@article{ART001254821},
author={Kyungsuk Choi},
title={Ethical and Legal Problems of Randomized Clinical Trials},
journal={Korean Journal of Medical Ethics },
issn={2005-8284},
year={2008},
volume={11},
number={1},
pages={45-62},
doi={10.35301/ksme.2008.11.1.45}
TY - JOUR
AU - Kyungsuk Choi
TI - Ethical and Legal Problems of Randomized Clinical Trials
JO - Korean Journal of Medical Ethics
PY - 2008
VL - 11
IS - 1
PB - The Korean Society For Medical Ethics
SP - 45
EP - 62
SN - 2005-8284
AB - Human experimentation can be ethically justified when subjects participate on a voluntary basis. Informed consent is required for clinical trials, including randomized clinical trials. Nevertheless, ethical issues arise when subjects are randomly distributed to experimental and control groups in randomized clinical trials. I argue that equipoise as well as informed consent is a condition of randomized clinical trials. Benjamin Freedman distinguishes theoretical equipoise from clinical equipoise. I call the former the “individual physician equipoise” and the latter the “clinical community equipoise.” Under clinical community equipoise, randomized clinical trials are ethically justified because physicians may still provide the best treatment to their patients. The above ethical principle should be applied to placebo-controlled randomized clinical trials. When experimental drugs and placebos are in clinical community equipoise, a trial may be ethically justified. In addition, placebo-controlled randomized clinical trials should be designed with double-blinding. The reason for this requirement is that physicians would cheat their patients without double-blinding. Current FDA regulations in Korea and the US do not sufficiently reflect the above ethical points. Institutional review boards should review their protocols in light of these ethical points. In particular, IRB regulations should reflect the basic ideas of equipoise in randomized clinical trials and double-blinding in placebo-controlled randomized clinical trials.
KW - randomized clinical trial;placebo-controlled trial;informed consent;clinical equipoise;double-blinding;Helsinki Declaration
DO - 10.35301/ksme.2008.11.1.45
ER -
Kyungsuk Choi. (2008). Ethical and Legal Problems of Randomized Clinical Trials. Korean Journal of Medical Ethics , 11(1), 45-62.
Kyungsuk Choi. 2008, "Ethical and Legal Problems of Randomized Clinical Trials", Korean Journal of Medical Ethics , vol.11, no.1 pp.45-62. Available from: doi:10.35301/ksme.2008.11.1.45
Kyungsuk Choi "Ethical and Legal Problems of Randomized Clinical Trials" Korean Journal of Medical Ethics 11.1 pp.45-62 (2008) : 45.
Kyungsuk Choi. Ethical and Legal Problems of Randomized Clinical Trials. 2008; 11(1), 45-62. Available from: doi:10.35301/ksme.2008.11.1.45
Kyungsuk Choi. "Ethical and Legal Problems of Randomized Clinical Trials" Korean Journal of Medical Ethics 11, no.1 (2008) : 45-62.doi: 10.35301/ksme.2008.11.1.45
Kyungsuk Choi. Ethical and Legal Problems of Randomized Clinical Trials. Korean Journal of Medical Ethics , 11(1), 45-62. doi: 10.35301/ksme.2008.11.1.45
Kyungsuk Choi. Ethical and Legal Problems of Randomized Clinical Trials. Korean Journal of Medical Ethics . 2008; 11(1) 45-62. doi: 10.35301/ksme.2008.11.1.45
Kyungsuk Choi. Ethical and Legal Problems of Randomized Clinical Trials. 2008; 11(1), 45-62. Available from: doi:10.35301/ksme.2008.11.1.45
Kyungsuk Choi. "Ethical and Legal Problems of Randomized Clinical Trials" Korean Journal of Medical Ethics 11, no.1 (2008) : 45-62.doi: 10.35301/ksme.2008.11.1.45
