@article{b96800212fea471fa97e570c8fcc1554,
title = "Challenges to building a gene variant commons to assess hereditary cancer risk: Results of a modified policy delphi panel deliberation",
abstract = "Understanding the clinical significance of variants associated with hereditary cancer risk requires access to a pooled data resource or network of resources—a “cancer gene variant commons”—incorporating representative, well-characterized genetic data, metadata, and, for some purposes, pathways to case-level data. Several initiatives have invested significant resources into collecting and sharing cancer gene variant data, but further progress hinges on identifying and addressing unresolved policy issues. This commentary provides insights from a modified policy Delphi process involving experts from a range of stakeholder groups involved in the data-sharing ecosystem. In particular, we describe policy issues and options generated by Delphi participants in five domains critical to the development of an effective cancer gene variant commons: incentives, financial sustainability, privacy and security, equity, and data quality. Our intention is to stimulate wider discussion and lay a foundation for further work evaluating policy options more in-depth and mapping them to those who have the power to bring about change. Addressing issues in these five domains will contribute to a cancer gene variant commons that supports better care for at-risk and affected patients, empowers patient communities, and advances research on hereditary cancers.",
keywords = "Data resources, Data sharing, Equity, Hereditary cancer, Human genetics, Privacy and security",
author = "Majumder, {Mary A.} and Blank, {Matthew L.} and Janis Geary and Bollinger, {Juli M.} and Guerrini, {Christi J.} and Robinson, {Jill Oliver} and Isabel Canfield and Robert Cook-Deegan and McGuire, {Amy L.}",
note = "Funding Information: With regard to incentives, another policy option would be to leverage the power of payers and providers (e.g., insurance companies, ordering institutions, genetic counselors) to encourage and facilitate testing by laboratories that commit to contributing results to the commons. An analogous option would be to leverage the power of funders to create professional incentives to share (i.e., you contribute data, you get more funding). As one panelist stated, “There is some ability to select where tests can be run for sequencing. Payers and providers can be the force that makes a difference in the commercial laboratory sector, and in the academic sector it is more the funders.” In the context of a cancer gene variant commons, several commentators have suggested that insurers make inclusion in a preferred laboratory network contingent on laboratory data sharing [12,13]. For scientific contributors funded by grants or contracts, this might entail a process to monitor compliance with the data-sharing plans in their grant applications or contracts, and applicable replication standards [14]. The NIH Policy for Data Management and Sharing disappointed some commentators by not requiring sharing and failing to integrate consideration of data-sharing plans into the review process [15]. The final policy, which will take effect in 2023, does state that non-compliance with an approved plan may be taken into account in future funding decisions [16]. Some funders in the cancer space are more exacting; for example, Susan G. Komen requires funded researchers to share data [17], the Parker Institute for Cancer Immunotherapy and the Chan Zuckerberg Initiative have developed extensive data-sharing agreements, and the NCI Cancer Moonshot program gives funding priority to researchers with plans that ensure maximal sharing [18]. Publisher Copyright: {\textcopyright} 2021 by the authors. Licensee MDPI, Basel, Switzerland.",
year = "2021",
month = jul,
doi = "10.3390/jpm11070646",
language = "English (US)",
volume = "11",
journal = "Journal of Personalized Medicine",
issn = "2075-4426",
publisher = "Multidisciplinary Digital Publishing Institute (MDPI)",
number = "7",
}