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《赫尔辛基宣言——下一版》

[Helsinki Declaration--next version].

作者信息

Czarkowski Marek

出版信息

Pol Merkur Lekarski. 2014 May;36(215):295-7.

Abstract

Authors of the new version of The Helsinki Declaration reorganized the document, and for the first time, included the issue of compensation and treatment for participants who are harmed as a result of participating in research, they provided unified and better protection for vulnerable groups, and more precisely described requirements for post-study arrangements and the use of placebos. Despite this, more consideration should be taken regarding research on human biological material and data, because the new version of The Helsinki Declaration still does not provide an acceptable level of protection for the rights and interests of donors of human biological materials. Although the new version of The Helsinki Declaration confirmed that when using identifiable human materials and data in medical research, informed consent must be obtained for its use and reuse, the obligation for the assessment of each project of medical research using human biological materials (identifiable and unidentifiable) by Research Ethics Committees was not implemented. Anonymisation is not an ethically neutral procedure. Moreover, the Helsinki Declaration does not explain the meaning of the term "anonymisation," which means that the criteria for the procedure might be provided by local stakeholders and because of this, these criteria may push into ethically unacceptable ranges.

摘要

《赫尔辛基宣言》新版本的作者对该文件进行了重新组织,首次纳入了对因参与研究而受到伤害的参与者的补偿和治疗问题,为弱势群体提供了统一且更好的保护,并更精确地描述了研究后安排及安慰剂使用的要求。尽管如此,对于人类生物材料和数据的研究仍应给予更多考量,因为《赫尔辛基宣言》新版本仍未为人类生物材料捐赠者的权益提供可接受水平的保护。虽然《赫尔辛基宣言》新版本确认在医学研究中使用可识别的人类材料和数据时,必须就其使用和再利用获得知情同意,但研究伦理委员会对使用人类生物材料(可识别和不可识别)的每项医学研究项目进行评估的义务并未得到落实。匿名化并非一个伦理中立的程序。此外,《赫尔辛基宣言》并未解释“匿名化”一词的含义,这意味着该程序的标准可能由当地利益相关者提供,因此,这些标准可能会陷入伦理上不可接受的范围。

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