The Resource Federal protection for human research subjects : an analysis of the Common Rule and its interactions with FDA regulations and the HIPAA privacy rule, Erin D. Williams

Federal protection for human research subjects : an analysis of the Common Rule and its interactions with FDA regulations and the HIPAA privacy rule, Erin D. Williams

Label
Federal protection for human research subjects : an analysis of the Common Rule and its interactions with FDA regulations and the HIPAA privacy rule
Title
Federal protection for human research subjects
Title remainder
an analysis of the Common Rule and its interactions with FDA regulations and the HIPAA privacy rule
Statement of responsibility
Erin D. Williams
Creator
Contributor
Subject
Language
eng
Summary
The Common Rule (45 CFR 46, Subpart A) governs research that is conducted on human beings if it is funded by one of eighteen federal agencies. It requires a review of proposed research by an Institutional Review Board (IRB), the informed consent of research subjects, and institutional assurances of compliance with the regulations. In 1974 CFR 46 was published following some cases of harm to human subjects, such as those caused by thalidomide drug trials and the United States Public Health Service syphilis study in Tuskeegee, Alabama. The regulations had their roots in numerous international agreements, such as the Nuremberg Code and the Declaration of Helsinki, and domestic policies, such as those put forth by the Department of Health, Education and Welfare (DHEW; now the Department of Health and Human Services, HHS). In 1991, 16 federal agencies adopted 45 CFR 46, Subpart A, which then became known as the Common Rule. Since the Common Rule took effect, events like the death of Jesse Gelsinger in 1999 due to his participation in a clinical trial, have prompted scrutiny of the Rule and its ability to protect research subjects. In order to help enhance research subject protections, in 2000 HHS removed the Office for Protection from Research Risks (OPRR) from the National Institutes of Health (NIH), and created a new office -- the Office for Human Research Protections (OHRP) -- in an elevated position in HHS
Member of
Cataloging source
SNM
http://library.link/vocab/creatorName
Williams, Erin D
Government publication
federal national government publication
Illustrations
illustrations
Index
no index present
Literary form
non fiction
Nature of contents
bibliography
http://library.link/vocab/relatedWorkOrContributorName
Library of Congress
Series statement
CRS report for Congress
Series volume
RL32909
http://library.link/vocab/subjectName
  • United States
  • United States.
  • United States
  • Human experimentation in medicine
  • Bioethics
  • Medical ethics
  • Clinical medicine
  • Medicine, Experimental
  • Bioethics
  • Clinical medicine
  • Human experimentation in medicine
  • Medical ethics
  • Medicine, Experimental
Label
Federal protection for human research subjects : an analysis of the Common Rule and its interactions with FDA regulations and the HIPAA privacy rule, Erin D. Williams
Instantiates
Publication
Note
  • "Updated June 2, 2005."
  • Title from title screen (viewed June 30, 2005)
Bibliography note
Includes bibliographical references and appendices
Carrier category
online resource
Carrier category code
  • cr
Carrier MARC source
rdacarrier
Content category
text
Content type code
  • txt
Content type MARC source
rdacontent
Extent
76 pages
Form of item
online
Media category
computer
Media MARC source
rdamedia
Media type code
  • c
Note
Hein Online
Other physical details
illustrations.
System control number
  • (OCoLC)60781753
  • (OCoLC)ocm60781753
System details
  • Mode of access: World Wide Web
  • System requirements: Adobe Acrobat Reader
Label
Federal protection for human research subjects : an analysis of the Common Rule and its interactions with FDA regulations and the HIPAA privacy rule, Erin D. Williams
Publication
Note
  • "Updated June 2, 2005."
  • Title from title screen (viewed June 30, 2005)
Bibliography note
Includes bibliographical references and appendices
Carrier category
online resource
Carrier category code
  • cr
Carrier MARC source
rdacarrier
Content category
text
Content type code
  • txt
Content type MARC source
rdacontent
Extent
76 pages
Form of item
online
Media category
computer
Media MARC source
rdamedia
Media type code
  • c
Note
Hein Online
Other physical details
illustrations.
System control number
  • (OCoLC)60781753
  • (OCoLC)ocm60781753
System details
  • Mode of access: World Wide Web
  • System requirements: Adobe Acrobat Reader

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