Research Revolution or Status Quo?: The New Common Rule and Research Arising From Direct-to-Consumer Genetic Testing

FAIR human neuroscientific data sharing to advance AI driven research and applications: Legal frameworks and missing metadata standards

“…One motivation contributing to the design of the GDPR was to empower the individual against economic interests of companies which often consider the acquired data as their property which they can use without further accountability. The examples for questionable or unethical acquisition, use and (not-) sharing of user data by the big tech companies are legion (e.g., The European Data Protection Supervisor (EDPS) 5 , 2020; Koch and Todd, 2018;Kurtz et al, 2022;Spector-Bagdady, 2021). In addition, the opaque handling of collected data, research practices and goals, created suspicions that these practices raise barriers for research and that egoistic economic goals of research can severely conflict with the interests of the individual as well as society.…”

“…Individual research participants may have only limited means for legal action (Spector-Bagdady, 2021). Generally, this may be sufficient for publicly funded neuroimaging research but it has been questioned if the Common Rule is sufficient to guarantee privacy rights to research subjects in the private sector, for example, for companies who collect genetic data to build database for commercial secondary use (Koch and Todd, 2018;Meyer, 2020). The existing situation leaves a large space for a field of unregulated research on human subjects and data processing/brokering, e.g., in privately funded research (Price and Cohen, 2019;Meyer, 2020).…”

“…This re-thinking was mainly due to the fact that it became more and more evident that this unstructured approach likely has a negative impact on the usability and usefulness of the shared data in current and future usage scenarios (Powell, 2021). Moreover, while the domain of genetics developed a relatively generous and open data culture, recent developments indicate a return to closed data policies with reluctance to share data or only under certain conditions, for example, data sharing policies in the commercial sector and in China (Koch and Todd, 2018;Chen and Song, 2018;PIPL Art. 38-43&53).…”

Genetics and COVID-19: How to Protect the Susceptible

“…The Common Rule, formally known as the Federal Policy for the Protection of Human Subjects, applies to research funded by several federal agencies and requires researchers to communicate risks and benefits of research to human subjects and to obtain their written consent. However, it does not apply to research funded by nongovernmental entities, and isolated genetic biospecimens do not ordinarily qualify as ‘human subjects’ [ 5 ].…”

General-Purpose Privacy Regulation and Translational Genomics

“…As discussed below, new types of entities, new legal developments, and new technological understanding mean the rules that have applied inside that bubble — while still vitally important — no longer tell the whole story of genetic privacy law. As research and technology relating to genomic information have developed exponentially, a similar increase has occurred in the awareness of and interest in the potential of genomics, 3 and as a result new parties are now utilizing genetic information in new ways. 4 Translational genomics — broadly, the application of genomic research for clinical purposes beyond pure research 5 — has moved beyond the bounds of its regulatory bubble.…”