Also in June, the HHS set up a new Office for Human Research Protections (OHRP; Washington, DC) to help implement the patient protection measures announced by Donna Shalala. OHRP replaces the Office for Protection from Research Risks (OPRR) that was part of the National Institutes of Health. Last year, a top-level advisory group recommended to former NIH Director Harold Varmus that OPRR, which had jurisdiction over a wide range of NIH-supported research, be moved to HHS. That group also recommended that other steps be taken to ensure that it be seen as an independent entity with adequate resources, stature, and oversight. As a result, “the new office will have increased resources and broader responsibility,” says Surgeon General David Satcher, who in his capacity as HHS Assistant Secretary for Health will oversee the new office.
OHRP takes on near federal-wide responsibility, with jurisdiction over some 17 agencies that conduct research involving human subjects. Even with the new structure, however, officials at the Food and Drug Administration (Rockville, MD) will retain authority to enforce patient protections in clinical trials to evaluate new therapeutic products and medical devices, according to Satcher. “The new organizational structure will enable more effective coordination.”
Edward Greg Koski has been appointed director of OHRP. Koski comes to HHS from Harvard Medical School (Boston, MA) and Partners HealthCare System (Boston, MA), where he was responsible for overseeing patient protections within a consortium of institutions conducting biomedical research involving human subjects.
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