A Framework for Tomorrow’s Pathogen Research

Final Report

Chairs

Ravindra Gupta

Ameenah Gurib-Fakim

Shahid Jameel

David Relman

Directors

Jesse Bloom

Filippa Lentzos

February 2024

“Scientists have an obligation to do no harm. They should always take into consideration the reasonably foreseeable consequences of their own activities. They should therefore: … always bear in mind the potential consequences - possibly harmful - of their research and recognize that individual good conscience does not justify ignoring the possible misuse of their scientific endeavour …”

IAP Statement on Biosecurity 2005

“… [scientific] responsibility has to go beyond vocation to encompass a deeper ethical commitment based on the empathic experience of interdependence and shared humanity.”

Thorpe 2004

Preface

The Bulletin of the Atomic Scientists began more than 75 years ago as an emergency action by scientists who saw an immediate need for a public reckoning in the aftermath of the atomic bombings of Hiroshima and Nagasaki. The scale of the loss of life and the obliteration of these cities in the late summer of 1945 proved a wake-up call for physicists about the potential destructive power and potential uses of their science and its newfound role in waging war. Many scientists at the time anticipated that the atom bomb would be “… only the first of many dangerous presents from the Pandora’s Box of modern science.”

Humankind now faces additional threats and the Bulletin grapples with many of them, including those posed by advances in biological research. The Bulletin publishes influential pieces on biosafety and biosecurity, advances in genetic engineering, the role of artificial intelligence in the future of medicine, and other relevant topics.

As a not-for-profit organization the Bulletin is independent of government funding and influence. Its magazine is found in nearly 10,000 libraries worldwide and its website draws more than 11 million pageviews per year; nearly half of its readers are younger than 35 years of age and half reside outside the United States. In 2022, the Bulletin convened an independent panel of experts in biosecurity, epidemiology, virology, ethics, and other areas: the Task Force on Research with Pandemic Risks. What follows is its report.

Worldwide, there are several other important initiatives underway that align with the work of the Task Force. Each initiative calls for broader and more sustained engagement by life scientists with a broad set of stakeholders to address the risk posed by technical advances in the life sciences. The Task Force exemplifies a response to such calls. Because the Task Force is non-governmental, international, multi-disciplinary and includes members from a variety of civic institutions, the goal is to offer a perspective that complements other initiatives.

Executive Summary

Throughout history, viral diseases have been among humankind’s greatest scourges. Many millions of people died worldwide during the 1918 influenza pandemic. Prior to initiation of the World Health Organization’s smallpox eradication program and the development and widespread use of measles vaccines, it is estimated that each of these diseases caused more than two million deaths annually.

Basic scientific knowledge obtained from studying viruses has been an essential step in creating lifesaving countermeasures. Today, therapeutics and vaccines have reduced the disease burdens of COVID-19, hepatitis C, influenza, poliomyelitis, and a variety of other viral diseases. The development of these countermeasures, enabled in part by research in virology and immunology, has greatly benefited public health and will continue to do so in the future.

Most viral disease outbreaks stretching back over millennia have been caused by viruses transmitted to humans through direct or indirect contact with domesticated and wild animals. Yet modern virology research also creates new avenues for outbreaks to arise, as researchers can also become infected while collecting field specimens or performing research with viruses in the laboratory. Depending on the virus under study, an infection may spread to other workers, family members, and the wider community. These risks have existed since the early days of virology research. For example, the last cases of smallpox occurred in a small outbreak triggered by an accidental infection originating from a laboratory studying the virus in Birmingham, United Kingdom, in 1978. While biosafety has improved since the 1970s, advances in virology research also open new risks.   

Recognizing the need for a focused conversation on the risks and benefits of a subset of research that could plausibly source a large outbreak, or even a pandemic, the Bulletin convened an independent and international panel of experts in biosafety, biosecurity, epidemiology, ethics, genetic engineering, virology, and other areas: the Task Force on Research with Pandemic Risks.

The scope of the research examined by the Task Force included (1) research on pathogens known to be capable of causing a pandemic that under current conditions (e.g., low population immunity) could result in extensive spread beyond the current infection burden; (2) manipulation of pathogens that are not currently thought capable of pandemic spread in ways that can be anticipated to increase their capacity to cause a pandemic (e.g., by increasing virulence or transmissibility); and (3) research on pathogens with unknown characteristics.

The Task Force’s report discusses the potential benefits of virology research and outlines how advances in science and technology may increase certain benefits. It then focuses on some of the potential risks of virology research, including biosafety and biosecurity, and outlines how advances in science and technology may increase some of these risks. The Task Force also examined ethical obligations to make research with pandemic risks more safe, secure, and responsible, suggesting actionable and sustainable strategies to effectively maximize the potential benefits and mitigate the foreseeable potential harms of research with known or potential pandemic pathogens, while attending to issues of equity and proportionality. The report argues for empirical studies on biosafety and biosecurity to make research with pandemic risks more safe, secure, and responsible. It also reviews the contemporary governance space for research with known or potential pandemic pathogens and argues that effective legislation, regulations, policies, and guidelines specifically regulating such research will strengthen the scientific enterprise and should be put in place and implemented without delay. It discusses challenges in building and sustaining trust in science in general and research with pandemic risks more specifically. Finally, the Task Force has issued several recommendations.

Key recommendations include:

  • Research with pandemic risks should have high-probability benefits for public health.
  • Where feasible, research questions about pathogens with pandemic risk should be addressed using surrogate systems, or by taking advantage of loss-of-function experiments on current human viruses.
  • International protocols should be established for research on pandemic risk pathogens. Those protocols should include methods for both sample collection and laboratory work.
  • Research on pandemic risk pathogens should be monitored locally, nationally and internationally. Funds should be allocated to optimize biorisk management strategies.
  • Scientific journals and their editors should enforce timely data-sharing and research integrity for the manuscripts they publish.

At present, occupational health and safety governance generally adequately weighs the direct biosafety risks to the researcher in the laboratory, but there is a small subset of research on known or potential pandemic pathogens for which biosafety risks go beyond the laboratory and affect the health of significantly larger groups of humans or other animals. Indeed, if a virus has true pandemic potential, the entire world can be affected by an accident.

Navigating research with pandemic risks warrants additional precautions. The overarching aim of the Task Force on Research with Pandemic Risks is to guide the development of a safe, secure, and responsible research environment for researchers, and in so doing, to earn public trust.