There is a revolution happening in health, driven by makers in biology. This nascent innovation ecosystem thrives in maker spaces and community bio labs that allow people of all ages to engage with engineering and biology in non-traditional settings, building on increasingly distributed and inexpensive health technologies. Concurrently people interested in solving public health problems are turning towards crowdfunding, which poses complex ethical, safety, security, and governance issues.

The Citizen Health Innovators Project will enable the fast-growing ecosystem of health innovators to develop a culture of responsibility that reflects its pluralistic and open-source ethos. We will facilitate interactions between this emerging ecosystem and formal regulatory institutions (FDA, etc.) to support responsible innovation in distributed networks. We believe that shining a spotlight on makers in biology will help demystify bio-innovation and bio-fabrication and encourage larger public interest and involvement.

This project is the beginning of a long-term process to establish a social license to operate, creating public trust and support for such an ecosystem. We anticipate that structured engagement with and within the health-focused maker ecosystem will lead to mechanisms to develop and adopt a culture of responsibility, ensuring that as participatory health innovation flourishes, social benefits are maximized and risks minimized. Constructive links with the federal policy community will enable on-going conversations with the nascent ecosystem, protect patients, and support innovation.

At the Wilson Center, Eleonore Pauwels is the Director of Biology Collectives Project, and Senior Program Associate within the Science and Technology Innovation Program. With funding from the Robert Wood Johnson Foundation, Eleonore directs the Citizen Health Innovators Project. In this context, her research focuses on developing regulatory and governance mechanisms for the fast-growing ecosystem of health innovators, built around maker spaces and community bio labs, to support responsible innovation in distributed networks. This is part of her larger effort to design actionable ethics and governance strategies to enable responsible and fair citizen participation in new health and genomics technologies. 

As a Senior Research Scholar with the Genetic Engineering and Society Center at North Carolina State University, Todd Kuiken pursues his decade-long collaboration with Eleonore and the Wilson Center, contributing his expertise to the Citizen Health Innovators Project.

Support for the Citizen Health Innovators Project was provided in part by the Robert Wood Johnson Foundation. The views expressed here do not necessarily reflect the views of the Foundation.