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최경석 ( Kyung Suk Choi ) 한국의료윤리학회 2008 한국의료윤리학회지 Vol.11 No.1
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 doubleblinding. 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.
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The Benefits of Colorectal Surgery Surveys in Australia and New Zealand
Auerilius Erastus Ricardo Hamilton,Amelia Alice Lin,Christopher John Young 대한대장항문학회 2020 Annals of Coloproctolgy Vol.36 No.2
Purpose: Pertaining to the Colorectal Surgery Society of Australia and New Zealand (CSSANZ) Executive and Research Support Committee, this study aimed to assess the usefulness and outcomes of surveys sent out by the society to its members. Methods: From 2009 to 2017, CSSANZ members received 38 surveys, most of which were distributed from within the society, and a few of which originated from other affiliated groups. Surveys were categorised by type, topics, times required for completion, delivery method, response rates, and advancement to publication. Results: Of 38 surveys, 20 (53%) were published and 18 remain unpublished. Four surveys were distributed annually on average, with 2.2 published annually on average, with a mean impact factor of 2.41 ± 1.55. Mean time to publication was 31 ± 17 months. Surveys contributed to 13 publications (34%). The most common survey topics were rectal cancer decision-making, in 6 publications (16%), preoperative assessment of colorectal patients, in 5 publications (13%), and anal physiology: continence and defaecation, in 4 publications (11%). Publication of surveys was not related to the number of surveys distributed per year, the number of questions per survey, or the time required by respondents to complete the surveys. Conclusion: Most of the CSSANZ-distributed surveys resulted in publications, and one third of the surveys contributed to higher degrees obtained by investigators. These surveys aid research into areas that are otherwise difficult to assess, often indicating areas for future research.
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