Ethical and Regulatory Aspects of Clinical Research Readings and Commentary

ISBN-10: 0801878136

ISBN-13: 9780801878138

Edition: 2004

Authors: Ezekiel J. Emanuel, John D. Arras, Robert A. Crouch, Jonathan D. Moreno

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All investigators funded by the National Institutes of Health are now required to receive training about the ethics of clinical research. Based on a course taught by the editors at NIH, Ethical and Regulatory Aspects of Clinical Research is the first book designed to help investigators meet this new requirement. The book begins with the history of human subjects research and guidelines instituted since World War II. It then covers various stages and components of the clinical trial process: designing the trial, recruiting participants, ensuring informed consent, studying special populations, and conducting international research. Concluding chapters address conflicts of interest, scientific misconduct, and challenges to the IRB system. The appendix provides sample informed consent forms. This book will be used in undergraduate courses on research ethics and in schools of medicine and public health by students who are or will be carrying out clinical research. Professionals in need of such training and bioethicists also will be interested.
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Book details

List price: $50.00
Copyright year: 2004
Publisher: Johns Hopkins University Press
Publication date: 9/30/2003
Binding: Paperback
Pages: 528
Size: 8.25" wide x 10.75" long x 1.25" tall
Weight: 3.080
Language: English

Jonathan D. Moreno is Kornfeld Professor and Director of the Center for Biomedical Ethics at the University of Virginia and a Fellow at the Center for American Progress. He has been a senior staff member for two presidential commissions and an advisor to the White House Office of Science and Technology Policy, the National Institutes of Health, the Department of Health and Human Services, the National Academy of Sciences, and the Howard Hughes Medical Institute. Moreno is past president of the American Society for Bioethics and Humanities. He lives in Washington, D.C.

Acknowledgments and Permissions
Commonly Used Acronyms
Frequently Cited Research Regulations, Guidelines, and Reports
List of Contributors
Scandals and Tragedies of Research with Human Participants: Nuremberg, the Jewish Chronic Disease Hospital, Beecher, and Tuskegee
U.S. Medical Researchers, the Nuremberg Doctors Trial, and the Nuremberg Code: A Review of Findings of the Advisory Committee on Human Radiation Experiments
The Jewish Chronic Disease Hospital Case
Ethics and Clinical Research
Racism and Research: The Case of the Tuskegee Syphilis Study
Ethical and Regulatory Guidance for Research with Humans
The Nuremberg Code
The Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects
The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research
The Common Rule, Title 45 (Public Welfare), Code of Federal Regulations, Part 46 (Protection of Human Subjects), Subparts A--D
The International Ethical Guidelines for Biomedical Research Involving Human Subjects
The ICH Harmonised Tripartite Guideline--Guideline for Good Clinical Practice (ICH-GCP Guideline)
The Ethics of Clinical Trial Design
The Distinction between Research and Treatment
Research and Practice
Demarcating Research and Treatment: A Systematic Approach for the Analysis of the Ethics of Clinical Research
The Ethics of Randomized Clinical Trials: Clinical Equipoise
Of Mice but Not Men: Problems of the Randomized Clinical Trial
Equipoise and the Ethics of Clinical Research
Randomized Controlled Trials: Lessons from ECMO
The Role of Placebos in Clinical Research
The Continuing Unethical Use of Placebo Controls
Placebo-Controlled Trials and the Logic of Clinical Purpose
Placebo-Controlled Trials and Active-Control Trials in the Evaluation of New Treatments, Part 1: Ethical and Scientific Issues
The Ethics of Placebo-Controlled Trials: A Middle Ground
The Ethics of Phase I Research
On the Nature and Ethics of Phase I Clinical Trials of Cancer Chemotherapies
The Changing Landscape of Human Experimentation: Nuremberg, Helsinki, and Beyond
The Ethics of Research Participant Recruitment
Justifications for the Recruitment of Research Participants
Philosophical Reflections on Experimenting with Human Subjects
Experimentation on Trial: Why Should One Take Part in Medical Research?
Access to Research
Wanted: Single, White Male for Medical Research
Why Should We Include Women and Minorities in Randomized Controlled Trials?
The Duty to Exclude: Excluding People at Undue Risk from Research
Payment of Research Participants
What's the Price of a Research Subject? Approaches to Payment for Research Participation
Justice for the Professional Guinea Pig
Paying People to Participate in Research: Why Not?
Informed Consent in Research
Consent Issues in Human Research
Informed (But Uneducated) Consent
A Moral Theory of Informed Consent
Is Informed Consent Always Necessary for Randomized, Controlled Trials?
Human Experimentation and Human Rights
Subject Interview Study
False Hopes and Best Data: Consent to Research and the Therapeutic Misconception
"Therapeutic Misconception" and "Recruiting Doublespeak" in the Informed Consent Process
Clinical Research with Special Populations
People with Cognitive Impairments
Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity
Are Research Ethics Bad for Our Mental Health?
Caring about Risks: Are Severely Depressed Patients Competent to Consent to Research?
The NIH Trials of Growth Hormone for Short Stature
In loco parentis: Minimal Risk as an Ethical Threshold for Research upon Children
Minors' Assent, Consent, or Dissent to Medical Research
Captive Populations: Soldiers, Prisoners, Students
Convenient and Captive Populations
Medical Experimentation on Prisoners
Students, Grades, and Informed Consent
Against Special Protections for Medical Students
Special Topics in Research Ethics
Genetics Research
Structuring the Review of Human Genetics Protocols: Gene Localization and Identification Studies
Structuring the Review of Human Genetics Protocols, Part II: Diagnostic and Screening Studies
Structuring the Review of Human Genetics Protocols, Part III: Gene Therapy Studies
Protecting the Privacy of Family Members in Survey and Pedigree Research
Stored Human Biological Specimens
Statement on Informed Consent for Genetic Research
Informed Consent for Genetic Research on Stored Tissue Samples
Use of Human Tissues in Research: Clarifying Clinician and Researcher Roles and Information Flows
Human Embryos and Stem Cells
Report of the Human Embryo Research Panel, Volume 1
The Inhuman Use of Human Beings: A Statement on Embryo Research
Ethical Issues in Human Stem Cell Research
Creating Embryos for Research: On Weighing Symbolic Costs
Drug Challenge and Drug Washout Studies
Drug-Free Research in Schizophrenia: An Overview of the Controversy
Psychiatric Symptom-Provoking Studies: An Ethical Appraisal
Research with Communities
A Model Agreement for Genetic Research in Socially Identifiable Populations
Groups as Gatekeepers to Genomic Research: Conceptually Confusing, Morally Hazardous, and Practically Useless
Protecting Communities in Research: Current Guidelines and Limits of Extrapolation
Protecting Communities in Biomedical Research
International Research
Unethical Trials of Interventions to Reduce Perinatal Transmission of the Human Immunodeficiency Virus in Developing Countries
Human Rights and Maternal-Fetal HIV Transmission Prevention Trials in Africa
AZT Trials and Tribulations
Fair Benefits for Research in Developing Countries
Ethical Imperialism? Ethics in International Collaborative Clinical Research
Ethics Are Local: Engaging Cross-Cultural Variation in the Ethics for Clinical Research
Ethical and Regulatory Challenges in a Randomized Control Trial of Adjuvant Treatment for Breast Cancer in Vietnam
The Behavior of Clinical Investigators: Conflicts of Interest
Understanding Financial Conflicts of Interest
Finder's Fees for Research Subjects
Conflicts of Interests and the Validity of Clinical Trials
In Whose Best Interest? Breaching the Academic-Industrial Wall
Scientific Misconduct
Altering Data: Fraud, Fabrication, and Falsification
Pressure to Publish and Fraud in Science
Science, Statistics, and Deception
Data Torturing
Preventing Scientific Misconduct
Rules of Authorship
When Authorship Fails: A Proposal to Make Contributors Accountable
Problems in the Publication of Research Methods and Findings
Underreporting Research Is Scientific Misconduct
The CONSORT Statement: Revised Recommendations for Improving the Quality of Reports of Parallel-Group Randomized Trials
Challenges to the Institutional Review Board System
Monitoring Clinical Research: An Obligation Unfulfilled
Ethics Review for Sale? Conflict of Interest and Commercial Research Review Boards
The Institutional Review Board and Beyond: Future Challenges to the Ethics of Human Experimentation
A Central Institutional Review Board for Multi-institutional Trials
Informed Consent Forms
Phase I Treatment of Adults with Recurrent Supratentorial High-Grade Glioma with Gliadel Wafers Plus Temodar
A Phase I Study of Intra-arterial Onyx-015 for Squamous Cell Cancer of the Head and Neck
Cohort-Varying Information Insert for Form for Consent to Participate in a Phase I Study
Nitric Oxide Inhalation Therapy for Myocardial Ischemia in Patients with Coronary Artery Disease
Double-Blind Drug Crossover and Withdrawal Project
Information and Consent Letter for Hemochromatosis Study
National Action Plan on Breast Cancer (NAPBC) Consent Form for Use of Tissue for Research
Patient Written Consent Form for Review of Medical Records
A Descriptive Study of the Views and Experiences of Persons Involved in a Measles Vaccine Study
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