Table of contents for 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.


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EXECUTIVE SUMMARY

1  INTRODUCTION
   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
   Summary, 44

2  A SYSTEMIC APPROACH TO HUMAN RESEARCH
   PARTICIPANT PROTECTION PROGRAMS
   The Need for a Systemic Approach, 45
   Defining Protection Programs, 48
   Establishing a Balanced Program, 52
   Functions Integral to the Protection System, 66
   Summary, 69

3  BACK TO BASICS: SCIENTIFIC, CONFLICT OF INTEREST,
   AND ETHICAL REVIEW OF RESEARCH PROTOCOLS
   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
   Summary, 107

4  THE PARTICIPANT-INVESTIGATOR INTERFACE
   Preparation of the Investigator and Protocol Design, 109
   The Informed Consent Process, 119
   Roles and Expectations of Research Participants, 129
   Summary, 134

5  IMPROVING PROTECTION THROUGH OVERSIGHT
   AND DATA AND SAFETY MONITORING
   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
   Summary, 160

6  IMPROVING HUMAN RESEARCH PARTICIPANT
   PROTECTION PROGRAM PERFORMANCE AND
   CLARIFYING ROLES
   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
   Summary, 195

7  IMPROVING AN EVOLVING NATIONAL HUMAN
   RESEARCH PARTICIPANT PROTECTION SYSTEM
   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
   Summary, 215



A Data Sources and Methods
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
C Clarifying Protocol Accountability
D Committee Biographies