New Project Aims to Provide Legal Guidance Needed to Do Business in Genomics

Technology changes faster than the laws designed to regulate it. Thus, while DNA testing has changed medicine and fueled growth in the lab industry, it has also created new legal challenges that few labs are prepared to deal with. As the journal Science reports, doctors and other providers are now facing lawsuits raising novel questions and untested theories designed to hold them liable for how they offer genetic testing, interpret tests and counsel patients about the process. And this legal confusion and lack of clarity pose barriers to progress. The good news is that a new project called LawSeq may soon provide the legal guidance industry and other stakeholders need to manage liability risks in carrying out their genomics endeavors.

The LawSeq Project

The three-year, $2 million LawSeq project, which is nearing completion, is sponsored by National Human Genome Research Institute (NHGRI), National Cancer Institute (NCI) and National Institutes of Health (NIH). It’s based cooperatively at the University of Minnesota and Vanderbilt University, where a working group of top legal and scientific experts are analyzing current U.S. federal and state legislation and regulation of translational genomics with the objective of producing generate guidance to industry and other stakeholders.

Among the LawSeq project team’s first initiatives:

• Creation of a searchable online database of relevant law and an annotated bibliography for free public access;
• Publication of analyses and recommendations to help shape the law as it pertains to genomic medicine;
• Staging of a national conference (a video will soon be available at the conference website).

Importance of Protocol

Providing such information will help create standards, which will support growth in this burgeoning field. As Science points out, the potential impact for labs is significant.

For example, there is currently no established protocol when understanding of a gene variant evolves after the initial testing. Science notes how a DNA change of unknown significance may later be reclassified to raise the risk of ovarian cancer. What is a lab’s responsibility in this situation? Should attempts be made to recontact patients? What if patients can’t be reached?

Moreover, there are issues if it becomes commonplace for labs and doctors to recontact patients, because those that don’t may face legal risks.

The LawSeq group of scientists and legal experts are addressing these and similar concerns.