Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary

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ISBN: 9780801878138 | 0801878136
Cover: Paperback
Copyright: 9/1/2003

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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.

Preface

Acknowledgments and Permissions

xix

Commonly Used Acronyms

xxv

Frequently Cited Research Regulations, Guidelines, and Reports

xxvii

List of Contributors

xxxi

Part I. Scandals and Tragedies of Research with Human Participants: Nuremberg, the Jewish Chronic Disease Hospital, Beecher, and Tuskegee

(24)

1. U.S. Medical Researchers, the Nuremberg Doctors Trial, and the Nuremberg Code: A Review of Findings of the Advisory Committee on Human Radiation Experiments

(4)

Ruth R. Faden, Susan E. Lederer, and Jonathan D. Moreno

2. The Jewish Chronic Disease Hospital Case

(5)

Jay Katz, with Alexander Morgan Capron and Eleanor Swift Glass, eds.

3. Ethics and Clinical Research

(4)

Henry K. Beecher

4. Racism and Research: The Case of the Tuskegee Syphilis Study

(5)

Allan M. Brandt

Part II. Ethical and Regulatory Guidance for Research with Humans

(70)

5. The Nuremberg Code

(1)

Nuremberg Military Tribunal, U.S. v. Karl Brandt, et al.

6. The Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects

(3)

The World Medical Association

7. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research

(6)

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

8. The Common Rule, Title 45 (Public Welfare), Code of Federal Regulations, Part 46 (Protection of Human Subjects), Subparts A-D

(17)

U.S. Department of Health and Human Services, National Institutes of Health, and Office for Human Research Protections

9. The International Ethical Guidelines for Biomedical Research Involving Human Subjects

(24)

The Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO)

10. The ICH Harmonised Tripartite Guideline-Guideline for Good Clinical Practice (ICH-GCP Guideline)

(15)

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

Part III. The Ethics of Clinical Trial Design

(56)

Section One. The Distinction between Research and Treatment

103

(10)

11. Research and Practice

103

(4)

Robert J. Levine

12. Demarcating Research and Treatment: A Systematic Approach for the Analysis of the Ethics of Clinical Research

107

(6)

Benjamin Freedman, Abraham Fuks, and Charles Weijjer

Section Two. The Ethics of Randomized Clinical Trials: Clinical Equipoise

113

(14)

13. Of Mice but Not Men: Problems of the Randomized Clinical Trial

113

(4)

Samuel Hellman and Deborah S. Hellman

14. Equipoise and the Ethics of Clinical Research

117

(4)

Benjamin Freedman

15. Randomized Controlled Trials: Lessons from ECMO

121

(6)

Robert D. Truog

Section Three. The Role of Placebos in Clinical Research

127

(17)

16. The Continuing Unethical Use of Placebo Controls

127

(3)

Kenneth J. Rothman and Karin B. Michels

17. Placebo-Controlled Trials and the Logic of Clinical Purpose

130

(7)

Benjamin Freedman

18. Placebo-Controlled Trials and Active-Control Trials in the Evaluation of New Treatments, Part 1: Ethical and Scientific Issues

137

(1003)

Robert Temple and Susan S. Ellenberg

19. The Ethics of Placebo-Controlled Trials: A Middle Ground

1140

Ezekiel J. Emanuel and Franklin G. Miller

Section Four. The Ethics of Phase I Research

144

(7)

20. On the Nature and Ethics of Phase I Clinical Trials of Cancer Chemotherapies

144

(2)

Mortimer B. Lipsett

21. The Changing Landscape of Human Experimentation: Nuremberg, Helsinki, and Beyond

146

(9)

George J. Annas

Part IV. The Ethics of Research Participant Recruitment

151

(38)

Section One. Justifications for the Recruitment of Research Participants

155

(11)

22. Philosophical Reflections on Experimenting with Human Subjects

155

(6)

Hans Jonas

23. Experimentation on Trial: Why Should One Take Part in Medical Research?

161

(5)

David Heyd

Section Two. Access to Research

166

(13)

24. Wanted: Single, White Male for Medical Research

166

(5)

Rebecca Dresser

25. Why Should We Include Women and Minorities in Randomized Controlled Trials?

171

(4)

Charles Weijjer and Robert A. Crouch

26. The Duty to Exclude: Excluding People at Undue Risk from Research

175

(4)

Charles Weijjer and Abraham Fuks

Section Three. Payment of Research Participants

179

(10)

27. What's the Price of a Research Subject? Approaches to Payment for Research Participation

179

(4)

Neal Dickers and Christine Grady

28. Justice for the Professional Guinea Pig

183

(2)

Trudo Lemmens and Carl Elliott

29. Paying People to Participate in Research: Why Not?

185

(12)

Paul McNeill

Part V. Informed Consent in Research

189

(36)

30. Consent Issues in Human Research

197

(5)

Robert J. Levine

31. Informed (But Uneducated) Consent

202

(1)

Franz J. Ingelfinger

32. A Moral Theory of Informed Consent

203

(4)

Benjamin Freedman

33. Is Informed Consent Always Necessary for Randomized, Controlled Trials?

207

(3)

Robert D. Truog, Walter Robinson, Adrienne Randolph, and Alan Morris

34. Human Experimentation and Human Rights

210

(3)

Jay Katz

35. Subject Interview Study

213

(3)

The Presidents Advisory Committee on Human Radiation Experiments

36. False Hopes and Best Data: Consent to Research and the Therapeutic Misconception

216

(5)

Paul S. Appelbaum, Loren H. Roth, Charles W. Lidz, Paul Benson, and William Winslade

37. "Therapeutic Misconception" and "Recruiting Doublespeak" in the Informed Consent Process

221

(4)

Mark Hochhauser

Part VI. Clinical Research with Special Populations

225

(48)

Section One. People with Cognitive Impairments

229

(11)

38. Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity

229

(5)

The National Bioethics Advisory Commission

39. Are Research Ethics Bad for Our Mental Health?

234

(3)

Robert Michels

40. Caring about Risks: Are Severely Depressed Patients Competent to Consent to Research?

237

(3)

Carl Elliott

Section Two. Children

240

(18)

41. The NIH Trials of Growth Hormone for Short Stature

240

(7)

Carol A. Tauer

42. In loco parentis: Minimal Risk as an Ethical Threshold for Research upon Children

247

(5)

Benjamin Freedman, Abraham Fuks, and Charles Weijjer

43. Minors' Assent, Consent, or Dissent to Medical Research

252

(6)

Sanford Leikin

Section Three. Captive Populations: Soldiers, Prisoners, Students

258

(15)

44. Convenient and Captive Populations

258

(4)

Jonathan D. Moreno

45. Medical Experimentation on Prisoners

262

(4)

Carl Cohen

46. Students, Grades, and Informed Consent

266

(4)

Harold E. Gamble

47. Against Special Protections for Medical Students

270

(15)

Nancy R. Angoff

Part VII. Special Topics in Research Ethics

273

(96)

Section One. Genetics Research

285

(20)

48. Structuring the Review of Human Genetics Protocols: Gene Localization and Identification Studies

285

(6)

Kathleen Cranley Glass, Charles Weijjer, Roberta M. Palmour, Stanley H. Shapiro, Trudo Lemmens, and Karen Lebacgz

49. Structuring the Review of Human Genetics Protocols, Part II: Diagnostic and Screening Studies

291

(6)

Kathleen Cranley Glass, Charles Weijjer, Trudo Lemmens, Roberta M. Palmour, and Stanley H. Shapiro

50. Structuring the Review of Human Genetics Protocols, Part III: Gene Therapy Studies

297

(5)

Kathleen Cranley Glass, Charles Weijjer, Denis Cournoyer, Trudo Lemmens, Roberta M. Palmour, Stanley H. Shapiro, and Benjamin Freedman

51. Protecting the Privacy of Family Members in Survey and Pedigree Research

302

(3)

Jeffrey R. Botkin

Section Two. Stored Human Biological Specimens

305

(8)

52. Statement on Informed Consent for Genetic Research

305

(3)

The American Society of Human Genetics

53. Informed Consent for Genetic Research on Stored Tissue Samples

308

(3)

Ellen Wright Clayton, Karen K. Steinberg, Mumn J. Khoury, Elizabeth Thomson, Lori Andrews, Mary Jo Ellis Kahn, Loretta M. Kopelman, and Joan 0. Weiss

54. Use of Human Tissues in Research: Clarifying Clinician and Researcher Roles and Information Flows

311

(2)

Jon F. Merz, Pamela Sankar, Sheila E. Taube, and Virginia LiVolsi

Section Three. Human Embryos and Stem Cells

313

(16)

55. Report of the Human Embryo Research Panel, Volume 1

313

(4)

Ad Hoc Group of Consultants to the Advisory Committee to the Director, NIH

56. The Inhuman Use of Human Beings: A Statement on Embryo Research

317

(2)

The Ramsey Colloquium

57. Ethical Issues in Human Stem Cell Research

319

(6)

National Bioethics Advisory Commission

58. Creating Embryos for Research: On Weighing Symbolic Costs

325

(4)

Maura A. Ryan

Section Four. Drug Challenge and Drug Washout Studies

329

(6)

59. Drug-Free Research in Schizophrenia: An Overview of the Controversy

329

(3)

Paul S. Appelbaum

60. Psychiatric Symptom-Provoking Studies: An Ethical Appraisal

332

(3)

Franklin G. Miller and Donald L. Rosenstein

Section Five. Research with Communities

335

(8)

61. A Model Agreement for Genetic Research in Socially Identifiable Populations

335

(2)

Morris W. Foster, Deborah Bernsten, and Thomas H. Carter

62. Groups as Gatekeepers to Genomic Research: Conceptually Confusing, Morally Hazardous, and Practically Useless

337

(3)

Eric T. Juengst

63. Protecting Communities in Research: Current Guidelines and Limits of Extrapolation

340

(2)

Charles Weijjer, Gary Goldsand, and Ezekiel J. Emanuel

64. Protecting Communities in Biomedical Research

342

(1)

Charles Weijjer and Ezekiel J. Emanuel

Section Six. International Research

343

(26)

65. Unethical Trials of Interventions to Reduce Perinatal Transmission of the Human Immunodeficiency Virus in Developing Countries

343

(3)

Peter Lune and Sidney M. Wolfe

66. Human Rights and Maternal-Fetal HIV Transmission Prevention Trials in Africa

346

(2)

George J. Annas and Michael A. Grodin

67. AZT Trials and Tribulations

348

(6)

Robert A. Crouch and John D. Arras

68. Fair Benefits for Research in Developing Countries

354

(2)

Participants in the 2001 Conference on Ethical Aspects of Research in Developing Countries

69. Ethical Imperialism? Ethics in International Collaborative Clinical Research

356

(2)

Marcia Angell

70. Ethics Are Local: Engaging Cross-Cultural Variation in the Ethics for Clinical Research

358

(5)

Nicholas A. Christakis

71. Ethical and Regulatory Challenges in a Randomized Control Trial of Adjuvant Treatment for Breast Cancer in Vietnam

363

(12)

Richard R. Love and Norman C. Fost

Part VIII. The Behavior of Clinical Investigators: Conflicts of Interest

369

(16)

72. Understanding Financial Conflicts of Interest

375

(2)

Dennis F. Thompson

73. Finder's Fees for Research Subjects

377

(1)

Stuart E. Lind

74. Conflicts of Interests and the Validity of Clinical Trials

378

(4)

Baruch A. Brody

75. In Whose Best Interest? Breaching the Academic-Industrial Wall

382

(3)

Joseph B. Martin and Dennis L. Kasper

Part IX. Scientific Misconduct

385

(34)

Section One. Altering Data: Fraud, Fabrication, and Falsification

393

(10)

76. Pressure to Publish and Fraud in Science

393

(2)

Patricia K. Woolf

77. Science, Statistics, and Deception

395

(2)

John C. Bailar III

78. Data Torturing

397

(2)

James L. Mills

79. Preventing Scientific Misconduct

399

(4)

Douglas L. Weed

Section Two. Rules of Authorship

403

(8)

80. When Authorship Fails: A Proposal to Make Contributors Accountable

403

(8)

Drummond Rennie, Veronica Yank, and Linda L. Emanuel

Section Three. Problems in the Publication of Research Methods and Findings

411

(8)

81. Underreporting Research Is Scientific Misconduct

411

(3)

Iain Chalmers

82. The CONSORT Statement: Revised Recommendations for Improving the Quality of Reports of Parallel-Group Randomized Trials

414

(11)

David Moher, Kenneth F. Schulz, and Douglas Altman for the CONSORT Group

Part X. Challenges to the Institutional Review Board System

419

(26)

83. Monitoring Clinical Research: An Obligation Unfulfilled

425

(4)

Charles Weijer, Stanley H. Shapiro, Abraham Fuks, Kathleen Cranley Glass, and Myriam Skrutkowska

84. Ethics Review for Sale? Conflict of Interest and Commercial Research Review Boards

429

(7)

Trudo Lemmens and Benjamin Freedman

85. The Institutional Review Board and Beyond: Future Challenges to the Ethics of Human Experimentation

436

(5)

Harold Edgar and David J. Rothman

86. A Central Institutional Review Board for Multi-institutional Trials

441

(4)

Michaele C. Christian, Jacquelyn L. Goldberg, Jack Killen, Jeffrey S. Abrams, Mary S. McCabe, Joan K Mauer, and Robert E. Wittes

Appendixes: Informed Consent Forms

445

(34)

A. Phase I Treatment of Adults with Recurrent Supratentorial High-Grade Glioma with Gliadel Wafers Plus Temodar

447

(4)

B. A Phase I Study of Intra-arterial Onyx-015 for Squamous Cell Cancer of the Head and Neck

451

(8)

C. Cohort-Varying Information Insert for Form for Consent to Participate in a Phase I Study

459

(1)

Benjamin Freedman

D. Nitric Oxide Inhalation Therapy for Myocardial Ischemia in Patients with Coronary Artery Disease

460

(8)

E. Double-Blind Drug Crossover and Withdrawal Project

468

(3)

F. Information and Consent Letter for Hemochromatosis Study

471

(3)

G. National Action Plan on Breast Cancer (NAPBC) Consent Form for Use of Tissue for Research

474

(2)

H. Patient Written Consent Form for Review of Medical Records

476

(2)

I. A Descriptive Study of the Views and Experiences of Persons Involved in a Measles Vaccine Study

478

(1)

Index

479

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Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary

Summary

Author Biography

Table of Contents

Supplemental Materials

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Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary

Summary

Author Biography

Table of Contents

Supplemental Materials

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