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Reform within the common rule? Commentary.

The Hastings Center Report, 01 Jan 2013, Spec No:S40-2
https://doi.org/10.1002/hast.140 PMID: 23315896 

This is a comment on "An ethics framework for a learning health care system: a departure from traditional research ethics and clinical ethics." Hastings Cent Rep. 2013 Jan-Feb;Spec No:S16-27. This is a comment on "The research-treatment distinction: a problematic approach for determining which activities should have ethical oversight." Hastings Cent Rep. 2013 Jan-Feb;Spec No:S4-S15.

Abstract 

No abstract provided.

Full text links 

Read article at publisher's site: https://doi.org/10.1002/hast.140

References 

Articles referenced by this article (10)

  • Federal Policy for the Protection of Human Subjects

    Office

    Federal Register, (117) 1991

  • Advance Notice of Proposed Rule Making, Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators

    Department

    Federal Register, (143) 2011

  • The Departments of Agriculture, Commerce, Defense, Education, Energy, Health and Human Services, Housing and Urban Development, Justice, Veterans Affairs, Transportation, Homeland Security, the Consumer Product Safety Commission, the Environmental Protection Agency, the Agency for International Development, the National Aeronautics and Space Administration, the National Science Foundation, and the Central Intelligence Agency
  • United States Department of Health, Education, and Welfare, Code of Federal Regulations, Title 45, Part 46.102(d)
  • Veterans Health Administration Office of the Assistant Deputy Under Secretary for Health for Policy and Planning Selected VHA Statistics: FY2011-2012 2012
  • Department of Veterans Affairs Veterans Health Administration Handbook 1058.05 Operations Activities That May Constitute Research 2011
  • Department of Veterans Affairs Veterans Health Administration Handbook 1058.05 2011 Generalizable knowledge, sec. 4b. VA operations activities “are certain administrative, financial, legal, quality assurance, quality improvement, and public health endeavors that are necessary to support VHA's four primary missions of delivering health care to the Nation's Veterans, conducting research and development, performing medical education, and contributing to national emergency response. Operations activities may or may not constitute research.”
  • Department of Veterans Affairs Veterans Health Administration Handbook 1058.05 2011 Generalizable knowledge, sec. 5a. “Activities that are not designed to produce information that expands the knowledge base of a scientific discipline (or other scholarly field) do not constitute research. Thus, a VHA operations activity does not constitute research if both of the following criteria are satisfied: (1) The activity is designed and implemented for internal VA purposes (i.e., its findings are intended to be used by and within VA or by entities responsible for overseeing VA, such as Congress or the Office of Management and Budget); and (2) The activity is not designed to produce information that expands the knowledge base of a scientific discipline (or other scholarly field)).”
  • Department of Veterans Affairs Veterans Health Administration Handbook 1058.05 2011 Generalizable knowledge, sec. 6
  • Department of Veterans Affairs Veterans Health Administration Handbook 1058.05 2011 Generalizable knowledge, sec. 7

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