By CRG staff - interview with Anita Allen

In October, the Presidential Commission for the Study of Bioethical Issues released a report titled Privacy and Progress in Whole Genome Sequencing, addressing individual privacy concerns arising from whole genome sequencing in clinical care. The full report is available at

Anita Allen, JD, PhD, is an appointee to the Presidential Commission for the Study of Bioethical Issues, and Henry R. Silverman Professor of Law at the University of Pennsylvania Law School.


GeneWatch: There is a lot of focus in the report on surreptitious testing-is there any particular reason to emphasize that rather than other issues like, say, biobanking?

Anita Allen: I think the examples of surreptitious testing that we mentioned in our work are so interesting that people often focus on them, even though they were just a part of what we were trying to bring to the public's attention. As you point out, surreptitious testing is one problem that makes it so important to have a good system of rules and ethics; but we are, I would say, more concerned or motivated by the problem of testing that's done in an orderly, lawful way for either clinical or research purposes, which nonetheless raise questions about data. What happens to the whole genome sequencing data that's produced from research or clinical care? Who has access to it, under what conditions and with what grounds of consent?

Obviously the report is addressed to the Administration, but beyond that, who else do you hope reads it?

As you say, the Commission's report was presented to President Obama, and that's our primary audience, the President and his advisors. But we have been very interested in being in a dialogue with various branches of government-the National Institutes of Health, the Department of Health and Human Services, and other agencies that may be involved in biomedical work and research. So the entire biomedical community, government and private, is really our audience. We think everybody should be mindful of the consequences of the new challenge of whole genome sequencing data collection, storage and sharing.

Have you been surprised by any of the response you've received since the report came out?

Well, the overwhelming response to the report has been extremely positive, from just about every sector. Not everyone is happy. In an unofficial capacity, as an advisor to an organization called the Electronic Privacy Information Center, I became aware that Deborah Peel, who is a very prominent patient rights advocate, is a little bit concerned that the report doesn't strike the right balance between protecting privacy and granting access to third parties. I think that from her point of view, the welcoming attitude that the report takes toward a collaborative research community working in tandem with the public to further medicine-that this might not be the most privacy-protective point of view.

That aside, I've been impressed by the large number of official communications that we've received from all kind of people, journalists like yourself and various agencies and so forth, praising the report for its proactive examination of this very difficult issue.

These aren't issues that you hear politicians bring up very much ...

Right-it's not stem cell research, it's not abortion. I think that's a good point, because it reveals a problem with our society which, in my view, is that a small number of highly contentious ethical issues command a disproportionate amount of the attention of the public; whereas we are soon to be a society in which, because of genetic testing in research and clinical care, and electronic medical records, we are facing a huge question: Who is going to have access to all of this information? What about medical information stored in the cloud? What about medical information that's subject to data breaches?

One of the strengths of our report is that it addresses the question of whole genome sequencing in a context which understands that not only are we engaging in whole genome sequencing, but we're also storing medical data in the cloud-third party entrustment is now the name of the game, we're not all just keeping medical data on our office computers or office servers. There's the problem that medical breaches are happening, so even if you don't want data to be exposed, sometimes by accident, or because of hacking, data gets exposed. The Commission, I think, properly recognized that among the reasons that we have to worry about whole genome sequencing is that the total information environment right now is one in which there's a lot of social networking, a lot of cloud storage, a lot of data breaches-but also a lot of technological capability to provide secure and safe management of very sensitive data.

Some of the examples of privacy breaches that come up-hypothetical or real-life-can be startling to think about. Was there anything that came up during the process of putting together this report that was startling even to you?

Well, I have been writing and teaching about privacy and data protection since before the Internet, so there's very little I find truly surprising! The kinds of things that are happening around the country are often stunning-everything from employees of hospitals who post to MySpace pages condemning a patient because she has an STD, to nursing students publishing pictures of themselves with placentas on Facebook, to billionaires surreptitiously testing their wives' lovers-some amazing things are happening out there. There's so much going on out there that's pretty stunning, even if I wasn't personally stunned or surprised.

I was just glad-glad that the Commission had the foresight to address a very cutting edge privacy issue that allows us to reflect more broadly on why we still hear about privacy in the age of revelation.

The Commission did not learn about any startling whole genome sequencing privacy breach.  This report is a proactive look by the Commission. The Commission searched for a specific example of a grievous privacy breach of one's whole genome sequencing information and fortunately did not find it. However, given how quickly the scientific community is working to bring down the cost of whole genome sequencing, the Commission recognizes that whole genome sequencing and its increased use in research and the clinic will raise such ethical dilemmas if the proper privacy protections are not put into place.

The promise of whole genome sequencing is dependent upon widespread public participation and individual willingness to share genomic data and relevant medical information. Researchers need genomic data and corresponding health information from many people to determine what genetic variations mean. However, the Commission concluded that without respecting and securing interests in privacy, individuals will be less likely to voluntarily supply the data that have the potential to benefit us all with life-saving treatments for genetic diseases. The Commission recognizes that confusion and uncertainty tend to erode trust, and that trust is the key to amassing the large number of genomic data sets needed to make powerful life-saving discoveries. Without the appropriate privacy protections, progress will be slowed.

One of the recommendations in the report that I was pleasantly surprised to see was the one stating that all citizens should benefit from the advances of whole genome sequencing.

Yes, that's an important point. It's not good enough that people who are attractive to researchers "get" to have their genome sequenced, and it's not good enough that people who have the insurance and the capacity to have genetic data used in their clinical care have that benefit. Think about it: If people are being encouraged to share their genomic data with researchers, yet the benefits of that research are not broadly distributed across all classes of people, all ethnicities, all regions of the country-that's an inequity. Among the most important bioethical principles is the principle of justice. So we thought it was important to emphasize that with all this data sharing going on, the benefits should be distributed broadly to include all classes of people.

The informed consent recommendation is also very important. It's really important to think about informed consent here in a new way, because when you are sharing genetic information, you are sharing information not just about yourself, but about your genetic family. People need to understand that, and to understand the consequences that can befall themselves and others if they choose to share that information. We need to have an informed consent process that takes into account not just whether an individual wants to partake in a particular research protocol or clinical opportunity and to share the data, but also whether they understand that it means facts about other people will inevitably be disclosed as well.

Is there an underlying assumption in the report that whole genome sequencing will be transformative in medical care?

Well, I believe it will be transformative-not just another tool, but transformative. I see this as the future, where a number of important decisions about clinical care-whether to have surgery, whether to have chemotherapy, whether to use drug X or drug Y-will be based on precise genetic information and not on guessing or overkill. It will save the health care system money in the long run, it will save patients unnecessary treatment, and we'll all stand to benefit.

We talked to a number of experts in the field about the promise of whole genome sequencing, and every single person believed that this technology will help us to eventually uncover and predict and treat conditions in a much more effective way than we do today.

Some people worry that if the privacy concerns are overblown, it will get in the way of progress. Was that idea taken into account in the way this report was developed?

You know, there are people who will say things like "privacy impedes progress." Some people say privacy impedes research, or national security, or law enforcement. I'm of the opinion that the opposite is true; that because our society respects privacy through both law and through medical and research ethics, we have an environment where people are more willing to participate and to trust. In the health care field, trust is absolutely essential. People won't go to their doctors or engage in research if they think that sensitive information about them is going to be passed along to third parties without their consent. By promising confidentiality and privacy, and by sticking to those promises through rigorous programs of data security, we are actually securing the bases for medical advances. Far from standing in the way, privacy actually provides a context in which people can comfortably utilize the health care system and comfortably participate in health research. I mean, who would take part in health research if they thought that everything about them is going to wind up in some public database on the Internet? Privacy, anonymity, the whole process of anonymizing research records, the process of providing for confidentiality in face-to-face encounters - these are conditions that make it socially possible for us to utilize the health care system and participate in research.

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