Institutional Review Boards and Bioethical Issues for Otologists and Audiologists
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Otologists and audiologists care for patients and conduct clinical research to find more effective treatments that benefit patients. Institutional Review Board (IRB) permission is necessary for conducting clinical trials on humans. Furthermore, many bioethical conflicts are encountered while conducting research. However, few otologists and audiologists in Korea know bioethics and the principles and regulations of IRBs in detail. This paper reviews the history of ethics in clinical research and current bioethical principles and IRB regulations. We outline what you need as otologists or audiologists to get IRB approval while considering the principles of bioethics.
Abstract
Otologists and audiologists care for patients and conduct clinical research to find more effective treatments that benefit patients. Institutional Review Board (IRB) permission is necessary for conducting clinical trials on humans. Furthermore, many bioethical conflicts are encountered while conducting research. However, few otologists and audiologists in Korea know bioethics and the principles and regulations of IRBs in detail. This paper reviews the history of ethics in clinical research and current bioethical principles and IRB regulations. We outline what you need as otologists or audiologists to get IRB approval while considering the principles of bioethics.
참고문헌 (26)
- Gallin JI, "Principles and practice of clinical research, In Principles and practice of clinical research", pp.1~10 (2007), Elsevier
- Beecher HK, "Ethics and clinical research", N Engl J Med, 274, pp.1354~1360 (1966)
- Nuremberg Military Tribunal, "The Nuremberg Code", JAMA, 276, pp.1691~ (1996)
- "International Ethical Guidelines for Biomedical Research Involving Human Subjects"[URL]
- Huisman MA, "Survival signaling and terminal differentiation in cholesteatoma epithelium", Acta Otolaryngol, 127, pp.424~429 (2007)
- Chicheportiche Y, "TWEAK, a new secreted ligand in the tumor necrosis factor family that weakly induces apoptosis", J Biol Chem, 272, pp.32401~32410 (1997)
- Albino AP, "Expression of p53 protein in human middle ear cholesteatomas: pathogenetic implications", Am J Otol, 19, pp.30~36 (1998)
- Council for International Organizations of Medical Sciences., "International ethical guidelines for biomedical research involving human subjects", Bull Med Ethics, pp.17~23 (2002)
- World Medical Association declaration of Helsinki, "Recommendations guiding physicians in biomedical research involving human subjects", JAMA, 277, pp.925~926 (1997)
- Grady C, "Ethical principles in clinical research, In Principles and practice of clinical research", pp.15~25 (2007), Elsevier
- Emanuel EJ, "What makes clinical research ethical?", JAMA, 283, pp.2701~2711 (2000)
- Miller FG, "Clinical research with healthy volunteers: an ethical framework", J Investig Med, 51(Suppl 1), pp.2~5 (2003)
- Danis M, "St-arting research", pp.21~48 (2012), Oxford University Press
- Miller J, "Ethical standards for human subject research in developing countries", IRB, 14, pp.7~8 (1992)
- Arpaillange P, "Proposal for ethical standards in therapeutic trials", Br Med J (Clin Res Ed), 291, pp.887~889 (1985)
- Kaufman JL, "Protecting research subjects", N Engl J Med, 346, pp.2093~2095 (2002)
- Bernstein M., "Payment of research subjects involved in clinical trials is unethical", J Neurooncol, 63, pp.223~224 (2003)
- Danis M, "En-rolling research participants", pp.49~77 (2012), Oxford University Press
- Danis M, "Pro-tecting research participants", pp.78~99 (2012), Oxford University Press
- Kaiser J, "Clinical trials. Proposed rules aim to curb financial conflicts of interest", Science, 295, pp.246~247 (2002)
- American Society of Clinical Oncology, "American Society of Clinical Oncology policy statement: oversight of clinical research", J Clin Oncol, 21, pp.2377~2386 (2003)
- Greco D, "Conflicts of interest in research involving human beings", J Int Bioethique, 19, pp.143~203 (2008)
- Hossne WS, "Committees for Ethics in Research involving human subjects", J Int Bioethique, 19, pp.131~200 (2008)
- Bratt DE, "Informed consent in medical research. Doctors are arrogant to think they need to debate issue of patient consent", BMJ, 314, pp.1477~ (1997)
- Wichman A, "Institutional review boards, In Principles and practice of clinical research", pp.47~57 (2007), Elsevier
- Weymuller EA Jr, "A consideration of ethical issues in the design of clinical trials", Am J Otolaryngol, 17, pp.2~11 (1996)