rules and international standards governing research involving human subjects, the International Research Panel will convene in a series of meetings that will examine:
• The dominant norms, and competing alternatives, driving the ethics of medical research in different global regions outside of the U.S.;
• The conflicts, if any, between U.S. norms and international standards;
• The challenges facing researchers conducting U.S.-funded research in global settings; and
• How best to address any major differences in regional norms for medical research.
The group plans to meet three times, with at least one of the meetings taking place outside the United States. Public comments will be solicited before the commission submits its final report to the president.
In addition, the Presidential Commission for the Study of Bioethical Issues will conduct a thorough fact-finding investigation into the 1946-48 research.
Some news reports have cited sources warning that an episode similar to the one in Guatemala could happen today, but Arras disagrees.
"The chance of something as morally egregious as the Guatemala study happening today as are pretty slim, given the system of controls that we now have in place – the whole institutional review board system was set up to guard against just this type of abuse," he said. "Bad things are happening and will happen. But probably not on this type of scale."
Many thorny issues remain, however. Arras said that most privately financed medical research, and an increasing share of government-financed research, is done outside the United States to reduce costs by avoiding U.S. regulations.
"With a lot of what goes on now, we are targeting certain populations not for a scientific reason, but simply because it's cheaper, because their legal and regulatory systems are more lax," Arras said. "That's not a healthy situation."
However, in countries with weak public health infrastructure, drug trials often offer the only access to certain types of medical care, creating some difficult ethical questions.
What "standard of care" is expected of researchers, one equivalent to that offered in industrialized nations or equivalent to the local standard? Do researchers and sponsors owe participants continuing care after a trial is over? When a patient in a drug trial becomes sick with an unrelated issue, what is the duty of the researcher?
"To what extent are you just a researcher versus a caregiver responding to problems on the ground there?" Arras asks. "That's a very deep conflict, and nobody quite seems to know how to solve it. That's why this area is so important, but also ethically, intellectually challenging."
— By Brevy Cannon
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March 7, 2011
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