On September 8, 2015, the U.S. Department of Health and Human Services proposed major changes to the regulations known as the Common Rule, whose purpose is to protect human subjects in federally funded research. The proposed changes have been criticized as unduly burdening the conduct of research. While some of the proposed changes are supported by legitimate practical, legal, or ethical considerations, we believe that others lack compelling justification. This article addresses those unjustified changes that we view as especially problematic, focusing on the proposed disparate treatment of secondary research involving data and secondary research involving biospecimens across a number of provisions. The primary rationale for this disparate treatment is that individuals have a strong autonomy interest in the research use of their biospecimens that does not extend to their private information. We explain why this and other justifications do not hold up to scrutiny and how the proposed changes will introduce new layers of complexity to the conduct of research while incentivizing behaviors that undermine the Common Rule's effectiveness and integrity. We conclude by recommending the removal of these unjustified complexities from the regulations that ultimately are adopted.
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. The Act also addresses potential barriers to data sharing. At the same time, the Act exacerbates or neglects several challenges, including 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.
Genomic citizen science initiatives that promote public involvement in the study or manipulation of genetic information are flourishing. These initiatives are diverse and range from data donation studies, to biological experimentation conducted in home and community laboratories, to self-experimentation. Understanding the values that citizen scientists associate with their activities and communities can be useful to policy development for citizen science. Here, we report values-relevant data from qualitative interviews with 38 stakeholders in genomic citizen science. Applying a theoretical framework that describes values as transcendent beliefs about desirable end states or behaviors that can be categorized according to the motivational goals that they express and the interests they serve, we identified nine core values of genomic citizen science: altruism, autonomy, fun, inclusivity, openness, reciprocity, respect, safety, and solidarity.
The practice of medicine, the delivery of health care and public health services, and biomedical research have all become more data-intensive. The importance of managing information has become apparent, and with it attention to building knowledge commons. This chapter describes factors that influence the creation and use of diverse sets of data that enable biomedical advances. First, we characterize these resources as a Medical Information Commons (MIC). We describe commons scholarship generally and MICs more specifically, and describe approaches to commons governance. Next, we highlight specific issues around privacy and consent, and then discuss participant interests in the commons. We describe the negative history of marginalized and racialized populations, and finally we pull all of these concepts together and discuss challenges in building MICs that are trustworthy and inclusive, and meet the needs of marginalized and racialized populations.
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.
Abstract “Citizen science” refers to the participation of lay individuals in scientific studies and other activities having scientific objectives. Citizen science gives rise to unique ethical issues that stem from the potentially multifaceted contributions of citizen scientists to the research process. We sought to explore the ethical issues that are most concerning to citizen scientist practitioners, participants, and scholars to support ethical practices in citizen science. We developed a best–worst scaling experiment using a balanced incomplete block design and fielded it with respondents recruited through the U.S.-based Citizen Science Association. Respondents were shown repeated subsets of 11 ethical issues and identified the most and least concerning issues in each subset. Latent class analysis revealed two respondent classes. The “Power to the People” class was most concerned about power imbalance between project leaders and participants, exploitation of participants, and lack of diverse participation. The “Show Me the Data” class was most concerned about the quality of data generated by citizen science projects and failure of projects to share data and other research outputs.
In their article “The Rise of Citizen Science in Health and Biomedical Research,” Wiggins and Wilbanks (2019) present a new typology for understanding the complex landscape of health and biomedical...
Abstract The speed and scale of the COVID‐19 pandemic has highlighted the limits of current health systems and the potential promise of non‐establishment research such as “DIY” research. We consider one example of how DIY research is responding to the pandemic, discuss the challenges faced by DIY research more generally, and suggest that a “trust architecture” should be developed now to contribute to successful future DIY efforts .
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