Literature review for securing scientific evidence
Drafting a primary opinion on the validity review of clinical practice or public health care implementation
Collecting opinions from multiple professional societies on the clinical practicality
Drafting a secondary opinion on the validity review of clinical practice or public health care implementation
Listening to the opinions of ethics and civic groups on ethical, legal, and social impacts
Debate or public hearing
Final drafting and reporting on the validity report for the implementation of clinical practice or public health care
Professional societies that are judged to have interests with specific genes are selected through meetings. The professional societies should include clinical practice professional societies that are considered to be closely related to a specific gene, preventive activity professional societies associated with prediction or health diagnosis, and societies specializing in clinical examinations.
This is the process of collecting opinions on the clinical practicality of specific genetic testing to the clinical treatment, preventive activities, and societies specializing in examinations selected at the first meeting of the KIGTE.
This is the process of integrating the clinical validity opinions obtained from multiple professional societies into the primary opinion based on the analytical and scientific validity that have already been compiled. Regarding clinical validity, it is possible to draw conflicting opinions on practicality depending on each professional society's position. Therefore, collecting opinions should be carried out by discussing the adequacy assessment committee of the KIGTE and an advisory council meeting of experts.
The second opinion of KIGTE is prepared when this process is complete.
Listening to the opinions from ethics and civic groups on specific genetic testing. The information expected to be obtained in this process are predictions of expected problems in terms of ethical and legal aspects of a specific genetic test and socio-cultural impacts.
This is the process of integrating the clinical validity opinions obtained from multiple professional societies into the primary opinion based on the analytical and scientific validity that have already been compiled. Regarding clinical validity, it is possible to draw conflicting opinions on usefulness depending on each professional society's position. Therefore, collecting opinions should be carried out through debates of the adequacy assessment committee of the KIGTE and an advisory council meeting of experts.
After the completion of this process, the secondary opinion of KIGTE is drafted .
The final report on the validity of clinical practice and public health care applications for specific genes prepared by the KIGTE is submitted to the Minister of Health and Welfare.
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