Grafner

When we choose to donate to biobanks, we often give up ownership of our own blood, saliva, urine and DNA for the sake of scientific research.

Now, ethics commentators are raising questions about whether asking someone for consent when they donate a sample, which can then be used for research purposes long after they die, is sufficient.

In a report published on 25 July in PLOS Biology, University of Alberta health law researchers Timothy Caulfield and Blake Murdoch argue that the legal and ethical principles surrounding consent for biobanking are worryingly vague.

We can volunteer to give our health information to researchers at biobanks so they can help prevent, diagnose and treat a wide range of serious and life-threatening illnesses for future generations. Yet the report argues that a consensus on who owns the samples of blood, urine and saliva, as well as what participants are agreeing to, doesn't exist. These issues are only going to intensify as more people question their rights.

Andrew Trehearne from UK Biobank, which asks donors to agree to give up ownership of samples, questions why a consensus is even necessary: "It's an interesting set of views, but it doesn't seem to offer any suggestions for improvement, and I can't see any detailed specifics. I am not sure why there has to be a consensus on consent type."

The report states that the 'broad' or 'blanket' consent strategies that biobanks use deviate from traditional legal norms. 'Broad consent' refers to when a donor consents to his/her samples being used once at the beginning of a research experiment it's the consent type used by UK Biobank, among others. Biobanks can then continue to use the samples for research purposes, without asking for further consent.

Is such 'passive' consent an issue? It's certainly something which has been debated before. Back in 2013, an article was published in the European Journal of Human Genetics which concluded that the 'broad consent' model is still preferable to using 'dynamic consent', where participants are asked to re-consent to every new experiment or use of their samples.

But the new report out this week says this view is outdated and that the arguments against using specific consent simply because it is 'inefficient and costly', just don't hold up. It's now very easy and cheap to keep in contact with participants electronically, for instance.

The crux of the issue with non-specific consent strategies is that participants might not fully understand what their DNA is being used for. The report argues that only 55 per cent of people agree with blanket consent if their specimens are being used to make profit for commercial companies.

Essentially, they lose trust in biobanks once they think they are receiving funding from industry. Biobanks, however, are reliant on such funding. They work largely on developing personalised medicine, and to get these studies to the clinical trial stage requires money.

What has given rise to these consent concerns now? The report refers to 'social trends', which have led to a discussion on policy namely a rise in support for biorights, the increasing involvement of industry, growing concern about privacy and high profile research controversies.

Biorights centre on the idea that research participants have an ongoing right to control their research samples, to benefit directly from the research, and/or to be financially compensated for their contribution.

People certainly seem not to like the fact they aren't in control, when consent is only given once. A 2016 study in the US found that nearly 44 per cent of a nationally representative sample believed blanket consent was unacceptable, while 38 per cent felt it was the worst in a range of consent policy options.

This hasn't dampened the success of UK Biobank, whose 500,000 participants joined them under broad consent and have remained with them for the duration.

One criteria participants must agree to is: "I give permission for long-term storage and use of my blood and urine samples for health-related research purposes (even after my incapacity or death), and relinquish all rights to these samples which I am donating to UK Biobank."

"We think it's important that [our participants] know what they are doing and what we are using their samples for, which is why we send out annual news letters and host events. Participants are also allowed to withdraw at any time," says Trehearne.

Part of 'what they are doing', is giving permission for long-term storage and use of blood and urine samples for health-related research purposes (even after incapacity or death), and relinquishing all rights to these samples.

Considering participants receive no payment or results on their own health, the vast number that still sign up are contributing, altruistically, to biomedical research.

Still, the issue of whether this is fair and whether agreeing to something once is enough to last a lifetime, is still up for discussion.

In the meantime, biobanks must strive to ensure they obtain proper, legal consent, or risk having to destroy an abundant amount of health data.

See the article here:

Scientists raise ethics alarm over use of DNA for research - Wired.co.uk