At the final session today of the Presidential Commission for the Study of Bioethical Issues, one issue that rose repeatedly was the importance of involving the community in discussions around ethical issues in clinical trials.
“A lot of people talked about individual rights and community rights, but how do we take that into consideration and understand more about the community rights?” asked Commission member Dr. Raju Kucherlapati, the Paul C. Cabot Professor in the Harvard Medical School Department of Genetics. “How do you define the community? Is it the town or small city? Is it the country? The world? The implications on how you define this are very important.”
Dr. John R. Williams, a consultant with the World Medical Association, said it was a question that still confounds experts. “It’s an evolving concept,” he said. “It differs from one environment to another. .. In the African context, a tribe, or clan, is pretty well identified with a recognizable leadership. It’s more difficult in the U.S. and Canada where there are large immigrant populations.”
Commission Chair Dr. Amy Gutmann, president of the University of Pennsylvania, had a related question: How important were community rights? She brought up the case of the U.S.-funded Guatemala experiments from 1946-1948 during which investigators deliberately infected trial participants with sexually transmitted diseases and, with some, did not treat them.
“As far as we know in Guatemala, the Guatemalan government agreed to the experiment,” she said. “As we know today, getting the agreement of governments in many cases does not pose a high bar. Raj asked a very, very important question: What is the value you see in community consultation, and at what level is it important?”
Dafna Feinholz, chief of the Bioethics Section, Division of Ethics and Science and Technology, Sector for Social and Human Sciences, United Nations Educational, Scientific and Cultural Organization, said there were several benefits of community partipation.
“The added value is more involvement from the community and knowing better if this (research) is responding to what the needs are,” she said.
That only led to another question – again from Kucherlapati:
“When we think about benefits accruing to the community, how would we consider that? Do we consider only those regions in which trials are conducted, or do we consider the benefits to the world as a whole – drugs that benefit everybody?”
The Commission will be studying the issue of protecting human subjects in domestic and international trials throughout the year and is expected to make its recommendations to President Obama late in the year.