Components of a proper informed consent for cancer genetic testing should include: |
1. Information on the specific genetic mutation(s) or genomic variant(s) being tested, including whether or not the range of risk associated with the variant will affect medical care. |
2. Implications of positive and negative results. |
3. Possibility that the test will not be informative. |
4. Options for risk estimation without genetic or genomic testing. |
5. Risk of passing a genetic variant to children. |
6. Technical accuracy of the test, including, where required by law, licensure of the testing laboratory |
7. Fees involved in testing and counseling and, for direct to consumer testing, whether the counselor is employed by the testing company. |
8. Psychological implications of test results (benefits and risks). |
9. Risks and protections against genetic discrimination by employers or insurers. |
10. Confidentiality issues, including, for direct-to-consumer testing companies, polices related to privacy and data security. |
11. Possible use of DNA testing samples in future research. |
12. Options and limitations of medical surveillance and strategies for prevention after genetic or genomic testing. |
13. Importance of sharing genetic and genomic test results with at-risk relatives so that they may benefit from this information. |
14. Plans for follow-up after testing. |