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 : Responsible Research: A Systems Approach to Protecting Research Participants

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Binding: Hardcover
Dewey Decimal Number: 174.28
EAN: 9780309084888
Edition: 1
ISBN: 0309084881
Label: National Academies Press
Manufacturer: National Academies Press
Number Of Items: 1
Number Of Pages: 316
Publication Date: January 13, 2003
Publisher: National Academies Press
Studio: National Academies Press




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Editorial Review:

Product Description:
Harvard Univ., Boston, MA. Text outlines an approach to ensure the protection of research participants through the establishment of effective Research Participant Protection Programs (HRPPPs). Includes such issues as the need for in-depth, complementary reviews of science, ethics conflicts of interest, informed consent, and accreditation. DNLM: Clinical Protocols.

Book Description:
When 18-year-old Jesse Gelsinger died in a gene transfer study at the University of Pennsylvania, the national spotlight focused on the procedures used to ensure research participants’ safety and their capacity to safeguard the well-being of those who volunteer for research studies.

Responsible Research outlines a three-pronged approach to ensure the protection of every participant through the establishment of effective Human Research Participant Protection Programs (HRPPPs). The approach includes:

  • Improved research review processes,
  • Recognition and integration of research participants’ contributions to the system, and
  • Vigilant maintenance of HRPPP performance.

Issues addressed in the book include the need for in-depth, complimentary reviews of science, ethics, and conflict of interest reviews; desired qualifications for investigators and reviewers; the process of informed consent; federal and institutional oversight; and the role of accreditation. Recommendations for areas of key interest include suggestions for legislative approaches, compensation for research-related injury, and the refocusing of the mission of institutional review boards. Responsible Research will be important to anyone interested in the issues that are relevant to the practice of using human subjects as research participants, but especially so to policy makers, research administrators, investigators, and research sponsors – but also including volunteers who may agree to serve as research participants.











 






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