Table 1 A proposed contents of the first layer of the information provision process
From: A tiered-layered-staged model for informed consent in personal genome testing
Information elements | Examples | |
|---|---|---|
1 | Purpose of the test | Prediction of disease risks |
Provision of information on carrier status for reproductive decision-making | ||
Education/information | ||
Entertainment | ||
2 | Target group | Adult consumers without health problems or positive family history |
Couples planning to conceive | ||
3 | Limitations | Probabilistic versus diagnostic information |
Test results may change over time | ||
4 | Implications and risks | Psychological implications (eg anxiety) |
Medical implications (eg unnecessary follow-up) | ||
Social implications (eg insurance) | ||
Implications for family members | ||
5 | Tiers | Non-medical tests |
Medical tests of limited versus high clinical validity and utility | ||
Medical tests subdivided into categories (tiers) of diseases tested for | ||
according to disease characteristics (eg severity, age of onset) | ||
6 | Follow-up | Follow-up testing and diagnostic workup for clinically actionable test results |
7 | Data protection | Access by third parties (eg researchers) |
8 | Sources of independent information | Links to government/consumer/patient organisation websites |
