Responsible Research
eBook - PDF

Responsible Research

A Systems Approach to Protecting Research Participants

,
  1. 313 pages
  2. English
  3. PDF
  4. Available on iOS & Android
eBook - PDF

Responsible Research

A Systems Approach to Protecting Research Participants

,

About this book

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, andVigilant 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 "e; but also including volunteers who may agree to serve as research participants.

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Information

Publisher
National Academies Press
Year
2003
eBook ISBN
9780309500463
Edition
0
Topic
Social Sciences
Index
Social Sciences

Table of contents

  1. Front Matter
  2. Preface
  3. Reviewers
  4. Acknowledgments
  5. Acronyms
  6. Contents
  7. List of Tables, Figures, and Boxes
  8. Executive Summary
  9. 1 Introduction
  10. 2 A Systemic Approach to Human Research Participant Protection Programs
  11. 3 Back to Basics: Scientific, Conflict of Interest, and Ethical Review of Research Protocols
  12. 4 The Participant-Investigator Interface
  13. 5 Improving Protection Through Oversight and Data and Safety Monitoring
  14. 6 Improving Human Research Participant Protection Program Performance and Clarifying Roles
  15. 7 Improving an Evolving National Human Research Participant Protection System
  16. References
  17. Appendix A Data Sources and Methods
  18. Appendix B
  19. Appendix C Clarifying Protocol Accountability
  20. Appendix D Committee Biographies
  21. Index