Legal, social, and ethical issues raised by whole genome sequencing

Using whole genome sequencing (WGS), scientists are able to describe an individual's entire genome on a molecular level.  In 1-4 years, it is expected that WGS will cost as little as $1,000, an impressive advancement given that it cost $100 million to complete the sequencing of the first human genome in 2000.

In last fall's briefing of the ABA Biotechnology Law Committee, Gary Merchant and Rachel Lindor of the Sandra Day O'Connor College of Law, discuss the legal, social, and ethical issues that WGS implicates.

The authors believe that WGS will soon bring about a genomic revolution that will have a significant impact on how we treat human disease.

The issues they identify are the following:

- whether the patents currently covering 4000 human genes will impede WGS (for an argument that this is unlikely, see this post);
- the difficulty of obtaining informed consent from research participants because of the complexity of genetic information and the potential scope of findings;
- whether findings incidental to the original purpose of a WGS should be revealed to the patient;
- how to maintain the confidentiality of the genetic information revealed and protect the patient's privacy;
- whether WGS should be conducted in non-CLIA certified labs;
- whether the FDA should pass regulations permitting only physicians to request WGS;
- liability issues in product liability and toxic tort cases and in cases against physicians;
- social and ethical issues related to predicting an individual's predispositions and predilections.