Journal of Sasang Constitutional Medicine (사상체질의학회지)

The Society Of Sasang Constitutional Medicine (사상체질의학회)
권호 표지
DOI QR코드

DOI QR Code

A Study on Constitutional Medicine Researchers' View and Attitude Concerning Human Research Ethics

체질의학임상연구자들의 임상연구 윤리에 대한 인식 및 태도 조사

  • Received : 2011.11.02
  • Accepted : 2011.12.05
  • Published : 2011.12.31
Download PDF
⟨ Previous Next ⟩

Abstract

1. Objectives This study aims to find out identify the recognition and attitude about the research ethic among Constitutional medicine researchers. 2. Methods This survey was conducted to the 37 researchers who were currently participating in Korea Constitution Multicenter Study guided by Korea institute of Oriental medicine(KIOM). The survey consist of 4 parts that level of acknowledgment about the systems and laws on clinical research ethic, clinical research experiences and education, the level of acknowledgment about Institutional Review Board(IRB) and the recognition about overall research ethic. 3. Results Thirty one questionnaires were collected. Most researchers had low level of acknowledgment about the guidelines of basic research ethic. It was proved that more than 65% of the respondents have never received education for clinical research ethic. Moreover, 70% of them felt the need for education of clinical research ethic. In addition, most of the respondents recognized the fact that IRB is responsible for ethically implementing clinical research. 39% of the researchers thought that they themselves have a firm ethical viewpoint, while the rest of the group showed somewhat difficulty on their own ethical implementation of clinical research. 4. Conclusions Most of researcher had partial awareness of regulations and laws on clinical research ethic. And Educational needs of research ethic was high. Therefore education and Public Relations need to be done to extend research ethic. Moreover, standardized course of education on research ethic should be developed and activated.

Keywords

References

  1. Jeong IS, Shoh JH, Shin JG. Evaluating the quality of informed consent in clinical research. Korean J med ethics 2010;13(1):43-58(Korean).
  2. The Nuremberg Code. Nuremberg Military Tribunal. 1947.
  3. World Medical Association Declaration of Helsinki :Ethical Principles for Medical Research Involving Human Subjects. 2000. Available from: URL: http://www.wma.net/e/policy/b3.htm.
  4. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. The National Commission for the Protection of Human Subjects of Biomedical and Behaviral Research April 18, 1979. Avaiable from: URL:http://www.hhs.gov/ohrp/humansubjects/ guidance/belmont.htm.
  5. ICH-GCP. Guidelines for Goodl Clinical Practice for Trials on Pharmaceutical Products. World Health Organization. 1995.
  6. 약사법 시행규칙 별표 3의 2. 의약품 임상시험 관리기준(제32조 관련). 2011.5.6.
  7. 생명윤리 및 안전에 관한 법률. 2011.4.28.
  8. 식품의약품안전청. 임상시험 윤리기준의 이해. 2005.
  9. 식품의약품안전청. 임상시험 정책방향. 2011. Available from: URL:http://clinicaltrials.kfda.go.kr/info/ morgue/board_list.jsp.
  10. Han SH, Yim DS. Current state of clinical trials in Korea. J Korean Med Assoc. 2010. 53(9):745-752 (Korean). https://doi.org/10.5124/jkma.2010.53.9.745
  11. Lim IA. Rha SY. Clinical trials and ethics. J Korea med assoc. 2010.53(9): 774-779(Korean). https://doi.org/10.5124/jkma.2010.53.9.774
  12. Jeong IS, Gu MO, Kim KS, Lee KJ, Yang S. Educational needs assessment on research Ethics among Nursion Researchers. J Korean Acad Nurs. 2010;40(4):515-523(Korean). https://doi.org/10.4040/jkan.2010.40.4.515
  13. Kim JS. An investigation into the IRB members' and investigators' perceptions of institutions of review boards. Yonsei University: Graduate school of public health. 2006.(Korean).
  14. Han SS, Ahn SH, Ku IH, Lee MS.The Development of a Research Ethics Education Program: Experiences, Current Situation, and the Need for Research Ethics Education. Korean J Med Ethics Educ 2007;10(1): 83-98.(Korean).
  15. Kang EH, Kim EA, Kwon I, Cho EH. Opinions and Suggestions of Biological Scientists on Research Ethics Education. Korean J Med Ethics Educ 2006;9(2):187-202.(Korean).
  16. Son SY. A study of researcher's view and attitudes concerning human research ethics. Korea university: Graduate school of public health. 2010.(Korean).
  17. Kim HC, Choi KS. Laws and ethics of Clinical Trial. Seoul:Ewha Institute for Biomedical Law & Ethics. 2007.(Korean).
  18. Choi KS. bioethics and Research ethics. Kor J Thinking and Expression. 2009;2(1)173-201(Korean).
  19. Park BJ, Kim OJ, Lee SM, Sohn DR, Shin SG. The current problems and proposed solutions for Institutional Review Board in Korea. Kor J Clin Pharmacol Ther 2004;12(2):137-146 (Korean).
  20. Son WC. Analysis of current research ethics education in Korean Universities. Seoul:Center for Education Research. 2007:143-183(Korean).
  21. Shin HY. The Characteristics of the Western Institutional Review Board. J Korea Bioethics Assoc. 2007;8(1):61-66(Korean)
  22. Back SJ, Kwon I. A study on improving institutional Bioethics Review Board by comparison of Institutional Review Board. Ewha institute for biomedical law and ethics. 2007;1(2):141-156(Korean).