Variant Bio’s Data and Sample Governance Principles and Commitments

A nurse taking a blood spot sample from a participant for a study in French Polynesia with Variant Bio and the Catholic Hospital Group of Lille. Moorea, July 2021. Photo credit: Tom Martienssen

At Variant Bio, we work with genomic and health data and samples from people around the world. Study participants naturally want to know what will happen to their data and samples once they are collected. While this is always addressed in detail during community consultation and through an informed consent process customized to the unique context of each study, we want to be widely transparent about the overarching principles surrounding how we handle data and samples across all projects. For this reason, we have made Variant Bio’s Data and Sample Governance Principles and Commitments publicly available via our website. This document was developed with input from advisors and community members. It outlines the ethical underpinnings of our approach to data and sample governance, as well as the related policies and practices we adopt in partnerships with local communities throughout the world.

Our commitments, copied here for ease of reference, are as follow:

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, including researchers, governments, or commercial entities, other than service providers and collaborators 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.
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.