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Variant Bio’s Data and Sample Governance Principles and Commitments

Updated September 3, 2024

I. Background and Purpose

Variant Bio is a mission-driven company, dedicated to strong ethics, benefit sharing, and developing life-saving therapies based on human genomic research. Our research model is based on respect for the people and communities we work with [1]. The purpose of this document is to describe the ethical basis of Variant Bio’s approach to data and sample governance and articulate our related commitments.

II. Ethical Principles Foundational to Data and Sample Governance

Principles of Research Ethics. Variant Bio values the canonical principles of research ethics established by The Nuremberg Code (2) and codified in the U.S. Code of Federal Regulations also known as the Common Rule. These include the principles of beneficence, non-maleficence, respect for persons, and justice both at the individual (3) and community/group levels [4;5]. We integrate these ethical principles of research in our work through our Ethics Advisory Board, commitment to community engagement, meaningful informed consent, data sharing, and data co-generation with research partners, tailored capacity building, and benefit sharing and results return with participating communities as expressions of both respect for persons and justice.

Incorporating a Communitarian Ethic. The common thread unique to Variant Bio’s principles of data and sample governance is the central role of a communitarian ethic that emphasizes the importance of community and reciprocity, the connection between individuals and the community, and balancing individual versus common good [6;7]. This ethic establishes community as a core unit of engagement, prioritizes developing and maintaining the right relationships with partnering communities and institutions, as well as deeply considering community-level, alongside individual-level benefits and risks in genomics research. Notably, Variant Bio’s adoption of a communitarian ethic does not eschew a liberal framework but rather serves as a balance to the “Western” tendency to focus nearly exclusively on individual rights in research, especially given diverse global contexts.

The central importance of community partnerships in Variant Bio’s approach to research serves as the ethical basis for specific practices; for example, solidarity with community partners manifests as allyship. Beyond justice as a fair distribution of research benefits and risks, Variant Bio practices processural or procedural justice by co-creating research governance policies and practices with communities and local researchers in tri-directional relationships whenever possible [8;9]. This focus on local leadership and capacity expresses a commitment to local control over samples, data, and research governance [10;11]; and concomitantly reflects and promotes a stewardship model of governance over samples, data, reputations, and relationships [12-15]. Consistently, Variant Bio is committed to not only FAIR principles of open science but also CARE principles [16].

III. Data and Sample Governance Commitments

In light of the overarching ethical principles described above, Variant Bio adopts the following data and sample governance policies and practices in its partnerships with local communities throughout the world and makes the following commitments:

  1. We will always ensure that research is reviewed by all relevant ethics committees, such as institutional review boards, and conducted in accordance with approved protocols.
  2. We will only collect data and samples from participants who have provided written informed consent and who meet the study’s inclusion/exclusion criteria.
  3. We will only use samples and analyze the data in a way that is consistent with the informed consent and study goals as conveyed to community members and participants.
  4. We will always require that study participants’ identifying information be removed before it is shared with us (data must be anonymized or pseudonymized).
  5. We will delete individual level data if requested by a study participant (data that has contributed to an analysis or publication at the time of such request will not be able to be removed from such analysis or publication).
  6. We will dispose of or return samples in accordance with ethical approvals, informed consent, and community wishes.
  7. We will not sell individual-level data or samples to third parties and will obligate partners to the same commitment.
  8. We will not share individual-level data or samples with anyone outside the study other than service providers, authorized researchers, and collaborators, which may include commercial partners developing medicines and diagnostic tests, who are obligated to the same commitment.
  9. We will ensure that, whenever possible, local research partners maintain custodianship over data and samples.
  10. We will comply with applicable laws and regulations for research broadly and data/sample storage, sharing, and custodianship specifically.
  11. We will learn about, seek to understand, and consider community customs, practices, and preferences for research broadly and data/sample storage, sharing, and custodianship specifically (e.g., we will return samples for ceremonial disposal where requested).
  12. We will treat all data and samples with respect and ensure that our access, analysis, sharing, and publishing approaches are culturally appropriate and supported by participating communities.
  13. We will share population-level findings with participating communities as a standard operational procedure [9;17].
  14. We will store all health, genetic, and other study data in accordance with privacy and security best practices designed to reduce the risk of unauthorized use or access to the data.
  15. We will plan and institute our research agreements so as to sustain data and sample governance commitments in the event the company is acquired.
  16. We will only use de-identified data when using AI methods, and the use of AI methods will be consistent with ethical approvals and informed consent.

Finally, Variant Bio’s data governance principles and commitments are not without exception due to historical contexts. For example, the company’s role in a project or partnership may develop after a study or resource is underway or led by other institutions.

Cited References

  1. Variant Bio, Inc. Ethics and Community Engagement (last accessed January 23, 2023)
  2. “Permissible Medical Experiments.” Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10. In. (Washington, U.S. Government Printing Office (n.d.)), pp 181-182.
  3. United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1978). The Belmont report : ethical principles and guidelines for the protection of human subjects of research. (Bethesda, Md.)
  4. Council for International Organizations of Medical Sciences (CIOMS). (1991) International Guidelines for Ethical Review of Epidemiological Studies. Geneva: CIOMS
  5. Canadian Institute of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council. (2018). Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans.
  6. Callahan, D. (2003). Individual good and common good: a communitarian approach to bioethics. Perspect Biol Med 46, 496-507.
  7. Munung, N.S., deVries, J., and Pratt, B. (2021). Genomics governance: advancing justice, fairness and equity through the lens of the African communitarian ethic of Ubuntu. Med Health Care Philos 24, 377-388.
  8. Billawala, T., Taiwo, T., and Hanchard, N.A. (2022). Genetics for all: Tri-directional research engagement as an equitable framework for international partnerships. HGG Adv 3, 100140.
  9. H3Africa Consortium (2017) Ethics and Governance Framework for Best Practice in Genomic Research and Biobanking in Africa. 
  10. Beaton, A., Hudson, M., Milne, M., Port, R.V., Russell, K., Smith, B., Toki, V., Uerata, L., Wilcox, P., Bartholomew, K., and Wihongi, H. (2017). Engaging Maori in biobanking and genomic research: a model for biobanks to guide culturally informed governance, operational, and community engagement activities. Genet. Med. 19, 345–351. 
  11. Trinidad, S.B., Ludman, E.J., Hopkins, S., James, R.D., Hoeft, T.J., Kinegak, A., Lupie, H., Kinegak, R., Boyer, B.B., and Burke, W. (2015). Community dissemination and genetic research: moving beyond results reporting. Am. J. Med. Genet. 167, 1542–1550.
  12. Claw, K.G., Anderson, M.Z., Begay, R.L., Tsosie, K.S., Fox, K., Garrison, N.A.; and Summer internship for INdigenous peoples in Genomics SING Consortium (2018). A framework for enhancing ethical genomic research with Indigenous communities. Nat. Commun. 9, 2957.
  13. Hudson, M., Garrison, N.A., Sterling, R., Caron, N.R., Fox, K., Yracheta, J. Anderson, J., Wilcox, P., Arbour, L., Brown, A., et al. (2020). Rights, interests and expectations: Indigenous perspectives on unrestricted access to genomic data. Nat. Rev. Genet. 21, 377–384.
  14. Fullerton, S.M., Anderson, N.R., Guzauskas, G., Freeman, D., and Fryer-Edwards, K. (2010). Meeting the governance challenges of next-generation biorepository research. Sci Transl Med 2, 15cm13.
  15. Trinidad, S.B., Blacksher, E., Woodbury, R.B., Hopkins, S.E., Burke, W., Woodahl, E.L., Boyer, B.B., and Hiratsuka, V.Y. (2022). Precision medicine research with American Indian and Alaska Native communities: Results of a deliberative engagement with tribal leaders. Genet Med 24, 622-630.
  16. Carroll, S.R., Garba, I., Figueroa-Rodríguez, O.L., Holbrook, J., Lovett, R., Materechera, S., Parsons, M., Raseroka, K., Rodriguez-Lonebear, D., Rowe, R., Sara, R., Walker, J.D., Anderson, J. and Hudson, M., 2020. The CARE Principles for Indigenous Data Governance. Data Science Journal, 19(1), p. 43.
  17. Trinidad, S.B., Ludman, E.J., Hopkins, S., James, R.D., Hoeft, T.J., Kinegak, A., Lupie, H., Kinegak, R., Boyer, B.B., and Burke, W. (2015). Community dissemination and genetic research: moving beyond results reporting. Am. J. Med. Genet. 167, 1542–1550.