Responsible research : 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.

Format:

• Book

Contributor:

• Federman, Daniel D., 1928-2017.
• Hanna, Kathi E.
• Rodriguez, Laura Lyman.
• Institute of Medicine (U.S.). Committee on Assessing the System for Protecting Human Research Participants.

Language:

English

Subjects (All):

• Human experimentation in medicine--Moral and ethical aspects.
• Medical ethics.
• Medical protocols.
• Patients--Legal status, laws, etc.
• Clinical Protocols.
• Human Experimentation.
• Patient Rights.
• Safety.

Medical Subjects:

• Clinical Protocols.
• Human Experimentation.
• Patient Rights.
• Safety.

Physical Description:

xix, 290 pages : illustrations ; 23 cm

Place of Publication:

Washington, D.C. : National Academies Press, [2003]

Summary:

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.

Contents:

• Context for This Report 30
• Basic Tenets of Ethical Human Research 31
• The Range of Human Research 32
• Recent Events 36
• Themes and Organization of This Report 40
• 2 A Systemic Approach to Human Research Participant Protection Programs 45
• The Need for a Systemic Approach 45
• Defining Protection Programs 48
• Establishing a Balanced Program 52
• Functions Integral to the Protection System 66
• The Need for Research Ethics Review Boards 70
• Three-Pronged Review 72
• Ensuring Discrete Scientific Review of Protocols 75
• Financial Conflicts of Interest and Protocol Review 82
• Ethics Review: Clarifying the Roles and Responsibilities of Research ERBs 86
• Organizing and Integrating the Review Processes 101
• Resource Needs 105
• 4 The Participant-Investigator Interface 108
• Preparation of the Investigator and Protocol Design 109
• The Informed Consent Process 119
• Roles and Expectations of Research Participants 129
• 5 Improving Protection through Oversight and Data and Safety Monitoring 136
• Government Regulation of Research 138
• Oversight by Federal Research Agencies 150
• Data and Safety Monitoring by the Program 152
• Data and Safety Monitoring by an Independent Body 154
• Communicating the Results of Data and Safety Monitoring 157
• Data Security: Protecting Confidentiality 159
• 6 Improving Human Research Participant Protection Program Performance and Clarifying Roles 162
• Continuous Quality Improvement 163
• Status of Accreditation 171
• Role Differentiation Within the HRPPP 177
• Managing Conflicts of Interest 182
• Compensation for Research-Related Injury 188
• Personal Liability of Research ERB Members 194
• 7 Improving an Evolving National Human Research Participant Protection System 197
• The Need for Better Advice and Guidance at the Federal Level 198
• The Need for Public Information Regarding Ongoing Clinical Research 200
• Communicating Research Results: A Role for Publishers 205
• The Impact of the Health Insurance Portability and Accountability Act of 1996 Requirements and Privacy Issues on HRPPPs 205
• Research Efforts to Counter Terrorism 211
• A Data Sources and Methods 231
• 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
• C Clarifying Protocol Accountability 249.

Notes:

Includes bibliographical references and index.

ISBN:

0309084881

OCLC:

50639306