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A Spotlight On: Ethics, Biosecurity and Genomic Data – James Giordano, Pellegrino Centre for Clinical Bioethics at Georgetown University Medical Centre

James Giordano is Professor of Neurology and Biochemistry and Senior Scholar in Residence of the Pellegrino Centre for Clinical Bioethics at Georgetown University Medical Centre. He is also Director of the Institute for Biodefence Research. James focuses on emerging trends in biotechnology and biomedicine that can impact global security and public health. He discusses the biosecurity risks of genomic data, where biosecurity responsibilities lie and the dangers of precision pathologies.

Please note the transcript has been edited for brevity and clarity.

FLG: Hello everyone. Welcome to the latest “A spotlight on” interview. Today I’m joined by James Giordano and we’re going to be talking about ethics, biosecurity and our genomic data. James, if you could please introduce yourself and tell everyone a little about what you do.

James Giordano: Thank you so very much. I’m Dr James Giordano. I am a Professor in the Department of Neurology and Biochemistry, and Senior Scholar in Residence at the Pellegrino Centre for Clinical Bioethics at Georgetown University Medical Centre. I also serve as a Senior Bioethicist in the Defence Medical Ethics Centre of the Uniformed Services University of Health Sciences, and I’m the Executive Director of the Institute for Biodefence Research, a federally funded think tank in the Greater Washington DC area that focuses on emerging trends in biotechnology and biomedicine can be used in ways that impact global security, public safety and national interest.

FLG: Fabulous. Public interest tends to go in waves, we’ve had nanotechnology and cloning in the recent past. Now there’s excitement and concern about AI and robots. What are the kinds of questions that those outside of your field should have in their minds?

James Giordano: I think if we talk about AI and robots, one of the questions that keeps coming up over and over again, is the relative autonomy of these systems. In other words, are humans in the loop? Are humans on the loop? Or are humans out of the loop? And what do each one of those iterations mean, in terms of the viability for human involvement, and the way that an AI system or systems will ultimately treat human users – either as stake or shareholders, or as objects or subjects of some kind of moral regard?

This brings us to the issue of whether or not one can develop AI and AI-like systems that are inherently ethical; which then begs the question, what ethics do we engage, and how do we employ those ethics? Is there some builder’s bias for ethical preferences, and what could that mean for the ways that AI systems behave? As well, a related issue what of the ethics in ways that humans develop and use AI? Taken together, such questions open a proverbial Pandora’s jar.

To wit, much of what we’re employing artificial intelligence, machine learning and decision technologies for is to process massive amounts of data that are required to engage the current level of convergent biomedical sciences. My particular area of expertise is how the brain sciences interface with AI and data sciences, particularly as relevant and applicable to neurogenomics. We currently are amassing copious data on a variety of levels, from the sub-cellular to the social, and from the individual to the international. Such data are being integrated to create, if you will, descriptions, depictions and definitions of the human being, human condition, human behaviour, and predictions of human behaviour, that can be used to modify human behaviour, and perhaps even direct human narratives and thoughts.

So, the question then becomes, what will we do with these data? How will AI treat these data? How, and in what ways will these data about the essence of us, our genomes, our genetic and neurological information, as well as all the information of our daily narratives and events, be filtered into data systems that ultimately feed AI?

As well, we must question who has the keys to the kingdom? Who holds provenance and custodianship over the data? These are some of the key issues that I think are important for a general audience to understand. Because on one side, we see that these systems are essentially being developed for what I’ll call the low hanging fruit – benevolent means, aims and ends. In other words, we’re trying to do some definitive good with these tools and this knowledge.

But let’s face it, what’s good for me may not be good for you. If I acquire certain goods, are there going to be enough goods to go around for you? Who defines what’s good? Culture? History? Politics? Economics? If in fact, that’s the case, what happens if and when those goods are unevenly and asymmetrically distributed? What does that mean for the haves versus the have nots? The key questions are unfolding a pace with the technology and are certainly deeply rooted in the realities of our social sphere.

FLG: Absolutely. To dive into the genomic data side of things, more and more organisations are starting to gather genomic data from public for profit companies to national or international biobanks, as well as military. Starting with public companies, what are some of the most prominent ethical issues that people should be considering here?

James Giordano: I think they’re really threefold and are not mutually exclusive.

First, who possesses these data? Where are these data going? What repository or depository? Where is the provenance of these data? Who or what entity holds custodianship of these data?

As soon as you ask who’s holding the information, the second question that arises is what the primary intent of is acquiring and using such data, and what are possible various diffusions of intent within various and diverse user groups. This harkens back to the first question, who’s holding the data, and what are their intentions?

The third, but surely not least important question that derives from that is, what will such intents actually yield? In other words, for what will these data really be used?

The ubiquity of data in our current society, and in the approximate future of the next five to ten years, is such that in reality, much of what makes us “us”, not only in the present, but in the historical sense – our past and our relatives past, is nested within the integration of data across all of the realms of our existence. Literally, the physical, the chemical, the biological, the psychological, the social, the economic, the political domains, are all broadly available in the data we have produced. The integration of these data systems requires that nodes and silos of information must be stacked, so as to link data nodes and connect them via edges within networks. So, it is the network properties that allow these ubiquitous, massive amounts of data to be operationalized in a formulaic, integrated and practical way; to be put into real world use both, effectively and efficiently.

But the structure and function of such networks, at least at present, also give rise to issues of security and safety. given that these data networks are stacked, it’s at those stack points that the systems might be hackable. Safety and security issues are essentially two-fold: First existing data can be used to provide a nexus for precision targeting of individuals, collectives, and groups; and second modifications and manipulations of those data be leveraged in ways that affect particular persons, populations, and/or nations – what does that bode for the near, intermediate and long term?

FLG: Absolutely, some real concerns there. When we’re starting to talk about groups as well, we’ve got national biobanks, such as the UK Biobank and the US’s All Of Us program. They’re collecting genomes with the aim to advance precision medicine. But then there are wider efforts such as the Nigerian 100k Genome Project, and they aim to increase the diversity of our datasets, as so many have had Western foundations. What are the kinds of things we need to be considering at the forefront of these projects, regarding risk and ethical limitations? How can we counter it before it becomes a problem?

James Giordano: It’s a wonderful question. Part of the issue is as you just illustrated. We’re seeing multinational diversification of capability and control, and with this comes the possibilities for difference in intent, as well as perhaps, those means, methods, guidelines and standards by which any data will be accumulated and/or used. Complexifying the issue to some extent is intense commercial interest, and commercial interests very often may be protected by intellectual property laws, both regional as well as international, that constrain transparency of research, development and use.

As well, commercial interests can veil political and national interests, with regard to how data are being uptaken, not only into commercial enterprises per se, but within those commercial enterprises that are useful for developing techniques and technologies that can be viable and valuable for initiatives of national security, intelligence and defence, either kinetically- in a warfare type of way, but increasingly evermore so, non-kinetically to manipulate information, to be able to influence economies, in ways that enable geopolitical hegemony, which in turn can affect relative balances of power in and across a variety of domains and dimensions.

And although we’d like to think that current guidelines are relatively uniform, and that there is consensus and concurrence, the truth of the issue is that this is not always the case. The capability conferred by genomic information, coupled with big data and AI, allows development of not only precision medical interventions, but perhaps also of precision problematics, and precision pathologies, and all that could entail and obtain.

Case in point, for example, most recently, AI based systems were utilised to generate algorithms, as well as complete formulas for the development of novel drugs; novel compounds that had therapeutically beneficial aims and applications. Concomitantly, it was recognised that those exact tools could also be employed to develop novel pathogens, novel drugs, and novel toxins that could have dramatically nefarious impact upon human health.

FLG: The term precision pathology almost seems sci-fi, how futuristic versus how present day are these biosecurity risks?

James Giordano: They are very, very real as the COVID crisis brought into stark relief in many ways. Although we’re aware of the relative burdens, risks, threats, and in some cases, harms; being aware does not necessarily mean being prepared and being prepared does not necessarily mean being responsive.

Now, let me be absolutely clear – there was nothing in any of the information that I’ve seen over the past two plus years to suggest or directly indicate that SARS-Cov-2, the COVID virus, was a manufactured bioweapon But that’s an irrelevant fact. Whether something occurs naturally or whether something occurs through some indirect or direct human involvement, not even oriented towards developing a novel weapon, but perhaps simply examining what possibilities are capable by employing the technology, given the new means and methods that are available, These things pose potential risks of “escaping back into the wild'”, and therefore accelerating unanticipated effects in nature. Not only might such effects be unanticipated, but in some cases these effects would be unregulatable and/or unmitigable.

So, one of the concerns that has been generated by the COVID crisis, is whether it might be possible that gain of function research, that is trying to explore what are the possibilities that naturally occurring indigenous viruses might be able to mutate and modify, and thus cause risk to humans was conducted in a way that while certainly may have been within the parameters of what is considered safe, didn’t account for or recognise unanticipated consequences, and therefore didn’t recognise what are referred to as runaway effects.

So simple modifications, although perhaps thought to be not risky for humans, if allowed to be released back into a wild state, might have a higher chance of mutability, a higher chance of zoonotic jump, and as a consequence, pose risk not only to humans directly, but to the fauna, and flora that are vital agricultural species, and thus pose threat to balances of economic capabilities and market stability and power.

There are convergent factors, that while I’m not going to say are creating a perfect storm, are in fact capable of creating powerful storms in a variety of domains, which only increases the necessity of first being , aware, , second, of both qualifying what these risks and threats and quantifying them, and third, being prepared and responsive to them in ways that utilize whole of nation approaches, both within nations and cooperatively among nations, so as to engage what we refer to as biosecurity by design.

In other words, it is – and will be increasingly – important to recognise that as we go, each step that is seen as beneficial may also carry with it certain burdens, and risks. That doesn’t necessarily preclude or exclude taking such steps forward, but it does necessitate being aware of what we have called footfall effects. In other words, where are we stepping forward? What is the terrain, so to speak, that we’re stepping into? Is it stable? Is it unstable? What do we know? What do we not know? What do we do about those things we don’t know, and we can’t do? Are we ready to take that next step forward? And, in so doing, what things do we need to do to make sure that identified risks, harms and threats are preventable? And for those that may not be preventable, it is critical to address if and to what extent any such risks may be retractable or recoupable, or at very least, in some ways are forgivable – given the relative balance of benefits and burdens conferred upon and borne by specific groups of share and stakeholders.

FLG: Absolutely. Can you run through, whether with a national lens or an international lens, what is our current framework for where that role of responsibility lies? Those international guidelines, those policies and procedures. What are the challenges and the gaps?

James Giordano: I think it’s important to start perhaps on a national level, because it’s always best to assure that one’s house is in order, before you begin to interact with your neighbours, so to speak. But it’s also a question of how big is your house and what’s its place in the neighbourhood? I mean, what are the level of alliances, cooperatives and in some cases, competitions that need to address and encountered. The reality is that bioscience and biotechnology, whether it’s in genomics, or the use of cooperative big biodata, the use of AI systems, or a variety of other approaches in biomedical, as well as other forms of natural life and physical sciences, is becoming ever more multinational. And, while primarily the province of developed nations, new developments and capabilities are also creating new relationships between developed and developing nations.

These capabilities, and incapabilities can widening asymmetries between those nations that are developed and developing, and utilising these approaches, and can exacerbate gaps between developed and those undeveloped nations and cultures that may not have access to such tools and methods, and thus may be forced into various types of co-dependencies. Let’s be realistic, any such dependencies represent power balances of the kind that philosopher Michel Foucault referred to as biopower, and biopolitics: the manipulation of biological variables to exercise might and control over groups of individuals, collectives, political bodies and nations.

So, the question becomes, how broad is the appreciation, recognition, sensitivity and sensibility of these issues, as the science and technology move forward? Are there guidelines or stipulations in place that provide at very least a level of awareness, if not accountability? With accountability, is their ability to address and affect in a nimble way, those procedures, directions and trajectories that might be problematic in the near, intermediate or longer term? I’m optimistic in that an awareness of the current state of the science has prompted a number of different discourses that can be broadened and dialectically engaged, to appreciate different views, different values, voices, and in that way, become more synthetic rather unidimensional or singular in perspective.

To be sure, rather than trying to advance a single position, I think it would be prudent to try to synthesise views and positions of what represent viable goods, right ways of doing things and what things should be prescribed or proscribed by that level of synthetic, integrative engagement. But while I am optimistic, I’m equally cautious – in a pragmatic sense, because what tends to happen by the nature of the developments themselves, is that science advances in ways that contribute to technology, the development of tools. Tool use contributes to the development of scientific knowledge, capability and expansion of its various applications.

An awareness of ethical, legal, social and environmental issues tends to occur after the fact. In other words, we build things first, we intend their use, and then either through that use in a variety of diverse environments, and /or through alteration of use, either intentionally or unintentionally, we then encounter various burdens that are incurred. Those burdens can then become risks, if not threats and harms.

So often we wait – and may realistically need to wait – for the technology and the science to mature, else, we can fall victim into being far too speculative and therefore pollyannish in our ethical, legal, social and environmental address. Or we can tend toward being performative, in other words, we can spend a lot of time, effort, and money in engaging ethical, legal and social discourses and address over things that are not yet real. The imperative in any ethical discourse, is to begin and progress from fact; what can the technology really do? What can it not do? What are the capabilities of the science? What are its constraints? What are we doing about those constraints? Are these challenges or are these new opportunities to be able to create inroads to do more? What are the consequences of doing more or not doing more? For whom? Who shall be the share and stakeholders? What’s the character of the research and how will that research be applied in a variety of real world uses in a range thing, agriculture, biomedicine, daily life, politics, warfare, to influence or directly affect balances of economic power?

Ultimately, we must consider how flexible we can and will need to be to put into place necessary guidelines and perhaps governances, and will we in fact, mind those governances. Simply because a signatory treaty or convention may be in place, does not necessarily guarantee adherence as we know. So again, on the optimistic side, there are things like the Biological Toxins and Weapons Convention, the Chemical Weapons Convention, and various signatory treaties, but these may not effectively identify or address the emerging risks and threats posed by new and near-term future developments in bioscience and technology.

We also need to move from national to multinational views, in those ways that engages dialectic and a multi- perspectival orientation. Because what we don’t want to do, is what we did with COVID. We don’t want to turn our eyes away, and/or create frictions and tensions, and create competitiveness and in some cases, conflict, where there should be cooperation. We don’t want to establish barriers because of our inherent competitiveness, whether its financial or leveraging power in other ways, and in so doing sacrifice public health, safety and security. This is where certain nationalistic interests, I think, should be in some way reconciled with an appreciation for multinational and global risks, harms and benefits.

FLG: Absolutely, and if you had to pick a dream structure for ensuring everything was streamlined, do you see us heading more to a collaborative approach? If we compare it to space where we have NASA and the European Space Agency? Or do you see the need for a more completely international regulatory body that is putting out the recommendations, more similar to perhaps the World Health Organisation, for example?

James Giordano: I think it’s important to look at any one of those engaged organisations, and institutions, and examine two things. First: what have they done correctly? And second: what have they not done correctly? In other words, to engage the process of both acknowledging the benefits, and what arises from those benefits, the real goods that are utilised by those organisations institutions efforts; and also, to examine, identify, and analyse the gaps. I Why are there gaps in capability? Are they inherent to the structure? Is it something in the way that structure functions? Is it the fact that we need a new set of structures? Is it that those structures based upon, for example, historical precedent, do not currently comport with the realities of the 21st century world stage? From that point, it is important to then examine how to compensate and bridge and close those gaps? And what’s it going to take to do that?

I think what we’re going to see is that previous conceptions of global balance of power will need to be re-examined and perhaps revised. As we move into the 21st century, I think that the idea of a singular superpower represents something that’s almost anachronistic. Multiple superpowers, and superpowers engaging lesser powers and proxies is becoming the new world order. This is what the philosopher-historian Roland Benedictory has referred to as the “new global shift”. In that global shift, I think one of the norms is going to be a trend towards cooperative competition, so-called coopetition, wherein groups are working in clusters, and those clusters are defined for the enterprise of the engagement and recognise that there are key elements and domains in which cooperation is essential. But that cooperation can also foster particular areas of competition, and that competition could also be cooperative. In other words, there is some a priori decision or consensus about what realms and domains of relative capability and hegemony are going to then be actualized.

That creates interdependencies and integrations whereby systems of checks and balances are inherent to the actual structure of the effort itself. There are a number of ways one could go about doing this. For example, our research group, working with others internationally, has looked at a number of different approaches to reflective or balanced equilibrium, for instance a Taggard based approach, which might then employ Rawlsian minimax or maximin distributions – providing for those who are least provided or capable, and in the event, also working to maximise BenefitWallet minimising burden and risk.

We’ve also proposed a paradigm for risk assessment and mitigation that engages a number of domains; notably, responsibility for realistic assessment and revisitation of those norms and guidelines that we have in place. From this it will be important to pose key questions, what we call the “W questions”: what is the science and technology? When will it be employed? Why is it being developed or employed? Who will get it? Where will they get it? Then framing the answers to these questions in what we refer to as the “six C’s”: which are the actual capability and constraints of the science and technology, and those of us who develop and use it; the consequences of use or non-use; the character -in other words, the actual purpose of research, development and uses in practice; the contexts of use – whether they be medical, social, political and/or military; the continuity of research, and of clinical care, if and when things go wrong.

Simply put, continuity of preparation and readiness. Continuity in the social sphere, in the political sphere, in the economic sphere to remain nimble and flexible, so that civic institutions can be prepared, ready and responsible. Then ultimately, there has to be discourse towards consensus and consent. If indeed, we’re going to go forward in these ways, then clearly there must be some consensus among the share and stakeholders who will be affected and involved, and some modicum of consent for use among the intended recipients of the science, technology and/or its ripple effects.

To date, I’ve been encouraged that there has been discourse in these dimensions. But I think that it needs to be – and remain – a work in progress. And it will be work, but I’ve argued as have many others, that the proverbial juice is worth the squeeze. I think that the consequences of failing to engage processes such as those I’ve discussed would be far more dire than the effort, time and toil required to engage those processes, in an ongoing way that is cooperative.

FLG: You’re talking about technology and innovation there. We had, earlier this year, a biotech company announce the $100 genome, making genomic data cheaper and more accessible than before. So, what opportunities and challenges do you see when we’re talking about increased data?

James Giordano: I think increased data, increased capability, the use of relatively facile and easy to acquire gene-editing and synthetic biological techniques, coupled with the ubiquity of media and information sharing, and access, provide not only opportunities in terms of things that can be realised beneficially, but also opportunities for things to potentially go wrong. Like anything else, the greater the diversification and greater the diffusion of intent in user groups, the broader the range of uses, and this can incur inadvertent misuse, inapt use, and uses that are in some cases in tension or in conflict. Here again, it’s important to bear in mind that my goods are not necessarily the same as yours. And my exercising what I think is a pursuit of my good might well impugn what you hold to be near and dear to you.

 Additionally, I think what tends to happen is as soon as this moves into the consumer space, the nature of consumerism is based upon commodification, and upon profit; and in those ways, there’s an inherent competitive aspect. Often, any cooperative aspects, in many ways, are predicated upon in gaining some competitive edge, because that’s what the market dictates. So, in moving these scientific and technological developments things into the commercial sphere, by commercialising data, bioscience and technology, and doing so in ways that are direct to consumer, there’s inherent tendency to increase diversification and diffuse ability of use in practice.

This also creates opportunities for inherent competition, and in some cases, conflicting competition. This necessitates advancing the discourse to reach some realistic consensus in terms of guidelines. When things are released into the consumer model and the public space, I believe there is responsibility to keep that public safe, as well as to provide that public with tools of knowledge, that can afford relative security to use those tools that are offered to them, in ways that are recognized tol be of greatest benefit, and to incur the least burdens, risks and harms.

FLG: Absolutely. A word you’ve actually used several times today is the word dire. So, do you think the benefits of precision medicine and the gathering of our genomic data is worth the risks we’re discussing?

James Giordano: It’s a good question., I think in terms of the worth, we characteristically identify defined benefits, and these benefits become the impetus to develop things, and use them in practice.

I wholly believe that the ground aims of research and development are benevolent. Realistically, even those things that are used for national security, intelligence, defence – if not explicit warfare, are developed with the purpose of some good: defending what a group, a collective hold near and dear. Namely, their way of life, their ideology, their politics, and in some cases, not simply defending these ideals, but destroying those things that are feared, which represent perceived risk and threat to things individuals and groups hold near and dear.

Let’ face it, no country goes off to war thinking ‘we’re absolutely wrong but we’re going to do this anyway’. We all tend to believe we are right. So essential to any discussions about the ways that science and technology can, will and/or should be use, is address of what those things are held to be good and right?

And as with any exploration of what is considered to be good and right, it’s important to identify and address both idiosyncratic as well as system, more broadly reaching benefits, risks, and harms. Are we ready to face the possibility of consequences that could be burdensome, risky, threatening or overtly harmful? Do we have the mechanisms in place to be able to, if not prevent these things? Are we flexible enough? Are we nimble enough? Are we aware enough on a variety of different levels – with a variety of different organisations and tools – to know when we’re drifting from whatever is our proverbial centre line of benevolent intent into those domains that have trajectories that could be somewhat more problematic at very least, if not in some cases overtly damaging? Damaging, for example to the extent that it creates socio-cultural, national, economic or other asymmetries then become problematic, and disruptive to, quality of life, or to safety and security on a variety of levels and scales?

 I think that it is important as we spend a tremendous time and energy, investing in those ways we can develop precision biology and biotechnology towards identifiable goods, to invest a similar extent of dedication of at least effort if not funding to recognising how those goods might, have trajectories can weaken, that can incur differential goods and what those differential goods mean and incur. It is and will be crucial to more effectively model real-world scenarios in the short and intermediate term, wherein key factors can be identified early enough to be addressed and mitigated so as to beneficial effects and reduce the burdens and constrain the risks and possible harms.

FLG: Do you think we’re currently on track to have those mitigations in place based on our current stances?

James Giordano: That’s a really good question. I think that there are certainly notable and laudable efforts underway. To be sure, I’m not the only voice in the field, there are many, and those voices are loud, and are multi-perspectival. As it should be. I believe those voices need to come together in a cooperative and coordinated way to paint realistic pictures of not only what can go right, but what kinds of things can go wrong, and how we need to be prepared, and responsive for those things if and when they occur.

Indeed, I’m encouraged that the nature of the discourse to date has been relatively a pace with the capability of the science and technology. There is a relative awareness of not only what appears to be the evident benefits, but of burdens, and in some cases, burdens that are incurred if we don’t go forward with the science and technology. But indubitably, these discourses need to be sustained, and to be expanded so as to meet and remain current with the momentum of science and technology, as well as the changes these will; likely evoke on the current and future multi-national and multi-cultural global stage.

FLG: It’s great to know that there is some optimism in the face of some big risks, that we really need to be building our security. So, thank you so much, James. That was fascinating.

James Giordano: It was a real pleasure. Thanks so very, very much.

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