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International Research Panel formed by Obama
Executive director answers questions
[Editor's note: Valerie Bonham, JD, executive director of the Presidential Commission for the Study of Bioethical Issues, answers these two questions about the new International Research Panel formed this year by President Barack Obama.]
IRB Advisor: The news release about the formation of the International Research Panel says President Obama asked the Presidential Commission for the Study of Bioethical Issues to report on the effectiveness of current U.S. rules and international standards for the protection of human subjects in scientific studies supported by the federal government. This request came on the heels of the recent disclosures that a federal study in the 1940's involved deceiving research participants in Guatemala. Investigators intentionally infected subjects with sexually-transmitted diseases (STDs). This research, shocking though it is, took place a long time ago. What are some of the other reasons why we need to take an in-depth look at today's research protection standards and their real world application?
Bonham: Last October's revelations about STD research studies in Guatemala were particularly disturbing because they involved vulnerable populations. It is another reminder of historic injustices in medical research programs, and the need to make it right.
There is nothing more ethically important than protecting people who are participants in scientific research. Many of the most important advances in medicine were driven by research that involved human participants. If we can't assure people that they will be safe and treated ethically, they won't volunteer for studies. Without volunteers, critically important research suffers. And society suffers.
IRB Advisor: With the panel's international membership and focus, what could be the impact of the eventual discussions and report? For example, might this achieve a consensus paper that could inform human subjects research protection policies in other countries. Why or why not?
Bonham: President Obama requested that the commission assure him that current rules for research participants protect people from harm or unethical treatment, domestically as well as internationally. He requested that the commission convene an international panel to conduct a thorough review of human subjects protection to determine if Federal regulations and international standards adequately guard the health and well-being of participants in scientific studies supported by the Federal Government.
The International Research Panel was announced earlier this month at the commission's meeting in Washington. The Panel includes some of the most distinguished ethicists, scientists, physicians, and researchers from around the world. Their diverse backgrounds, and commitment to the highest ethical standards will help inform the Bioethics Commission's report to the President which is due at the end of the year.