Ethical Justification for Research on Dangerous Pathogens
Recent inflammatory headlines suggested researchers had created a more dangerous version of COVID.1 However, those researchers said the headlines were misleading.2 Nevertheless, it spotlighted the ethical concerns involving research on pathogens.
Medical Ethics Advisor (MEA) recently spoke with James Giordano, PhD, MPhil, about the ethical implications of research on dangerous pathogens. Giordano is professor of neurology and biochemistry at Georgetown University; chief of the neuroethics program at the Pellegrino Center for Clinical Bioethics; and a senior research fellow of biosecurity, technology, and ethics at U.S. Naval War College in Rhode Island.
(Editor’s Note: This transcript has been lightly edited for clarity.)
MEA: What is the ethical justification, if any, for conducting research on dangerous pathogens?
Giordano: This research has to be able to fulfill some public good. We need to consider the risks and harms of both doing the research (that is, risk and harms of commission) and not doing the research (harms of omission), and weigh them appropriately. The actual risk of harm posed by pathogens needs to be determined, regarding both its quantitative probability of affecting human populations in the near future and its impact. There are two new technological capabilities that pose particular importance to such considerations. One is gene editing, such as CRISPR, which makes it easier and faster to manipulate genes and thereby create new or modified genotypes. The second is synthetic biology, which enables rapid ability to take genetic blueprints and create phenotypes from them, and have those be disseminable phenotypes, which are reproducible.
Pathogens that are either not dangerous or do not pose any discrete risks to humans could be modified in some way to increase their pathogenicity and/or a new pathogenic species could be developed.
Such outcomes could be the result of “runaway science” — that is, research with benevolent intent, but which produced inadvertent or unanticipated outcomes. Such outcomes could be purposely evoked by bad (state or non-state) actors with nefarious intent.
While that looms large on the horizon of possibility, there are a number of relative safeguards in place to at least defer the probability of such events. The Biological Weapons Convention includes language that explicates what kinds of things can or cannot be done with particular microbes, and what agents constitute biological weaponry.
However, the convention, as well as certain other signatory treaties, have not really kept pace with the capabilities of CRISPR or synthetic biology. As a result, their governance and restrictive capacities are relative.3-6
There is ongoing work to revisit and perhaps revise these treaties so as to make them more current and capable. I’m optimistic about the viability and value of such efforts.
In addition to concerns about scientific developments, it’s important to consider that iterative human intrusion and disruption of global ecologies can increase the potential for encountering various microbes that pose pathogenic risk to humans. Factors here include such things as global warming, urban and suburban spread, and environmental contamination. Given these realities, doing research that explores the pathogenicity of various organisms and agents would seem to be a valuable preparedness process.
The ethical grounds for doing this type of research are based on the underlying principle of beneficence. Such research serves a viable public good by identifying risk, examining what is “out there,” and what could (or should) we do to prepare for and respond to exposure to pathogens, if they should be encountered.
If we are to be prepared and responsive, we must first study those pathogens and then develop appropriate methods for mitigating or preventing the spread to vulnerable species.
MEA: What about ethical obligations to avoid harm?
Giordano: It is crucial to ensure all necessary protocols, resources, and procedures are in place and operational so as to maintain safety and contain risk. Both means and ends must be consistent with the ethical goal of doing good, in ways that serve the identified target audience — a group of individuals, a population, or the world at large.
If, on the other hand, the research is done in ways that are intrinsically not appropriately safe, so as to maintain the security of the laboratory and contain any harmful products, deliverables, or artifacts of the research itself, the ethical failure is one of commission. In other words, you engaged in the research, but you did it in bad ways. You omitted the necessary safeguards.
MEA: What are the ethical concerns if no one conducts this research?
Giordano: If such research is not done, and we are aware that these risks could occur, we are guilty of harm by omission. A potential risk was known; the risk was observed to be evolving into an identifiable threat; and nothing was done proactively to explore it, address it, or contain it. Colloquially — you didn’t do something, you just stood there.
MEA: What are researchers’ obligations to be transparent with the public who might be wary (or outright distrust) this research?
Giordano: Given that particular agencies or institutions in the government are charged with serving and protecting the polis, it is a delicate balance between what information you make broadly available and maintaining protective capability against any threat, foreign or domestic. Complete transparency in such situations can lead to escalating brinkmanship.
But in an open democracy, it is important to communicate the need for such research on pathogens, the general focus and intent of such research, the necessary safety constraints that the research demands, and maintain scientific and national security value, as well as the probity of this type of work.
1. Zimmer C, Mueller B. Lab manipulations of Covid virus fall under murky government rules. The New York Times. Oct. 22, 2022.
2. The Brink staff. NEIDL researchers refute UK article about COVID strain. The Brink. Oct. 17, 2022.
3. Gerstein D, Giordano J. Rethinking the biological and toxin weapons convention? Health Secur 2017;15:638-641.
4. DiEuliis D, Giordano J. Gene editing using CRISPR/Cas9: Implications for dual-use and biosecurity. Protein Cell 2018;9:239-240.
5. DiEuliis D, Giordano J. The need for modernization of biosecurity in the post-COVID world. mSphere 2022;7:e0002522.
6. DiEuliis D, Giordano J. Balacing act: Precision medicine and national security. Mil Med 2021;187:32-35.
Recent inflammatory headlines suggested researchers had created a more dangerous version of COVID. However, those researchers said the headlines were misleading. Nevertheless, it spotlighted the ethical concerns involving research on pathogens.
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