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Responsible Research: A Systems Approach to Protecting Research Participants
     

Responsible Research: A Systems Approach to Protecting Research Participants

by Daniel D. Federman, Kathi E. Hanna, Laura Lyman Rodriguez, Committee on Assessing the System for Protecting Human Research Participants
 

ISBN-10: 0309084881

ISBN-13: 9780309084888

Pub. Date: 01/13/2003

Publisher: National Academies Press

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

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.

Product Details

ISBN-13:
9780309084888
Publisher:
National Academies Press
Publication date:
01/13/2003
Pages:
316
Product dimensions:
6.00(w) x 9.00(h) x (d)

Table of Contents

Executive Summary1
1Introduction29
Context for This Report30
Basic Tenets of Ethical Human Research31
The Range of Human Research32
Recent Events36
Themes and Organization of This Report40
Summary44
2A Systemic Approach to Human Research Participant Protection Programs45
The Need for a Systemic Approach45
Defining Protection Programs48
Establishing a Balanced Program52
Functions Integral to the Protection System66
Summary69
3Back to Basics: Scientific, Conflict of Interest, and Ethical Review of Research Protocols70
The Need for Research Ethics Review Boards70
Three-Pronged Review72
Ensuring Discrete Scientific Review of Protocols75
Financial Conflicts of Interest and Protocol Review82
Ethics Review: Clarifying the Roles and Responsibilities of Research ERBs86
Organizing and Integrating the Review Processes101
Resource Needs105
Summary107
4The Participant-Investigator Interface108
Preparation of the Investigator and Protocol Design109
The Informed Consent Process119
Roles and Expectations of Research Participants129
Summary134
5Improving Protection through Oversight and Data and Safety Monitoring136
Government Regulation of Research138
Oversight by Federal Research Agencies150
Data and Safety Monitoring by the Program152
Data and Safety Monitoring by an Independent Body154
Communicating the Results of Data and Safety Monitoring157
Data Security: Protecting Confidentiality159
Summary160
6Improving Human Research Participant Protection Program Performance and Clarifying Roles162
Continuous Quality Improvement163
Status of Accreditation171
Role Differentiation Within the HRPPP177
Managing Conflicts of Interest182
Compensation for Research-Related Injury188
Personal Liability of Research ERB Members194
Summary195
7Improving an Evolving National Human Research Participant Protection System197
The Need for Better Advice and Guidance at the Federal Level198
The Need for Public Information Regarding Ongoing Clinical Research200
Communicating Research Results: A Role for Publishers205
The Impact of the Health Insurance Portability and Accountability Act of 1996 Requirements and Privacy Issues on HRPPPs205
Research Efforts to Counter Terrorism211
Summary215
References217
Appendixes
AData Sources and Methods231
BProtecting Participants in Social, Behavioral, and Economic Science Research: Issues, Current Problems, and Potential Solutions, Report from the Panel on IRBs, Surveys, and Social Science Research236
CClarifying Protocol Accountability249
DCommittee Biographies263
Index277

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