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 32 p. GA 1.13:HEHS-99-55 https://www.govinfo.gov/app/details/GAOREPORTS-HEHS-99-55 P0b002ee18037c47f f:he99055 DGPO 2010-08-12 2011-03-24 GAOREPORTS-HEHS-99-55 machine generated eng fdlp REPORT GAOREPORTS-HEHS-99-55 HEHS-99-55 Research program management Ethical conduct Informed consent (medical law) Health research programs Internal controls Medical records Medical research Right of privacy Medical information systems Letter Report HEHS A considerable amount of health research relies on personally identifiable information. Although some of this research is subject to review by institutional review boards -- 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 institutional review board. In any case, the process of institutional review board 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. Moreover, according to recent studies, the institutional review board system on the whole is strained. Nevertheless, although external review of their research is limited, most of the organizations in GAO's study indicated that they have security safeguards in place to limit internal and external access to paper and electronic databases, and many say that they have taken steps to ensure the anonymity of research and survey subjects. GAO summarized this report in testimony before Congress, Medical Records Privacy: Uses and Oversight of Patient Information in Research, by Bernice Steinhardt, Director of Health Services Quality and Public Health Issues, before the Senate Committee on Health, Education, Labor and Pensions. GAO/T-HEHS-99-70, Feb. 24 (10 pages). https://www.govinfo.gov/content/pkg/GAOREPORTS-HEHS-99-55/html/GAOREPORTS-HEHS-99-55.htm https://www.govinfo.gov/content/pkg/GAOREPORTS-HEHS-99-55/pdf/GAOREPORTS-HEHS-99-55.pdf GAO/HEHS-99-55 https://www.govinfo.gov/app/details/GAOREPORTS-HEHS-99-55 Letter Report GAO/HEHS-99-55; Medical Records Privacy: Access Needed for Health; Research program management Ethical conduct Informed consent (medical law) Health research programs Internal controls Medical records Medical research Right of privacy Medical information systems Public Law 104-191