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 |