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DHHS Makes Changes to Agencies Overseeing Human Research.

On 6 June, the Department of Health and Human Services announced the creation of the Office for Human Research Protections, a new agency to lead efforts for protecting human subjects in biomedical and behavioral research, and named E. Greg Koski as its first director.

As recommended last year by the Advisory Committee to the Director of NIH, the new office will be located at the HHS department level, in the office of the Assistant Secretary for Health. It replaces the Office for Protection from Research Risks, which was part of the National Institutes of Health and had authority over NIH-funded research. The new office will provide leadership for all seventeen federal agencies that carry out research involving human subjects under regulation known as the Common Rule. It will focus entirely on protection for human subjects, while treatment for animal subjects will be overseen separately by a new Office of Laboratory Animal Welfare at NIH. OPRR had been responsible for both human and animal subjects.

The OHRP will also work with NIH and the Food and Drug Administration to carry out new patient protection initiatives announced by DHHS. These initiatives are aimed at educating and training clinical investigators and members and staff of institutional review boards, providing guidance on obtaining informed consent, improving the monitoring of research, clarifying policies on potential conflicts of interest affecting researchers, and updating other policies.

Koski had been director of human research affairs at Partners HealthCare System, Inc., in Boston, and associate professor of anesthesia at Harvard Medical School. He has a background in basic and clinical research.
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Publication:The Hastings Center Report
Date:Jul 1, 2000
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