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.

Human experimentation in medicine.

Medical ethics.

Medical protocols.

Patients--Legal status, laws, etc.

Patients.

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