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Responsible research [electronic resource] : a systems approach to protecting research participants /
Daniel D. Federman, Kathi E. Hanna, and Laura Lyman Rodriguez, editors ; Committee on Assessing the System for Protecting Human Research Participants, Institute of Medicine of the National Academies.
imprint
Washington, D.C. : National Academies Press, c2003.
description
xix, 290 p. : ill.
ISBN
0309084881, 9780309084888
format(s)
Book
Holdings
A Look Inside
Reviews
This item was reviewed in:
SciTech Book News, June 2003
To find out how to look for other reviews, please see our guides to finding book reviews in the Sciences or Social Sciences and Humanities.
Summaries
Description for Bookstore
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 participantsrs" safety and their capacity to safeguard the well-being of those who volunteer for research studies. Responsible Researchoutlines 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 participantsrs" 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.
Description for Bookstore
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.
Description for Bookstore
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.
Long 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.
Main Description
Issues addressed in the book include the need to distinguish the 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 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
Executive Summaryp. 1
Introductionp. 29
Context for This Reportp. 30
Basic Tenets of Ethical Human Researchp. 31
The Range of Human Researchp. 32
Recent Eventsp. 36
Themes and Organization of This Reportp. 40
Summaryp. 44
A Systemic Approach to Human Research Participant Protection Programsp. 45
The Need for a Systemic Approachp. 45
Defining Protection Programsp. 48
Establishing a Balanced Programp. 52
Functions Integral to the Protection Systemp. 66
Summaryp. 69
Back to Basics: Scientific, Conflict of Interest, and Ethical Review of Research Protocolsp. 70
The Need for Research Ethics Review Boardsp. 70
Three-Pronged Reviewp. 72
Ensuring Discrete Scientific Review of Protocolsp. 75
Financial Conflicts of Interest and Protocol Reviewp. 82
Ethics Review: Clarifying the Roles and Responsibilities of Research ERBsp. 86
Organizing and Integrating the Review Processesp. 101
Resource Needsp. 105
Summaryp. 107
The Participant-Investigator Interfacep. 108
Preparation of the Investigator and Protocol Designp. 109
The Informed Consent Processp. 119
Roles and Expectations of Research Participantsp. 129
Summaryp. 134
Improving Protection through Oversight and Data and Safety Monitoringp. 136
Government Regulation of Researchp. 138
Oversight by Federal Research Agenciesp. 150
Data and Safety Monitoring by the Programp. 152
Data and Safety Monitoring by an Independent Bodyp. 154
Communicating the Results of Data and Safety Monitoringp. 157
Data Security: Protecting Confidentialityp. 159
Summaryp. 160
Improving Human Research Participant Protection Program Performance and Clarifying Rolesp. 162
Continuous Quality Improvementp. 163
Status of Accreditationp. 171
Role Differentiation Within the HRPPPp. 177
Managing Conflicts of Interestp. 182
Compensation for Research-Related Injuryp. 188
Personal Liability of Research ERB Membersp. 194
Summaryp. 195
Improving an Evolving National Human Research Participant Protection Systemp. 197
The Need for Better Advice and Guidance at the Federal Levelp. 198
The Need for Public Information Regarding Ongoing Clinical Researchp. 200
Communicating Research Results: A Role for Publishersp. 205
The Impact of the Health Insurance Portability and Accountability Act of 1996 Requirements and Privacy Issues on HRPPPsp. 205
Research Efforts to Counter Terrorismp. 211
Summaryp. 215
Referencesp. 217
Appendixes
Data Sources and Methodsp. 231
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 Researchp. 236
Clarifying Protocol Accountabilityp. 249
Committee Biographiesp. 263
Indexp. 277
Table of Contents provided by Syndetics. All Rights Reserved.

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