[Helsinki Declaration--next version]

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.