Work within Legal and Ethical Framework
Given the privacy of individuals, the transfer of exclusively anonymized data seems to be a practical solution. However, anonymization terminates the ability to link records to new records or contact participants again. In addition, some argue that full anonymization is impossible as long as the original documents still exist [2, 50], raising concerns about possible data misuse and invasion of privacy. This work shows that the transmission of anonymised data is perhaps no less strictly regulated. The authors thank ICN for promoting and supporting this project. In particular, authors Maria De Medina Redondo, Yann Reydelet and Anja Eskat of the Clinical Trials Center of the University Hospital Zurich; Harriet Hudd of the Karolinska Trial Alliance; Mohammed Lamorde and Andrew Kambugu of the Kampala Institute of Infectious Diseases; paralegal Surinder Kaur of the Singapore Clinical Research Institute; Lawyer Jill Niu and managers Shu-Ting Chuang, Chin-Ting Hsu, Cheng-Li Lin, Chung-Hsuan Yang, Yu-Wen Chen, Feng-Shuo Pai, I-Hsuan Chiang of the Clinical Trials Center of China Medical University Hospital and Taiwan Center for Drug Evaluation for supporting the data collection and realization of this manuscript. Work role contexts may include, but are not limited to: The heterogeneous nature and complexity of multiple diseases and the deep characterization of individuals have led to the rapid development of personalized medicine. Access to large amounts of health data is the next challenge for this medical model . When the data available in a country may not be sufficient to effectively develop new pharmacogenetic treatment strategies and algorithms to diagnose patients, EHR represents a formidable resource for achieving the validity of results and increasing the impact of research. However, the lack of a uniform ethical and legal environment is an obstacle for the scientific community [2, 12].
This study shows that researchers are currently working in a very complex legal and ethical landscape. Regulations vary from country to country or region and are often incomplete, leading to uncertainty. There are also differences between regulations within a country. In Turkey, for example, while data protection law allows the use of unencrypted data with subjects` consent, sub-regulations restrict the use of unencrypted health data. In addition, rapid regulatory change over time makes it difficult for researchers to keep abreast of the latest regulations in all jurisdictions. There is an unmet need for an accessible resource that provides information on country-specific ESN requirements. Nevertheless, the complexity of this field means that, in many cases, researchers still need the advice of experienced professionals . This could be facilitated by international networks of research institutions such as the ICN. Sariyar M, Schluender I, Smee C, Suhr S. Sharing and reusing sensitive data and samples: helping researchers identify ethical and legal requirements. Biopreservation Biobank. 2015;13(4):263–70.
doi.org/10.1089/bio.2015.0014. Some suggest that ethical action is the one that best protects and respects the moral rights of those affected. This approach is based on the conviction that man has a dignity based on his human nature in himself or on his ability to freely choose what he does with his life. On the basis of this dignity, they have the right to be treated as an end in itself and not only as a means to other ends. The list of moral rights – including the right to make one`s own decisions about what kind of life to lead, to be told the truth, not to be harmed, to some extent of privacy, etc. – is widely debated; Some argue that non-humans also have rights. Rights are often understood as duties – especially the duty to respect the rights and dignity of others. 52 Reporting service providers must report any allegations or suspicions of physical or sexual assault against ACAF residents to police and the Ministry of Health and Aging. With this work, the ICN highlights the unmet need for a single framework for international cooperation to facilitate ESN. Harmonizing requirements for global EDNs will reduce inefficiency and waste in research. Achieving this ambitious vision poses many challenges, including inconsistent terminology and definitions, as well as heterogeneous and dynamic legal constraints.
Here we identify areas of agreement and significant differences as a necessary first step to facilitate international cooperation.