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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5 Comments to A new start looking at ethics in overseas clinical trials

  1. March 3, 2011 at 9:50 am | Permalink

    Dan W Block: “The things that have happened since Guatemala have improved the prospect of them not happening ever again.” His premise is too narrow in today’s world by focussing on deliberately infecting someone in a clinical trial similar to that which occurred in Guatemala in 1946-8.

    Today’s neuroscience experimentation and development can and does take place with non-consenting subjects given the technology of today. The psychological disposition today is the same as it was in 1946-8 which is what is being repeated. We cannot pat ourselves on the back because we have only observed the external trappings that are repulsive by addressing them and not addressing the essence of the activity which brings about these abuses.

    Because neuroscience research can be carried out clandestinely by distributive means using today’s technology it is being done with the same kinds of abuses that occurred in Guatemala, Nazi Germany or anywhere that people so psychologically disposed take it upon themselves to use non-consenting human subjects in extremely abusive experiments for neuroscience knowledge that results in serious injuries and death. This is being ignored. We cannot be complacent and must always be alert to abuses in scientific and medical research especially when the profits are substantial.

  2. March 3, 2011 at 2:21 pm | Permalink

    At the Center for Global Development, we are running a working group on clinical trials and regulatory institutions in developing countries, with a focus on neglected infectious diseases. We would welcome the opportunity to contribute to the work of the Presidential Commission. Here is a description of our work: http://www.cgdev.org/section/initiatives/_active/ghprn/workinggroups/clinical_trials

  3. March 16, 2011 at 12:00 pm | Permalink

    I feel there is good reason to suggest that Dan W. Brock is misinformed in regards to status of current human experimentation globally.

    Substantial numbers of eye-witness reports, in addition to detailed analysis of probable technology, exist right across the web. Whilst most claims are certainly without foundation, some are too technically detailed to be dismissed.

    One such technical description exists here:

    http://deepthought.newsvine.com/radio

  4. Eric J Suba MD's Gravatar Eric J Suba MD
    April 8, 2011 at 2:56 pm | Permalink

    Since 2004, our organization (The Viet/American Cervical Cancer Prevention Project) has published (in several peer-reviewed journals, including the American Journal of Public Health) scientific and ethical concerns regarding ongoing studies of cervical screening conducted among women of lowest socioeconomic status in India with support from the U.S. National Cancer Institute and from the Bill & Melinda Gates Foundation. These concerns have been largely ignored or dismissed. A summary of these concerns was published on our website in 2007 and is available at:
    http://www.vietnamcervicalcancer.org/index.php?option=com_content&task=view&id=19&Itemid=43

    A summary of lessons we’ve learned from Vietnam over the past 16 years was published online last month at:
    http://onlinelibrary.wiley.com/doi/10.1002/dc.21655/pdf

  5. May 3, 2011 at 10:02 am | Permalink

    “It’s pretty unlikely that kind of thing could happen now” – not quite the same as “There’s no way in hell that kind of thing could happen now”

    The fact that there are clinical trials being conducted in areas where the subjects of the trial don’t have a word for it (which suggests they don’t understand what they’re getting into) makes me wonder if they’ll understand the true implications of what’s being done to them.

  1. By on March 4, 2011 at 10:32 am

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