 Great, thank you. I am so much. I don't have slides. It's a fake I've already trashed four drafts of PowerPoints, and I'm violating my basic rule of presentation Which is if you don't have data use slides as a distraction, but here it is My comments are going to be focused primarily on through the lens of the IRB And by first raise a very basic question in the US. We have a very weird system of oversight of research Not all human subjects research has to be reviewed by an IRB. They aren't under the regulations So a question I think may be towards the LC folks Will citizen science research actually increase the amount of research that is outside the regs and The question they are Getting it published. Will that be the rule and force them to get an IRB or is this an opportunity for looking at another way of oversight? Okay, that's a throwaway in terms of IRB issues I would first like to remind people of some of the basics It is fun to trash IRBs. I know I am the recipient of that often times IRBs are part of a system. You can't just fix the IRB We live within a web of federal wide assurance issues federal laws state laws local regs Conditions of grant award that masquerade as regulations such as the new NIH genome data sharing policy and Institutional policies and procedures as well as local cultural issues The IRB has to listen to all of these. Okay. That's point number one Point number two the IRB focuses on their review on a protocol specific basis We don't go out and say hey, I think you're a good researcher. No What we do is we look at both the science and the study team If it's bad science It's harmful. If it's bad science is any risk at all justifiable for a participant I would say no in terms of the research team The team in aggregate has to have all of the appropriate expertise The team could be a single person this team could be many people the team could involve True investigators consultants ad hoc advisory groups. It doesn't all have to be investigators The study staff is considered by the IRB in the context of what each member is going to do in that specific protocol If I'm the PI I can't do statistics. I can't even spell t-test So I'm not doing statistics whereas the statistician should not be reading the x-rays My feeling is that the citizen scientists have to go through the same filter. They bring very valuable Pieces of information to the table. They shouldn't be doing statistics unless they're statistically trained They should again. What is the expertise they're bringing? So I think as we talk about this we really do need to talk about how do we keep maintaining the integrity of the science and the integrity of the team My third area the first was just that throw away the second was how the IRB views things Are there new issues? I think we've heard top we've heard many people refer to you defining the role of the citizen scientist And I think I'm going to mad I'm going to expand that a little bit saying Understanding maximizing and protecting the citizen scientist role. I think it starts with definition If you are doing research out of an institution this a research institution and if you are an investigator We have ways of dealing with external investigators. It's not always pretty It's credentialing. It's quarry checks. It's conflict of interest It's education if you're going anywhere toward a patient You're going to have a TB test and Lord knows what other infectious disease screening That is the price for being an investigator at an institution If you're a consultant or an ad hoc advisor, you kind of skip many of those issues So number one, I think is truly defining we are getting investigators coming in who realize that the importance of having Citizens involved in the research and they don't tell us what they're going to do So our first question is well, can you you know, so we're thinking oh, we want to maximize their potential Well, okay. Have a quarry check. I mean so I think it's very important that from the get-go What is the role the citizen scientist is doing and hence what is how does that complement the rest of the team? I think Potential issues that need to be looked at Avoiding undue influence of the citizen scientists. We have heard investigators say well, you know I'm so happy to have my citizen scientist on board. I'm a little reticent to question their input That is not a healthy or respectful system We have to avoid meaningless inclusion Okay, check got a patient on my study team all done I think that's the bigger risk and we really need to look at that I think we need to define who is the citizen scientist Is it an individual who is speaking for him or herself and some of these were already noted? Or is it the leader of an advocacy group who actually owns a for-profit company is coming in with their own agenda? Very very different. They all bring things but very different And I think there's some possibly new gnarly issues that IRBs are going to have to consider I just I just point out a few and I'm hopefully others can come up with other with others Well having a citizen scientist as part of the study team raised the potential of coercive recruitment Forceful recruitment of kindred folk you owe it to me. You have the same disease What do you mean? You're not going to be in this research saying no may be more difficult Will citizens who are not the citizen scientist, how are they feel about their colleague having access to their potentially Identifiable information. Is this a new risk that'll have to be considered? I think I Forget who commented on this with somebody mentioned the issue of blurring of clinical and research boundaries Particularly with all the apps that we're talking about, you know I have my little wristwatch that has my blood pressure my O2 sat and it's going to go right into my Electronic medical record and be there for research information. Well, let's say my blood pressure is you know 400 over 300. I'm hoping everybody realizes that's not normal In fact, it's really bad not normal And it ends up in my medical record. Who's going to check it out to see if it's wrong or be that I'm about to Have a stroke. I think we need to include clinicians as we start talking about all this massive data coming in Is it my primary care doctor's responsibility to go and say, you know pearls looking bad today? So there's liability issues there and then the final one is I think something I already Comment on in a question and that's sustainability at both citizen scientists and citizen fatigue Some of these studies that we're seeing they want to go out to our entire patient group and Look at issues one minute and I speak very slowly and use every second I have left You know, how often can we go to our entire patient community? We have more and more requests for Blast emails for this important study that important study. Oh, we want to pull all these cohorts together I do worry about Overloading our citizens and I think also the citizen scientists who are being called to the table Currently are being called to many tables We really need to improve the education and the expertise of I think a very valuable population out there And with that I will stop. Thank you