Opinion: The Biden-Harris FDA should make friends with independent researchers

Support for open science — accessible, collaborative, and radically transparent research done outside of traditional science venues — has been growing. During the Covid-19 pandemic, you might even say it is having a moment.

Networks of amateur and professional researchers around the world have emerged to help develop and disseminate solutions for preventing Covid-19 and gathering data relevant to managing the disease.

As these efforts begin to achieve milestones and mature — possibly spinning off into small companies — some are certain to attract the attention of the Food and Drug Administration, which has regulatory authority over biomedical interventions and health products, as well as food and additives.

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The bioeconomy is not homogeneous, and neither are independent scientists, also known as biohackers, DIY-ers, community biologists, and biomedical citizen scientists. Many within these rapidly growing communities are seeking access to scientific tools and informational resources to facilitate their participation in the development, testing, and marketing of novel consumer products created with things like genetically modified organisms, cybernetic implants, or synthetic biological parts, emerging fields in which regulation can be opaque.

Their broader objective is to promote creative approaches to research that are accessible, affordable, and community-driven. If these movements are successful at moving the epicenter of research — or even just a handful of important projects — from academic labs to the network of independent scientists working across borders and disciplines, the regulatory apparatus will also need to shift to accommodate the products that will inevitably emerge. For this to happen successfully, regulators and researchers must understand and respectfully work with one another.

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In a recent commentary published in Science, two of us (C.G. and P.Z., along with co-authors) explored the FDA’s authority as it generally applies to independent biomedical research and argued that further clarity from the agency on how it will enforce its authority would help “give fair warning to those who might underestimate the scope of FDA jurisdiction as well as reassure those who are not likely to face enforcement actions.”

Although the FDA has made isolated overtures in this space to help communicate its authority and regulatory intentions, the agency should establish new channels of communication with citizen scientists, especially during the pandemic. Specifically, the Science commentary proposed that the FDA set up an office staffed by individuals knowledgeable about independent science that the community can contact with questions or to share information with regulators.

There are many reasons why this suggestion might not be implemented, at least not any time soon. These include significant resource constraints and the FDA’s focus on more pressing matters, such as overseeing Covid-19 vaccines.

But the idea is worth exploring now, perhaps even especially during a pandemic.

Public dissemination and consumption of scientific information appears to be at an all-time high, fueling interest in participating in scientific research and discovery that was growing even before the pandemic. Yet as more individuals become independent scientists, confusion and misunderstanding of the ways in which their activities might run afoul of public health and safety regulations increases rather than subsides. Designating one or more FDA staffers to field questions directly from such researchers would, we believe, go a long way toward helping them navigate the complex regulatory thicket they might be skirting.

Most citizen scientists will likely be eager to understand how to steer clear of FDA regulation. But others, including independent researchers developing Covid-19-related diagnostic tools and therapies in community labs or via Just One Giant Lab, will knowingly enter this thicket with the aim of obtaining FDA authorization to sell products to consumers or to partner with local governments. The problem for them is that no obvious regulatory on-ramp exists for research and development activities that originate outside the scientific establishment. To use the existing infrastructure requires deep pockets, which these projects rarely have. A dedicated liaison is an important first step in helping them understand what resources are required to move forward.

A dedicated liaison could also provide independent biomedical researchers with valuable feedback on experimental designs. The FDA employs some of the world’s top scientific and research design experts. Access to the agency’s expertise could be a massive value-add especially for independent researchers looking to enter the startup space.

At the same time, the agency would benefit by staying up to date on scientific innovation occurring in nontraditional settings at a time when these communities are still emerging and potentially open to input from the agency. Although independent scientists face more practical barriers in their work than institution-based scientists, such as procuring equipment and materials, they are not constrained by the priorities of funders and institutions. This means they have the freedom to pursue exactly what interests them, including research questions or approaches that have been neglected by the scientific establishment.

And because they work outside institutions, they also have the freedom to experiment with new forms of governance. Some independent researchers, for example, have begun the process of establishing a community-run ethics review mechanism for biomedical citizen-science projects. Although this mechanism is still in the early stages of development, if successful it could be a significant innovation in research ethics to the extent that it thoughtfully prioritizes different objectives, concerns, and values than procedures followed in institutional settings. Given the FDA’s role in overseeing biomedical discovery, commercialization, and the ethical conduct of biomedical research, it is in the agency’s interest to remain apprised of the successes and failures of these efforts.

Reorganizing and creating new offices or divisions is a way the FDA can change its own internal culture and communicate the public health and scientific importance of new developments. The creation of an Office of Independent Science would be a way for the agency to signal to emerging research communities that their issues are important and the agency is serious about engagement. Trust between the FDA and the community can build a bridge, setting the stage for the development of a more robust infrastructure for independent biodesign and biomedical research and — who knows? — maybe even product approvals.

It would be a first step in a long path toward mainstream acceptance of independent science if the FDA created a way for small teams to get questions answered quickly and without having to pay lawyers to get the attention of what can seem like a faceless bureaucratic agency. This would require a commitment from FDA to be as transparent as possible and make it easy to engage — and recognition from both sides that trust will take some time to build.

In this vein, the agency could build on its work to better engage with patient communities that exist in institutional research spaces and that often cross pollinate with the open science movement, and expand on its work engaging with hacking communities in the device cybersecurity space.

Yes, we’re dreaming big. But this is the right time for pie-in-the sky thinking. A new administration is now in place in Washington with fresh ideas and new perspectives. The FDA has made efforts to be more transparent and flexible during the pandemic and should want to continue to do so. And independent researchers are increasingly coalescing into identifiable communities, opening the door for regulators to create more robust partnerships with them.

If the FDA made it easy to do so, more independent scientists would undoubtedly reach out for meetings, advice, and even offer useful input on ways the FDA could continue to best assist this growing scientific field. Trust is a two-way street, after all, and both regulators and independent scientists can be valuable to one another.

Christi Guerrini is a health policy researcher and assistant professor in the Center for Medical Ethics and Health Policy at Baylor College of Medicine in Houston. Alex Pearlman is a science and technology journalist and bioethicist. Patti Zettler is an associate professor of law at The Ohio State University Moritz College of Law who studies the FDA.

Source: STAT