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Volumn 157, Issue 6, 2009, Pages 971-982

Regulatory and ethical considerations for linking clinical and administrative databases

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL TRIAL; CONFIDENTIALITY; DATA BASE; ETHICS; GOVERNMENT REGULATION; HEALTH CARE QUALITY; HEALTH INSURANCE; HUMAN; INFORMED CONSENT; LEGAL ASPECT; MEDICAL ETHICS; MEDICAL RESEARCH; PROFESSIONAL STANDARD; REGISTER; RESEARCH ETHICS; UNITED STATES;

EID: 67049172103     PISSN: 00028703     EISSN: 10976744     Source Type: Journal    
DOI: 10.1016/j.ahj.2009.03.023     Document Type: Article
Times cited : (105)

References (29)
  • 1
    • 84859891472 scopus 로고    scopus 로고
    • Research methods to speed the development of better evidence\-The registries example
    • In: Mc Cellan MB, Mc Ginnis JM, Nabel EG, Olsen LM, editors Washington, DC: The National Academies Press
    • Peterson E. Research methods to speed the development of better evidence\-the registries example. In: Mc Cellan MB, Mc Ginnis JM, Nabel EG, Olsen LM, editors. Evidence-based medicine and the changing nature of health care: 2007IOM Annual Meeting Summary. Washington, DC: The National Academies Press; 2008. p. 132-41.
    • (2008) Evidence-based Medicine and the Changing Nature of Health Care: 2007IOM Annual Meeting Summary , pp. 132-141
    • Peterson, E.1
  • 6
    • 0034600270 scopus 로고    scopus 로고
    • Determining when quality improvement initiatives should be considered research: Proposed criteria and potential implications
    • Casarett D, Karlawish JHT, Sugarman J. Determining when quality improvement initiatives should be considered research - Proposed criteria and potential implications. JAMA 2000;283:2275-80. (Pubitemid 30246780)
    • (2000) Journal of the American Medical Association , vol.283 , Issue.17 , pp. 2275-2280
    • Casarett, D.1    Karlawish, J.H.T.2    Sugarman, J.3
  • 8
    • 55749107539 scopus 로고    scopus 로고
    • Publication Guidelines for improvement studies in health care: Evolution of the SQUIRE Project
    • Davidoff F, Batalden P, Stevens D, et al. Publication Guidelines for improvement studies in health care: evolution of the SQUIRE Project. Ann Intern Med 2008;149:670-6.
    • (2008) Ann Intern Med , vol.149 , pp. 670-676
    • Davidoff, F.1    Batalden, P.2    Stevens, D.3
  • 10
    • 77958054126 scopus 로고    scopus 로고
    • Code of Federal Regulations (CFR): PART 160\-GENERAL ADMIN-ISTRATIVE REQUIREMENTS [Internet] Last accessed March 26, 2009
    • Code of Federal Regulations (CFR): PART 160\-GENERAL ADMIN-ISTRATIVE REQUIREMENTS [Internet]. National Archives and Records Administration. Availableat: http://www.access.gpo.gov/nara/cfr/ waisidx-06/45cfr160-06.html. Last accessed March 26, 2009.
    • National Archives and Records Administration
  • 11
    • 85031190127 scopus 로고    scopus 로고
    • National Archives and Records Administration Last accessed March 26, 2009
    • Code of Federal Regulations (CFR): PART 164\-SECURITY AND PRIVACY [Internet]. National Archives and Records Administration. Available at: http://www.access.gpo.gov/nara/cfr/ waisidx-06/45cfr164-06.html. Last accessed March 26, 2009.
    • Code of Federal Regulations (CFR): PART 164\-SECURITY and PRIVACY [Internet]
  • 13
    • 0043281506 scopus 로고    scopus 로고
    • Health Insurance Portability and Accountability Act (HIPAA): Must there be a trade-off between privacy and quality of health care, or can we advance both?
    • DOI 10.1161/01.CIR.0000085720.65685.90
    • Califf RM, Muhlbaier LH. Health Insurance Portability and Account-ability Act (HIPAA)\-must there be a trade-off between privacy and quality of health care, or can we advance both? Circulation 2003; 108:915-8. (Pubitemid 37048216)
    • (2003) Circulation , vol.108 , Issue.8 , pp. 915-918
    • Califf, R.M.1    Muhlbaier, L.H.2
  • 17
    • 84882819180 scopus 로고    scopus 로고
    • U.S. Department of Health and Human Services National Institutes of Health; Research repositories, databases, and the HIPAA Privacy Rule Last accessed March 26, 2009
    • HIPAA Privacy Rule information for researchers [Internet]. U.S. Department of Health and Human Services National Institutes of Health; Research repositories, databases, and the HIPAA Privacy Rule. Available at: http://privacyruleandresearch.nih.gov/ research-repositories.asp. Last accessed March 26, 2009.
    • HIPAA Privacy Rule Information for Researchers [Internet]
  • 18
    • 85031182411 scopus 로고    scopus 로고
    • Duke University Health System Human Research Protection Program; Policy on research databases and specimen repositories Last accessed March 26 2009
    • Website of Duke University School of Medicine Institutional Review Board [Internet]. Duke University Health System Human Research Protection Program; Policy on research databases and specimen repositories. Available at: http://irb.duhs.duke.edu/wysiwyg/downloads/DatabaseRepository-policy-from- website-version-6-1-04.pdf. Last accessed March 26 2009.
    • Website of Duke University School of Medicine Institutional Review Board [Internet]
  • 19
    • 0003392972 scopus 로고
    • Washington, DC: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research: US Government Printing Office
    • The Belmont Report: ethical principles and guidelines for the protection of human subjects of research. Washington, DC: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research: US Government Printing Office 1979.
    • (1979) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research
  • 20
    • 0037122963 scopus 로고    scopus 로고
    • The effect of the new federal medical-privacy rule on research
    • DOI 10.1056/NEJM200201173460312
    • Kulynych J, Korn D. The effect of the new federal medical-privacy rule on research. N Engl J Med 2002;346:201-4. (Pubitemid 34438889)
    • (2002) New England Journal of Medicine , vol.346 , Issue.3 , pp. 201-204
    • Kulynych, J.1    Korn, D.2
  • 21
    • 0032902199 scopus 로고    scopus 로고
    • Genetic determinism and the overprotection of human subjects [6]
    • DOI 10.1038/7692
    • Wilcox AJ, Taylor JA, Sharp RR, et al. Genetic determinism and the overprotection of human subjects. Nat Genet 1999;21:362. (Pubitemid 29159570)
    • (1999) Nature Genetics , vol.21 , Issue.4 , pp. 362
    • Wilcox, A.J.1    Taylor, J.A.2    Sharp, R.R.3    London, S.J.4
  • 23
    • 0035352687 scopus 로고    scopus 로고
    • Searching for "research involving human subjects": What is examined? What is exempt? What is exasperating?
    • Pritchard IA. Searching for "research involving human subjects": what is examined? What is exempt? What is exasperating? IRB: Ethics Hum Res 2001;23:5-13. (Pubitemid 33753766)
    • (2001) IRB Ethics and Human Research , vol.23 , Issue.3 , pp. 5-13
    • Pritchard, I.A.1
  • 25
    • 49749117999 scopus 로고    scopus 로고
    • The rationale for incorporation of HIPAA compliant unique patient surgeon and hospital identifierfields in the STSdatabase
    • Jacobs JP, Haan CK, Edwards FH, et al. The rationale for incorporation of HIPAA compliant unique patient, surgeon, and hospital identifierfields in the STSdatabase. Ann Thorac Surg2008; 86:695-8.
    • (2008) Ann Thorac Surg , vol.86 , pp. 695-698
    • Jacobs, J.P.1    Haan, C.K.2    Edwards, F.H.3
  • 26
    • 85031186268 scopus 로고    scopus 로고
    • U.S. Department of Commerce National Technical Information Service Last accessed March 26, 2009
    • Website of NTIS Products\-Social Security Administration's Death Master File [Internet]. U.S. Department of Commerce National Technical Information Service. Available at: http://www.ntis.gov/ products/ssa-dmf.aspx. Last accessed March 26, 2009.
    • Website of NTIS Products\-Social Security Administration's Death Master File [Internet]
  • 29
    • 85031190366 scopus 로고    scopus 로고
    • U.S. Department of Health & Human Services Last accessed March 26 2009
    • Office for Human Research Protections (OHRP)\-OHRP correspon-dence [Internet]. U.S. Department of Health & Human Services. Available at: http://www.hhs.gov/ohrp/policy/correspond/ Pronovost20080730.html. Last accessed March 26 2009.
    • Office for Human Research Protections (OHRP)\-OHRP Correspon-dence [Internet]


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