Table 14.

Standards for informed consent for genetic testing in gastrointestinal (GI) practice (364)

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.