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• 07 May 2024

US funders to tighten oversight of controversial ‘gain of function’ research

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A US policy that goes into effect next year tightens oversight of risky pathogen research conducted in biosafety facilities. Credit: Associated Press/Alamy Stock Photo

After years of deliberation, US officials have released a policy that outlines how federal funding agencies and research institutions must review and oversee biological experiments on pathogens with the potential to be misused or spark a pandemic.

The policy, which applies to all research funded by US agencies and will take effect in May 2025, broadens oversight of these experiments. It singles out work involving high-risk pathogens for special oversight and streamlines existing policies and guidelines, adding clarity that researchers have been seeking for years.

“This is a very welcome development,” says Jaime Yassif, vice-president of global biological policy and programmes at the Nuclear Threat Initiative, a research centre in Washington DC that focuses on national-security issues. “The US is the biggest funder of life sciences research [globally], so we have a moral obligation to guard against risks.”

Balancing act

Manipulating pathogens such as viruses inside an enclosed laboratory facility, sometimes by making them more transmissible or harmful (called gain-of-function research), can help scientists to assess their risk to society and develop countermeasures such as vaccines or antiviral drugs. But the worry is that such pathogens could accidentally escape the laboratory or even become weaponized by people with malicious intent.

Policymakers have had difficulty developing a clearly articulated review system that evaluates the risks and benefits of this research, while ensuring that fundamental science needed to prepare for the next pandemic and to advance medicine isn’t paralysed. The latest policy, released on 6 May by the US Office of Science and Technology Policy, is the next stage of a long-running US balancing act between totally banning high-risk pathogen research and assessing it with standards that some say are too ambiguous.

The shifting sands of ‘gain-of-function’ research

In 2014, after several accidents involving mishandled pathogens at US government laboratories, the presidential administration announced a moratorium on funding for research that could make certain pathogens — such as influenza and coronaviruses — more dangerous, given their potential to unleash an epidemic or pandemic. At the time, some researchers said the ban threatened necessary flu surveillance and vaccine research.

The government ended the moratorium in 2017, after the US National Science Advisory Board for Biosecurity (NSABB), a panel of experts that advises the US government, concluded that very few experiments posed a risk. That year, the US Department of Health and Human Services (HHS) instead implemented a review framework for proposals from scientists seeking federal funding for experiments involving potential pandemic pathogens. This framework applied to proposals to any agency housed under the HHS, including the National Institutes of Health (NIH) — the largest public funder of biomedical research in the world.

Researchers raised concerns about the transparency of this review process, and the NSABB was asked to revisit these policies and guidelines in 2020, but the COVID-19 pandemic delayed any action until 2022. During that time, the emergence of the coronavirus SARS-CoV-2 , and the ensuing debate over whether it had leaked from a lab in China, put biosafety at the top of researchers’ minds worldwide. The NIH, in particular, was scrutinized during the pandemic for its role in funding potentially risky coronavirus research. In response, some Republican lawmakers have — so far unsuccessfully — put forward legislation that would once again place a moratorium on research that might increase the transmissibility or virulence of pathogens.

Finding a balance

The latest policy aims to address concerns that have arisen over the past decade about lax oversight, ambiguous wording and lack of transparency.

It breaks potentially problematic research into two categories. The first includes research on biological pathogens or toxins that could generate knowledge, technologies or products that could be misused. The second includes research on pathogens with enhanced pandemic potential.

Research falls into the first category if it meets several criteria. For example, it must involve high-risk biological agents, such as smallpox, that are on specific lists. It must also have particular experimental outcomes, such as increasing an agent’s deadliness.

Research that falls into the second category includes pathogens intended to be modified in a way that is “reasonably anticipated” to make them more dangerous. That criterion means that even research on pathogens that are not typically considered dangerous — seasonal influenza, for example — can fall into the second category. Previously, pathogen surveillance and vaccine-development research were not subject to additional oversight in the United States; the latest policy eliminates this exception, but clarifies that both surveillance and vaccine research are “typically not within the scope” of research in the second category.

Layers of review

Scientists and their institutions are responsible for identifying research that falls into the two categories, the policy states. Once the funding agency confirms that a research proposal fits into either group, that agency will request a risk–benefit assessment and a risk-mitigation plan from the investigator and institution. If a proposal is deemed to fit into the second category, it will undergo an extra review before the project gets the green light. A report of all federally funded research that fits into the second category will be made public every year.

NIH reinstates grant for controversial coronavirus research

The directive also mandates that agencies outside the HHS that fund biological research, such as the US Department of Defense, must abide by the same rules. This is a huge step forward, says Tom Inglesby, director of the Johns Hopkins Center for Health Security in Baltimore, Maryland. But it applies only to federally funded research; the policy recommends, but does not require, that non-governmental organizations and the private sector follow the same rules.

Federal agencies and research institutions will now create their own implementation plans to comply with the policy before it goes into effect in 2025. Yassif says that the policy’s success will hinge on how these stakeholders implement it.

Nevertheless, the policy sets a worldwide standard and might inspire other countries to re-evaluate how they oversee life-sciences research, says Filippa Lentzos, a biosecurity researcher at King’s College London who chairs an advisory group for the World Health Organization (WHO) on the responsible use of life-sciences research. Later this month, at the World Health Assembly in Geneva, Switzerland, WHO member states will consider a proposal to urge nations to cooperate on developing international standards for biosecurity.

Nature 629 , 510-511 (2024)

doi: https://doi.org/10.1038/d41586-024-01377-x

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Salesforce Ignite is a customer-facing, digital strategy and design consulting team within Salesforce. We help C-level executives at Fortune 2000 companies recognize and interpret forces of change in their market, and collaborate with them to plot a course towards a more robust digital future through human-centered design. Our engagements combine elements of strategy, user-research, visioning, ideation, visual storytelling, business model design, rapid prototyping, and in-market concept testing and experimentation. Intern Responsibilities:

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How I Got the Job: Consulting at Booz Allen Hamilton

Carrie Collins, MPP Class of 2024, shares how she leveraged the resources available to her at Harris to secure her job as Associate Management Consultant at Booz Allen Hamilton before graduation. 

I've always been interested in public sector consulting, so it was frustrating when I wasn't able to attend a Consulting Day event hosted through the Career Development Office (CDO) . I reached out to Ethan Rucker , the Associate Director of CDO, and asked if I could get him my resume and cover letter to share with Booz Allen Hamilton, which I knew would be at the fair. Ethan said, “While I can't promise they'll review it, you can send it to me.”  

So I reached out to Kamillia Forbes , former president of Harris Student Government , who works at Booz Allen. I said, “Kam, I'm applying to this job, and you already have it. What do I need to know to really make myself stand out?” So she and I had a quick call while I was working on the cover letter for Ethan. 

I eventually was given a screening call, where the Booz Allen representative instructed me to apply for a general management senior consultant position. On the night of my dog's birthday party, Booz Allen said that they wanted to interview me.

To prepare for the interview, I really did my homework. Kam connected me to Dave Sulek, Senior Vice President at Booz Allen, and we spoke about what Booz Allen is, what they do, why he pushed for more MPP hires, and what he thinks it's done for Booz Allen. During our conversation, something he said really struck me: “Booz Allen isn't really a consulting firm—we are a technology firm that does consulting. And that doesn't always appeal to people who are coming from public policy.” But for me, it was a watershed moment. 

Government historically moves a little slower than other sectors, so technology as a solution had never really seemed viable to me. But, if governments worked with third party consulting firms, it could work. 

I can use technology solutions to make the government better. It was a big light bulb moment.

The process with Booz Allen unfolded fairly quickly: I had behavioral interviews that were followed a couple days later with an email about security clearance, and the next day I got an email that they wanted to have a call to discuss my full-time offer. We went through the salary negotiation process, and I will be starting in August as a General Management Consultant at the Associate Level—the highest level they've ever hired out of Harris. I'm most excited, however, because I was able to get my offer signed even before finals during my fall quarter, which was huge.

At Booz Allen, I will also be on the Civilian Services team, so my whole job is how to use technology to create better delivery of government services for civilians. My soon-to-be colleagues are using generative AI, machine learning, and data science to optimize the use of resources to make sure we are giving as much as possible where there is the greatest need.

Subsequently, I spoke to Harris alums who work at Booz Allen and asked: "What kind of moments could I draw on to keep me pushing forward through mission-driven projects?" And every single person said that not only were they wildly fulfilled by their job, but they also saw immediate results from many of the projects—and got to know the people those projects benefited. Knowing that so many people who had come from the same program as I did felt like they were working towards tangible goals was a huge relief. It was a no-brainer to accept my job at Booz Allen.

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