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Table 2 Ethical-legal-social criteria and sub-criteria for genetic/genomic testing

From: Genetic/genomic testing: defining the parameters for ethical, legal and social implications (ELSI)

  Criteria Sub-criteria Reference
Ethical Patient rights Right to health 1, 3, 6, 8, 9
Free and informed consent 1, 2, 3, 4, 5, 6, 7, 8, 9
Knowing or not knowing results and implications 1, 2, 3, 4, 5, 7, 8
  Respect for privacy and confidentiality 1, 2, 3, 4, 5, 6, 7, 8, 9
  Respect for human dignity 1, 2, 4, 8, 9
Non-discrimination Avoid genetic reductionism 1, 2, 3, 4, 5, 8, 9
Genetic exceptionalism 1, 2, 4, 6
  Avoid stigmatization 1, 3, 4, 5, 6, 7, 8, 9
Legal Protection of the Information Actions to ensure the protection of biological samples, and all physical and electronic information 3, 4, 5, 6, 7, 9
Testing Circumstances of application 2, 3, 5, 6, 7, 8, 9
  Advantages, disadvantages and limitations 1, 3, 4, 5, 6, 9
Health regulation Qualified health personnel 2, 3, 5, 6, 7, 8
Surveillance 7, 8
  Medical-patient-company responsibility 3, 5, 7, 9
  Countries responsibility 1, 4, 6, 7, 9
  Analytical validity 4, 6, 7, 8, 9
  Validity and clinical utility 6, 7, 8, 9
  Laboratory accreditation 7, 8
Commercialization Direct-to-consumer testing 5, 6, 9
Medical tourism 7
  Advertising 6, 7, 9
  Cross-border business 4, 7, 9
Social Counseling Pre-clinical and post-results 1, 2, 3, 5, 6, 7, 8, 9
In clinic 1, 2, 3, 4, 5, 6, 7, 8, 9
Training Education and dissemination 1, 3, 4, 6, 7
Reporting of Results Concept of health and disease 3, 9
Communication of the risks 3, 4, 5, 7, 8, 9
Unexpected findings 3, 4, 5, 7, 8, 9
Accessibility Access to services under the principle of justice 1, 2, 3, 4, 6, 8, 9
  1. 1. Universal Declaration on the Human Genome and Human Rights, UNESCO 1997
  2. 2. Oviedo Convention, Council of Europe 1997
  3. 3. Review of Ethical Issues in Medical Genetics, WHO 2003
  4. 4. International Declaration on Human Genetic Data, UNESCO 2003
  5. 5. Declaration of Reykjavik, WMA 2019
  6. 6. Medical genetic services in Developing Countries. The Ethical, Legal, and Social Implications of Genetic Testing and Screening, WHO 2006
  7. 7. Guidelines for Quality Assurance in Molecular Genetic Testing, OECD 2007
  8. 8. Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Genetic Testing for Health Purposes, Council of Europe 2008
  9. 9. Report of the International Bioethics Committee on Updating Its Reflection on the Human Genome and Human Rights, UNESCO 2015