Who owns your genes?

March 28, 2016 – The DCRI’s Laura Beskow, MPH, PhD, discusses the muddled state of laws regarding patients’ genetic information.

In recent years, researchers have been touting the promise of precision medicine – therapies targeted to specific individuals based on their genetic profile. The National Institute of Health’s Precision Medicine Initiative, which seeks to enroll one million Americans in a long-term outcomes study, is one of the most ambitious efforts to realize the potential of precision medicine.

laura-beskowBut while researchers are moving the science forward, the laws governing such research often lag behind. In a recent editorial in The Conversation, Director of of the DCRI’s Program for Empirical Bioethics Laura Beskow, MD, PhD, and two co-authors discuss how the patchwork of laws and regulations surrounding research do not provide the protections that many participants would want or expect.

For example, several U.S. courts have rejected patients’ claims to ownership of their own genetic material. Rules and institutions intended to protect patients, such as the Federal Common Rule and Institutional Review Boards (IRBs), do not cover every study conducted within the United States. These exceptions have left many patients confused as to what might happen to any information they might provide to researchers.

“We think it is essential for all those involved in research – IRBs, researchers and study participants – to understand what protections are available and what their limitations are,” Beskow and her colleagues wrote. “To the extent that the current laws fall short of the types of protections and controls expected by participants in research studies like the Precision Medicine Initiative, we may be able to propose ways that the laws can be updated or supplemented.”