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President’s Bioethics Commission Meets to Continue Consideration of Human Subjects Protection at President’s Request

Commission will hear from Vice President Rafael Espada of Guatemala

May 9, 2011

Who

Presidential Commission for the Study of Bioethical Issues

What

Public Meeting

When

Wednesday, May 18, 9 a.m. – 5 p.m.
Thursday, May 19, 9 a.m. – 12:45 p.m.

Where

Warwick New York Hotel
65 W 54th Street
New York, NY 10019

Topic

Human Subjects Protection

NEW YORK, N.Y. – Following the revelation last fall that the U.S. Public Health Service supported research about sexually transmitted diseases in Guatemala from 1946 to 1948 that involved intentionally infecting vulnerable human populations, President Obama tasked the Bioethics Commission with two assignments: 1. to oversee a thorough fact-finding investigation into the specifics of the Inoculation Study; and 2. to assure him that current rules for research participants protect people from harm or unethical treatment, domestically as well as internationally.

Commission Executive Director Valerie Bonham will brief the Commission on May 18 about the status of the investigation. Ms. Bonham is leading the 15 person investigation team that is conducting the fact-finding for the Commission. She is a senior attorney who worked previously with President Clinton's Advisory Committee on Human Radiation Experiments, the closest analog in U.S. history to the fact-finding being undertaken now.

The Government of Guatemala has undertaken its own research and that effort is being led by Guatemala’s Vice President, Rafael Espada, M.D. Vice President Espada will also brief the Commission on May 18 on what his panel has uncovered.

The Commission will spend the rest of the two day meeting continuing its review of contemporary standards to protect human research participants. The Commission began this work with leading experts in global health, medicine and medical ethics at its meeting in Washington, D.C., in March. This second meeting on Human Subjects Protection will continue that dialogue with experts including Murray M. Lumpkin, M.D., M.Sc., Deputy Commissioner for International Programs, U.S. Food and Drug Administration; Ronald Bayer, Ph.D., Professor and Co-Chair at the Center for the History & Ethics of Public Health at the Mailman School of Public Health; Johannes J. M. van Delden, M.D., Ph.D., President, CIOMS; Dafna Feinholz, Ph.D., Chief of the Bioethics Section, Division of Ethics of Science and Technology, Sector for Social and Human Services, UNESCO; and others.

This meeting is free and open to the public on a first come, first served basis. The Commission welcomes input from anyone wishing to provide public comment on any issue before it. Individuals who wish to present at the public meeting must register by email to info@bioethics.gov on or before May 10, 2011, and provide complete contact information, including name, title, affiliation, address, email, and phone number.

The Commission will do its best to accommodate requests to speak, and will determine the amount of time allotted to each presenter and the approximate time that each oral presentation is scheduled to begin. To accommodate as many speakers as possible the time for public comments may be limited to no more than one or two minutes each. If the number of individuals wishing to speak is greater than can reasonably be accommodated during the scheduled meeting, the Commission may randomly select speakers from among those who register to speak. Written comments will also be accepted and are especially welcome.

The meeting will be live-streamed and archived on the Commission website at www.bioethics.gov. Transcripts will be posted on the website after the meeting.

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