Geoff Lomax is CIRM’s Senior Officer to the Standards Working Group 

The commission that advises the President on bioethical issues recently issued a report titled Privacy and Progress in Whole Genome Sequencing. The report concludes “that to realize the enormous promise that whole genome sequencing holds for advancing clinical care and the greater public good, individual interests in privacy must be respected and secured.”

The commission’s report is a timely one. Sequencing a person’s DNA – also called whole genome sequencing – can help doctors and scientist better understand the unique qualities of a disease, and the technology is becoming more common in biomedical research. For example, National Public Radio had a good story recently about how genome sequencing helped doctors provide a pair of California twins with a highly effective treatment for a rare condition called DRD.

Despite these benefits, whole genome sequencing also runs into issues of privacy. Concerns arise over the possibility of discrimination from health insurance or jobs when a person’s entire genetic sequence becomes available.

The report make a series of recommendations designed to ensure the responsible conduct of genomic research. In a blog post, Commission chair Amy Gutmann indicated “this is a forward-looking report. It’s not a response to a crisis.”

Gutmann also indicated, “the Commission’s recommendations clump into two big categories, one is consent to whole genome sequencing and to the possible findings and how they will be treated, and the other is oversight.” Consent is the process researchers use to get permission from individuals to participate in research. Oversight typically involves a group of independent experts reviewing research studies to ensure they are being conducted safely and ethically.

Reading the Commission’s recommendations reminded me of the forward-looking nature of CIRM’s existing requirements, particularly as they apply to privacy. These requirements embodied in our Medical and Ethical Standards Regulations first we put in place in 2006. The regulations were recommended by our Scientific and Medical Accountability Standards Working Group. The Working Group placed special emphasis on the need for both comprehensive consent and effective research oversight.

CIRM has extensive requirements for consenting individuals for research, and our regulations created a new oversight body – the Stem Cell Research Oversight Committee. Shortly after the standards were enacted we published an article on some of their most innovative aspects.

The Standards Working Group has continued to build on this framework to ensure CIRM policies embody the most current thinking related to research ethics and oversight. For instance, the Presidential Commission emphasized the need for the consent process to include information about DNA sequencing and whether findings could be communicated back to research participants. The Standards Working Group took a similar position when it was discussing the informed consent process for CIRM’s Human Induced Pluripotent Stem Cell Initiative.

In May, I blogged about our efforts to develop an effective informed consent process. The model informed consent document CIRM recommends for its grantees includes information about DNA sequencing and asks cell donors whether they would like to have information communicated back to them.

The CIRM Standards Working Group will continue to look forward to support CIRMs mission of accelerating stem cell science under the highest standards. The Presidential Commission’s most recent report reassures us that our standards recognize and respond to the most pressing issues in genomic privacy.

G.L.