During a commission session focused on “Control, Access, and Human Genome Sequence Data,” Jane Kaye, D.Phil., director of the Centre for Law, Health and Emerging Technologies (HeLEX) at Oxford University, discussed the challenges biobanks face in securing informed consent from enrollees.
One is the diffuse oversight of biobanks among research ethics committees and institutional research boards. Authority is nationally based and often committee specific, posing a problem for global networks seeking to share samples and data. Another challenge is the contrast between the principle that participants should be able to withdraw from studies at any time and the reality that withdrawal cannot be promised when data and samples are shared widely.
“We can no longer promise that individuals can remain anonymous as we had been able to do so previously when it comes to data sharing,” Dr. Kaye said, given the uniqueness of DNA data, the ability to replicate data, and the sharing of data and linking to other datasets globally. “I think there are limitations on how far we can anonymize effectively, particularly when we get very rich data and we get whole genome sequence data. I think this can be detrimental to science, because in actual fact it’s the richness of the data that is so important.”
“What we need to do is make a conceptual shift away from simply thinking about privacy as something that has to be protected but rather to think of it as something that needs to be enacted through partnerships,” with research subjects informed about the use of data, especially if it is to be used for secondary purposes, Dr. Kaye said. Electronic oversight, or e-governance, she said, can help keep data away from unauthorized persons.