United States Government Publishing Office publisher pbl distributor dst United States Government Accountability Office author aut Government Organization text government publication eng GAOREPORTS Legislative Agency Publications gao legislative 2010-08-12 U.S. Government Printing Office 2001-05-23 monographic deposited born digital 14 p. GA 1.13:GAO-01-775T https://www.govinfo.gov/app/details/GAOREPORTS-GAO-01-775T P0b002ee180387875 f:d01775t DGPO 2010-08-12 2011-03-24 GAOREPORTS-GAO-01-775T machine generated eng fdlp REPORT GAOREPORTS-GAO-01-775T GAO-01-775T Biomedical research Safety regulation Safety standards Ethical conduct Informed consent (medical law) Testimony A01073

At the federal level the Department of Health and Human Services (HHS) is seeking to strengthen protection of 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 intended 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. https://www.govinfo.gov/content/pkg/GAOREPORTS-GAO-01-775T/html/GAOREPORTS-GAO-01-775T.htm https://www.govinfo.gov/content/pkg/GAOREPORTS-GAO-01-775T/pdf/GAOREPORTS-GAO-01-775T.pdf GAO-01-775T https://www.govinfo.gov/app/details/GAOREPORTS-GAO-01-775T Testimony GAO-01-775T; Human Subjects Research: HHS Takes Steps to Strengthen Protections, But Concerns Remain; Biomedical research Safety regulation Safety standards Ethical conduct Informed consent (medical law) Title 42 Section 262 42 U.S.C. 262 Public Law 96-517