 So as a person who Who's I you know a straddler because I you know start I come to this as a rare disease person you know as some of you know and then I become a pharmacogeneticist and then I become a sort of a Hanger on in the GWAS community. Let me just put it that way So I think that that's a really nice way of thinking about boundaries Which is what this panel is supposed to be about and I have lots of thoughts about boundaries But but here's one that I don't think we've talked about very much and and I don't want to belabor it again and that's the boundary between clinical research and patient care one of the appeals of working in the electronic medical record as a research environment is that it blurs that boundary and And we've talked about for example deploying whole genomes or pieces of whole genomes into the electronic record as a As a tool for clinical care And I think we have to recognize that we we open a whole Pandora's box when we do that and those are research questions And I don't want to draw a boundary between research and clinical care But I think we're in a new era so Pearl's last slide with the with the with the with the sort of Circle the circle. I'm not sure I buy the circle. I'm not sure how I would redraw it But but when you're taking care of a patient you're taking care of a patient at the clinical level and you're taking care of a patient Who may also be a research? Subject at the same time and you may be blurring those those those boundaries, so I Think that that's not a wine That's a great opportunity and the opportunity really is provided to us by the development of a sophisticated electronic medical records and other very very High-dimensional data that's beyond any human beings ability to handle that without the ability without without the help of a of a sophisticated Computer support system, so so I think that we're at a place where straddlers are really important I agree with that. I think we're at a place where some of the boundaries get blurred and that's a good thing We do need to train people and I'm not sure how to do that I don't see very many clinical geneticists on the wards So who are the who are the models for the internal medicine folks? I don't know about pediatrics and And and I'll leave you with the thought that I I can't believe they pay me to come to work every day It's a really exciting time despite all the sort of doom and gloom that you hear about it So I think this is an opportunity to really to change the way medicine is practiced and I have to say just one word in defense of my circle Number one not a lot of thought went into it secondly The only thing I really wanted to point out was I think we too often talk about Going from research into clinical care And I just wanted that we really have to set up our clinical care system that can act as a resource for future research So you could fill in that circle and then make everybody happy Back and forth exactly exactly now you like the circle, huh? Yeah, okay Question for you over here When this point has come up in other settings And I don't ask that you represent the entire bioethics slash LC slash IRB community Oh, thank you when it comes up There are a number of people whose hair catches on fire if you were to put that little diagram up with the two arrows on it Because they start going on about the therapeutic Misconception and that there needs to be firewalls between clinical care and clinical research And so I wonder number one How you read that the larger situation of that Setting and then number two is this question of the boundary between clinical care and Research on the agenda for the advanced notice of proposed rulemaking and can you tell us a little bit about that? For your second, I would say no, I really don't think the advanced notice addresses this in a You know might be snippets, but I really don't see it There certainly not the research into clinical care issue. I do not see that But it's too bad. It's it would have been a great opportunity in terms of is this on the radar screen Absolutely the four days prior to this I was at the premier meeting which is public responsibility to medicine research kind of that Sort of trade organization for IRBs and I have cooks and all that Which gets 2,500 people and I would say 20% of the topics were genetics or genetic related and A lot of it is how do you get consent? What do you do with the data? We all realize the electronic medical record is becoming very Kind of users of for everyone. So yes, it is on the agenda I don't think anyone knows what to do with it and I do think in terms of people's hair going on fire There is the huge concern of therapeutic misconception, but I think there's different kinds of research I mean, and I think while I agree. I think we really need to merge as much as possible There still is a issue if you're in a therapeutic clinical trial. I am I am making my decisions about you per protocol Not because of the specific things that you're coming into me for and I think that is a huge difference between True clinical care versus research. I think so there are Types of research. I think we have to absolutely protect that. I think as we merge data I think we do have to protect the stuff that really doesn't have any utility but it's important for someone taking care of that person maybe for You know some other medical problem just to realize that person actually isn't a research study and you know Maybe he's getting a research. There's so many issues. I think that interface has become so difficult Again, we're looking we're using 1970s regulations And I almost think we need very different regulations for different kinds of research I think genetics is pushing it almost because of volume. I think so I think this is actually an opportunity I mean, I don't you know, try to just do the extremes here. I think most of us live in the middle We've got to find some way of making that middle Defineable so that my bill is at least, you know, sort of like yours so we can communicate And I think that discussion is starting to happen at not this year's premier meeting but last year's premier meeting There was a panel that actually happened to participate in that talked actually about You know the use of electronic health records and how that, you know, is going to really push together both the two-way communication between research and clinical education and For at least there were about 200 people in the audience. I think for that permer session One of the well-attended ones and there was universal agreement That's a topic that permer needs to spend a lot more time discussing Yeah, we actually we also had a great debate between Jim Evans and Robert Green on whether or not action ability is a criterion to you So I mean, we're mirroring some of the same discussions here, but to a very different group. So I think that's good Pearl, well, I agree with you that I think So, you know, most people when asked about use of their genomic information in research do ultimately say it's okay I think certainly publications from Amy McGuire and Wiley Burke established that people Want to be asked even though it's okay and I think that gets to the problem with the newborn screening bloodspot cards with regard to lawsuits in Texas and Minnesota in that People wanted to be asked so the storage of Newborn screening bloodspot cards at least in Texas had been going on for many years it was actually codified in state law and then Department of State Health Services rules and the procedure For which the research or the procedures under which the research was done in Texas Followed federal regulations and again department rules. So I think that in moving forward with genomics research I think we just need to be very mindful and very careful that Even when we're following federal regulations that that doesn't preclude people from getting angry or filing lawsuits or you know staging a social media revolution with regard to this particularly particularly I think in this Era of waxing and waning distrust of government, you know, it is I don't know if I can say this in HGRI sponsored Thing but you know, I think that this is something that you know And we we saw this in Texas, but it's I think it is generalizable and that this is something that politicians can make a lot Of hay over right that they can look very good by saying, you know Your government is like taking your genetic information and I'm gonna introduce a law that's gonna stop that so I think that We as a community just need to be very careful moving forward about engaging the public And not just saying well, hey like I followed the you know letter of the OHRP rule I think you're absolutely right in terms of people want to be asked and then Asked or if I had the world I would notify. This is what we do and this is why we do it But then you immediately get the problem of those people want to opt out and how do you handle that and in our systems, you know We can't it's hard to deliver on opting out throughout the entire, you know system Well, I'll tell you that that's what the state law in Texas that was so in order for them to drop the lawsuit because again The the our state lawyers felt like this was absolutely something that they were not going to win in court even though You know again, there was nothing that they could point to that was Illegal or didn't follow federal regulations and so I mean I think that we had we were forced to implement and opt out So everybody who gets a new board screen in Texas now gets piece of paper About, you know, and they have to be talked to about opting out And it is costing a huge amount of money just for the personnel to process that even though it's a Tiny fraction the fact that we have four hundred thousand live births in Texas every year means that you know the personnel and The money to kind of go through those pull the cards destroy them and send a letter back Say and yeah, we destroyed your bloodspot card is not insignificant And the last thing I'll say is how much we talk about Consents opting out etc. You know two days after it happens people can't remember they signed anything let alone what it said so Yeah, I think there's another But and maybe this is just obvious for for everyone here, but You know one of the issues relating to blurring is that in clinical care you can really do anything you want and This is most frequently In the situation of off-label use of drugs I mean pearl and I both trained as pediatricians everything we prescribe is on off-label use of drugs The studies haven't been done and yet it's accepted clinical care The point that I'm making is is that we shouldn't necessarily hold What we're doing to an extraordinarily high standard compared to everything else that occurs and in the clinical care environment We meet need to be cognizant of it We need to be thoughtful, but we shouldn't necessarily again create such an exceptional environment that in the long run It's going to prevent smart people from doing innovative things with information that ultimately advances knowledge and we've seen that repeatedly in the You know novel use of agents that are out there through off-label with regard to the Patients just want to be asked paper I wouldn't want to criticize a paper that I'm actually a co-author on but I wouldn't just like to point out one limitation Which is that we you know these were focus groups and very educated Patients and you know to me part of the message was they actually don't care what we do But they appreciated being asked, but I'm not sure that they speak for everyone I will say I re-consented a couple cohorts now and For you know one cohort which was very largely middle-to-lower class the every single person who sent back the Re-consent Save one said that they wanted results return and they wanted they were perfectly happy with DB gap But a significant fraction of them did not want newsletters Don't bother with me the one other point that I just wanted to add to your Important discussion of the common rule proposed changes is that one of the changes is not just that tissues are identified But that genetics data is identifiable, which means that everything in DB gap is identifiable And so that's a very very important change and so for the people who didn't respond to that On the first round if you want to respond on the second round That's something that will really make all these kinds of databases that we really need and are talking about You know impossible as far as things for clarifying that because they don't exactly say tissues identifiable This is tissues identifiable because it has DNA that is identifiable, you know So that's their roundabout sentence on that Actually wanted to touch on that issue a little more So our hospital lawyers Have taken the opinion that DNA sequence is Identifiable information Therefore because we're a hip of covered entity it comes under a hepper also DNA sequence And while in some ways that might not sound like a big deal what it means is that all of the Computers that you use for sequencing All of the computers that you use for processing the data The systems you use for reporting it I Mean ignoring being able to share it beyond your institution All of those systems have to be certified hippocomplient Which is not a trivial undertaking for a genome sequencing analysis pipeline, which is what we've had to do And so I end the redundancy back up so the systems have to be redundant So these Things that might seem like a small thing actually turn out to be really big deals So as a clinical lab we are under those rules already But it does also have implications for data sharing But as a clinical lab we can share with other clinical labs providing we have the appropriate signatures But but but I think really as a community we really have to think about this implication of DNA Sequence whether it really is identified with information or not We've had that conversation. Luckily come out on the side of no You appreciate the problem, but not at this time I'm told on the last but I'm not going to talk about hospital lawyers, which I find almost an oxymoron, but It the the anecdote you'd described seems to me sort of a microcosm of a much bigger problem And that is this business of you know varying standards of whatever you want Across the country whether it's a hospital lawyer talking about DNA or whether it's an IRB that just you know Your IRB decides this but our IRB decides that it's not like one group is more ethical Than the other but it seems it that is a big barrier to to moving forward And I'll just leave it at that