© The Author (2008). Published by Oxford University Press. All rights reserved
Editorial
The Ministry of Health, Labor and Welfare in Japan has revised the Guideline for Clinical Research on 31 July 2008 and this revised guideline will be valid from 1 April 2009. The guideline was originally released in July 2003 and this is the second revision. Because of rapid progress in clinical research and necessary adaptation to the new situation, main points of the second revision of the guideline are (i) procedures to obtain informed consent, (ii) necessity of compensation for health damage due to clinical research, (iii) procedures to report serious health issues of participants to the director of the institute, (iv) observance of appropriate standard operation procedure, (v) structure and function of Institutional Review Board (IRB) and (vi) preservation of living materials from donors.
Worldwide, multiple cases on ethical issues of clinical research have been reported, such as lack of publication of the conflict of interest regarding the fund from tobacco company for research on CT screening of lung cancer. There are other stories regarding publication of papers of clinical research conducted without obtaining informed consent.
JJCO has for the past few years spent efforts to implement a fair policy on conflict of interest. However, with the change in guidelines and a fast moving world of clinical research, issues still remain such as conflict of interest, informed consent and approval from IRB. Through helpful discussions with editors and reviewers and their proposals, I, as editor-in-chief, would like to further proceed how to handle submitted articles on clinical research in terms of ethics, conflict of interest, informed consent and IRB.
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