Credit for and Control of Research Outputs in Genomic Citizen Science.

Citizen science encompasses activities with scientific objectives in which members of the public participate as more than passive research subjects from whom personal data or biospecimens are collected and analyzed by others. Citizen science is increasingly common in the biomedical sciences, including the fields of genetics and human genomics. Genomic citizen science initiatives are diverse and involve citizen scientists in collecting genetic data, solving genetic puzzles, and conducting experiments in community laboratories. At the same time that genomic citizen science is presenting new opportunities for individuals to participate in scientific discovery, it is also challenging norms regarding the manner in which scientific research outputs are managed. In this review, we present a typology of genomic citizen science initiatives, describe ethical and legal foundations for recognizing genomic citizen scientists' claims of credit for and control of research outputs, and detail how such claims are or might be addressed in practice across a variety of initiatives.

The Genomic Commons.

Over its 30 or so years of existence, the genomic commons-the worldwide collection of publicly accessible repositories of human and nonhuman genomic data-has enjoyed remarkable, perhaps unprecedented, success. Thanks to the rapid public data release policies initiated by the Human Genome Project, free access to a vast array of scientific data is now the norm, not only in genomics, but in scientific disciplines of all descriptions. And far from being a monolithic creation of bureaucratic fiat, the genomic commons is an exemplar of polycentric, multistakeholder governance. But like all dynamic and rapidly evolving systems, the genomic commons is not without its challenges. Issues involving scientific priority, intellectual property, individual privacy, and informed consent, in an environment of data sets of exponentially expanding size and complexity, must be addressed in the near term. In this review, we describe the characteristics and unique history of the genomic commons, then address some of the trends, challenges, and opportunities that we envision for this valuable public resource in the years to come.

NIH's genomic data sharing policy: timing and tradeoffs.

NIH's new genomic data sharing (GDS) policy covers both human and model-organism genotypic and phenotypic data, and strives to balance rapid release of data with embargo periods to ensure that data producers have sufficient time to analyze their results. But how well does the policy achieve this balance?

Prepublication data sharing.

Rapid release of prepublication data has served the field of genomics well. Attendees at a workshop in Toronto recommend extending the practice to other biological data sets.

Contrasting academic approaches to COVID-19 vaccine production and distribution: What can the Oxford and Texas experiences teach us about pandemic response?

This article contrasts the different approaches to COVID-19 vaccine development adopted by Oxford University, on one hand, and Texas Children's Hospital and Baylor College of Medicine (collectively, Texas), on the other hand. Texas was praised widely in the press and academic literature for adopting an "open source" approach to vaccine development. Oxford, however, chose to license its vaccine technology to pharmaceutical manufacturer AstraZeneca and received significant public criticism as a result. Yet the Oxford vaccine reached far more individuals in developing countries than the Texas vaccine. We compare the two vaccines' experiences, drawing attention to a constellation of interrelated elements that contribute to a successful vaccine production program, including not only IP licensing, but also timing, technology transfer, and resource mobilization, all in the context of the prevailing funding environments. This comparative analysis sheds light on how the innovation ecosystem functioned during the COVID-19 pandemic, providing useful insights for policy makers and advocates as they prepare for future pandemics and other global health challenges.

Industry price guarantees for publicly funded medicines: learning from Project NextGen for pandemics and beyond.

The affordability of publicly funded medicines has been a longstanding concern. In 2023, the Biden administration took several steps on this front, including incorporation of a price constraint in an agreement between the US Biomedical Advanced Research and Development Authority (BARDA) and Regeneron Pharmaceuticals, Inc. to develop a new COVID-19 monoclonal antibody. The agreement included a 'Most Favored Nation' (MFN) clause in which Regeneron agreed that the US commercial list price of certain products developed using BARDA funding would not exceed their retail price in comparable global markets. The Administration for Strategic Preparedness and Response (ASPR) included similar language in subsequent agreements, with a promise that this would become a new standard. Even beyond the preparedness context, government funders and purchasers might consider incorporating similar clauses in future contracts, especially given that the Regeneron agreement and its progeny have been praised as 'groundbreaking.' Yet a closer look reveals cause for skepticism. Regeneron's MFN clause includes several loopholes related to covered purchasers and reference countries, prices, and conditions. We describe agreement terms that can make the difference between legally meaningful price constraints and mere window dressing. Our critical analysis offers important lessons for future efforts to improve the affordability of medical technology developed with public funds.

"Idealists and capitalists": ownership attitudes and preferences in genomic citizen science.

The perspectives of genomic citizen scientists on ownership of research outputs are not well understood, yet they are useful for identifying alignment of participant expectations and project practices and can help guide efforts to develop innovative tools and strategies for managing ownership claims. Here, we report findings from 52 interviews conducted in 2018 and 2019 to understand genomic citizen science stakeholders' conceptualizations of, experiences with, and preferences for ownership of research outputs. Interviewees identified four approaches for recognizing genomic citizen scientists' ownership and related credit interests in research outputs: shared governance via commons models; fractional ownership of benefits; full and creative attribution; and offensive and defensive patenting. Interviewees also agreed that the model selected by any project should at least maximize access to research outputs and, as appropriate and to the extent possible, broadly distribute rights of control and entitlements to research benefits.

Legal reform to enhance global text and data mining research.

Outdated copyright laws around the world hinder research.

Researcher Knowledge, Attitudes, and Communication Practices for Genomic Data Sharing.

This study examines knowledge, attitudes, and communication practices toward genomic data sharing among principal investigators and research coordinators engaged in cancer and non-cancer studies. We conducted 25 individual semi-structured interviews and conducted a qualitative thematic analysis. Most interviewees had basic knowledge of data sharing requirements, but lacked specific details of recent changes to NIH policy. Principal investigators perceived more risks to participants for data sharing than the research coordinators who generally obtained consent. Interviewees perceived a trend toward providing fewer data sharing options to participants in the consent process, and had observed that parents of pediatric patients asked more questions than adult patients. Our findings highlight potential areas for improvement related to data sharing during consent processes.

Legal terms of use and public genealogy websites.

Public genealogy websites, to which individuals upload family history, genealogy, and sometimes individual genetic data, have been used in an increasing number of public health, epidemiological, and genetic studies. Yet there is little awareness among researchers of the legal rules that govern the use of these online resources. We analyzed the online Terms of Use (TOU) applicable to 17 popular genealogy websites and found that none of them expressly permit scientific research, while at least 13 contain restrictions that may limit or prohibit scientific research using data obtained from those sites. In order to ensure that researchers who use genealogy and other data from these sites for public health and other scientific research purposes do not inadvertently breach applicable TOUs, we recommend that genealogy website operators consider revising their TOUs to permit this activity.

The international serious adverse events consortium.

The International Serious Adverse Events Consortium is generating novel insights into the genetics and biology of drug-induced serious adverse events, and thereby improving pharmaceutical product development and decision-making.