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Responsible Research: A Systems Approach to Protecting Research Participants

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Overview

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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Product Details

  • ISBN-13: 9780309084888
  • Publisher: National Academies Press
  • Publication date: 1/13/2003
  • Pages: 316
  • Product dimensions: 6.02 (w) x 9.44 (h) x 0.98 (d)

Table of Contents

Executive Summary 1
1 Introduction 29
2 A Systemic Approach to Human Research Participant Protection Programs 45
3 Back to Basics: Scientific, Conflict of Interest, and Ethical Review of Research Protocols 70
4 The Participant-Investigator Interface 108
5 Improving Protection Through Oversight and Data and Safety Monitoring 136
6 Improving Human Research Participant Protection Program Performance and Clarifying Roles 162
7 Improving an Evolving National Human Research Participant Protection System 197
References 217
App. A Data Sources and Methods 231
App. B Protecting Participants in Social, Behavioral, and Economic Science Research: Issues, Current Problems, and Potential Solutions, Report from the Panel on IRBs, Surveys, and Social Science Research 236
App. C Clarifying Protocol Accountability 249
App. D Committee Biographies 263
Index 277
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