Biobanks, governance, and informed consent and individual control - a view from the United States

Published on August 31, 2015   24 min
0:00
ELLEN WRIGHT CLAYTON: Well, my name is Ellen Wright Clayton. And I'm really delighted to talk with you today about biobanks, governance, and informed consent. I've been working on these issues for many years in the United States. I am a faculty member at Vanderbilt University, where I co-founded the Center for Biomedical Ethics in Society. I'm also a general pediatrician and a law professor.
0:24
So the outline of my talk today is that we will first talk about the structure and governance of biobanks. We'll talk about where the data and biospecimens come from. We'll talk about who the downstream users are and how much control individuals can and should have. And then we'll close by talking about the impact of the debate about return of individual research results on how biobanks and biological research goes forward.
0:54
So what's in a biobank? We tend to think about it just as the biospecimens or the information that's derived from them. Typically, biospecimens are finite. If you have a tissue sample or a leftover blood sample, there's only so much of it to go around. The exception of this, of course, is for cell lines, where you actually take a group of cells and then you immortalize them by transfecting them with a virus. And we also have in biobanks a variety of approaches to genotyping, ranging from just looking at variants in one or two genes, to looking at various panels for looking at genetic variation to increasingly thinking about whole exome -that's the part of the genome that's actually transcribed into protein- to the whole genome itself, which includes all the regulatory elements and the other things that we're just beginning to understand. But the important thing to recognize is that biobanks contain a lot of other information as well. And that's because most genetic research is actually devoted to seeing how genetic variation affects health and disease. And so as a result, we have to have a lot of other information about the individuals whose biological information we have. And this includes not only their health, but increasingly can include information about where they live, their environmental exposures, their behaviors, whether they smoke or drink or exercise or eat healthy food, a variety of other information. And this is really important as you think about biobanks and how they're organized, and what the potential risks are that attend these biobanks.
2:45
So I want to begin by sort of setting forth a taxonomy of biobanks that helps us understand the various levels of inputs and outputs and why they matter. So where do we get information for biobanks from? We certainly get them from clinician investigators, physicians or advanced practice nurses who were engaged in research and who collect information about their patients. We also get inputs from researchers, people who don't necessarily have direct patient contact, but who nonetheless collect information through research protocols that include both information about genetic variation, but also many other things about patients. And then we also have residual samples and data. It turns out that when you have surgery that pathologists are actually required to keep samples for various periods of time. People have blood samples taken all the time. There's data collected in their electronic health record. All of this is collected not primarily for research, but rather primarily for clinical care. It then goes into a biobank. And there are a lot of variations in biobanks that I'm going to turn to next, that turn out to be very important for how people think about them. Whether they are locally controlled or whether they're shared. Where they're located: Are they located in people's health care institution? Are they put in national databases? Who gets access to the information? Is it controlled? Or is it available for anybody to see? And then we think about of a variety of downstream users or researchers, who could be located in universities, can be located in the commercial sector, can be located in the government. And so we think about these as well going forward. So the next thing I want to do is to talk about biobanks and the variations there and how they matter going forward.
4:51
So the first issue is, who's involved in governance? Is it just federal employees? This is the case, at least in the United States, for nationally controlled databases, such as dbGaP, other things like that, which as a matter of federal law can be overseen only by federal employees. It cannot involve individuals who are outside the federal government. If the biobank is local or in an institution, it can have a variety of institutional members. And it can also have a variety of community members who may be involved as well. And we see many, many variations on this theme, ranging on what exists in academic health centers to what exists in entities like the Genetic Alliance to entities, private entities, like 23andMe. So it matters. And there can be many variations on the theme about who's involved in governing biobanks. Issues in governance that surround stewardship of biospecimens. Remember that I said that biospecimens by their nature are limited for the most part, except in the case of cell lines. That means that you only have a certain amount of it. And so then you have questions about who gets access to the specimens? For what purposes? Is it really good science? Are you really going to be getting genomic data that you can feed back into the biobank? Or is it a more 'open access' system? Now once you get or transform biospecimens into data, once you do, full genome sequencing or various genetic tests, the data themselves are not limited. But at least for the biospecimens itself, you have to think about 'are you making the best possible use of the biospecimens?' A major issue is control of access. Are you going to control access or not? This is, as I said, there are some biobanks in the United States where the access is not controlled, like the Personal Genome Project. That once the data is out there, anybody can get access to it. They can do whatever they want with it. Many biobanks, both in the federal level and in the institutional level, are controlled access. One of the reasons they're controlled is to make sure that there are mechanisms in place that think about having researchers be responsible for the work that they do. Are there are penalties for misuse? This can exist only in a controlled biobank. But the questions that remain are 'can misuse be detected?' For instance, at Vanderbilt we have a very large biobank called BioVU, where we not only require a data use agreement, but where we have robust mechanisms in place to detect whether people are trying re-identify people in the biobank or not. That misuse may be harder to detect in other kinds of biobanks. And then what are the penalties for misuse? Again, going back to BioVU, we have a policy that if people inappropriately try to access these records that they can actually have very serious penalties. Other biobanks have lesser penalties, for instance, losing access to the biobank or potentially losing access to federal funding. So as you think about issues in governance, you can see that there's a whole array there about who's involved, what kinds of controls are there and downstream use, what penalties are there for misuse.
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Biobanks, governance, and informed consent and individual control - a view from the United States

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