In practice, informed consent was designed to respect persons and to clarify researchers’ obligations, but genomic data challenges those assumptions in ways that consent forms alone cannot resolve. A Science study led by Melissa Gymrek at the Massachusetts Institute of Technology with Yaniv Erlich at the Whitehead Institute demonstrated that so-called de-identified genetic datasets can be re-identified through public records and genetic markers, showing that consent that assumes future anonymity is often illusory. The U.S. Department of Health and Human Services Office for Civil Rights has noted limits to privacy frameworks that apply unevenly across clinical, research and commercial contexts, and the U.S. Department of Justice policy on forensic genetic genealogy illustrates how nonresearch uses can bypass expectations set at the point of consent.
Why consent falls short
Consent documents become legally sufficient without guaranteeing ongoing control when data are copied, combined and analyzed by actors outside original agreements. Broad consent models used by major research initiatives such as the National Institutes of Health All of Us Research Program permit wide secondary use and depend on governance rather than continual individual choice. Technical realities like long-term data storage, cross-border sharing and advances in re-identification techniques increase the gap between what participants sign and how their genomes are used, while literacy about genetics remains uneven across communities.
Consequences and cultural dimensions
The consequences are both personal and collective. Genetic information carries familial implications, affecting relatives who did not consent, and can have cultural and territorial significance for Indigenous communities. Scholars such as Kim TallBear at the University of Alberta and advocacy by the National Congress of American Indians emphasize that consent processes must respect community sovereignty and collective harms that individual consent cannot address. Legal protections such as the Genetic Information Nondiscrimination Act enacted by the U.S. Congress reduce some risks in employment and health insurance but leave gaps in areas like life insurance and law enforcement access.
Practical responses combine policy, governance and technology. Experts including Bartha Maria Knoppers at McGill University advocate governance frameworks that pair dynamic consent options with controlled-access repositories, stronger oversight by data access committees and technical safeguards such as privacy-preserving computation and careful provenance tracking. Strengthening genomic privacy therefore requires moving beyond a one-time signed form toward layered protections that reflect the enduring and relational nature of genetic information.
