Legal and Ethical Regulation of Reporting of Secondary Findings
https://doi.org/10.17803/lexgen-2024-3-3-74-92
Abstract
In medical literature the notion of secondary findings is defined as randomly discovered features of human health which may af fect their well-being. A large number of secondary findings are occasionally detected and may be disclosed to the patient as a result of the digitalization of healthcare and the development of medical databases. The aim of this paper is to determine the possibility of reporting secondary findings to patients and participants of scientific research, while also establishing a procedure for transferring such data in accordance with the legal requirements and limitations. The article provides an analysis of Russian legislation, and considers doctrinal and ethical approaches to the issue of reporting of secondary findings. The author concludes that the current legislation does not consider the special features of secondary findings, and does not address situations which could arise in the context of scientific research. The author has established that informed consent has an important role in reporting of secondary findings, while the procedure of informing patients and including special sections in the consent should remain at the discretion of the medical or scientific organization or the doctor. In conclusion, the author attempts to formulate proposals to amend the Russian legislation in relation to the issue considered.
Supporting agencies: supported by the Ministry of Education and Science of the Russian Federation. Registry number – 730000Ф.99.1.БВ16АА01000. Topic (goal) – scientific and methodological support for work on legal regulation of accelerated development of genetic technologies.
About the Author
E. K. Moskovkina
LLC “Biotech campus”
Russian Federation
Russian Federation
Elizaveta K. Moskovkina, the Head of the Legal Support Group
Moscow
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Review
For citations:
Moskovkina E.K. Legal and Ethical Regulation of Reporting of Secondary Findings. Lex Genetica. 2024;3(3):74-92. (In Russ.) https://doi.org/10.17803/lexgen-2024-3-3-74-92
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