4. 道德指引
In medical research involving competent human subjects, each potential subject
must be adequately informed of the aims, methods, sources of funding, any
possible conflicts of interest, institutional affiliations of the researcher, the
anticipated benefits and potential risks of the study and the discomfort it may
entail, and any other relevant aspects of the study. The potential subject must be
informed of the right to refuse to participate in the study or to withdraw consent to
participate at any time without reprisal. Special attention should be given to the
specific information needs of individual potential subjects as well as to the methods
used to deliver the information. After ensuring that the potential subject has
understood the information, the physician or another appropriately qualified
individual must then seek the potential subject’s freely-given informed consent,
preferably in writing.- Declaration of Helsinki5
7. 知情同意
在研究开始时未获得知情同意可能会导致高昂的代价。例如：在美国的一个案例，由于
未获得知情同意，五百多万份血样不得不销毁。8
道德指引
Patients have a right to privacy that should not be violated without informed
consent. Identifying information, including names, initials, or hospital numbers,
should not be published in written descriptions, photographs, or pedigrees unless
the information is essential for scientific purposes and the patient (or parent or
guardian) gives written informed consent for publication. Informed consent for this
purpose requires that an identifiable patient be shown the manuscript to be
published.- Uniform Requirements for Manuscripts Submitted to Biomedical
Journals9
11. 知情同意
参考文献
1.Rasid, M. (1998). AIDS in Africa: A personal experience. Canadian Medical Association Journal, 158(8).
1051–1053. Available at http://ukpmc.ac.uk/articles/PMC1229229/pdf/cmaj_158_8_1051.pdf
2.Barnes, R. (1998). Confidentiality in medical publishing. Canadian Medical Association Journal, 159(5).
443. Available at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1229634/pdf/cmaj_159_5_443.pdf
3.Hoey, J. (1998). Patient consent for publication—an apology. Canadian Medical Association Journal,
159(5). 503–504. Available
athttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC1229651/pdf/cmaj_159_5_503.pdf
4.Pedron, J. A., & Pimple, K. D. (2001). A Brief Introduction to Informed Consent in Research with
Human Subjects. Available at http://poynter.indiana.edu/sas/res/ic.pdf
5.59th WMA General Assembly, Seoul. (2008). World Medical Association Declaration Of Helsinki:
Ethical Principles for Medical Research Involving Human Subjects. Available
athttp://www.wma.net/en/30publications/10policies/b3/17c.pdf
6.Resnik, D. B. (2009). Do informed consent documents matter? Contemporary Clinical Trials, 30(2).
114–114. doi: 10.1016/j.cct.2008.10.004. Available
at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2670580/
12. 知情同意
参考文献
7.Shalala, D. (2000). Protecting research subjects—what must be done. New England Journal of
Medicine, 343(11) 808–810.
8.Akst, J. (2009). Consent issues nix blood samples. The Scientist. Available at http://classic.the-
scientist.com/blog/display/56230/%20and%20http://www.texascivilrightsproject.org/?p=1096
9.International Committee of Medical Journal Editors. Uniform Requirements for Manuscripts
Submitted to Biomedical Journals: Ethical Considerations in the Conduct and Reporting of Research:
Privacy and Confidentiality. Available at http://www.icmje.org/ethical_5privacy.html
10.The American Journal of Psychiatry. Guidelines For Authors On Preparing Manuscripts. Available
athttp://ajp.psychiatryonline.org/misc/ifora.dtl
11.Journal of the American Medical Association. Instructions for Authors. Available at http://jama.ama-
assn.org/site/misc/ifora.xhtml#EthicalApprovalofStudiesandInformedConsent
12.Levine, S. B., & Stagno, S. J. (2001). Informed consent for case reports: The ethical dilemma of right
to privacy versus pedagogical freedom. Journal of Psychotherapy Practice and Research, 10. 193–201.
Available at http://jppr.psychiatryonline.org/cgi/content/full/10/3/193
