[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 --> 00:15.780]  I have a community lab in the Chicago area called BioBlaze Community Biolab and I also
[00:16.400 --> 00:25.120]  teach at universities. I have a doctorate degree and so I'm a little bit unique, not completely,
[00:25.120 --> 00:29.980]  but a little bit unique in the biohacking community because I live in both worlds.
[00:29.980 --> 00:38.260]  In academia, I've also worked in industry and I also have a biohacking space and a special heart
[00:38.260 --> 00:49.000]  for biohacking. So what I'd like to chat with you guys about today is the idea of an institutional
[00:49.000 --> 00:58.640]  review board for biohackers. And so I know this is Biohacking Village and so probably most of you
[00:58.640 --> 01:05.080]  who are listening are familiar with what biohacking is and who biohackers are, but
[01:05.080 --> 01:10.580]  I just want to give a brief overview of my definition because everyone's definition is
[01:10.900 --> 01:18.340]  a little bit different. And then talk about just what is an institutional review board,
[01:18.340 --> 01:27.600]  also known as an IRB for short. Why do I think biohackers need an IRB? And I just want to
[01:27.600 --> 01:35.920]  mention, I put these names so I don't forget to mention, that Alex Perlman, Amanda Plimpton,
[01:35.920 --> 01:41.020]  Todd Kochen, these are some people in the community that are pretty well known
[01:41.020 --> 01:49.180]  who share this idea with me and there are others as well. But we have been talking about this for
[01:49.180 --> 01:55.900]  about a year, I would say, and trying to shape what this would mean and what this would look
[01:55.900 --> 02:03.780]  like for biohackers. And then a little bit on how you could help. So who is considered a
[02:03.780 --> 02:11.480]  biohacker? I consider biohackers lay scientists for the most part, and I think I just made this
[02:11.480 --> 02:18.680]  up because I googled it, it's not really coming up, but scientists who people are doing research
[02:18.680 --> 02:26.860]  in non-traditional settings for the most part. So non-traditional institutions and where people
[02:26.860 --> 02:35.340]  who maybe people, some people like me, have a PhD, some people have master's or bachelor's degrees,
[02:35.600 --> 02:45.220]  but they're not always in science or biology, those degrees, but also people with GEDs,
[02:45.220 --> 02:53.180]  homeschool kids, so many different kinds of people. But the idea in general is that usually
[02:53.180 --> 03:02.060]  this they're doing research in non-traditional places. Anybody really who has a great idea
[03:02.060 --> 03:10.420]  but does not have or want access to a traditional track, I would call a biohacker.
[03:11.220 --> 03:18.400]  Some of the non-traditional institutions that research is being done in are community labs
[03:18.400 --> 03:25.400]  like mine, kitchens, garages, sheds out back, and even a castle in the Netherlands.
[03:28.440 --> 03:37.040]  Also this is kind of my idea about biohackers. So biohackers are independent scientists and
[03:37.040 --> 03:40.840]  and a lot of times I like to just say independent scientists because
[03:41.780 --> 03:45.600]  people kind of understand that a little bit better, a little bit quicker.
[03:46.100 --> 03:50.640]  But biohackers are independent scientists who are often disillusioned with the way
[03:50.640 --> 03:56.100]  traditional science is done in academia and industry and all of the red tape that goes
[03:56.100 --> 04:04.300]  along with that and the stifling of creativity and innovation. And these are people who want
[04:04.300 --> 04:12.740]  to make positive impacts for humanity. So what is an institutional review board or an IRB?
[04:12.740 --> 04:18.920]  So according to Oregon State University, which I think is a pretty good definition for our purposes,
[04:19.440 --> 04:26.140]  an IRB is an administrative body, we'll talk about what that is in a second, established to
[04:26.140 --> 04:32.080]  protect the rights and welfare of human research subjects that are recruited to participate in
[04:32.080 --> 04:38.420]  research activities that are conducted under the auspices of the institution with which it is
[04:38.420 --> 04:45.460]  affiliated. So it's kind of a lot of words that I want to break down these three main things that
[04:45.460 --> 04:55.140]  I've highlighted just in the next few slides. So who makes up the administrative body in an IRB?
[04:55.140 --> 05:05.040]  So it would be members of the organization itself. And so an IRB is specific to an institution
[05:05.040 --> 05:12.560]  as in the definition. So members of that organization make it up, also physicians and
[05:12.560 --> 05:20.640]  clinicians, bioethicists and lawyers. Those are some examples of the kinds of people that make
[05:20.640 --> 05:27.880]  up this administrative body. So how does the IRB protect the rights and welfare of human research
[05:27.880 --> 05:37.240]  subjects? The board will review research plans and to make sure that they are ethical. The board
[05:37.240 --> 05:44.920]  will ensure that there is informed consent that will be sought and obtained from all research
[05:44.920 --> 05:49.960]  subjects. And in general, it protects the rights of the marginalized
[05:50.500 --> 05:57.600]  so that people are not preyed upon and everything is ethically done.
[05:59.480 --> 06:08.740]  An IRB is specific for research activities in that institution. So for example,
[06:09.490 --> 06:19.560]  each university will have its own IRB. In industry, each company will have its own IRB.
[06:19.740 --> 06:27.700]  So what I want to also kind of throw out there, if I could, is can we please get over the word
[06:27.700 --> 06:36.280]  institution as biohackers? So unfortunately, this is what it's called. It's called an institutional
[06:36.280 --> 06:45.000]  review board. But adoption of an institutional review board does not mean we all want to become
[06:45.000 --> 06:53.520]  like traditional institutions. And I found that a lot of people are really hung up on this word.
[06:53.520 --> 07:01.480]  And so anyway, it's what it's called. It can be tailored to fit to each institution,
[07:01.480 --> 07:10.080]  which means we can make it our own. So we can shape this the way that it works
[07:10.080 --> 07:17.980]  for the biohacking community. Also, this would be completely voluntary. I mean, we all know you
[07:17.980 --> 07:24.780]  can't tell biohackers they have to do anything. And this is not the idea here as well. It would
[07:24.780 --> 07:33.240]  completely voluntary and fluid. So meaning if people don't want to go through an IRB for their
[07:33.240 --> 07:40.740]  research, they don't have to. Maybe they want to go through the IRB for a certain project,
[07:40.740 --> 07:46.800]  but it doesn't mean they have to be committed to going through the IRB for every single project.
[07:46.800 --> 07:55.980]  Voluntary and fluid. Why do I think biohackers need an IRB? So there are several
[07:57.120 --> 08:07.200]  reasons that I've listed here, but one is for clinical trials. If any of us want our work
[08:07.780 --> 08:15.100]  that is human health based to get to the masses, we're going to need to go through
[08:15.100 --> 08:24.020]  clinical trials in order to do it the legal way. And in order to enter into clinical trials,
[08:24.020 --> 08:36.100]  there has to be an IRB for the proposed research on humans. We want to be taken seriously.
[08:36.360 --> 08:44.180]  So sometimes biohacking is viewed negatively. Not always, it just is nice, but sometimes it is
[08:44.180 --> 08:52.160]  viewed negatively. So we want to be taken seriously with our great ideas to help humanity.
[08:52.760 --> 09:01.200]  And also, an IRB would be needed for collaborations with universities, for example,
[09:01.200 --> 09:08.480]  or pharma, or to get funding. I have in parentheses, or to avoid the need for collaboration,
[09:08.480 --> 09:18.080]  because right now, sometimes there may have to be a tradeoff with collaborating with universities,
[09:18.080 --> 09:24.840]  for example, but then you're under their IRB, and maybe it's not really your idea of how you
[09:24.840 --> 09:32.760]  want the research to go anymore. And so I've had this also, like, we had our own IRB. We wouldn't
[09:32.760 --> 09:38.900]  need to also collaborate so much with these other places to get their IRB,
[09:38.900 --> 09:44.340]  to be under their umbrella. So either way, you want to look at that for the collaboration.
[09:46.320 --> 09:51.800]  A note, I can't resist adding to this conversation, a note on clinical trials
[09:51.800 --> 09:57.930]  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 --> 10:16.650]  Right now, that PI must be an MD or a PhD. And in the biohacking community,
[10:16.650 --> 10:23.770]  this doesn't fit sometimes. What is the research institute? Can we scribble in
[10:24.330 --> 10:31.850]  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 --> 10:43.890]  And so I would really like to get some discussions going based around this,
[10:43.890 --> 10:52.070]  but it's a little bit of an aside. So why now? Well, one thing is right now,
[10:52.070 --> 10:58.930]  walls preventing communication are coming down, and I do hope that continues. It's really hard to
[10:58.930 --> 11:06.110]  find something positive about this pandemic, but this is one thing that I really think is positive.
[11:06.950 --> 11:13.390]  We need everyone's innovative ideas to come to the forefront, especially right now. And
[11:14.150 --> 11:19.230]  just an example that I'd like to give for walls coming down that are preventing communication
[11:19.760 --> 11:26.260]  is the Just One Giant Lab, or the Jogo Collaborative Platform's Open COVID-19 Initiative.
[11:27.270 --> 11:35.350]  And in this initiative, it's really, really refreshing, and I love it, and I hope it
[11:35.350 --> 11:45.460]  continues. So for example, I'm working on an open source diagnostic test for detection of SARS-CoV-2.
[11:46.040 --> 11:54.640]  I'm working on it with a global group through Jogo, other independent labs, like Onika Bio in
[11:54.640 --> 12:03.020]  New York with Ellen Jorgensen, and also someone at the CDC. So this is really amazing, you know,
[12:03.020 --> 12:10.360]  that biohackers and independent scientists are able to work with someone from the CDC, for example,
[12:10.360 --> 12:16.640]  or physicians are in this group. And anyway, it's really amazing. So I think this is a really
[12:16.640 --> 12:26.600]  good time to try to get this IRB idea going, because of all of this communication as equals
[12:26.600 --> 12:34.700]  that's not really happened in the past. So how can you help? Volunteer to serve,
[12:35.460 --> 12:42.080]  either on the committee trying to work this out and create an IRB. Another thing that I didn't
[12:42.080 --> 12:49.900]  mention is that there are some independent IRBs out there, but they're very, very expensive,
[12:49.900 --> 12:57.440]  and that just cuts out most regular people who aren't in industry or academia from getting their
[12:57.440 --> 13:06.060]  ideas through to the masses. But anyway, volunteer to serve either on an IRB that we create,
[13:06.060 --> 13:12.580]  or to serve in helping shape it. What are your ideas on how that would look?
[13:12.580 --> 13:22.820]  You can help by bridging gaps. This is a major ask. So if you are an MD who is sympathetic and
[13:23.520 --> 13:29.320]  interested and finds value in the biohacking community and the ideas coming out of it,
[13:29.320 --> 13:38.080]  if you're an MD or in the government, regulatory agencies, for example, if you can bridge gaps,
[13:38.080 --> 13:46.500]  that would be amazing. I love bridging gaps. So we really have a huge gap to overcome
[13:47.300 --> 13:56.520]  in this. So anyway, that's about it. I hope you love the idea, or at least we can have a
[13:56.520 --> 14:06.180]  nice conversation about this idea of an IRB for biohackers. Please contact me if you would like
[14:06.180 --> 14:11.900]  in the future. Otherwise, I'll be taking some questions. Thank you.