Responsible Research

A Systems Approach to Protecting Research Participants

Autor: Institute of Medicine, Committee on Assessing the System for Protecting Human Research Participants, National Academy of Sciences

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Legare: Copertă tare

Editura: National Academies Press

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When 18-year-old Jesse Gelsinger died in a gene transfer study at the University of Pennsylvania, th...

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Autor

Institute of Medicine, Committee on Assessing the System for Protecting Human Research Participants, National Academy of Sciences

Limbă

engleză

Legare

Carte - Copertă tare

Publicat

2003

Pagini

312

EAN

9780309084888

ISBN

0309084881

Enbook ID

04577694

Editura

National Academies Press

Greutate

622

Dimensiuni

270 x 226 x 21

Descriere completă

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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Responsible Research

A Systems Approach to Protecting Research Participants

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