Saxena from the WHO, Ethics department, also supported. The system must be encrypted and ensure that only the responsible for the research is accessing that data. Any access to the platforms is a breach of privacy and violation of the rights of research subjects. These digital platforms exist in hospitals, schools, research institutions and many others. Rationale: Every day, more patients’ data is being stored on digital platforms. (Consideration of social media is applicable to digital platform use). This information must be encrypted to ensure the privacy of the research subjects and only available to the responsible of the study. Special attention must be given to the storage of personal information on digital platforms. IFMSA representing a younger voice in the room brought attention to an area that was not explicitly stated in the section of Confidentiality, Privacy and Consent: Otmar Kloiber stated a strong position about open access to research and that all findings should be reported and made available–the outcomes and the lack of outcomes. As well, as whether the document should have greater flexibility or whether the document should be “stricter”-with requiring specific recommendations to be “must” versus “should.” Other hot points were on reporting of research trials–content of the reporting and making it mandatory. Other areas that continued to spark controversial debate included the use of “placebo” in trial and justification of such usage. Interestingly, consensus was reached on many areas of the draft document, but a fundamental debate existed about whether the declaration should be aspirational or should strive to be more pragmatic, similarly, there was clear notion that double standards should not exist in research practices around the globe. There was significant input from the U.S., Germany, United Kingdom, Brazil and Japan constituencies-as well as engagement from WHO and PAHO, and academics on both content and the specific language. Once adopted the Declaration of Helsinki at the next WMA GA will set the new standards of medical research around the globe. on August 26 th 2013 hosted by the American Medical Association (AMA) at the Jay Adams Historical Hotel-where stakeholders discussed key aspects of this document. IFMSA had the opportunity to participate in the final consultation in Washington D.C. The comments received during the pubic consultation process may be viewed at the following link: Click here to view DoH Public consultation 2013_submissions. It was first adopted at the 18 th WMA General Assembly, Helsinki, Finland, June 1964 and last revised at the 59 th WMA General Assembly, Seoul, October 2008. The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.
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