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Human research protections
  • Published Date:
    07/29/2010
  • Language:
    English
Filetype[PDF - 166.48 KB]


Details:
  • Corporate Authors:
    Centers for Disease Control and Prevention (U.S.). Office of the Associate Director for Science.
  • Description:
    1. Purpose -- 2. Scope -- 3. Background -- 4. Policy -- 5. Responsibilities -- 6. Acronyms and abbreviations -- 7. Definitions -- 8. References -- Appendix: Procedures.

    This policy affirms the Centers for Disease Control and Prevention’s (CDC) commitment to protecting the rights and welfare of all participants in research with which CDC is associated by enumerating specific roles, responsibilities, and procedures for CDC staff. Human research is defined and governed by HHS and other regulations: The Basic Policy for Protection of Human Research Subjects (the Common Rule), codified for HHS at Title 45, Part 46, Subpart A of the Code of Federal Regulations; Additional HHS protections for specified vulnerable populations at Title 45, Part 46, Subparts B, C, and D of the Code of Federal Regulations; Clinical investigations regulated by the Food and Drug Administration, particularly Title 21, Parts 50 and 56 of the Code of Federal Regulations.

    All of CDC’s human research activities, whether subject to the above federal regulations or not, will be guided by the ethical principles of respect for persons, beneficence, and justice. Thus, this policy extends CDC’s commitment beyond CDC activities covered by these regulations, to cover additional activities sponsored or supported by CDC or in which CDC has substantial involvement.

    This document is scheduled for recertification on or before the last working day of July 2015.

    CDC-SA-2010-01

  • Supporting Files:
    No Additional Files
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