[MUSIC] I'm Robin Wilson. I teach at the University of Illinois College of Law where I direct our Epstein Health Law and Policy Program as well as our Family Law and Policy Program. Some pieces of my talk you'll see we'll sort of straddle those two areas, although much of it will be sort of law and science and health law in particular. Okay, so I want to talk then about the legal and ethical issues in the era of genomics and in many ways what we've seen is a field that has developed at warp speed. And it's out stripped the pace of the law, or at least the willingness of legislators to keep up with some of those developments. And we can talk about why that is. So if you look at the slide, you'll see that basically all of this progress has been sort of truncated since 1970 when Frederick Sanger developed this sort of DNA sequencing techniques that were going to give us the human genome. And the ability to map it and discover that in individual people, to the US Department of Energy, developing an early genome project. And then of course, NIH and DOE receive funding from Congress in 1988. And then between 88 and 2001, 90% of the human genome is sequenced and published. And then we have, in 2011, it's just one marker, the National Center for Biotechnology Information takes the genomic sequences, the entirety of sequences for different organisms, like 151 different bacteria, as just one example. Now what does that mean for us? It means that to some extent, you have the potential to determine an individual's susceptibility to disease or to health conditions or their health status. To discover it from tests that they might actually be getting for all kinds of other reasons. It could be diagnostic test, it could be a comparison of an individual's genetic sequences to other people for example, think Ancestry.com. And one of the specific issues that's very difficult is when you have a marker for a disease. It's not the set or sequence of genes that cause the disease. It runs in parallel with that disease. And because of the way DNA recombines, sometimes, there'll be a break between the marker and the disease-causing genes themselves. Someone might have the marker and actually not have the disease-causing genes. So there are all kinds of fairness issues and risks related to uncertainty as result of that. Now we like to think about the human genome and everything that we can do to discover a person's sort of genetic content as somehow new, and not having been done in the past. And yet we have been doing newborn screening for all kinds of things for decades. And the state has mandated those screens for 30 heritable, treatable diseases. Now that's important because if it's a metabolic disease, think of child who just needs to have a particular thing in their diet without which they would be mentally challenged. Obviously, we want to figure out what that is and to treat those children within the first weeks of their lives. Later when we look at the risks of informed consent, particularly in the human subjects context where some of this work has been done, we'll talk about a person named Jesse Gelsinger who was born with a rare liver disease. That might be discoverable at birth and we have used these techniques to discover things like PKU for decades. What's different and new is that we can discover things now that are not treatable. In other words, we can know something about a person that has implications for their lives, across their lives, and sometimes for their legal rights, for example the ability to be employed, where there's nothing that can be done about it at all. And I think that raises a host of new issues. So think about the BabySeq Trial. Okay, this was a trial that investigated the use of human genome sequencing in newborns. So they took 240 healthy newborns at Brigham and Women's Hospital. And then they took newborns who were from the NICU at Boston Children's Hospital. And half of the babies were screened and have their DNA sequenced. And half were only screened and not sequenced. Well, the point here was to diagnose disorders and conditions that were both treatable and importantly non-treatable. So there, when you have a non-treatable disease, especially if it's one that is going to have cataclysmic outcomes for you across your life, think Huntington's Chorea, okay? A person who frequently, the natural history of that disease is that a person in their adulthood, think 40s and 50s will have a reflexive chorea that's completely uncontrollable. Frequently, it ends with them gagging or dying by having choked on their own tongues. Now if you once sequenced that in a child, do you then need to tell that child about the fact that they may at the end of their lives, if they live long enough, their going to die from Huntington's chorea? That's the basic idea. Once you tell them that, you've armed them with information that potentially they have to disclose for all kinds of reasons. Not least of which is insurance status or employability because employers may have an interest in, for example very high value employees remaining alive. So they might take a different look at a person if they knew that this was a potential thing. Okay, so then where are we with risks? We can sort of think across these risks from this sort of fairly young scientific discipline in sort of several different ways. We can think about property rights, so do you have a right in your tissue, for example. We'll talk about that first. Then this question that I've already sort of been hammering which is what do we need to tell you about the things that we find. Or even about the test that we're going to do and whether they have the ability to discover something that might be legally meaningful. Or maybe even not legally meaningful today but would have some meaning in the future. Then of course that tees up a whole set of questions that probably have been dealt with by others in this course about privacy. So I'll talk a little bit about personal health information. Talk a little bit about genetic information and the boom that the Feds are putting down on disclosure. Especially with new penalties that are much more robust than they've had in the past. And then we'll talk a little bit about ethical dilemmas.
