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Validity Assessment System for Implementing Genetic Testing into Clinical Practice or Public Healthcare
  • 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

1. Evidence-based Literature Review
  • The first step in examining the validity of implementing genetic testing into clinical practice or public health care begins with securing scientific evidence. The scientific evidence here refers to specifying the relevance of genes to disease to a particular gene and reviewing published papers on genetic testing subject to analytical accuracy evaluation. The literature reviewed at this time is conducted mainly on systematic reviews or meta-analysis papers corresponding to the first level of evidence in the literature presented by the Scottish Intercollegiate Guidelines Network (GN).
  • If there are no systematic literature reviews or meta-analysis papers currently published, evidence-based medical experts and genetic testing experts should be appointed to evaluate the quality of the literature.
  • Only the literature evaluated as high quality are selected, and meta-analysis is conducted again. In South Korea, the Health Technology Assessment project group of the Health Insurance Review and Assessment Service (HIRA) has already applied the systematic EBM methodology, such as the quality evaluation of literature, to the Health Technology Assessment project. Hence it is possible to consider linking them together.
2. Drafting a Primary Opinion on the Validity Review of Clinical Practice or Public Health Care Implementation
  • Defining disease-genetic relationship and specific implementation
  • Review of clinical validity results obtained through the evidence-based literature review process
  • Analytical validity
  • Recommendations or guidelines for specific genetic testing published at the level of domestic and international government agencies, organizations, or professional societies
  • The first opinion of the KIGTE

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.

3. Collecting Opinions of Professional Societies

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.

4. Drafting a Secondary Opinion on the Validity Review of Clinical Practice or Public Health Care Implementation

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.

5. Listening to the Opinions of Ethics and Civic Groups

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.

6. Debate and Public Hearings

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 .

7. Confirmation of Final Opinion by the KIGTE and Drafting of the Report

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.