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    "text": " Hello everyone, my name is Sarah Blossom Ware and I'm really excited to be speaking with you today. I have a community lab in the Chicago area called BioBlaze Community Biolab and I also teach at universities. I have a doctorate degree and so I'm a little bit unique, not completely, but a little bit unique in the biohacking community because I live in both worlds. In academia, I've also worked in industry and I also have a biohacking space and a special heart for biohacking. So what I'd like to chat with you guys about today is the idea of an institutional review board for biohackers. And so I know this is Biohacking Village and so probably most of you who are listening are familiar with what biohacking is and who biohackers are, but I just want to give a brief overview of my definition because everyone's definition is a little bit different. And then talk about just what is an institutional review board, also known as an IRB for short. Why do I think biohackers need an IRB? And I just want to mention, I put these names so I don't forget to mention, that Alex Perlman, Amanda Plimpton, Todd Kochen, these are some people in the community that are pretty well known who share this idea with me and there are others as well. But we have been talking about this for about a year, I would say, and trying to shape what this would mean and what this would look like for biohackers. And then a little bit on how you could help. So who is considered a biohacker? I consider biohackers lay scientists for the most part, and I think I just made this up because I googled it, it's not really coming up, but scientists who people are doing research in non-traditional settings for the most part. So non-traditional institutions and where people who maybe people, some people like me, have a PhD, some people have master's or bachelor's degrees, but they're not always in science or biology, those degrees, but also people with GEDs, homeschool kids, so many different kinds of people. But the idea in general is that usually this they're doing research in non-traditional places. Anybody really who has a great idea but does not have or want access to a traditional track, I would call a biohacker. Some of the non-traditional institutions that research is being done in are community labs like mine, kitchens, garages, sheds out back, and even a castle in the Netherlands. Also this is kind of my idea about biohackers. So biohackers are independent scientists and and a lot of times I like to just say independent scientists because people kind of understand that a little bit better, a little bit quicker. But biohackers are independent scientists who are often disillusioned with the way traditional science is done in academia and industry and all of the red tape that goes along with that and the stifling of creativity and innovation. And these are people who want to make positive impacts for humanity. So what is an institutional review board or an IRB? So according to Oregon State University, which I think is a pretty good definition for our purposes, an IRB is an administrative body, we'll talk about what that is in a second, established to protect the rights and welfare of human research subjects that are recruited to participate in research activities that are conducted under the auspices of the institution with which it is affiliated. So it's kind of a lot of words that I want to break down these three main things that I've highlighted just in the next few slides. So who makes up the administrative body in an IRB? So it would be members of the organization itself. And so an IRB is specific to an institution as in the definition. So members of that organization make it up, also physicians and clinicians, bioethicists and lawyers. Those are some examples of the kinds of people that make up this administrative body. So how does the IRB protect the rights and welfare of human research subjects? The board will review research plans and to make sure that they are ethical. The board will ensure that there is informed consent that will be sought and obtained from all research subjects. And in general, it protects the rights of the marginalized so that people are not preyed upon and everything is ethically done. An IRB is specific for research activities in that institution. So for example, each university will have its own IRB. In industry, each company will have its own IRB. So what I want to also kind of throw out there, if I could, is can we please get over the word institution as biohackers? So unfortunately, this is what it's called. It's called an institutional review board. But adoption of an institutional review board does not mean we all want to become like traditional institutions. And I found that a lot of people are really hung up on this word. And so anyway, it's what it's called. It can be tailored to fit to each institution, which means we can make it our own. So we can shape this the way that it works for the biohacking community. Also, this would be completely voluntary. I mean, we all know you can't tell biohackers they have to do anything. And this is not the idea here as well. It would completely voluntary and fluid. So meaning if people don't want to go through an IRB for their research, they don't have to. Maybe they want to go through the IRB for a certain project, but it doesn't mean they have to be committed to going through the IRB for every single project. Voluntary and fluid. Why do I think biohackers need an IRB? So there are several reasons that I've listed here, but one is for clinical trials. If any of us want our work that is human health based to get to the masses, we're going to need to go through clinical trials in order to do it the legal way. And in order to enter into clinical trials, there has to be an IRB for the proposed research on humans. We want to be taken seriously. So sometimes biohacking is viewed negatively. Not always, it just is nice, but sometimes it is viewed negatively. So we want to be taken seriously with our great ideas to help humanity. And also, an IRB would be needed for collaborations with universities, for example, or pharma, or to get funding. I have in parentheses, or to avoid the need for collaboration, because right now, sometimes there may have to be a tradeoff with collaborating with universities, for example, but then you're under their IRB, and maybe it's not really your idea of how you want the research to go anymore. And so I've had this also, like, we had our own IRB. We wouldn't need to also collaborate so much with these other places to get their IRB, to be under their umbrella. So either way, you want to look at that for the collaboration. A note, I can't resist adding to this conversation, a note on clinical trials and the investigational new drug applications, or the IND applications. The two main things that you have to first fill in are, who is the PI, the primary investigator? Right now, that PI must be an MD or a PhD. And in the biohacking community, this doesn't fit sometimes. What is the research institute? Can we scribble in BioBlades Community Biolab, or my shed out behind my house, or my kitchen as a research institute? Both of these questions immediately are ruling out a lot of the biohacking community. And so I would really like to get some discussions going based around this, but it's a little bit of an aside. So why now? Well, one thing is right now, walls preventing communication are coming down, and I do hope that continues. It's really hard to find something positive about this pandemic, but this is one thing that I really think is positive. We need everyone's innovative ideas to come to the forefront, especially right now. And just an example that I'd like to give for walls coming down that are preventing communication is the Just One Giant Lab, or the Jogo Collaborative Platform's Open COVID-19 Initiative. And in this initiative, it's really, really refreshing, and I love it, and I hope it continues. So for example, I'm working on an open source diagnostic test for detection of SARS-CoV-2. I'm working on it with a global group through Jogo, other independent labs, like Onika Bio in New York with Ellen Jorgensen, and also someone at the CDC. So this is really amazing, you know, that biohackers and independent scientists are able to work with someone from the CDC, for example, or physicians are in this group. And anyway, it's really amazing. So I think this is a really good time to try to get this IRB idea going, because of all of this communication as equals that's not really happened in the past. So how can you help? Volunteer to serve, either on the committee trying to work this out and create an IRB. Another thing that I didn't mention is that there are some independent IRBs out there, but they're very, very expensive, and that just cuts out most regular people who aren't in industry or academia from getting their ideas through to the masses. But anyway, volunteer to serve either on an IRB that we create, or to serve in helping shape it. What are your ideas on how that would look? You can help by bridging gaps. This is a major ask. So if you are an MD who is sympathetic and interested and finds value in the biohacking community and the ideas coming out of it, if you're an MD or in the government, regulatory agencies, for example, if you can bridge gaps, that would be amazing. I love bridging gaps. So we really have a huge gap to overcome in this. So anyway, that's about it. I hope you love the idea, or at least we can have a nice conversation about this idea of an IRB for biohackers. Please contact me if you would like in the future. Otherwise, I'll be taking some questions. Thank you."
}