Synbio is a diverse field with diverse applications, and the different contexts (e.g., gain-of-function research, biofuels) raise different ethical and governance challenges. The objective of this course is to increase learners’ awareness and understanding of ethical and policy/governance issues that arise in the design, conduct and application of synthetic biology. The course will begin with a short history of recombinant DNA technology and how governance of that science developed and evolved, and progress through a series of areas of application of synbio. Content will be presented in many forms, including not only reading and lectures, but also recorded and live interviews and discussions with scientists, ethicists and policy makers. Learners will have the opportunity to think, write and talk about the issues and challenges in their own work and in real-life case examples. A final project will engage students in the development of governance models for synbio.
Governance & Engagement in SynBio
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Из курса от партнера Johns Hopkins University
Engineering Life: Synbio, Bioethics & Public Policy
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Governance
In the final week of the course, we will talk about both models of governance for emerging biotechnologies and the role of public engagement in the development and oversight of the science. The work of the week includes lecture videos, one outside video, and readings, as well as interviews with LeRoy Walters and Jane Calvert. The final course project builds on the Week 2 and 4 peer-assessed projects, and goes a step further, asking you to develop and defend a decision-making process for a government policy related to the release of genetically modified mosquitoes.
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Debra JH Mathews, PhD, MAAssistant Director for Science Programs
Berman Institute of Bioethics
[MUSIC]
In the last week of the course, we will be talking about two topics, governance and
synthetic Biology, and public engagement.
So governance is a word that is intended to capture
a range of modes of oversight and
regulation of an activity by a range of different actors.
Everything from traditional laws and regulations coming from governments,
through non-governmental organizations, institutions, professions, and others.
And it's not the case that for any given technology or
across technologies, that one particular mode of governance or regime,
collection of government's approaches is going to be appropriate.
There are important and substantive differences between technologies and
between different applications of a particular technology.
So the technologies and the applications will vary.
There will be a different constellation of moral concerns raised by a technology or
by a particular application of a technology.
There are different stakeholders, different groups of folks stand to
benefit or bear the burdens of a particular technology or
application, and different backgrounds constraints.
So the existing for example, regulatory landscape, or
intellectual property landscape, will vary across technologies or applications
in ways that impact how we think about governing that technology or application.
But I do think that sort each new technology or
each new application is sort of an opportunity to try to get it right again.
Because these are all quickly evolving, sort of cutting edge
technologies, and they can be hard to govern effectively.
And ideally you would want your governance
to be flexible and responsive to changing technologies.
In SynBio there exists
a number of different kinds of governance, of both the science and the applications.
And there have been a series of recommendations for
how we might think about governing this technology.
Governance can happen at many different levels.
As I said in the definition on the first slide,
a whole range of actors might engage in governance.
This can go from something
as sort of informal as norms, so how one is expected
to behave as a member of a particular field or profession.
Self-governance, wherein people within a field take it
upon themselves to place limits or provide guidance for
how to engage in research or deploy technology.
The institution at which you work engages in governance of science.
Funders, through their decisions about what they will and won't fund, or
what can and cannot be done with funding, engages in governance.
Journals, in academia, publication is along with grants,
are the coin of the realm, it's a key point for governance within science.
States and nations of course, engage in governance all the time
and in science that is increasingly global.
There's also interest in global governance of the science.
So just provide a few examples of each of these levels of governance,
some of which you've already seen in this course.
So with regard to norms, in the first week on recombinant DNA technology,
I talked about Andrew Lewis who was working with hybrid adenoviruses.
And made a decision that he would only share
these viruses with people that he thought would
handle them carefully and appropriately,
and understood the danger associated with them.
The SB2.0 resolutions, which I'll talk about later this week,
was an attempt by the synthetic biology community itself,
to engage in or to define norms of behavior within the field.
Self governance, the first week again with recombinant DNA technology and
the moratorium on recombinant DNA research.
Followed by a seminar and a more, those early steps in self
governance lead to more formal governance at the level of funders.
And the government through NIH and the recombinant DNA advisory committee.
Also, self governance at the commercial or
industrial level, and I'll talk about this later this week as well with regard.
To DNA synthesis companies screening
orders that are coming through their doors.
And self governance can happen by individuals, or
at the level of professional society, for example, as well.
At the level of institutions, your research
university engages in governance all the time.
We have institutional biosafety committees.
We have material transfer agreements that regulate how
research resources move within and out of the university.
And how research institutions deal with intellectual property.
What kind of licensing agreements they write for
technologies developed at their institutes.
Funders, both public and private, again,
the examples that you have already seen in weeks one and two of the rack,
here in the US to govern recombinant DNA research.
And the NIH gain a function funding clause,
would also fall into this category.
Journals, as I mentioned before,
are very important in particular in academic science, we have to publish.
Journals are uniquely situated to exert influence on academic scientists.
In the case of synthetic biology, a case that I'll talk about later this week.
There was a statement from a large number of journals
about the publication of dual use research of concern.
And how they were going to monitor and
make decisions about the publication
of potentially concerning research.
Journals also have requirements about data sharing and
data deposition in public databases.
In the US, states do sometimes make research policy, both with regard
to what kinds of research activities can take place within their borders.
And the funding of research,
in particular in the case of the use of certain human tissues.
So for example, newborn blood spot DNA, and the sale or
transfer of human eggs, and funding of stem cell research.
Nations, of course, make laws, have regulations,
develop federal funding priorities.
And in some jurisdictions there are QUANGOs, or
Quasi Autonomous Non Governmental Organizations, hence QUANGOs.
An example of sort of national regulations affecting synthetic biology,
came in week two in the discussion of the H5N1 case,
and the Dutch export control rules that were evoked in that case.
And then finally governance at the global level.
This is trickier because nations have different background constraints,
have different regulatory tools available to them, limits on power, etc.
But there are examples of course, out of the United Nations,
UN declarations, global agreements, etc, that can have some effect.
And an example there is the convention on biological
diversity that you heard about in the week on biofuels.
And then of course there can be combinations across all of these
levels of governance.
It's also the case that governance can be approached from
different perspectives, right, and I'm just going to talk about three of these.
One, the first one, is the precautionary principle,
which is most closely associated with the EU.
A definition of the precautionary principle out of the Rio Declaration 1992,
is that where there are threats of serious or irreversible damage,
lack of full scientific certainty shall not be used as a reason for
postponing efforts to mitigate the damage.
The Rio Declaration out of the Rio Summit of course,
was related specifically to the environment and development, and so
the focus was on environmental degradation.
The precautionary principle is
often now framed around protecting the environment,
human, animal and plant health.
So again, the idea here is that you don't have to have all
the scientific data in to take precautions against potential harm.
Another approach that is gaining in prominence right now,
not just in the EU but internationally, is responsible innovation.
We talk a bit about that with Jane Calvert in my interview with her.
As defined by the European Commission, responsible innovation is an approach that
anticipates and assesses potential implications and
societal expectations with regard to research and innovation.
So it's the idea that research and
innovation should take place with a broad lens
with regard to the impact of that research or innovation.
And then the third approach that I'm going to talk about is prudent vigilance,
which came out of the Presidential Commission for
the Study of Bioethical Issues here in the United States,
in their report on synthetic biology and emerging technologies.
And in contrast to the precautionary principle,
prudent vigilance is the idea that you establish processes for
assessing risks and benefits,
sort of both before and after projects are undertaken.
So it's sort of a watch and wait approach.
You're going to let the technology move forward, but
you're going to keep a close eye on it.
And the orientation or the approach that one takes to government.
The orientation or approach that one takes to governance,
influences what that governance is going to look like.
So another important aspect of governance
that we're going to talk about this week is the role of various stakeholders.
You've done some stakeholder mapping now.
And that includes of course, the public in many or most cases.
So one example here from the National Coordinating Center for
Public Engagement is that it describes sort of
The various ways in which activity and benefits of higher ed and
research can be shared with the public.
And importantly, engagement is viewed as a two-way process.
It's not just the scientists communicating,
it's the scientists listening as well.
And public engagement has evolved over time from sort of
basic science communication or outreach.
Basically the scientific community telling the general public,
here's what we're doing.
Through a long period of functioning within sort of the deficit model,
meaning the general public does not understand this stuff.
They have a deficit, they don't get it, they don't have the knowledge,
they don't have the understanding.
And the scientific community needs to sort of fill that gap.
They need to educate the public about what it is science does,
what are scientific values, and what science is doing at any given time.
And this really now has transitioned into the model of engagement,
which is more along the lines of the definition I just showed you.
Engagement really is about that two way street and importantly,
and I think Tanya Bubula captured it well in her 2009 paper.
Public deliberations or engagement should be an honest effort at relationship and
trust building rather than persuasion.
With mechanisms for
actively incorporating the input of lay participants into decision-making.
So the scientific community really does have a lot to learn
from the general public.
And that's what engagement is supposed to be about as well.
Public engagement is not only important but it's also I think,
a duty of the scientific community.
Often, public funds are being used to conduct research and
to develop, for example, intellectual property.
And that comes with duties for transparency and
accountability to the people who are paying the bills.
The public ultimately are likely to bear the burdens and
reap the benefits of these technologies.
Science, in theory, should be done in
the service of improving human well being.
So it's important to talk to the public and
to learn from them what in fact would be
nurturing of that well being, and what would harm that well being.
In addition, there are values as I've talked about earlier in the course
that are important, that are not scientific values.
The general public holds values that come from a different place and
that are valuable as well, and ought to be incorporated
into our thinking about research and innovation.
It's also important to understand those values,
given that oftentimes this governance is being developed
in democratic pluralistic societies, right?
There are lots of different people who live in society, and again,
are going to bear the burdens and reap the benefits of science and technology.
And their voices need to be heard.
Then finally, science in particular, publically funded science,
but science generally does best when there is as
Tanya Bubula noted, a trusting relationship between
the scientific community and the broader public.
Neither can thrive without the trust of the other.
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