Browse > Article

Study on the Perception of Informed Consent for Elderly Subjects Participated in Oriental Medicine Clinical Trials  

Kim, Yun-Young (Korea Institute of Oriental Medicine)
Kwon, Ji-Hye (Korea Institute of Oriental Medicine)
Lee, Si-Woo (Korea Institute of Oriental Medicine)
Kim, Ho-Suk (Korea Institute of Oriental Medicine)
Yoo, Jong-Hyang (Korea Institute of Oriental Medicine)
Publication Information
Journal of Physiology & Pathology in Korean Medicine / v.26, no.2, 2012 , pp. 248-252 More about this Journal
Abstract
This study aimed to evaluate the perception of informed consent for subjects who are participated in oriental medicine clinical trials and over 60 years old. In this research, 215 subjects who were participated in clinical trials were surveyed between Apr. 13, 2011 and Jul. 20, 2011. And the collected data was analyzed with computer software of SPSS 17.0. In the case of objective perception, almost all of subjects answered that they have ever heard of the consent form. However, 50.7 points were collected for the question of "As I already signed the consent form, I have to participate in the clinical trials", which showed the subjects had misperception about quitting the clinical trials. In the case of subjective perception, subjects well knew that the purpose of clinical trial is research, not medical treatment. However, the perception about the purpose of clinical trials that they are participated in was low. In the both cases of objective and subjective perception with general characteristics, they showed differences (p<0.045) with the marital status of subjects, however other categories did not show any difference. In conclusion, researchers should provide sufficient explanation as well as adequate Information in order to protect the personality of subjects, so that the subjects can make a right decision.
Keywords
Oriental Medicine Clinical Trial; informed consent; perception; Elderly Subjects;
Citations & Related Records
연도 인용수 순위
  • Reference
1 신희영. 피험자 동의의 개선방안. 대한임상약리학회지 16(1):13-20, 2008.
2 문한림, 김훈교, 이경식, 강봉규, 송혜향. 임상시험과 피험자 동의서에 대한 인식조사 - 암환자와 가족을 대상으로 -. 대한임상약리학회지 3(2):141-153, 1995.
3 홍소연. 의료행위에서의 간섭주의의 정당화. 석당논총. 33: 199-224, 2003.
4 National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report : Ethical principles and guidelines for the protection of human subjects of research. 1979.
5 맹광호. 의료 및 생명과학연구와 '동의'에 관한 국제사회 논의 동향 - 유네스코 국제생명윤리위원회 활동을 중심으로 -. 한국의료윤리교육학회지 10(1):1-8, 2007.
6 문한림, 김훈교. 임상시험을 위한 피험자 동의서에 관한 인식 조사 - 암 환자를 진료하는 의료인을 대상으로 -. 8(2):202-212, 2000.
7 김양희. 암 임상연구에 참여하는 환자들의 피험자 동의서에 관한 인식조사. 연세대학교 보건대학원. 2008.
8 정인숙, 손지홍, 신재국. 임상연구에서 피험자 서면동의의 질평가. 한국의료윤리학회지 13(1):43-58, 2010.
9 Joffe, S., Cook, E.F., Cleary, P.D., et al. Quality of informed consent in cancer clinical trials: a cross-sectional survey. Lancet. 358: 1772-1777, 2001.   DOI   ScienceOn
10 의약품 임상시험 관리기준(Korea Good Clinical Practices). 식품의약품안전청. 2010.
11 김옥주. 생명과학연구자들을 위한 인간 대상 연구 윤리. 서울 대학교 의과대학. 2007.
12 International Conference on Harmonization(ICH). Good Clinical Practice: Consolidated Guideline. 1996.
13 최경석. 무작위 임상시험의 윤리적, 법적 문제. 한국의료윤리교육학회지 11(1):45-62, 2008.
14 Fallowfield, L.J., Jenkins, V., Brennan, C., Sawtell, M., Moynihan, C., Souhami, S.L. Attitudes of parients to randomised clinical trials of cancer therapy. European Journal of Cancer. 34(10):1554-1559, 1998.   DOI   ScienceOn
15 안명숙, 민혜숙. 사전동의에 대한 의사, 간호사 및 환자의 인식과 경험. 임상간호연구. 14(2):59-70, 2008.
16 Flory, J., Emanuel, E. Interventions to improve research participants' understanding in informed consent for research. JAMA. 292: 1593-1601, 2004.   DOI   ScienceOn