Journal of the Korean Medical Association (대한의사협회지)

Korean Medical Association (대한의사협회)
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Clinical trials and ethics

임상시험과 윤리

  • Lim, In-Ae (Human Research Protection Center, Severance Hospital, Yonsei University Health System) ;
  • Rha, Sun-Young (Department of Internal Medicine, Yonsei University College of Medicine, Department of Internal Medicine, Yonsei University College of Medicine, Human Research Protection Center, Severance Hospital,)
  • 임인애 (세브란스병원 피험자 보호센터) ;
  • 라선영 (연세의대 내과학교실, 세브란스병원 피험자 보호센터)
  • Published : 2010.09.10
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Abstract

Based on recently developed biotechnology, many new drugs have been developed for improving patient treatment outcomes. To develop novel drugs, proper clinical trials are essential. As clinical trials involve humans in research, the protection of participants is important not only for the participants' safety but also for future patients. Ethics in a clinical trial is not the same as in clinical practice with enough evidence. Hence, the whole procedure of a clinical trial should be well organized, scientifically and ethically planned, and monitored properly by an Institutional Review Board (IRB). Here the importance of ethics in clinical trials, related issues, and the monitoring system will be discussed.

Keywords

References

  1. National Teacher Training Center For Health personnel. Clinical Ethics. rev Ed. Seoul: Seoul National University Press; 1999.
  2. Belmont Report. 1979. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
  3. Kathleen CG, Duff W. The physician/investigato's obligation to patients participating in research: The case of placebo controlled trials. J Law Med Ethics 2005; 33: 575-585. https://doi.org/10.1111/j.1748-720X.2005.tb00520.x
  4. Korea Food&Drug Administration Public Notification No.2009-211. Korea Good Clinical Practice. (Dec 22, 2009).
  5. Office of Human Subjects Research[Internet]. Bethesda, MD, US; [cited 2010 Jul 17]. Available from: http://ohsr.od.nih.gov/guidelines/nuremberg.html.
  6. Korea Food&Drug Administration Public Notification No.2009-211. Korea Good Clinical Practice. Article 17 (Dec 22, 2009).
  7. Choi EK, Kim OJ. Ethical consideration in genomic cohort study. J Prev Med Public Health 2007; 40: 122-129. Korean. https://doi.org/10.3961/jpmph.2007.40.2.122
  8. Hofmann B. Broadening consent-and diluting ethics? J Med Ethics 2009; 35: 125-129. https://doi.org/10.1136/jme.2008.024851
  9. Criteria for IRB approval of research, 45 C.F.R. Sect. 46. 111 (2007).
  10. Centers for Disease Control and Prevention [Internet]. Atlanta, USA; [updated 2010 Jun 07; cited 2010 Jul 17]. Available from: http://www.cdc.gov/tuskegee/index.html.
  11. Civil Act of South Korea, Ch. II. Article 4 (Majority).
  12. Daugherty CK, Ratain MJ, Emanuel EJ, Farrell AT, Schilsky RL. Ethical, scientific, and regulatory perspectives regarding the use of placebos in cancer clinical trials. J Clin Oncol 2008; 26: 1371-1378. https://doi.org/10.1200/JCO.2007.13.5335
  13. Freedman B. Equipoise and the ethics of clinical research. N Engl J Med 1987; 317: 141-145. https://doi.org/10.1056/NEJM198707163170304
  14. National Bioethics Advisory Commission(NBAC). Ethical and Policy issues in Research involving Human Participants Volume I 2001.
  15. World Medical Association [Internet]. France; [updated 2010 Oct; cited 2010 Jul 18]. Available from: http://www.wma.net/en/20activities/10ethics/10helsinki/index.html.

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