Text: Health Care Ethics USA

IRBs: A Select Bibliography

Winter 2009

Boyce, T.L. and B. Ward. "Any Affiliation Can Lead to Bias." British Medical Journal (August 11, 2008): 337.

Brody, Baruch A., Cheryl Anderson, S. Van McCrary, Laurence McCulough, Robert Morgan and Nelda Wray. "Expanding Disclosure of Conflicts of Interest: The View of Stakeholders." IRB: Ethics and Human Research 25, no. 1 (January-February 2003): 1-8.

Christian, Michaele C. and Jacquelyn L. Goldberg. "A Central Institutional Review Board for Multi-Institutional Trials." The New England Journal of Medicine 346, no. 18 (May 2002): 1405-1408.

Emmanuel, Ezekiel, ed. The Oxford Textbook of Clinical Research Ethics. New York: Oxford University Press, 2008.

Fisher, Celia B., Matthew Oransky, Meena Mahadevan, Merrill Singer, Greg Mirhej and Derrick Hodge. "Marginalized Populations and Drug Addiction Research: Realism, Mistrust, and Misconception." IRB: Ethics and Human Research 30, no. 3 (May-June 2008): 1-9.

Gabriele, Edward F. "The Belmont Ethos: The Meaning of the Belmont Principles for Human Subject Protections." Journal of Research Administration 34, no. 2 (2003): 19-24.

Go, R.S. "Issues Behind Disclosures of Conflicts of Interest." Journal of the American Medical Association 300, no. 18 (November 12, 2008): 2120.

Goodman, J. W. and R. N. Fiore. "Toward a Comprehensive Research Ethics Consultation Service." American Journal of Bioethics 8, no. 3 (March 2008): 31-2.

Horng, Sam and Christine Grady. "Misunderstanding in Clinical Research: Distinguishing Therapeutic Misconception, Therapeutic Misestimation & Therapeutic Optimism." IRB: Ethics & Human Research 25, no. 1 (January-February 2003): 11-16.

Iltis, Ana, ed. Research Ethics. New York: Routledge, 2008.

La Vaque, Theodore J. and Thomas Rossiter. "The Ethical Use of Placebo Controls in Clinical Research: The Declaration of Helsinki." Applied Psychophysiology and Biofeedback 26, no. 1 (2001): 23-27

London, Alex. "Does Research Ethics Rest on a Mistake? The Common Good, Reasonable Risk and Social Justice ." American Journal of Bioethics 5, no. 1 (2005): 37.

Macklin, Ruth. "How Independent Are IRBs?" IRB: Ethics & Human Research 30, no. 3 (May-June 2008): 15-19.

Markham, M. "'Conflict-of-Interest' and Participation in IRB Deliberations: An Alternative Perspective." Cancer Investigator 26, no. 2 (March 2008): 115-7.

Marshall, Mary Faith. "Vulnerable Subjects and Civic Professionalism: Would Six-Sigma Research and Research Ethics Consultation Solve the Vulnerability Problem?" The American Journal of Bioethics. 4, no.3 (2004):54

McGuinness, S. "Research Ethics Committees: The Role of Ethics in a Regulatory Authority." Journal of Medical Ethics 34, no. 9 (September 2008): 695-700.

McNeil, Caroline. "Central IRBs: Why Are Some Institutions Reluctant to Sign On?" Journal of the National Cancer Institute 97, no. 13 (July 2005): 953-955.

McNeil, Caroline. "Debate Over Institutional Review Boards Continues as Alternative Options Emerge." Journal of the National Cancer Institute 99, no. 7 (April 2007): 502-503.

Murphy, Timothy. Case Studies in Biomedical Research Ethics. Cambridge, MA: MIT Press, 2004.

Phillips, Donald F. "IRBs Search for Answers and Support During a Time of Institutional Change." Journal of the American Medical Association 283, no. 6 (February 2000): 729-730.

Pullman, Daryl. "Conflicting Interest, Social Justice and Proxy Consent of Research." Journal of Medicine and Philosophy 27, no.5 (2002): 523-545.

Rector, Thomas S. "How Should We Communicate the Likelihood of Risks to Inform Decisions about Consent?" IRB: Ethics & Human Research 30, no. 4 (July-August 2008): 15-18.

Russell-Einhorn, Michele, Thomas Puglisi and David Perlman. "Are Shared IRB Systems Economical Tools for Multi-Site Institutions?" Journal of Health Care Compliance, January-February 2002: 50-51.

Skrutkowski, Myrian, Charles Weijer, Stan Shapiro, Abraham Fuks, Adrian Langleben, and Benjamin Freedman. "Monitoring Informed Consent in an Oncology Study Posing Serious Risk to Subjects." IRB: A Review of Human Subjects Research 20, no. 6 (November-December 1998): 1-6.

Slater, Eve E. "IRB Reform." The New England Journal of Medicine 346, no. 18 (May 2002): 1402-1404.

Striefel, Sebastian. "Ethical Research Issues: Going Beyond the Declaration of Helsinki." Applied Psychophysiology and Biofeedback 26, no. 1 (2001): 39-59.

Vawter, Dorothy, Karen G. Gervais, and Thomas B. Freeman. "Strategies for Achieving High-Quality IRB Review." The American Journal of Bioethics. 4, no.3 (2004):74.

Von Bartheid, C.S. "Investigator Attendance." IRB: A Review of Human Subject Research 30, no. 4 (July-August 2008): 19.

Wechsler, Jill. "Central vs. Local: Rethinking IRBs." Applied Clinical Trials, February 2007.

Wolf, L. E. and Zandecki, J. "Conflicts of Interest in Research: How IRBs Address Their Own Conflicts." IRB: A Review of Human Subject Research 29, no. 1 (January-February 2007): 6-12.

Also, the Catholic Medical Association and the National Catholic Bioethics Center recently published A Catholic Guide to Ethical Clinical Research. Copies of the booklet, which contains guidelines and cases, may be obtained from the National Catholic Bioethics Center (www.ncbcenter.org).

 

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