I'll be live-tweeting the #NExTRAC #genedrive discussion here for as much of the meeting I can make.
The #NExTRAC #genedrives discussion is a test for its new framework for publicly deliberating emerging biotechnology, and evaluating whether and how such work should proceed. More info on the NExTRAC framework here osp.od.nih.gov/wp-content/upl…
The Gene Drives in Biomedical Research Working Group is charged with considering "whether existing biosafety guidance is adequate for contained lab research...and outline conditions (if any) under which NIH could consider supporting field release..."
to date, the committee has been in listening mode, trying to understand what the important questions are from a range of perspectives. The purpose of this workshop is to listen to many of these.
The members of the #NExTRAC gene drive working group are here osp.od.nih.gov/wp-content/upl…
Now an overview of #genedrives by Anthony James. Since most people following this thread know what these are, I'll pass on the boilerplate
One thought on James' final point: We need to remember, ala @LinseyMcgoey, that institutionalized ways of not knowing also have politics embedded within them, and should be open to debate. Strategic ignorance is just that, a strategic resource we need to acknowledge.
Now looking at biosafety landscape for contained #genedrive research. First up is Kathryn Harris
after boilerplate on NIH guidelines, we turn to Lyric Bartholomay for a discussion on what these guidelines mean in practice from a researcher point of view.
Continuing the #synbio trend of employing comics to reach wider publics.
Up now, David Gillum (ASU) on the biosafety officer perspective. Starts with a distinction between "confinement" and containment". Containment is the normal practice of BSOs, confinement is broader, as covered in Akari et al (2015)
A lot of IBCs have low confidence in assessing the risks of #genedrives. @ABSAOffice has been working on building awareness of, and methods for assessing, biosafety issues with them, but still missing lots of BSOs in this training.
Many BSOs are good at "barrier confinement" (i.e. physical containment), but not on moleculer, ecological, or reproductive confinement.
Gillum calls for more standardized procedures for non-barrier confinement risk assessment. Also need principles and procedures for non-anthropod systems.
Gillum gives a shoutout to our paper on "Embracing Experimentation in Biosecurity Governance" paper in science. You can read it for free here: evansresearch.org/2020/04/embrac…
Q&a period: How do we make risk assessments more public? It’s a problem because of concerns that they might be misconstrued. (And the belief is that danger from misconstruing is greater than value of making public)
This is a perfect example of the absencing of knowledge in this space. I’m not saying this is bad, but that we should be having the discussion, like we are here, on whether such knowledge should be public.
Another form of absencing: because the assumption in contained research is that the work is, well, contained, less focus is given to the questions around more open field trials. This plays into a discourse of inevitability ->
once we’ve done enough research to show that contained systems “work”, the assumption is that of course field trials need to happen. This puts huge burden on many societal/ecological concerns to get in line rather than reshape what research is done.
Unfortunately, I have to sign off now.
finally back! and hopping into a great question: who gets to be an expert or a stakeholder? Sarah Hartley: think about who would be harmed; about the goals and values that might be harmed and how to protect them. Don't just think about who has expertise on the science
what has been the biggest surprise for moving to field trials? making mosquitos consistently. also the cost of monitoring is enormous to detect and extremely rare event.
And we’re back for day 2!
Starting with a panel on US and international oversight frameworks, such as they are, for #genedrive field releases.
Starting off with a review of the 2016 @theNASEM study on Gene Drives on the Horizon, which at the time concluded there wasn't enough knowledge in place to warrant field releases. nap.edu/catalog/23405/…
They built a framework for a novel oversight process to understand what knowledge was needed. This included a focus on ecological risk assessment, and building in public engagement into research, risk assessment, and governance.
Gene Drives on the Horizon noted a bit of a paradox: there needs to be coordination across governance domains because of likely spread, but also localized governance processes because of social and ecological variations. Need more work to understanding how to manage this tension.
Lots has changed since 2016, though, as noted by Stephanie James. She notes the formation of the Gene Drive Research Forum. Now part of @Gene_Convene fnih.org/what-we-do/gen…
@WHO has called for new methods of vector control, including the need for further research on #genedrives. (does someone have the link handy?)
Pretty sure that the slides aren't advancing for Dr James' presentation. Hopefully they will be on the site afterwards
African advances in #genedrive oversight. I wish that this discussion included who was funding this work, and how that might impact the types of oversight systems being put in place (and how to mitigate conflicts of interest).
Still lots to do
And a shoutout for @Gene_Convene. Personally, I think a forum like this (and others) is a vital step in ensuring an oversight system like that argued for in Gene Drives on the Horizon has a chance of coming into being.
A lot going on at the Convention on Biological Diversity. including the need for obtaining free and prior informed consent for #genedrive release. bch.cbd.int/synbio/ahteg/2…
Next steps expected at the CBD. [Also just a reminder that the US isn't a party to the CBD...yet?]
And now up is @DrToddOliver on "moving towards gene drive field trials?" [notice the "?"!]
He brings up the point raised yesterday that funding the monitoring of release and governance needs to be incorporated to the total cost of developing these technologies.
He also notes that community engagement is essential (as many others have noted) in the planning and conducting of field trials.
@DrToddOliver notes the non-gene drive field trials that have happened since 2016 that can provide some evidence for being able to consider #genedrive possible trials.
Lots of points here on why #genedrive developers should work with diverse communities of expertise early and often, and how those can lead to changes in research design and decisions on whether to move forward or not with trials.
Need to seriously reconsider how the US can engage more in the international negotiations on #genedrive oversight. Also a call for co-funding ecological research work with gene drive development.
Q&As: did the #CFRB updates in 2017 help or hurt us in figuring out how to regulate #genedrives? We should focus on the expertise we need (e.g. ecological expertise), then decide on the agency to decide.
What is the definition of "community" that #NExTRAC should use for its deliberations, asks @Kenneth_Oye. Also asks what specific topics and areas are most important to fund, or how should we make such a decision?
answers: communities should be varied depending on level of assessment. On funding, the funders must understand the levels of support needed for the engagement and field oversight. The funders should pay, esp the funders who signed up to this committment science.sciencemag.org/content/358/63…
should we consider an international body to make decisions about moving forward with research and trials? Stephanie James argues against this, citing the importance of local regulators. Instead, place efforts towards ensuring local governance bodies have info needed
How could we be doing ecological assessments better? It's important for the funders to understand the importance of this, but it needs to be done on a case by case way.
I actually have a question here: I see the value of case-by-case approaches, but how can we ensure the cross-case, higher level concerns are also captured in these more localized (in space, time, and content) governance systems?
We need to still keep the debate seriously open on whether we can consider field trials as ever being really "contained", says @DrToddOliver.
What's the connection between existing policies and making community engagement happen, asks @JasonDelborne? It doesn't look like there is a policy mechanism to ensure that trial design, for example, is appropriately engaged.
How should @NIH be considering islands as appropriate sites for #genedrive field trials? We should not jump to islands as ok for these. There are several steps to consider the practicalities of how trials might work, e.g. the limitations of 'containment' in practice.
How do we get data to decide whether field trials should move forward? We need to think much more deeply about possible pathways to harm. I think this is the paper Stephanie James was noting liebertpub.com/doi/full/10.10…
And we're back with a session on public engagement from local communities
Pretty old school public acceptance talk from california mosquito board
in presentation from a representative from the Florida keys, there was apparently a lot of concern about a few global activist voices derailing conversations about how to productively address mosquito problems.
Central I think to this whole meeting is the question of who is allowed to speak for "the public" [a concern also central to Science and Technology Studies (STS)]. I think the whole event is trying, but not quite addressing this point. Or rather...
I think everyone recognizes that we need to be innovative in thinking about public engagement with #genedrive governance. Maybe the conversation should turn to how we might know whether engagement is "going better".
FWIW I'm implying that #NExTRAC look towards work like Remaking Participation by @jasondchilvers @mbkearnes on how to build a capacity to experiment and learn from those experiments in engagement and participation. routledge.com/Remaking-Parti…
what I'm hearing from the florida keys rep is that there is a value to waiting for community engagement until tech is fully developed and approved because there is less time to have disinformation campaign gain a strong foothold in the debate on whether and how to more forward
I get the sentiment, I think the concern is legitimate. But I think the answer is NOT to keep the public in the dark for longer. I think it's more along the lines of developing strategies to engage with more global actors that swoop into local debates, and when that can't work...
...developing local capacity to understand rationales and evidence for different arguments, and their own ability to reframe any #genedrive debate around what they value
Now up is @LaveryJim talking about the need to move from a persuasive approach to community engagement towards a learning approach. here here! true for much beyond #genedrive and #NExTRAC
We shouldn't get into a headspace that assumes there is a preexisting group to engage with on #genedrives. instead think of communities as "those affected by the conduct or outcomes of the research"

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