The blog of the Presidential Commission for the Study of Bioethical Issues

A new start looking at ethics in overseas clinical trials

Dr. James Wagner, Commission Vice Chair

In the public meeting today on the ethics around human subjects in clinical trials overseas, members of the Presidential Commission for the Study of Bioethical Issues were looking for both perspective and ideas on how to move ahead.

Dan W. Brock, the Frances Glessner Lee Professor of Medical Ethics, and Director of the Division of Medical Ethics at Harvard Medical School, who was the Staff Philosopher for an earlier Bioethics Commission some three decades ago, gave them some perspective.

Addressing the revelation last year of a U.S.-sponsored clinical trial that deliberately infected Guatemalans with a sexually transmitted disease, Brock said he doubted that practice continued today.

“It’s pretty unlikely that kind of thing could happen now. That’s a good thing,” he said. “If we think back to 1946 to 1948, just after World War II, we were sensitized to experiences by German atrocities. Those issues (of deliberate infection of trial participants with a disease) hadn’t been on the table in any comprehensive way as they have been now.”

Brock noted the safeguards in the oversight process with any government-funded study, which have Institutional Review Boards, as well as past reviews by other panels, including past Bioethics Commissions. “I think we can pat ourselves on the back a little bit,” he said. “The things that have happened since Guatemala have improved the prospect of them not happening ever again.”

Other experts talked about what needs to be reviewed now. Dr. Eric M. Meslin, the Director of the Indiana University Center for Bioethics and a former executive director of a past National Bioethics Commission during the Clinton administration, gave the Commission several ideas of topics in need of exploration.

He raised several issues. Among them:

  • With the shifting of more clinical trials to developing countries, what is the justification for a principal investigator to conduct research in a country other than his or her own?
  • With funds now coming from a greater variety of government and non-government sources, how is that influencing the types of research being done now?
  • With more community advisory boards playing oversight roles in research, how has that changed the nature of research?
  • With more than 1,000 guidelines for clinical trials from more than 100 countries, is there a way of harmonizing these multiple standards of research?
  • And what is the obligation of governments and corporations to trial participants about their standard of care?

Commission Vice Chair Dr. James Wagner, President of Emory University, also at several points raised an issue critical to him: informed consent of people participating in trials.

He asked panelists a number of times whether standards now in place really helped people understand what they were getting into.

“There are societies that do not have words (for clinical trials),” Wagner said. “In northern Ethiopia, I’ve heard that researchers help stage a dramatic presentation and act out what it would mean. I think that’s laudable. But the fact it is necessary demonstrates that some populations are saying, “Oh I think that we understand.’ “

Brock said that he believed most people entering clinical trials knew what they were getting into. “What a patient wants to know is basically what is going to happen to them and how might that matter in my life?”

The Commission’s next meeting on the issue will take place in a few months. An International Research Panel will be meeting separately and ultimately will make its recommendations to the full Commission by this fall.

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