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Is Biobanking Privacy Overrated? Is Reasonable Security Enough?

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At A Glance

Name: Michael Malinowski

Title: Ernest R. and Iris M. Eldred Endowed Associate Professor of Law at the Paul M. Hebert Law Center at Louisiana State University; co-founder and associate director of the Program in Law, Science, and Public Health

Background: Clerked for Judge Emilio M. Garza and Chief Judge Carolyn Dineen King, US Court of Appeals for the Fifth Circuit

Education: BA from Tufts University, JD from Yale University Law School

 

Biobanking is big business — or rather big science. It’s also a spark for ethical debates, and some see it as a privacy powder keg. To many researchers, it’s a big headache. But it’s nevertheless a tremendous resource that pharmacogenomics and other kinds of biological data are helping to fuel.

But does the increasing number and variety of biobanks, from tissue repositories to DNA banks, mean they ought to be regulated more thoroughly? Or is it enough to take at face value results from a recent NIH-funded study showing that a wide majority of individuals don’t mind having their personal information — their name, age, address, telephone numbers, and health history — linked with their genotype and overseen by the federal government? Are data in biobanks as secure as people believe them to be?

Today in the United States, there is no federal privacy laws for health or science research, though 25 states have their own regulations. Also, federal employees are shielded by a federal law enacted under the Clinton Administration.

All this has left bioethicists, legal scholars, legislators, and patient advocates, wondering whether there needs to be an expansion of the so-called Common Rule. The Common Rule is a short name for the Federal Policy for the Protection of Human Subjects, and was adopted by a number of federal agencies in 1991. Each agency incorporated the policy into its own Code of Federal Regulations. The Common Rule applies to human subjects research conducted, supported, or otherwise subject to regulation by the department of Health and Human Services.

SNPtech Pharmacogenomics Reporter spoke with Michael Malinowski, a law professor at Louisiana State University who wants to see the Common Rule expanded into a unified regulatory framework.

You had said that the Common Rule for biobanking ought to be expanded, and maybe the federal government should begin to regulate biobanking rather than have it be a state issue. Let’s talk about that.

What I believe is that the Common Rule should be expanded. There are all kinds of ways to make it non-invasive depending upon the actual consent you obtain, and depending upon the actual risk and the individual, and depending upon the actual benefits to the individual. We have in the Common Rule an application for biological materials, for example. If they’re anonymous, many people say — and this is not universal — that the Common Rules doesn’t apply. If there’s encryption, we say the Common Rules applies, but maybe you don’t need to have informed consent. (By Common Rule applying, it just means an IRB has to look at it to make a determination about whether or not there should be informed consent.)

When I say expand the Common Rule, I don’t say ‘Impose [Health Insurance Portability and Accountability Act] privacy regulations, or even informed consent. I think the opposite; I think you can apply the Common Rule well and work it out in a way that you achieve what the Common Rule says to achieve, but you do it within non-invasive ways. I think we do a lot more than what we’ve done [to ensure] patient protection under the Common Rule.

Give us a quick overview of the Common Rule.

What happened was the Department of Health and Human Services issued a set of regulations protecting human subjects. … The Food and Drug Administration came out with its own version, which is similar-it has a trigger, which is for federal funding; if there is federal funding, the HHS rule applies. The FDA version is triggered if there is data being subjected to an FDA application. So if it’s any kind of application like, say, an investigational new drug application or a device application-anything like that triggers the FDA’s versions.

What ended up happening was that a bunch of federal agencies that were giving money for research started adopting their own version of the department of Health and Human Services Common Rule. This happened through the 1980s. Ultimately, under the Clinton administration, it was decided that, across the board, we would apply the Common Rule.

FDA’s regulations are still out there; they’re almost consistent, but not quite. Under the HHS, it’s any federal money. Under the FDA’s … it’s if you’re going to ask the FDA to let this research happen, or if you will ask the agency to hand over a license that ties to that research.

There has already been some mention of bringing into this mix the IRB system. The IRB system we have in the United States is terribly flawed; it needs to be revisited. I don’t believe you should throw away the mechanism just because it’s not being done properly. I want to build up mechanisms that we have here, but that aren’t working eight now, and I want to use those mechanisms because they are familiar, and we have experience working with them. I want to use them as a basis for something more, and I think we need consistency, and I don’t want to do anything jolting and removed.

If you go back a century, and you look at all those doctors who had gathered their biopsies and put them in the repositories, they thought they were doing a good thing. And they were; they advanced research immensely. I think that we need to take an approach now that appreciates that things may get a lot more complicated than we anticipated as they go forward. And what I find is that if you do a blanket of regulation over a practice, and you do it in a sensitive way, and that you do it so that it is not invasive, and that it permits us to perform advanced research, you come up with assurance. And I think to get all the participation we need, we need something like that.

What is the goal, then?

I think the goal is to make sure that patient participation is voluntary, that research goes forward, and that the participation itself is informed. I’m not the biggest advocate, necessarily, of privacy. I think that, to be honest, for something like a biobanking situation, I think that the concept is oversold. I think that if we’re going to get a health-care return that’s meaningful enough and the loss of privacy for the individual is miniscule or reasonable because of the protections around it, I’m more than comfortable with that; that’s the way I go. I think privacy has been way hyped — especially by the bioethicists in the United States.

So you’re not surprised that a recent pilot study operated by the NIH and the University of North Carolina, Chapel Hill, found that some 80 percent of patients didn’t mind participating in study in which their DNA and personal information were to be linked by the federal government?

I’m not surprised at all. Down here in Louisiana, we have a charity hospital system, and I constantly read in the literature how African Americans don’t feel comfortable participating in research. And yet here in the Baton Rouge system, it’s one of the strongest selling features. The African Americans in the charity hospital system, from what I understand, say that patient participation is extraordinary. I think there’s a lot of stuff out there that’s common knowledge we maybe need to take a good empirical look at again. Especially things like biobanking, where the risks to the individual is going to be miniscule, because it’s really about numbers.

 

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