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:
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.
Table of Contents
|2 A Systematic Approach to Human Research Participant Protection Programs||45-69|
|3 Back to Basics: A Scientific, Conflict of Interest, and Ethical Review of Research Protocols||70-107|
|4 The Participant-Investigator Interface||108-135|
|5 Improving Protection Through Oversight and Data and Safety Monitoring||136-161|
|6 Improving Human Research Participant Protection Program Performance and Clarifying Roles||162-196|
|7 Improving an Evolving National Human Research Participant Protection System||197-216|
|Appendix A: Data Sources and Methods||231-235|
|Appendix B: Protecting Particpants in Social, Behavioral, and Economic Science Research: Issues, Current Problems, and ...||236-248|
|Appendix C: Clarifying Protocol Accountability||249-262|
|Appendix D: Committee Biographies||263-276|
Find relevant information like your own rough draft from among the thousands of reports available for free at NAP.edu. Copy and paste up to 8 pages of content—whether from your own draft or an outside article—and Reference Finder will recommend NAP publications related to your text.
View Reference Finder
The National Academies Press (NAP) has partnered with Copyright Clearance Center's Rightslink service to offer you a variety of options for reusing NAP content. Through Rightslink, you may request permission to reprint NAP content in another publication, course pack, secure website, or other media. Rightslink allows you to instantly obtain permission, pay related fees, and print a license directly from the NAP website. The complete terms and conditions of your reuse license can be found in the license agreement that will be made available to you during the online order process. To request permission through Rightslink you are required to create an account by filling out a simple online form. The following list describes license reuses offered by the National Academies Press (NAP) through Rightslink:
Click here to obtain permission for the above reuses. If you have questions or comments concerning the Rightslink service, please contact:
Rightslink Customer Care
Tel (toll free): 877/622-5543
To request permission to distribute a PDF, please contact our Customer Service Department at 800-624-6242 for pricing.
To request permission to translate a book published by the National Academies Press or its imprint, the Joseph Henry Press, please click here to view more information.
Loading stats for Responsible Research: A Systems Approach to Protecting Research Participants...