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0	7180	Hello everyone, my name is Sarah Blossom Ware and I'm really excited to be speaking with you today.
7360	15780	I have a community lab in the Chicago area called BioBlaze Community Biolab and I also
16400	25120	teach at universities. I have a doctorate degree and so I'm a little bit unique, not completely,
25120	29980	but a little bit unique in the biohacking community because I live in both worlds.
29980	38260	In academia, I've also worked in industry and I also have a biohacking space and a special heart
38260	49000	for biohacking. So what I'd like to chat with you guys about today is the idea of an institutional
49000	58640	review board for biohackers. And so I know this is Biohacking Village and so probably most of you
58640	65080	who are listening are familiar with what biohacking is and who biohackers are, but
65080	70580	I just want to give a brief overview of my definition because everyone's definition is
70900	78340	a little bit different. And then talk about just what is an institutional review board,
78340	87600	also known as an IRB for short. Why do I think biohackers need an IRB? And I just want to
87600	95920	mention, I put these names so I don't forget to mention, that Alex Perlman, Amanda Plimpton,
95920	101020	Todd Kochen, these are some people in the community that are pretty well known
101020	109180	who share this idea with me and there are others as well. But we have been talking about this for
109180	115900	about a year, I would say, and trying to shape what this would mean and what this would look
115900	123780	like for biohackers. And then a little bit on how you could help. So who is considered a
123780	131480	biohacker? I consider biohackers lay scientists for the most part, and I think I just made this
131480	138680	up because I googled it, it's not really coming up, but scientists who people are doing research
138680	146860	in non-traditional settings for the most part. So non-traditional institutions and where people
146860	155340	who maybe people, some people like me, have a PhD, some people have master's or bachelor's degrees,
155600	165220	but they're not always in science or biology, those degrees, but also people with GEDs,
165220	173180	homeschool kids, so many different kinds of people. But the idea in general is that usually
173180	182060	this they're doing research in non-traditional places. Anybody really who has a great idea
182060	190420	but does not have or want access to a traditional track, I would call a biohacker.
191220	198400	Some of the non-traditional institutions that research is being done in are community labs
198400	205400	like mine, kitchens, garages, sheds out back, and even a castle in the Netherlands.
208440	217040	Also this is kind of my idea about biohackers. So biohackers are independent scientists and
217040	220840	and a lot of times I like to just say independent scientists because
221780	225600	people kind of understand that a little bit better, a little bit quicker.
226100	230640	But biohackers are independent scientists who are often disillusioned with the way
230640	236100	traditional science is done in academia and industry and all of the red tape that goes
236100	244300	along with that and the stifling of creativity and innovation. And these are people who want
244300	252740	to make positive impacts for humanity. So what is an institutional review board or an IRB?
252740	258920	So according to Oregon State University, which I think is a pretty good definition for our purposes,
259440	266140	an IRB is an administrative body, we'll talk about what that is in a second, established to
266140	272080	protect the rights and welfare of human research subjects that are recruited to participate in
272080	278420	research activities that are conducted under the auspices of the institution with which it is
278420	285460	affiliated. So it's kind of a lot of words that I want to break down these three main things that
285460	295140	I've highlighted just in the next few slides. So who makes up the administrative body in an IRB?
295140	305040	So it would be members of the organization itself. And so an IRB is specific to an institution
305040	312560	as in the definition. So members of that organization make it up, also physicians and
312560	320640	clinicians, bioethicists and lawyers. Those are some examples of the kinds of people that make
320640	327880	up this administrative body. So how does the IRB protect the rights and welfare of human research
327880	337240	subjects? The board will review research plans and to make sure that they are ethical. The board
337240	344920	will ensure that there is informed consent that will be sought and obtained from all research
344920	349960	subjects. And in general, it protects the rights of the marginalized
350500	357600	so that people are not preyed upon and everything is ethically done.
359480	368740	An IRB is specific for research activities in that institution. So for example,
369490	379560	each university will have its own IRB. In industry, each company will have its own IRB.
379740	387700	So what I want to also kind of throw out there, if I could, is can we please get over the word
387700	396280	institution as biohackers? So unfortunately, this is what it's called. It's called an institutional
396280	405000	review board. But adoption of an institutional review board does not mean we all want to become
405000	413520	like traditional institutions. And I found that a lot of people are really hung up on this word.
413520	421480	And so anyway, it's what it's called. It can be tailored to fit to each institution,
421480	430080	which means we can make it our own. So we can shape this the way that it works
430080	437980	for the biohacking community. Also, this would be completely voluntary. I mean, we all know you
437980	444780	can't tell biohackers they have to do anything. And this is not the idea here as well. It would
444780	453240	completely voluntary and fluid. So meaning if people don't want to go through an IRB for their
453240	460740	research, they don't have to. Maybe they want to go through the IRB for a certain project,
460740	466800	but it doesn't mean they have to be committed to going through the IRB for every single project.
466800	475980	Voluntary and fluid. Why do I think biohackers need an IRB? So there are several
477120	487200	reasons that I've listed here, but one is for clinical trials. If any of us want our work
487780	495100	that is human health based to get to the masses, we're going to need to go through
495100	504020	clinical trials in order to do it the legal way. And in order to enter into clinical trials,
504020	516100	there has to be an IRB for the proposed research on humans. We want to be taken seriously.
516360	524180	So sometimes biohacking is viewed negatively. Not always, it just is nice, but sometimes it is
524180	532160	viewed negatively. So we want to be taken seriously with our great ideas to help humanity.
532760	541200	And also, an IRB would be needed for collaborations with universities, for example,
541200	548480	or pharma, or to get funding. I have in parentheses, or to avoid the need for collaboration,
548480	558080	because right now, sometimes there may have to be a tradeoff with collaborating with universities,
558080	564840	for example, but then you're under their IRB, and maybe it's not really your idea of how you
564840	572760	want the research to go anymore. And so I've had this also, like, we had our own IRB. We wouldn't
572760	578900	need to also collaborate so much with these other places to get their IRB,
578900	584340	to be under their umbrella. So either way, you want to look at that for the collaboration.
586320	591800	A note, I can't resist adding to this conversation, a note on clinical trials
591800	597930	and the investigational new drug applications, or the IND applications.
599570	608670	The two main things that you have to first fill in are, who is the PI, the primary investigator?
609190	616650	Right now, that PI must be an MD or a PhD. And in the biohacking community,
616650	623770	this doesn't fit sometimes. What is the research institute? Can we scribble in
624330	631850	BioBlades Community Biolab, or my shed out behind my house, or my kitchen as a research institute?
631870	638250	Both of these questions immediately are ruling out a lot of the biohacking community.
638490	643890	And so I would really like to get some discussions going based around this,
643890	652070	but it's a little bit of an aside. So why now? Well, one thing is right now,
652070	658930	walls preventing communication are coming down, and I do hope that continues. It's really hard to
658930	666110	find something positive about this pandemic, but this is one thing that I really think is positive.
666950	673390	We need everyone's innovative ideas to come to the forefront, especially right now. And
674150	679230	just an example that I'd like to give for walls coming down that are preventing communication
679760	686260	is the Just One Giant Lab, or the Jogo Collaborative Platform's Open COVID-19 Initiative.
687270	695350	And in this initiative, it's really, really refreshing, and I love it, and I hope it
695350	705460	continues. So for example, I'm working on an open source diagnostic test for detection of SARS-CoV-2.
706040	714640	I'm working on it with a global group through Jogo, other independent labs, like Onika Bio in
714640	723020	New York with Ellen Jorgensen, and also someone at the CDC. So this is really amazing, you know,
723020	730360	that biohackers and independent scientists are able to work with someone from the CDC, for example,
730360	736640	or physicians are in this group. And anyway, it's really amazing. So I think this is a really
736640	746600	good time to try to get this IRB idea going, because of all of this communication as equals
746600	754700	that's not really happened in the past. So how can you help? Volunteer to serve,
755460	762080	either on the committee trying to work this out and create an IRB. Another thing that I didn't
762080	769900	mention is that there are some independent IRBs out there, but they're very, very expensive,
769900	777440	and that just cuts out most regular people who aren't in industry or academia from getting their
777440	786060	ideas through to the masses. But anyway, volunteer to serve either on an IRB that we create,
786060	792580	or to serve in helping shape it. What are your ideas on how that would look?
792580	802820	You can help by bridging gaps. This is a major ask. So if you are an MD who is sympathetic and
803520	809320	interested and finds value in the biohacking community and the ideas coming out of it,
809320	818080	if you're an MD or in the government, regulatory agencies, for example, if you can bridge gaps,
818080	826500	that would be amazing. I love bridging gaps. So we really have a huge gap to overcome
827300	836520	in this. So anyway, that's about it. I hope you love the idea, or at least we can have a
836520	846180	nice conversation about this idea of an IRB for biohackers. Please contact me if you would like
846180	851900	in the future. Otherwise, I'll be taking some questions. Thank you.