Christi J. Guerrini

The rise of the ethical license

The Broad Institutes recent licensing of its gene editing patent portfolio demonstrates how licenses can be used to restrict controversial applications of emerging technologies while society deliberates their implications.

Genealogy databases and the future of criminal investigation

The police can access your online family-tree research—and use it to investigate your relatives The 24 April 2018 arrest of Joseph James DeAngelo as the alleged Golden State Killer, suspected of more than a dozen murders and 50 rapes in California, has raised serious societal questions related to personal privacy. The break in the case came when investigators compared DNA recovered from victims and crime scenes to other DNA profiles searchable in a free genealogical database called GEDmatch. This presents a different situation from the analysis of DNA of individuals arrested or convicted of certain crimes, which has been collected in the U.S. National DNA Index System (NDIS) for forensic purposes since 1989. The search of a nonforensic database for law enforcement purposes has caught public attention, with many wondering how common such searches are, whether they are legal, and what consumers can do to protect themselves and their families from prying police eyes. Investigators are already rushing to make similar searches of GEDmatch in other cases, making ethical and legal inquiry into such use urgent.

Myriad take two: Can genomic databases remain secret?

Trade-secrecy laws clash with a right to ones health data An ongoing legal challenge to the business model of Myriad Genetics highlights how recent policy developments have contributed to a collision between individual interests in access to personal health data and commercial interests in trade secrecy. Following a landmark ruling by the U.S. Supreme Court invalidating its patents on BRCA1/2 genetic variants (1), which increase the risk of female breast and ovarian cancer, Myriad now faces efforts to dismantle the proprietary database of variants and their clinical interpretation that it began developing when it was the exclusive provider of BRCA1/2 tests. Although the competing claims that anchor this dispute are hard to reconcile, we see room for legal compromise and opportunity for policy innovations to incentivize companies to invest in test development while ensuring that their findings can be used by others.

Persistent Confusion and Controversy Surrounding Gene Patents

The development of patent-specific educational resources and prompt resolution of patentability rules unsettled by recent US Supreme Court decisions are urgently needed in the genomics industry.

Sharing data under the 21st Century Cures Act

On 13 December 2016, President Obama signed the 21st Century Cures Act (“the Act”) into law. Many of its provisions support the creation of an “Information Commons,” an ecosystem of separate but interconnected initiatives that facilitate open and responsible sharing of genomic and other data for research and clinical purposes. For example, the Act supports the National Institutes of Health in mandating data sharing, provides funding and guidance for the large national cohort program now known as All of Us, expresses congressional support for a global pediatric study network, and strengthens patient access to health information. The Act also addresses potential barriers to data sharing. For example, it makes the issuance of certificates of confidentiality automatic for federally funded research involving “identifiable, sensitive” information and strengthens the associated protections. At the same time, the Act exacerbates or neglects several challenges, for example, increasing complexity by adding a new definition of “identifiable” and failing to address the financial sustainability of data sharing and the scope of commercialization. In sum, the Act is a positive step, yet there is still much work to be done before the goals of broad data sharing and utilization can be achieved.

Citizen science, public policy

New research models may benefit from policy modifications Citizen science initiatives that support collaborations between researchers and the public are flourishing. As a result of this enhanced role of the public, citizen science demonstrates more diversity and flexibility than traditional science and can encompass efforts that have no institutional affiliation, are funded entirely by participants, or continuously or suddenly change their scientific aims. But these structural differences have regulatory implications that could undermine the integrity, safety, or participatory goals of particular citizen science projects. Thus far, citizen science appears to be addressing regulatory gaps and mismatches through voluntary actions of thoughtful and well-intentioned practitioners. But as citizen science continues to surge in popularity and increasingly engage divergent interests, vulnerable populations, and sensitive data, it is important to consider the long-term effectiveness of these private actions and whether public policies should be adjusted to complement or improve on them. Here, we focus on three policy domains that are relevant to most citizen science projects: intellectual property (IP), scientific integrity, and participant protections.

Should police have access to genetic genealogy databases? Capturing the Golden State Killer and other criminals using a controversial new forensic technique

On April 24, 2018, a suspect in California’s notorious Golden State Killer cases was arrested after decades of eluding the police. Using a novel forensic approach, investigators identified the suspect by first identifying his relatives using a free, online genetic database populated by individuals researching their family trees. In the wake of the case, media outlets reported privacy concerns with police access to personal genetic data generated by or shared with genealogy services. Recent data from 1,587 survey respondents, however, provide preliminary reason to question whether such concerns have been overstated. Still, limitations on police access to genetic genealogy databases in particular may be desirable for reasons other than current public demand for them.

The Patient Who Continues to Smoke On-Treatment: An Ethical Dilemma:

The Patient Who Continues to Smoke On-Treatment: An Ethical Dilemma Otolaryngology– Head and Neck Surgery 2018, Vol. 158(3) 469–472 American Academy of Otolaryngology—Head and Neck Surgery Foundation 2018 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0194599817752634 http://otojournal.org Ankita Patro, Christi J. Guerrini, JD, MPH, Andrew T. Huang, MD, and Andrew G. Sikora, MD, PhD

Gene Patents in Canada: Is There a New Legal Landscape?

In 2016, the Children’s Hospital of Eastern Ontario (CHEO) announced the settlement of its patent lawsuit against US-based Transgenomic, Inc. At issue in the case was CHEO’s ability to test for gene mutations associated with long QT syndrome (LQTS) that are described in Transgenomic’s patents. CHEO challenged the patents as invalid, and Transgenomic ultimately agreed to license them on a royalty-free basis to CHEO and other healthcare institutions for LQTS testing and research. While widely celebrated in the media, the ethical rhetoric surrounding the settlement has at times obscured the practical and legal context in which it was made and will operate. Here, we provide a nuanced account of the events surrounding the settlement and its implications for research and clinical care. Although the settlement is remarkable for the transparency of its terms and its inclusion of a license intended to benefit unaffiliated test providers, we conclude that another significant implication of the settlement may be its elimination of the opportunity to clarify an increasingly confused area of Canadian law against a backdrop of continued international controversy surrounding the patenting of genes and gene-based diagnostic and therapeutic methods.

Author Correction to: Gene Patents in Canada: Is There a New Legal Landscape?

An error was subsequently identified in the article, and the following correction should be noted