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Highlights

At the federal level the Department of Health and Human Services (HHS) is seeking to better protect human subjects in biomedical research by enhancing the visibility of its human subjects protection activities, improving its monitoring of compliance with relevant regulations by institutions and investigators, and strengthening enforcement of those regulations. HHS has also issued new guidance and is collecting information to improve oversight and monitoring at the institutional level. HHS activities directed at the investigator level consist largely of educational efforts to heighten investigators' awareness of and compliance with ethical policies and practices in conducting research. Overall, HHS' actions appear promising, but GAO has some concerns about the pace and scope of HHS' efforts to ensure the safety and protection of participants in clinical trials.

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