Questions to be considered when approving genetic testing



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Contents Page


Introduction 2

Principles 2 – 20

- Informed Consent & Competent Adults & Minors 4 – 5


- Informed Consent & Mentally Incompetent 5 – 6
- Information Requirements 7 – 8
- Consent for Surplus Material 8 – 9
- Researchers & Medical Information 10 – 13
- Research Participants & Research Results 13 – 15
- Genetic Research – Specific Issues 16 – 18
- Multiple Genetic Testing 18
- “At Risk” Individuals 18
- Pharmaceutical Companies 18 – 19
- Outside EU 19 – 20
Appendix 1: Commentary on Principle No 6 21 – 23
Appendix 2: Terms 24 – 26
Appendix 3: Checklist - Samples of Human Material 27 – 29
Appendix 4: Guide for production of Patient Information Leaflet 30





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