Bioethics Blogs

Regulation of genetic testing in the United States

 Incidental findings and the resulting problems are increasing in magnitude

According to a report by the Presidential Commission for the Study of Bioethical Issues in the United States, companies, clinicians and researchers must inform consumers, patients and study participants of incidental findings in relation to genetic tests and research trials that could affect their health. This report has been released by the Commission itself, as revealed in The Scientist (12 December 2013). Earlier that same year, the American College of Medical Genetics and Genomics (ACMG) had made recommendations on the advisability of alerting patients about 57 genetic diseases that could be accidentally discovered after performing individual genome sequencing. The Presidential Commission has now indicated that the patient has the right to decide whether he or she wishes to know the result of that test. According to Commission member Stephen Hauser, incidental findings and the resulting problems are increasing in magnitude. People who undergo genetic test using whole-genome sequencing should be warned that “Each of us has scores of deleterious mutations in our genes and these will be picked up every time a whole-genome sequence is obtained”. Clinicians and researchers must anticipate that there could be incidental findings in the tests and inform the patients and persons involved before the tests are carried out. The Commission also advocates shared decision-making. Another of the Commission’s recommendations is the creation of disease-risk lists, about which clinicians involved in genetic counselling should be informed; patients should also be advised of their occasional finding in a genetic test and their right to know or not (http://bioethics.gov/node/3183).

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.