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  • Ethical Discrepancy between Observational and Experimental Methodologies in Research
  • Kenji Matsui (bio)
Kenji Matsui

Kenji Matsui is Associate Professor at the Center for Clinical Bioethics, which was established in December 2009 at the University of Toyama, Japan. Dr Matsui has also been Visiting Scholar at the Department of Health Science at Shiga University of Medical Science, Japan. His current research interests include the ethical analysis of risks involved in clinical research and the ethics of research on stored human samples.

Acknowledgements

I am grateful to Dr Reidar K. Lie and Dr Joseph Milium of the Department of Bioethics at the National Institutes of Health, USA, and my colleagues, Dr Shimon Tashiro and Dr Yusuke Inoue at the University of Tokyo, Japan, for their critical reviews and very helpful comments on the several draft versions of the paper. I also thank all participants of the Asian Bioethics Network Meeting Kyoto, Japan, held on 13-14 January 2010, for their very helpful discussions that helped develop the primitive idea of the paper. This study is partly supported by the Grants-in-Aid for Scientific Research (C) and (B) (no. 19602001 & 20390184) of Japan Society for the Promotion of Science, and is also partly funded by the research grant in 2010 from the Japan Medical Education Foundation. No conflict of interest is declared.

Notes

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2. Kass, N.E. (2001) An Ethics Framework for Public Health, American Journal of Public Health, 91, 1776-82; Levine, R.J., and S. Gorowitz, eds. (2000) Biomedical Research Ethics: Updating International Guidelines A Consultation, Council for International Organizations of Medical Sciences (CIOMS), Geneva.

3. Coughlin, S.S. (2006) Ethical issues in epidemiologic research and public health practice, Emerging Themes in Epidemiology, 3, 16, doi: 10.1186/1742-7622-3-16; Armenian, H.K. (2009) Epidemiology: a problem-solving journey, American Journal of Epidemiology, 169, 127-31.

4. Cuttini, M., and R. Saracci (2009) Commentary: Can we facilitate the ethical approval of international observational studies?, International Journal of Epidemiology, 38, 1108-9.

5. Op cit.

6. Bernard, C. (1957) An Introduction to the Study of Experimental Medicine, trans. H.C. Greene, Dover Publications, New York.

7. Op cit.

8. Op cit.

9. Rothman, K.J., S. Greenland, and T.L. Lash (2008) Types of Epidemiologic Studies. In Modern Epidemiology, third edition, eds. K.J. Rothman, S. Greenland, and T.L. Lash, Lippincott Williams & Wilkins, Philadelphia, PA.

10. Manolio, T.A. (2002) Design and Conduct of Observational Studies and Clinical Trials. In Principles and Practice of Clinical Research, ed. J.I. Gallin, Elsevier, San Diego, CA; Pickering, G. (1970) Clinical Research-3. In The World Health Organization (1969) Medical Research: Priorities and Responsibilities. Proceedings of a Round Table Conference organized by CIOMS with the assistance of WHO and UNESCO, Geneva.

11. Rothman, K.J. (2002) Epidemiology: An Introduction, Oxford University Press, New York.

12. Last, J.M. (1991) Epidemiology and ethics. In Ethics and Epidemiology: International Guidelines. Proceedings of the XXVth CIOMS Conference, Geneva, Switzerland 7-9 November 1990. Co-sponsored by the World Health Organization, eds. Z. Bankowski, J.H. Bryant, and J.M. Last, CIOMS, Geneva.

13. CIOMS (2009) International Ethical Guidelines for Epidemiological Studies, Geneva.

14. Cuttini, M. and R. Saracci (2009) Commentary: Can we Facilitate the Ethical Approval of International Observational Studies?, International Journal of Epidemiology, 38, 1108-9.

15. Keynes J.M. (1983) The General Theory of Employment. In The Collected Writings of John Maynard Keynes, Vol. 14, ed. D.E. Moggridge, MacMillan, London.

16. Allebeck, P. (2009) A New Helsinki Declaration — But What about Public Health Research?, European Journal of Public Health, 19, 129.

17. CIOMS (2009) International Ethical Guidelines for Epidemiological Studies, Geneva; CIOMS (1991) International Guidelines for Ethical Review of Epidemiological Studies, Geneva.

18. Rothman, K.J., S. Greenland, and T.L. Lash (2008) Types of Epidemiologic Studies. In Modern Epidemiology, third edition, eds. K.J. Rothman, S. Greenland, and T.L. Lash, Lippincott Williams & Wilkins, Philadelphia, PA.

19. Armenian, H...

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