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President’s Bioethics Commission To Wrap Up Historical Investigation

August 25, 2011

Report due to President in September

At its public meeting on August 29 in Washington, the Presidential Commission for the Study of Bioethical Issues will publicly discuss several key findings as it refines the conclusions of its historical investigation into the U.S. Public Health Service (U.S. PHS) studies done in Guatemala in the 1940s. The U.S. PHS research involved intentionally exposing and infecting vulnerable populations to sexually transmitted diseases. The Commission’s historical investigation is due to President Obama in September.

Following the revelation last fall that the U.S. PHS supported research on sexually transmitted diseases in Guatemala from 1946 to 1948, President Obama tasked the Bioethics Commission with two assignments: 1. oversee a thorough fact-finding investigation into the specifics of the studies (due in September); and 2. assure him that current rules for research participants protect people from harm or unethical treatment, domestically as well as internationally (due in December).

August 29 — Day One

The Commission will wrap up its historical investigation on day one, August 29, of its two day meeting. On August 29, Commission members will discuss key findings from the investigation, and answer questions including:

    * Why Guatemala?
    * Why were vulnerable populations targeted?
    * Was this good science and did the researchers actively work to keep it secret?
    * Were ethics rules of the time violated?

The full meeting agenda can be found on the Commission website here: http://bioethics.gov/cms/meeting-six

On that day the Commission also hopes to hear from the Vice President of Guatemala, Rafael Espada, M.D. The Vice President was scheduled to address the Commission in May at the Commission’s public meeting in New York, but had to reschedule. The Government of Guatemala has undertaken its own research into the 1940s studies and that effort is led by Vice President Espada. To date, Guatemala has not yet released its investigation report.

August 30 — Day Two

On day two of the meeting, August 30, the Commission will focus on its second task for President Obama and continue its review of contemporary standards to protect human research participants. In particular, the Commission looks forward to receiving the proceedings and recommendations from the International Research Panel formed to consider the effectiveness of current federal rules and international standards governing research involving human subjects. The Panel met three times and has a list of recommendations it will present to the Commission. The International Research Panel’s recommendations will be made public and the Commission will take public comment on the Panel’s recommendations. The Commission will use the Panel’s proceedings and recommendations to inform its final report to President Obama.

That final report is due to the President in December.

This meeting is free and open to the public on a first come, first served basis. The Commission will do its best to accommodate requests to speak. Written comments will also be accepted and are especially welcome.

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