The Ethics of Consent in a Shifting Genomic Ecosystem

Abstract

The collection and use of human genetic data raise important ethical questions about how to balance individual autonomy and privacy with the potential for public good. The proliferation of local, national, and international efforts to collect genetic data and create linkages to support large-scale initiatives in precision medicine and the learning health system creates new demands for broad data sharing that involve managing competing interests and careful consideration of what constitutes appropriate ethical trade-offs. This review describes these emerging ethical issues with a focus on approaches to consent and issues related to justice in the shifting genomic research ecosystem.

A global perspective on embryological and fetal collections: Where to from here?

“…Regarding provenance of FECs, there are several challenges to address ranging from the terminology used to describe embryos and fetuses in collections, authority to donate, and broader issues that include the current discourse on consent in medicine and health (Beach et al, 2020; Lee, 2021; Saksena et al, 2021). These issues are relevant to collections that may continue to receive specimens and expand today, and which serves as a source for research data.…”

“…Privacy: Operational procedures need to protect the identity and privacy of the donor and their families. This is especially important in cases where tissues of the remains are used for DNA extraction and genomic sequencing (Beach et al, 2020;Lee, 2021;Saksena et al, 2021). 3.…”

“…Our recommendation for the continued use and establishment of FECs are summarized in Figure 4: Consent: For the discipline to continue to act upon an ethical framework and to gain the trust of the community, it is imperative that informed consent is highly valued. The nature of informed consent itself and how it is interpreted, is subject to changing perceptions of respect, autonomy, and dignity (Beach et al, 2020; Hutchinson et al, 2020; Lee, 2021; Saksena et al, 2021). Like the Trans‐European Pedagogic Anatomical Research Group (TEPARG) and the IFAA guidelines on body donation, internationally agreed guidelines pertaining to FECs should advocate for informed consent for all future donations with the most accurate information on the FECs provided to potential donors to inform their choice to donate.…”

“…For those remains collected without informed consent prior to the adoption of international guidelines, we concur with Jones (2014) that the most beneficial outcome is that these specimens are retained in the FECs but made accessible. Privacy: Operational procedures need to protect the identity and privacy of the donor and their families. This is especially important in cases where tissues of the remains are used for DNA extraction and genomic sequencing (Beach et al, 2020; Lee, 2021; Saksena et al, 2021). Commercial and other gain: Where financial or other gains may be realized, it is imperative that this is transparent and communicated to the donor of the remains, or the successive NOK and appropriate consent is accordingly acquired.…”

Éléments fondamentaux des documents de consentement à participer à la recherche sur le génome humain au Canada et de la Bibliothèque génomique humaine pancanadienne : orientation pour l’établissement de politiques

“…Les documents de consentement doivent inclure l'option de reprise de contact avec les personnes participantes, y compris les personnes mineures émancipées et l'option d'obtenir le consentement des enfants, le cas échéant. Dans de rares cas, selon sa nature, un projet de recherche pourrait exiger une éventuelle reprise de contact et un renouvellement de consentement 4,7,9,13,16 .…”