9780801885020

Evaluating the Science and Ethics of Research on Humans

by
  • ISBN13:

    9780801885020

  • ISBN10:

    0801885027

  • Edition: 1st
  • Format: Paperback
  • Copyright: 2007-01-01
  • Publisher: JOHNS HOPKINS UNIV PRESS

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Summary

Biomedical research on humans is an important part of medical progress. But, when health and lives are at risk, safety and ethical practices need to be the top priority. The need for the committees that regulate and oversee such research -- institutional review boards, or IRBs -- is growing. Evaluating the Science and Ethics of Research on Humans is a guide for new and veteran members of IRBs that will help them better understand the issues involved and the tasks they will be required to perform. The most important purpose of an IRB is to protect the human participants in research. For three major research areas -- drugs, medical devices, and genetic information -- Dennis J. Mazur shares the methods he has found useful in protecting human participants through the systematic review of scientific protocols and informed consent forms and through adherence to the federal regulations that apply. New members will gain understanding of how proposed research projects are to be reviewed from both scientific and ethical dimensions, how and when to ask key questions of principal investigators, how to work with principal investigators and research teams to ensure the best protection of human participants, and why to schedule regularly spaced reviews of a project that may have adverse outcomes. Containing helpful summaries and checklists throughout and based on Mazur's thirty years of research experience, this accessible and informative guide will give all IRB members the tools they need to protect human lives and facilitate the research process.

Author Biography

Dennis J. Mazur, M.D., Ph.D., is a professor of medicine and senior scholar at the Center for Ethics in Health Care, Oregon Health and Science University. Dr. Mazur chaired the institutional review board in the Department of Veterans Affairs Medical Center, Portland, Oregon, for over fifteen years, and Dr. Mazur helped develop and continues to chair the VISN 20 northwest regional multi-site institutional review board.

Table of Contents

Prefacep. ix
Introduction / What Can the New IRB Member Expect?p. 1
The IRB, Its Work, and Its Challenges
What Is an IRB, and What Does It Do?p. 13
Basic Terms and Concepts Used in IRB Workp. 33
What Is Risk?p. 58
The Scientific Protocol and the Informed Consent Form
Prescreening of Proposalsp. 87
The Scientific Protocolp. 94
The Informed Consent Formp. 123
Recruitment, Selection, and Compensation of Study Participantsp. 142
Research involving Questionnaires and Surveysp. 147
Protection of Participants' Privacy in Research Data and Specimensp. 152
The Continuing Work of the IRB
The Ethical Issues of Informed Consentp. 167
Continuing Review, Communication, and Feedbackp. 174
Where Are IRBs Making Mistakes, and How Can We Minimize Mistakes?p. 188
Strategies for Managing the IRB Workload and Supporting IRB Decision Makingp. 196
Decision-Making Capacity and Accountability in Researchp. 205
Summary / The IRB's Key Rolep. 223
A Check List for Reviewing a Scientific Protocolp. 231
A Check List for Reviewing an Informed Consent Formp. 237
Notesp. 239
Website References for Cited Documentsp. 245
Indexp. 247
Table of Contents provided by Ingram. All Rights Reserved.

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