WEBVTT 00:00.000 --> 00:07.180 Hello everyone, my name is Sarah Blossom Ware and I'm really excited to be speaking with you today. 00:07.360 --> 00:18.080 I have a community lab in the Chicago area called BioBlaze Community Biolab and I also teach at universities. 00:18.080 --> 00:29.980 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. 00:29.980 --> 00:40.340 In academia, I've also worked in industry and I also have a biohacking space and a special heart for biohacking. 00:40.340 --> 00:53.020 So what I'd like to chat with you guys about today is the idea of an institutional review board for biohackers. 00:53.020 --> 01:12.500 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. 01:12.660 --> 01:21.640 And then talk about just what is an institutional review board, also known as an IRB for short. 01:22.020 --> 01:26.800 Why do I think biohackers need an IRB? 01:26.800 --> 01:46.040 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. 01:46.040 --> 01:57.780 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. 01:57.780 --> 02:00.800 And then a little bit on how you could help. 02:01.760 --> 02:04.380 So who is considered a biohacker ? 02:04.680 --> 02:22.260 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. 02:22.260 --> 02:47.260 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, 02:47.260 --> 02:50.220 so many different kinds of people. 02:50.220 --> 02:57.640 But the idea in general is that usually this they're doing research in non-traditional places. 02:58.080 --> 03:10.420 Anybody really who has a great idea but does not have or want access to a traditional track, I would call a biohacker. 03:11.220 --> 03:25.400 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. 03:28.440 --> 03:34.300 Also this is kind of my idea about biohackers. 03:34.300 --> 03:45.600 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. 03:46.100 --> 04:02.540 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. 04:02.660 --> 04:07.920 And these are people who want to make positive impacts for humanity. 04:07.920 --> 04:12.740 So what is an institutional review board or an IRB? 04:12.740 --> 04:39.720 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. 04:40.020 --> 04:49.200 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. 04:49.780 --> 04:55.140 So who makes up the administrative body in an IRB? 04:55.140 --> 05:00.220 So it would be members of the organization itself. 05:00.220 --> 05:07.260 And so an IRB is specific to an institution as in the definition. 05:07.260 --> 05:17.180 So members of that organization make it up, also physicians and clinicians, bioethicists and lawyers. 05:17.500 --> 05:23.000 Those are some examples of the kinds of people that make up this administrative body. 05:23.640 --> 05:28.900 So how does the IRB protect the rights and welfare of human research subjects? 05:29.400 --> 05:36.320 The board will review research plans and to make sure that they are ethical. 05:36.600 --> 05:46.380 The board will ensure that there is informed consent that will be sought and obtained from all research subjects. 05:46.380 --> 05:57.600 And in general, it protects the rights of the marginalized so that people are not preyed upon and everything is ethically done. 05:59.480 --> 06:07.260 An IRB is specific for research activities in that institution. 06:07.260 --> 06:13.720 So for example, each university will have its own IRB. 06:13.720 --> 06:19.560 In industry, each company will have its own IRB. 06:19.740 --> 06:31.440 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? 06:31.440 --> 06:34.940 So unfortunately, this is what it's called. 06:34.940 --> 06:37.840 It's called an institutional review board. 06:38.380 --> 06:48.020 But adoption of an institutional review board does not mean we all want to become like traditional institutions. 06:48.140 --> 06:53.520 And I found that a lot of people are really hung up on this word. 06:53.520 --> 06:56.820 And so anyway, it's what it's called. 06:57.920 --> 07:04.680 It can be tailored to fit to each institution, which means we can make it our own. 07:04.680 --> 07:12.500 So we can shape this the way that it works for the biohacking community. 07:12.600 --> 07:16.760 Also, this would be completely voluntary. 07:16.760 --> 07:21.440 I mean, we all know you can't tell biohackers they have to do anything. 07:21.440 --> 07:24.580 And this is not the idea here as well. 07:24.580 --> 07:27.760 It would completely voluntary and fluid. 07:27.760 --> 07:35.740 So meaning if people don't want to go through an IRB for their research, they don't have to. 07:35.740 --> 07:46.800 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. 07:46.800 --> 07:49.540 Voluntary and fluid. 07:50.160 --> 07:54.180 Why do I think biohackers need an IRB? 07:54.180 --> 08:02.620 So there are several reasons that I've listed here, but one is for clinical trials. 08:02.620 --> 08:20.480 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. 08:20.480 --> 08:31.880 And in order to enter into clinical trials, there has to be an IRB for the proposed research on humans. 08:32.400 --> 08:36.100 We want to be taken seriously. 08:36.360 --> 08:40.540 So sometimes biohacking is viewed negatively. 08:40.540 --> 08:45.160 Not always, it just is nice, but sometimes it is viewed negatively. 08:45.160 --> 08:52.160 So we want to be taken seriously with our great ideas to help humanity. 08:52.760 --> 09:04.200 And also, an IRB would be needed for collaborations with universities, for example, or pharma, or to get funding. 09:04.200 --> 09:26.920 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. 09:26.940 --> 09:32.300 And so I've had this also, like, we had our own IRB. 09:32.300 --> 09:40.880 We wouldn't need to also collaborate so much with these other places to get their IRB, to be under their umbrella. 09:40.880 --> 09:44.340 So either way, you want to look at that for the collaboration. 09:46.320 --> 09:57.930 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. 09:59.570 --> 10:08.670 The two main things that you have to first fill in are, who is the PI, the primary investigator? 10:09.190 --> 10:14.350 Right now, that PI must be an MD or a PhD. 10:14.350 --> 10:18.970 And in the biohacking community, this doesn't fit sometimes. 10:18.970 --> 10:22.010 What is the research institute? 10:22.030 --> 10:31.850 Can we scribble in BioBlades Community Biolab, or my shed out behind my house, or my kitchen as a research institute? 10:31.870 --> 10:38.250 Both of these questions immediately are ruling out a lot of the biohacking community. 10:38.490 --> 10:46.630 And so I would really like to get some discussions going based around this, but it's a little bit of an aside. 10:46.890 --> 10:49.210 So why now? 10:49.210 --> 10:57.790 Well, one thing is right now, walls preventing communication are coming down, and I do hope that continues. 10:57.790 --> 11:06.110 It's really hard to find something positive about this pandemic, but this is one thing that I really think is positive. 11:06.950 --> 11:13.170 We need everyone's innovative ideas to come to the forefront, especially right now. 11:13.170 --> 11:26.260 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. 11:27.270 --> 11:36.490 And in this initiative, it's really, really refreshing, and I love it, and I hope it continues. 11:36.770 --> 11:45.460 So for example, I'm working on an open source diagnostic test for detection of SARS-CoV-2. 11:46.040 --> 11:59.900 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. 11:59.900 --> 12:12.580 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. 12:12.580 --> 12:14.280 And anyway, it's really amazing. 12:14.280 --> 12:29.700 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. 12:29.700 --> 12:32.560 So how can you help? 12:32.760 --> 12:40.900 Volunteer to serve, either on the committee trying to work this out and create an IRB. 12:40.900 --> 12:59.640 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. 12:59.640 --> 13:09.140 But anyway, volunteer to serve either on an IRB that we create, or to serve in helping shape it. 13:09.140 --> 13:12.580 What are your ideas on how that would look? 13:12.580 --> 13:14.800 You can help by bridging gaps. 13:14.800 --> 13:17.180 This is a major ask. 13:17.180 --> 13:40.380 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. 13:40.380 --> 13:42.680 I love bridging gaps. 13:42.680 --> 13:49.080 So we really have a huge gap to overcome in this. 13:49.080 --> 13:52.380 So anyway, that's about it. 13:52.380 --> 14:02.380 I hope you love the idea, or at least we can have a nice conversation about this idea of an IRB for biohackers. 14:02.380 --> 14:07.640 Please contact me if you would like in the future. 14:07.640 --> 14:11.240 Otherwise, I'll be taking some questions. 14:11.240 --> 14:11.900 Thank you.