意得辑资源_出版道德规范_知情同意

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如果你提交的稿件未获得书面知情同意或机构审查委员会的批准,则稿件将被拒绝。

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意得辑资源_出版道德规范_知情同意

  1. 1. 知情同意 Helping you get published
  2. 2. 知情同意你完成了一项关于非洲艾滋病流行病学的研究并认为有必要使读者对你的研究患者的状况有更好地了解。基于此目的,你你在论文中添加了一幅你在现场工作时拍摄的照片 – 一位正在微笑的小男孩(并附有其所患疾病的注释)。这样做有什么错误吗?
  3. 3. 知情同意这篇论文于1998年4月发表在《加拿大医学协会期刊》(CMAJ)。1论文招致了一位读者的强烈批评2 ,他质疑男孩的父母或监护人是否已书面同意发表此照片(及这种发表行 你知道吗?为是否违反保密性规定)。他进而质疑这种 “知情同意”是在臭名昭著的希违规行为是否是出于科学目的。最后, 特勒政权下的“纳粹医生”所实CMAJ的总编辑发表了公开声明,就“在未 施的残忍暴行后所提出的一个研获得同意的情况下,即草率地发表关于患者 究和发表的道德问题。4病情的信息和患者照片” 3 的行为表示了道歉。
  4. 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 beinformed 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 thespecific 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
  5. 5. 知情同意在包括人类参与者的研究中,书面知情同意书非常重要,其原因如下6:1. 这些文件可作为参与者希望了解(即使在同意参与研究后)的有关详细信息的永 久性记录(例如:参与者希望退出研究时的联系人)。2. 这种文件中的信息非常详细(例如:电话和传真号)而且不能通过与参与者对话 进行有效地表达。3. 道德委员会或机构审查委员会可能不具备相关资源来监督通过对话寻求参与者同 意。因此,书面知情同意通常是研究获得这类机构道德批准的基本途径。
  6. 6. 知情同意4. 知情同意书可作为法律文件,在与研究有关的诉讼中,任何一方都可将其用作证 据。5. 如果参与者知道研究者遵守相关的道德规范,他们就更容易相信研究者,这样就 会带来长期的利益。“简而言之,如果我们不能保证研究的整体完美性—尤其是 患者的安全—将会失去公众对基因治疗和其它救治疗法的支持。志愿者将不会志 愿参与研究。” 76. 希望以后使用参与者数据(例如:进行后续研究)的研究者可使用这些文件获得 参与者的详细联系信息。
  7. 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 Identifying information, including names, initials, or hospital numbers, should not be published in written descriptions, photographs, or pedigrees unless the information is essential for scientific purposes and the patient (or parent or guardian) gives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
  8. 8. 知情同意另外,很多公认的期刊将未获得知情同意书视为拒绝稿件的充分理由。例如,《美国精神病学杂志》在其作者指南中规定:“如果你提交的稿件未获得书面知情同意或机构审查委员会的批准,则稿件将被拒绝。”10其它期刊如《美国医学会期刊》规定,论文的方法部分必须包括相关机构审查委员会或道德委员会的正式评审/弃权声明。11总而言之,获得并提供书面同意书是研究和论文的关键因素。这样做可确立你作为一名科研人员和作者的诚信度。今天,期刊编辑“在不能绝对保证匿名或未获得书面知情同意的情况,将不会发表你的论文,不管论文具有多高的科学或教育价值。” 2
  9. 9. 知情同意资源赫尔辛基宣言 关于由人类参与的医学研 http://www.wma.net/en/ 究的道德准则声明 30publications/10policies/b3 /17c.pdf生物医学期刊投稿统一 关于对提交给生物医学期 http://www.icmje.org/要求 刊的论文的道德要求指南美国心理学协会出版手 对研究参与者的权利和保 http://www.apa.org/册,第六版 密性进行了详细规定,尤 pubs/books/4200066.aspx 其针对行为科学。
  10. 10. 知情同意资源科学编辑委员会关于提 不正确处理研究主题的行为 http://www.councilscienceed倡科学期刊出版诚信的 示例。 itors白皮书 .org/i4apages/index.cfm? pageid=3360美国医学会文体手册 规定了在撰写医学期刊论文 http://www.amamanualofstyl 时应遵守的道德和法律要求 e 指南。 .com/oso/public/index.html
  11. 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.pdf2.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.pdf3.Hoey, J. (1998). Patient consent for publication—an apology. Canadian Medical Association Journal,159(5). 503–504. Availableathttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC1229651/pdf/cmaj_159_5_503.pdf4.Pedron, J. A., & Pimple, K. D. (2001). A Brief Introduction to Informed Consent in Research withHuman Subjects. Available at http://poynter.indiana.edu/sas/res/ic.pdf5.59th WMA General Assembly, Seoul. (2008). World Medical Association Declaration Of Helsinki:Ethical Principles for Medical Research Involving Human Subjects. Availableathttp://www.wma.net/en/30publications/10policies/b3/17c.pdf6.Resnik, D. B. (2009). Do informed consent documents matter? Contemporary Clinical Trials, 30(2).114–114. doi: 10.1016/j.cct.2008.10.004. Availableat http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2670580/
  12. 12. 知情同意参考文献7.Shalala, D. (2000). Protecting research subjects—what must be done. New England Journal ofMedicine, 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=10969.International Committee of Medical Journal Editors. Uniform Requirements for ManuscriptsSubmitted to Biomedical Journals: Ethical Considerations in the Conduct and Reporting of Research:Privacy and Confidentiality. Available at http://www.icmje.org/ethical_5privacy.html10.The American Journal of Psychiatry. Guidelines For Authors On Preparing Manuscripts. Availableathttp://ajp.psychiatryonline.org/misc/ifora.dtl11.Journal of the American Medical Association. Instructions for Authors. Available at http://jama.ama-assn.org/site/misc/ifora.xhtml#EthicalApprovalofStudiesandInformedConsent12.Levine, S. B., & Stagno, S. J. (2001). Informed consent for case reports: The ethical dilemma of rightto 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
  13. 13. 意得辑官方网站www.editage.cn

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