Responsible Research: A Systems Approach to Protecting Research Participants

by Federman, Daniel D.

• ISBN13: 9780309084888
• ISBN10: 0309084881
• Edition: 1st
• Format: Hardcover
• Copyright: 2002-01-01
• Publisher: NATL ACADEMY OF SCIENCE

Summary

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 Summary	1	(28)
Introduction	29	(16)
Context for This Report	30	(1)
Basic Tenets of Ethical Human Research	31	(1)
The Range of Human Research	32	(4)
Recent Events	36	(4)
Themes and Organization of This Report	40	(4)
Summary	44	(1)
A Systemic Approach to Human Research Participant Protection Programs	45	(25)
The Need for a Systemic Approach	45	(3)
Defining Protection Programs	48	(4)
Establishing a Balanced Program	52	(14)
Functions Integral to the Protection System	66	(3)
Summary	69	(1)
Back to Basics: Scientific, Conflict of Interest, and Ethical Review of Research Protocols	70	(38)
The Need for Research Ethics Review Boards	70	(2)
Three-Pronged Review	72	(3)
Ensuring Discrete Scientific Review of Protocols	75	(7)
Financial Conflicts of Interest and Protocol Review	82	(4)
Ethics Review: Clarifying the Roles and Responsibilities of Research ERBs	86	(15)
Organizing and Integrating the Review Processes	101	(4)
Resource Needs	105	(2)
Summary	107	(1)
The Participant-Investigator Interface	108	(28)
Preparation of the Investigator and Protocol Design	109	(10)
The Informed Consent Process	119	(10)
Roles and Expectations of Research Participants	129	(5)
Summary	134	(2)
Improving Protection through Oversight and Data and Safety Monitoring	136	(26)
Government Regulation of Research	138	(12)
Oversight by Federal Research Agencies	150	(2)
Data and Safety Monitoring by the Program	152	(2)
Data and Safety Monitoring by an Independent Body	154	(3)
Communicating the Results of Data and Safety Monitoring	157	(2)
Data Security: Protecting Confidentiality	159	(1)
Summary	160	(2)
Improving Human Research Participant Protection Program Performance and Clarifying Roles	162	(35)
Continuous Quality Improvement	163	(8)
Status of Accreditation	171	(6)
Role Differentiation Within the HRPPP	177	(5)
Managing Conflicts of Interest	182	(6)
Compensation for Research-Related Injury	188	(6)
Personal Liability of Research ERB Members	194	(1)
Summary	195	(2)
Improving an Evolving National Human Research Participant Protection System	197	(20)
The Need for Better Advice and Guidance at the Federal Level	198	(2)
The Need for Public Information Regarding Ongoing Clinical Research	200	(5)
Communicating Research Results: A Role for Publishers	205	(1)
The Impact of the Health Insurance Portability and Accountability Act of 1996 Requirements and Privacy Issues on HRPPPs	205	(6)
Research Efforts to Counter Terrorism	211	(4)
Summary	215	(2)
REFERENCES	217	(60)
APPENDIXES
A Data Sources and Methods	231	(5)
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	(13)
C Clarifying Protocol Accountability	249	(14)
D Committee Biographies	263	(14)
Index	277