Reasons Underlying the Human Biological Material Policy

Federal, state and university regulations require that the use of human subjects in research be reviewed and approved by an IRB. At the UW, Human Subjects Review Committees carry out this function. The Office of Sponsored Programs, Human Subjects Division provides administrative support for the Committees.

UW policy exists to protect the rights, well-being, and personal privacy of individuals, to assure a favorable climate for the conduct of scientific inquiry, and to protect the interests of the University of Washington (found in University of Washington Handbook VOL. IV, Part II, Chapter 2, "Use Of Human Subjects").

HIPPA & Human Subjects

Research at the UW and Compliance with HIPAA
The UW Human Subjects Division created a guide that answers many of the questions surrounding HIPPA and Human Subjects.

Laws, Regulations and Codes

What follows is a list of laws, regulations and codes that are relevant to the human subjects protections process. Links to the websites are provided below.

• US Department of Health & Human Services (DHHS): Title 45 Public Welfare, Part 46 Protection of Human Subjects
  Federal Policy for the Protection of Human Subjects (Basic DHHS Policy for Protection of Human Research Subjects)
  
  
• Title 21 Food and Drugs, Chapter I Food and Drug Administration, DHHS, Part 50 and Part 56
  Protection of Human Subjects and Institutional Review Boards
  
  
• Washington State Legislature: Chapter 42.48 RCW
  (Select RCW & Dispositions under areas to search and Search using the keyword 42.28)
  State of Washington Code on the protection of research records with personal identifiers
  
  
• Washington State Legislature: Chapter 70.02 RCW
  (Select RCW & Dispositions under areas to search and Search using the keyword 70.02)
  State of Washington Code on the protection of health care information from disclosure
  
  
• The Belmont Report
  Report of the Belmont Commission on the protection of human subjects
  
  
• University of Washington Multiple Project Assurance Document
  - 10/23/06 (pdf) 290 kb FWA#: FWA00006878 Exp. Date: 10/20/2009
  The UW's agreement with DHHS assuring compliance with federal regulations in the review of projects involving human subjects in research

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