Biobanking: Current Failures and New Models of Consent

Kieran O’Doherty, Assistant Professor at the University of Guelph, joins Pharma IQ to discuss current failures and new models of consent in biobanking.

Pharma IQ: Thanks for joining us. Now, can you first give us an example of where informed consent fails in the context of biobanking?

K O’Doherty: In traditional research ethics protocols or in other studies that we can think of, the reason why we’ve got informed consent there, is because in the past there’s been certain ethical failures, we can call them, where researchers have conducted studies where we would now say those were just really not acceptable ethically, and there were significant risks or harms to the research participants. So, informed consent means that a research participant has to know exactly what a certain study is about, what the risks are to them and to larger society, before they can then say, yes, I’m going to take part in this. And a researcher has to have this very specific informed consent, usually, in order to be able to conduct a study. Now, with biobanks, what we have is that we’re building research platforms, more than anything else, that are supposed to be available for many different kinds of studies. So, when the biobank is first constructed, and when research participants are first enrolled in the biobank and their tissues are collected, whether it’s blood or whatever it is, often the researchers don’t know what kind of studies are going to be conducted with the samples. So, the idea of informed consent just can’t be used in the same way. So, I can go to somebody and say, I want to collect your blood to put into a biobank, but I can’t tell you what studies we’re going to use it for. So, this is the main failure of informed consent. There are a few other things, but that, I’d say, is the main one.

Pharma IQ: I see. What are some alternative models of consent that are being composed?

K O’Doherty: Well, if the existing model of informed consent were used, what it would mean technically, is that every time a researcher goes to a biobank to use the samples for a study, technically speaking, they’d have to go back to the research participants and recontact them every time a new study is conducted, and reconsent them for that particular study. So, that’s clearly not feasible, mainly because sometimes people can’t be contacted any more, and sometimes it’s also just not financially feasible to do that every time. So, some of the models that have been proposed, one is a model of open consent, where the idea is that the people building the biobank, or the researchers, will make some kind of commitment to doing research only in a certain area. So, they still can’t give precise details of all the studies that might be conducted, but they can say, for example, we’re only going to be doing research in the area of heart disease. And they can then put together an informed consent protocol when enrolling participants, where the participants can then say, okay, yes, I understand that you’re going to do research in this broad area and yes, I agree that you can do that. The biobank would be, in that case, prohibited though from going beyond that kind of research context. So that’s one model that’s been proposed. Another proposal’s been, it’s often called Broad Consent, or where these restrictions are loosened even further, so that basically the research participant would say, here’s my sample, here’s my biospecimen, you can essentially go ahead and do whatever you want with it.
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So, those things have been proposed, but they’re still problematic, because they’re just… Most research ethics boards in many jurisdictions just aren’t really happy with that kind of situation, because they feel it doesn’t provide enough protection for the research participants, especially because there are so many privacy risks with biobanks, with the large-scale sharing of data, and especially with DNA research, where any time, really, a person could be identified if their sample is held with the biobank. So, a further model that’s been proposed is one of involving research participants more actively in the governance structure of the biobank. So, if we assume that informed consent restrictions have to be loosened in some way or another to make the whole sort of process feasible, then the argument is that, yes, we need to loosen informed consent, but we should have some kind of compensatory mechanism whereby people can be given some other kind of mechanism of having input or some kind of say in what gets done with their samples. So, examples here would be that, in a given biobank, you could have all research participants be registered with a kind of a participant association or donor’s participation, who could then elect representatives to act on their behalf when decisions get made about whether samples get released for a certain study or not.

Pharma IQ: Well, thank you for joining us today, Dr O’Doherty, and we look forward to hearing more from you at the upcoming biobanking conference in August.