Course: Ethics of Human Subject Research

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Readings

Reading List (37KB) This document contains a comprehensive list of all readings, including those for the live chat sessions.

Textbooks

Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary . Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003.


Topic Readings

Introduction to Ethical Analysis

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, "The Belmont Report"(1979)

Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003, pp. 33-38.

Ezekiel Emanuel, David Wendler, and Christine Grady. 2000. What Makes Clinical Research Ethical? JAMA 283(20): 2701-11.

Cases and Codes

Henry K. Beecher, "Ethics and Clinical Research" (1966)

Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003, pp. 16-20.

Allan Brandt, "Racism and Research: The Case of the Tuskegee Syphilis Study"

Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003 , pp. 20-23.

Vanessa Northington Gamble, "Under the Shadow of Tuskegee: African Americans and Health Care", American Journal of Public Health, 1997; 87(11): 1773-1778.

"The Nuremberg Code" (1949)

Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003, p. 29.

World Medical Association, "Declaration of Helsinki" (1964, rev. 2000)

Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003, pp. 30-32.

Assessment of Risks and Benefits

Charles Weijer, Gary Goldsand and Ezekiel Emanuel. "Protecting Communities in Research: Current Guidelines and Limits of Extrapolation." (1999)

Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003, pp. 340-341.

Charles Weijer and Ezekiel Emanuel. "Protecting Communities in Biomedical Research." (2000)

Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003, pp. 342-343.

Neal Dickert and Christine Grady. "What's the Price of a Research Subject? Approaches to Payment for Research Participation." (1999)

Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003, pp. 179-183.

Ruth Grant and Jeremy Sugarman. 2004. Ethics in Human Subjects Research: Do Incentives Matter? Journal of Medicine and Philosophy 29(6): 717-738.

Respect for Persons and Informed Consent

Robert J. Levine, "Consent Issues in Human Research" (1995)

Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003, pp. 197-201.

Franz J. Ingelfinger, "Informed (But Uneducated) Consent" (1972)

Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003, pp. 202-203.

Jay Katz, "Human Experimentation and Human Rights" (1993)

Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003, pp. 210-213.

Informed Consent and Cultural Relativism

Nicholas A. Christakis. "Ethics are Local: Engaging Cross-Cultural Variation in Ethics Research." (1992)

Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003, pp. 358-363.

Macklin R, "International Research and Ethical Imperialism," Chapter 8 in Against Relativism: Cultural Diversity and the Search for Ethical Universals in Medicine, New York: Oxford University Press (1999): 188-217

Introduction to Institutional Review Boards (IRBs)

Harold Edgar and David J. Rothman, "The Institutional Review Board and Beyond: Future Challenges to the Ethics of Human Experimentation" (1995)

Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003, pp. 436-440.

Department of Health and Human Services, National Institutes of Health, Office for Protection from Research Risks, Code of Federal Regulations , Title 45, Part 46 "Protection of Human Subjects" (1991)

Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003, pp. 39-55.

Charles Weijer, Stanley H. Shapiro, Abraham Fuks, Kathleen Cranley Glass and Myriam Skrutkowska, "Monitoring Clinical Research, An Obligation Unfulfilled" (1995)

Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003, pp. 425-429.

Protection and Access

Dresser, Rebecca, "Wanted. Single, White Male for Medical Research" (1992)

Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003, pp. 166-171.

Charles Weijer and Robert A. Crouch, "Why Should we Include Women and Minorities in Randomized Controlled Trials?" (1999)

Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003, pp. 171-174.

The National Bioethics Advisory Commission. "Research Involving Persons with Mental Disorders that May Affect Decision-Making Capacity."

Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003, pp. 229-233.

Justice in Research Ethics: International Issues

Council for International Organizations of Medical Sciences (CIOMS), in collaboration with the World Health Organization (WHO), "International Ethical Guidelines for Biomedical Research Involving Human Subjects" (2002)

Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003, pp. 56-80.

Richard Love and Norman Fost. "Ethical and Regulatory Challenges in a Randomized Controlled Trial of Adjuvant Treatment in Vietnam."

Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003, pp. 363-367.

Research Ethics and Human Rights

Christopher Beyrer and Nancy Kass. Human rights, Politics and Research Ethics Review. Lancet 2002; 360(9328):246-51.

Coercion and Undue Inducement in Research: Money and Other Offers

No readings assigned.