 Alright, thanks. I have a, as you can see, a large topic to cover, and I do want to acknowledge the help of the co-chairs for the current CERC work group, Ingrid Holman, also for the Consent and Community Consultation work group in Emerge 1, Ellen Clayton, who were both helpful with this presentation, as well as the work groups themselves. So I want to cover briefly things that we've accomplished in these work groups, because I think that's been a fair number of things. And one certainly that's been mentioned over and over is issues related to biobanking and consent, and a couple of the things that we've done is developed model consent language, which is online with NHGRI. And currently, with the new arrival of our pediatric biobanks, we have continued working on model consent language, but really for pediatric biobanking model. So that's currently in process and making, you know, I think there are a lot of interesting issues that are different, and so it's been good to get that going as well. I think another large area that we've worked in is developing a framework for addressing return of results within the network. And in Emerge 1, we looked at this as an issue that we would be dealing with going forward, and certainly as part of the GWAT studies, there were results that many of the groups debated whether or not they were returnable. And so really the work of the group was to set up a framework that other networks, as well as Emerge, but similar networks could use and adopt for themselves in ways of addressing what was returnable and how to think about actually doing that. And that was actually published paper as well. Other things that we have worked on across the network, both at our individual sites, as well as in group activities, was to engage stakeholders related to a variety of issues, issues that we were dealing with in Emerge 1 and 2 to inform our further discovery and science-related issues. And I think some of those have been biobank governance and consent, which led to a group paper, data sharing and related privacy issues, return of results, the value of genomic research, integrating genomic data into the electronic health record and clinical decision support, which led to recent paper as well. And in all these engagement activities, we have worked with a variety of different stakeholders, which I'll address a little bit later, but from the patient and the public on to clinicians and other types of health plan and administrative stakeholders. So there have been a variety of different people involved. We've also worked on educational methods for patients and physicians about genomic medicine, which is at a critical area for moving genomic medicine into the clinic. Some of the areas we focused on have been working with the clinical decision support, getting education at the point of care to physicians, patient portal, developing materials for those, and sharing those across the network, as well as a patient website. So those have been some of the things that we have developed. We have assessed, and this was particularly in Emerge One, the application of data sharing guidelines within the network. And that's obviously been a critical piece for our work with electronic health records, sharing phenotypes, and other types of data. And we have looked at how our varying institutions have applied oversight to those guidelines and recognize that there has been a gap in knowledge around oversight for data sharing, as well as consenting issues related to data sharing, and how those issues are enforced. And so we have done, looked at that quite a bit, as well as just review across our institutions of consent, particularly for the pharmacogenomics project and how varied that ended up being. And one of the other large things that I'll mention is that we've obtained supplemental funding for a survey that we are conducting across all of our tenemers sites. And that's related to the notice of proposed rule making, and we are focusing particularly on the acceptance of broad consent in bio-banking research, as well as public views on data sharing. And we hope that this project will inform a number of bioethics and policy issues going forward, particularly related to this rule. And I think it's a unique project similar to our PGX project, in that it's similar across all the sites. But I think what's more unique about this project is it's almost exactly the same at every site. And the type of project doing a survey demands that kind of methodology, and so I think we're experiencing what it's like to conduct something that's the very same across all of our institutions. So that's been something that has been a learning experience, as well. But I think we'll contribute to a lot of information going forward. So some of the things that we have learned that I want to mention is the role of LC projects in our merge work. And we've already mentioned it numerous times today in this meeting about engagement, role of consent. And I think that it's clear that in the preclinical discovery phase, going towards implementation, that the LC work is critical to all of those stages. We've also certainly seen that community and stakeholder consultation is essential for this work, particularly as we move towards implementation, that it's impossible to do this without stakeholder engagement. Consent for genomic research is many strategies. Educating stakeholders is a critical aspect, oversight and consenting, and the importance of interacting with other networks and investigators. And finally, what we have to offer in this area. So our future directions, I think in terms of where eMERGE3 can go, we would like to see the integration of bioethics aims into our scientific studies. And I think, as I mentioned, that's become clear how important that is as we talk about implementation. Assessing the impact of genomics medicine, there is a lot of room for looking at healthcare systems, for payers of healthcare services and tests, other stakeholders, administrators, health plan administrators, as well as patients and providers. And again, when we look at the impact on patients and providers, these are the right kinds of outcomes to look at. And I think that's a big question, particularly we've noted in the PGX project. Continuing to engage stakeholders, evaluating, assessing new models for consultation, developing breast practices, and examining the role of stakeholder preferences and developing policies in this area. Continue to look at consent, assessing our model languages and developing new models for consenting. EHR and clinical decision support, assessing point of care education, using those clinical decision support tools, assessing when is clinical decision support useful, what policies and processes need to be in place for genomic data to be entered into the EHR, and how do those policies affect individuals. And finally, because I'm a genetic counselor, I would be remiss if I didn't say anything about family history. And so I think thinking about family history data in the EHR is, I think all of us around the table know how poorly that's gathered, and I just want to put a plug-in for the importance of thinking about that with integrating that into our electronic system. Also engaging in educating IRB panel members and other institutional officials about genomic medicine and research, and that we can see how variable that is, and it's so critical to moving this type of work forward. And also, exploring new models for supporting physicians and other healthcare providers and clinical decisions around tests. We've identified clinical decision support, but I am sure that there are many other models, or other ways of working on that, as well as other models for patient and public education. Okay, thank you, Maureen, and we'll go now to the designated reactor, and it'll be Wendy Chun. Hi, can everyone hear me? We can. Okay, very good. So, next slide, please. So I think one of the things that's emerged over the discussion this morning and this afternoon is that Emerge 3 may be at a point of some changing in terms of information that may be obtained in terms of sequencing and potentially decisions to be made in terms of what information will be returned to participants. So just some thoughts in terms of thinking about how that may change over time and realizing that the next section will be on return of results and so not wanting to seal that thunder. I think the research community, when we think about samples that have been collected before the area when they were consented specifically with the idea of doing these comprehensive exomer genome sequencing, I think I'm going to bring up a couple points to this, but I think one of the things the community has realized is that there's no single correct solution in terms of approaching the things that I'm going to talk about. And so just because Emerge has so many different sites and some of the issues may be site specific, well hopefully there will be consensus and common methods of consenting, educating the community. I just encourage everyone to realize that there's not necessarily going to be one standard answer that absolutely every site must fit. And so just realizing that local community representatives, local IRBs may have issues with this, hopefully there can be some guidance in terms of Emerge in terms of governance overall. But I think to realize that there may be local issues is important to understand and to acknowledge. One of the things as we've, at Columbia we've actually done some surveys of the research community both in terms of online surveys as well as semi-structured interviews. And as we've done that, trying to think about this issue specifically of samples that were collected before this genomic era of whole exome genome sequencing and then what to do about return of both incidental findings as well as return of individual research results. One of the major issues that came out of surveying the research community over 250 researchers was that there seems to be quite a bit of variability between the IRBs. Variability both in terms of knowledge and expertise around genomic issues and quite a bit of education that needs to be done. And what we are hearing recurrently is that the same issue different IRBs would in fact have different rulings on this and that these issues hadn't been specifically addressed in the original consent form that it was very dependent upon local IRBs, their composition, their understanding of this information. And so just in reflecting in a position where Emerge 3 may be, I hope that it's an opportunity to study that process. In fact to gain some experience and some understanding about what may lead to some of these local differences as well as potentially the opportunity to develop centrally materials to educate or materials to be able to explain this to IRBs because where there should be more consensus that is building, hopefully it's not just simply doing this understanding of simple sort of medical and genetic issues in terms of this. So I think that's something that if Emerge is able to do that it's a more sort of it's a broader issue across the research community in terms of how to deal with this and in fact just because there will be ten sites to be able to do this across could provide some really useful information in terms of the larger community. Next slide. Next slide please. Thank you. So in terms of consent, one of the issues with consenting has been across many smaller studies that again, consents largely didn't address some of the issues that may start to emerge. And so thinking about this and thinking that there may be different ways of dealing with the consent, there's again I just urge people to think about there may not be one size that fits all for this. Clearly just over time what participants may have been expecting may have changed so that when many of the Emerge participants original and consented they nor we I think we're thinking about some of the things that are possible to know from the genomic information and so they although they may have signed a very broad sweeping consent may not have thought about some of the details about what's now possible to be returned to them and so again thinking about how to educate the community about that either retrospectively on prior consent to patients or prospectively on newly consented patients really is going to take some creative ways of educating the community about this. So many people thought about how to be able to approach this in the standard written consent unfortunately is not the most effective way of educating our participants and so one of the things that many people have thought about doing is having either video educational materials or online resources things that participants you know can be able to go to with the online resources be able to take deeper dives even potentially and be able to go back to it iteratively over time even you know speak with other family members or other valued sources physicians or other health care providers to gain more information but that material can be very useful and one of the things that we've learned in doing that process is that it needs to be very accessible and that some of the very complicated things that we'll do in a genetic counseling session for instance may not be what you would want to include in one of these very broad educational sessions when talking probably about different types of results that could be returned and again it is possible especially with this online education to provide deeper layers for individuals who really want to get into it but realizing that many of our research participants if we give them all that information up front don't even they literally tune out they get saturated by this information and really can't absorb a lot of the critical details and want to know what more on the need to know basis when it's something that's relevant to them and then dive much deeper when they know that it's something that they really need to pay attention to and tune into so in thinking about that some of the different groups have thought about a staged consenting process or staged information process that is the original time one participant's consent you know may not be the time to overwhelm them will follow this information but it's more on the need to know basis and so as it comes the opportunity in terms of being able to think about return of particular results or situations that may arise being able to then give more relevant information at a time that's proximal to when that's relevant to them this also can be an issue for participants who have been enrolled many many years ago just in terms of their life stage what's happened to them over life their preferences may in fact have changed over that time period and so it may be relevant for them to rethink these issues you know at a proximal time to when it might be relevant to them one of the wonderful things about a merge of courses by many of the patient portals that are available that actually provides a lot of the infrastructure to be able to do that and it's something that again as we talk to the larger research community many many researchers wish they had that as part of what they could do to more easily streamline in terms of recontacting and reeducating participants I will say the one pushback we've heard from the research community about this idea of a stage consent however is that it may actually alert research participants if they feel as if they've been singled out during that process to alert them that there may be something you know that sort of lingering or something that they should be worried about and so as individual sites think about governance and how they might do this to just keep that in mind on whether they're going to do this in terms of a community wide effort or whether they're going to target or single out individuals might have specific information if you return to them next slide so I'm again going to try and focus on the LC issues in terms of the return of results rather than the next group they'll speak more broadly about this but again these can be very complicated and depending on whether or not this is done all up front at the consent initially or in a staged manner the issues can be quite complicated but it is in our opinion sort of necessary to be able to make these as streamlined and simple and sort of thought sweeping in terms of concepts rather than getting into too much of the nitty gritty one of the issues that will come across you know has come across a merge because of the addition of the pediatric population and again because it's gone on now for several years is that there are special populations in certain situations have just naturally changed over time so there are special issues when it comes to minors and what information and what sort of ability they have to provide their ascent into being able to have any information provided back to them and of course developmentally those children may change over time so that at one period of time they may be minors in the study and they may be of maturity later within that study and need to essentially go back and re-consent those individuals and clearly the pediatric sites have been thinking about this. In addition individuals may actually have differences even in their vital status there may be individuals obviously who are deceased over time but that information could still be potentially quite important to other family members for hereditary conditions and so trying to incorporate and think about that in terms of the consenting process for return of results would be important to do as well as individuals that may lose cognitive capacity over time again thinking about a healthcare proxy who might have a vested interest in that information and how that might influence in terms of information being returned. Another issue that frequently comes up is with such large biobanks obviously there are many, many different users of that information and in terms of governance realizing that many of those secondary users may not feel the same sense of obligation in terms of annotating or returning that information in its detailed way and so individual governance at each of the sites will be important in terms of being able to coordinate return of that or annotation cataloging in detailed ways from some researchers who in fact are expert in terms of understanding that but may not necessarily be motivated in terms of prioritizing for that return that will be important for the central sites to be able to do. If I could just go back I think I didn't quite finish with that slide. Thanks very much. And then an issue that will be coming up as again you make some decisions in terms of what sequencing to do. Again we discussed the ACMG guidelines in terms of mandatory return of results. That'll be I'm sure a very hot area of discussion with an emerge to try and decide whether or not to what to do in terms of that policy. But just to realize that again I would urge to realize that the clinical requirement that we have in terms of return of that results may not be necessarily what gets adopted in terms of return of research results within that. Again it's already been mentioned but just to emphasize there's a tremendous opportunity to be able to educate providers sort of on demand with the info buttons and other information and really to just emphasize that I think Emerge has a tremendous opportunity here in terms of implementation to be able to figure out best practices and essentially disseminate that throughout the rest of the clinical community because I do think you're going to have the ability within different EHR systems to be able to figure out what works and that really is going to be tremendously valuable to others next slide. And I'll just wrap up by saying that you know being able to do this is you know really invaluable to emerge and it's clearly what many of the rest of those of us outside of Emerge would find useful and to be able to just as you're thinking about doing all of these things to be able to collect data on the process as you're going through and to learn from this I think is going to be tremendously valuable and to realize that there may be some as well regulatory issues that come up clearly the FDA is starting to think about how to regulate some of these and so there may be things that will come up as obstacles but hopefully not barriers in terms of implementation. And I think that's my last slide. Thank you so now we'll go on to read Pirates as the for the summary.