@article{oai:repo.qst.go.jp:00056034,
 author = {栗原, 千絵子 and 齊尾武郎 and 栗原 千絵子},
 issue = {2},
 journal = {臨床評価},
 month = {Jan},
 note = {Purpose：To provide an explanatory overview of the draft revision of International Ethical Guidelines for
Biomedical Research Involving Human Subjects submitted by the CIOMS (Council for International
Organizations of Medical Science) for public consultation from September 2015 to March 1, 2016.
Methods：Narrative, non-systematic review of literature on research ethics.
Results：We identified nine topics where major changes were proposed in the draft: (1) social value of
research; (2) choice of control in clinical trials; (3) biobank and data archive; (4) treatment and
compensation for research-related harms; (5) research in disaster situations; (6) implementation research;
(7) use of online information; (8) research ethics committees and review; and (9) public accountability.
Discussion and Conclusion：Though logical constructions and ethical considerations of this proposed
draft are still premature, there are significant changes worth noting. These changes shall provide the
ethical foundation for research aiming at global health, focusing on critical issues of public health, such as
an Ebola outbreak; earthquakes; tsunamis; and military conflicts, as well as research using new
technologies for the analysis of large amounts of data or whole genome sequence. Most importantly,
CIOMS argues that ethical justification of health-related research involving human subjects is derived from
its social value, which must be generated only from scientifically valid research; and that placebo control is
ethically acceptable when it does not cause more than a minor increase above minimal risk. Both of these
arguments are in marked contrast to the 2013 version of the Declaration of Helsinki as CIOMS raises the
ante of science and ethics as well as requiring researchers to balance science and ethics, involving a more
difficult trade off.},
 pages = {613--28},
 title = {CIOMS生物医学研究指針の改訂 ─ グローバル・ヘルスと研究の価値 ─},
 volume = {43},
 year = {2016}
}