United States Government Publishing Office publisher pbl distributor dst United States Government Accountability Office Health, Education, and Human Services Division author aut Government Organization text government publication eng GAOREPORTS Legislative Agency Publications gao legislative 2010-08-12 U.S. Government Printing Office 1999-02-24 monographic deposited born digital 14 p. GA 1.13:T-HEHS-99-70 https://www.govinfo.gov/app/details/GAOREPORTS-T-HEHS-99-70 P0b002ee18038a7e2 f:he99070t DGPO 2010-08-12 2011-03-23 GAOREPORTS-T-HEHS-99-70 machine generated eng fdlp REPORT GAOREPORTS-T-HEHS-99-70 T-HEHS-99-70 Medical research Medical information systems Medical records Health research programs Internal controls Right of privacy Testimony HEHS Pursuant to a congressional request, GAO discussed the the use of medical records for research, focusing on: (1) to what extent medical information used for research depends on personally identifiable information; (2) research that is and is not subject to current federal oversight requirements; and (3) how the institutional review board (IRB) ensures the confidentiality of health information used in research.<p/>GAO noted that: (1) the survey revealed that a considerable amount of health research relies on personally identifiable information; (2) while some of this research is subject to IRB review--either because it is federally supported or regulated research or because the organization voluntarily applies federal rules to all of its research--some of the organizations conduct records-based research that is not reviewed by an IRB; (3) the process of IRB review does not ensure the confidentiality of medical information used in research--primarily because the provisions of the Common Rule related to confidentiality are limited; (4) according to recent studies, the IRB system on the whole is strained; and (5) nevertheless, although external review of their research is limited, most of the organizations in the study told GAO that they have various security safeguards in place to limit internal and external access to paper and electronic databases, and many say they have taken measures to ensure the anonymity of research and survey subjects. https://www.govinfo.gov/content/pkg/GAOREPORTS-T-HEHS-99-70/html/GAOREPORTS-T-HEHS-99-70.htm https://www.govinfo.gov/content/pkg/GAOREPORTS-T-HEHS-99-70/pdf/GAOREPORTS-T-HEHS-99-70.pdf GAO/T-HEHS-99-70 https://www.govinfo.gov/app/details/GAOREPORTS-T-HEHS-99-70 Testimony GAO/T-HEHS-99-70; Medical Records Privacy: Uses and Oversight of Patient Information in Research; Medical research Medical information systems Medical records Health research programs Internal controls Right of privacy Public Law 104-191