Beyond the HIPAA Privacy Rule Enhancing Privacy, Improving Health Through Research (2009) / Chapter Skim
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Appendix A: Previous Recommendations to the Department of Health and Human Services
Appendix A: Previous Recommendations to the Department of Health and Human Services
Pages 285-292
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with recommendations on how to improve the way the Privacy Rule regulates research. Table A-1 describes the recommendations of the National Committee on Vital and Health Statistics, the Association of American Medical Colleges, the Secretary's Advisory Committee on Human Research Protections, and the National Cancer Advisory Board.
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Institutional Review Boards 1. HHS should classify research recruitment as a NCVHS (IRBs)
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Research exempt under the Discrepancies between the 1. Revise categories of research not requiring NCVHS Common Rule Common Rule and the Privacy authorization to include research determined by IRB SACHRP Rule create challenges for IRBs and to be exempt from Common Rule requirements Privacy Boards that must make (SACHRP)
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analyzing the samples could reveal unique DNA identifiers of the individual. Types of covered entities Academic medical centers cannot The covered entity status, hybrid entity status, and AAMC organize in a manner that reflects affiliated covered entity status should be redefined to the functional operations of the reflect the function served by the different parts of the medical school, affiliated practice organization, not the organizational form of the plans, and teaching hospital.
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NOTE: Association of American Medical Colleges (AAMC) , National Cancer Advisory Board (NCAB)
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In spring 2003, AAMC conducted a survey of 331 investigators, Institutional Review Board personnel, privacy officials, research administrators, deans, and others involved in research to gain knowledge about how the Privacy Rule has influenced the research process. AAMC then created a database of qualitative case reports documenting research projects that were affected, delayed, hindered, benefited, abandoned, or foregone because of the Privacy Rule (see also Chapter 5 for survey results)
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. REFERENCES NCI (National Cancer Institute)
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