Journal of Science Policy & Governance | Volume 16, Issue 01 | April 13, 2020
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Policy Memo: The Frontiers of DNA Regulation: Developing a National Policy Framework Encouraging Transparency, Security, and Cost-efficiency of Genetic Technology and Data
Shawn McGuirk (1), Stefanie Sultmanis (1,2), Alana R. Westwood (1), Kathlyn N. Woolfson (1,2), Noushin Nabavi (1)
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Keywords: Science and Data Science; Science and Technology Policy; High-throughput Sequencing; Data Privacy and Security
Executive Summary: Genetic sequencing informs research, policy, and regulatory decisions that impact national priorities like agriculture, forestry, and human health. Emerging high-throughput sequencing (HTS) technologies are disrupting these sectors by providing precise information more quickly, thus raising concerns regarding responsible adoption by governments. The challenges of HTS include a lack of infrastructure, guidelines for data stewardship, and standardization of methods. Poor HTS practices can lead to more than bad data; without a policy framework, governments face safety, security, and quality risks. Without controls, increasing use and application of HTS could lead to privacy breaches, genetic discrimination, and disadvantageously high-cost models. Despite the proliferation of HTS in public and private sectors worldwide, we were unable to identify any national policy frameworks regulating its adoption or use. International networks are developing guidelines in specific areas (e.g. plant health diagnostics and precision medicine). However, these recommendations lack implementation policies. In Canada, used here as a case study, few government departments and agencies (henceforth ‘DAs’) have policies on genetic sequencing. Since the development of national HTS policy frameworks may offer substantial benefits and mitigate risks, we present the following policy options:
Given the identified risks, we recommend that national governments consider centralized (1) or semi-centralized (2) options. The former is preferable to ensure the development of cohesive policies across government bodies; however, the latter may be more immediately actionable.
- Centralized: funding government housed HTS infrastructure while developing a national policy framework for genetic sequencing
- Semi-centralized: supporting DA’s in co-developing policies and infrastructure for HTS technology and genetic sequencing
- Decentralized: relying on programs within DAs to determine and meet their HTS infrastructure and policy needs
Given the identified risks, we recommend that national governments consider centralized (1) or semi-centralized (2) options. The former is preferable to ensure the development of cohesive policies across government bodies; however, the latter may be more immediately actionable.
I. Issue Statement
Genetic sequencing supports government programs and regulations worldwide also impacting healthcare and driving economic improvements in agriculture, forestry, and other sectors (e.g. Rothschild and Plastow 2008, Goldberg et al. 2015, Olmos et al. 2018). HTS can accomplish in months (Maree et al. 2018) what took conventional methods years to complete (Rott et al. 2017), thus disrupting sectors and industries that rely on genetic sequencing. We examine the potential impacts of HTS and make recommendations to guide national policies.
In this memo, we focused on Canada as a case study. Canada has invested in the adoption of HTS in some DAs but has not yet developed comprehensive national policy frameworks for its adoption and regulation.
In Canada, the federal government provides the most support for genetics research and its applications for public use (Genomics R&D Initiative: Participating Departments and Agencies in Canada, 2020) through in-house genetic sequencing services (DNA Sequencing, Genotyping and Bioinformatics 2020; Genome Canada’s Strategic Vision, Annual Report 2018) to fund academic, industry, and non-profit organizations (Genomics at the Canadian Forest Service Publications 2013). Currently, there is a lack of any formal Canadian DA policies or guidelines for HTS technology procurement (including pricing expectations), use, reporting, data privacy, and security. Without coherent regulatory frameworks, governments could face issues of reliability, reproducibility, data breaches, technological misuse, and/or inconsistent application and stewardship of data.
In this memo, we focused on Canada as a case study. Canada has invested in the adoption of HTS in some DAs but has not yet developed comprehensive national policy frameworks for its adoption and regulation.
In Canada, the federal government provides the most support for genetics research and its applications for public use (Genomics R&D Initiative: Participating Departments and Agencies in Canada, 2020) through in-house genetic sequencing services (DNA Sequencing, Genotyping and Bioinformatics 2020; Genome Canada’s Strategic Vision, Annual Report 2018) to fund academic, industry, and non-profit organizations (Genomics at the Canadian Forest Service Publications 2013). Currently, there is a lack of any formal Canadian DA policies or guidelines for HTS technology procurement (including pricing expectations), use, reporting, data privacy, and security. Without coherent regulatory frameworks, governments could face issues of reliability, reproducibility, data breaches, technological misuse, and/or inconsistent application and stewardship of data.
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Shawn McGuirk is a Senior Policy Advisor and Canadian Science Policy Fellow at the Natural Sciences and Engineering Research Council of Canada (NSERC), as well as an alumnus of the Government of Canada Recruitment of Policy Leaders program. As a Ph.D. and Vanier Scholar in Biochemistry at the Goodman Cancer Research Centre of McGill University, his research centered on the role of metabolism and metabolic plasticity in breast cancer progression. Shawn also strives to elevate the voices of young researchers in science policy, notably through his roles on the board of directors of Acfas and as a director and past president of the student-led non-profit organization Science & Policy Exchange. Learn more about Shawn at: https://www.linkedin.com/in/ shawnmcguirk/
Contact: [email protected]
Stefanie Sultmanis earned her Ph.D. from the University of Toronto studying evolutionary mechanisms of gene expression in plant development. As a Mitacs Canadian Science Policy Fellow (2018) Stefanie developed a policy on the use of sequencing technologies in plant health. She continues to contribute to Canadian science policy, now exploring broader areas such as scientific integrity and management. Learn more about Stefanie at https://www.linkedin.com/in/stefanie-sultmanis-phd/
Contact: [email protected]
Alana R. Westwood straddles the worlds of science and policy, blending backgrounds in biology and philosophy to pursue more effective approaches to environmental conservation. Currently a Mitacs Canadian Science Policy Postdoctoral Fellow at Natural Resources Canada, she builds upon a career with academia and non-profits to address the science and policy of conserving ecosystems and species. Learn more about Alana at www.alanawestwood.com.
Contact: [email protected]
Katie Woolfson completed her Ph.D. in Biology at the University of Western Ontario, where she used bioinformatics tools to investigate the molecular and chemical underpinnings of plant defense metabolism. She joined the Canadian Food Inspection Agency as a Mitacs Canadian Science Policy Postdoctoral Fellow (2018-2019), where she applied her plant science expertise toward developing solutions and implementing strategies to protect Canada’s plant resources through collaborative action.
Contact: [email protected]
Noushin Nabavi earned a Ph.D. in Cell and Systems Biology from the University of Toronto with funding support from the Natural Sciences and Engineering Research Council of Canada (NSERC). She then joined the Universities of California (Siebel Stem Cell Fellow) and British Columbia (Mitacs Accelerate Fellow) to work on human health and disease models and cancer genomics projects. She was awarded the Mitacs Canadian Science Policy Fellowship in 2018-2019 to join the BC public service as a data science fellow to work on integrated data projects aimed at answering complex societal issues for evidence-informed decision making.
Contact: [email protected]
Contact: [email protected]
Stefanie Sultmanis earned her Ph.D. from the University of Toronto studying evolutionary mechanisms of gene expression in plant development. As a Mitacs Canadian Science Policy Fellow (2018) Stefanie developed a policy on the use of sequencing technologies in plant health. She continues to contribute to Canadian science policy, now exploring broader areas such as scientific integrity and management. Learn more about Stefanie at https://www.linkedin.com/in/stefanie-sultmanis-phd/
Contact: [email protected]
Alana R. Westwood straddles the worlds of science and policy, blending backgrounds in biology and philosophy to pursue more effective approaches to environmental conservation. Currently a Mitacs Canadian Science Policy Postdoctoral Fellow at Natural Resources Canada, she builds upon a career with academia and non-profits to address the science and policy of conserving ecosystems and species. Learn more about Alana at www.alanawestwood.com.
Contact: [email protected]
Katie Woolfson completed her Ph.D. in Biology at the University of Western Ontario, where she used bioinformatics tools to investigate the molecular and chemical underpinnings of plant defense metabolism. She joined the Canadian Food Inspection Agency as a Mitacs Canadian Science Policy Postdoctoral Fellow (2018-2019), where she applied her plant science expertise toward developing solutions and implementing strategies to protect Canada’s plant resources through collaborative action.
Contact: [email protected]
Noushin Nabavi earned a Ph.D. in Cell and Systems Biology from the University of Toronto with funding support from the Natural Sciences and Engineering Research Council of Canada (NSERC). She then joined the Universities of California (Siebel Stem Cell Fellow) and British Columbia (Mitacs Accelerate Fellow) to work on human health and disease models and cancer genomics projects. She was awarded the Mitacs Canadian Science Policy Fellowship in 2018-2019 to join the BC public service as a data science fellow to work on integrated data projects aimed at answering complex societal issues for evidence-informed decision making.
Contact: [email protected]
Acknowledgments
We acknowledge the Mitacs Canadian Science Policy Fellowship (CSPF) Program, of which all co-authors are members. The CSPF is a competitive fellowship that places Ph.D. graduates from Canadian universities into roles as policy analysts in government departments and agencies for one year. All authors confirm that this is a policy exercise by citizen scientists, and all information included was derived from publicly available sources. All information and suggestions presented herein belong to the authors alone who contributed equally to this manuscript and are in no way a reflection of Mitacs or the views of departments and agencies of the Government of Canada or its provinces.
We acknowledge the Mitacs Canadian Science Policy Fellowship (CSPF) Program, of which all co-authors are members. The CSPF is a competitive fellowship that places Ph.D. graduates from Canadian universities into roles as policy analysts in government departments and agencies for one year. All authors confirm that this is a policy exercise by citizen scientists, and all information included was derived from publicly available sources. All information and suggestions presented herein belong to the authors alone who contributed equally to this manuscript and are in no way a reflection of Mitacs or the views of departments and agencies of the Government of Canada or its provinces.
DISCLAIMER: The findings and conclusions published herein are solely attributed to the author and not necessarily endorsed or adopted by the Journal of Science Policy and Governance. Articles are distributed in compliance with copyright and trademark agreements.
ISSN 2372-2193
ISSN 2372-2193