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Under the designation “patient-led research” (PLR) or “citizen-driven biomedical research,” citizens, patients, and families have increasingly become the leading force in the initiation or conduct of health research projects, pursuing a range of activities from analyses of genomic data for diagnosing rare diseases, identification of potential therapeutic drugs, organization and crowdfunding of clinical trials’ cohorts, and even self-surveillance or self- experimentation. Many of the participants in citizen-driven biomedical research are patients and families confronted with a condition that is the subject of their research, therefore facing new epistemic and governance challenges, and often testing the ethical and regulatory limits within which health research has traditionally operated.

This new form of research where citizens and patients are the primary producers and mobilizers or instigators of knowledge promises to break new ground in underserved health domains, but also suffers from a lack of legitimacy when it comes to assessing the quality of patients’ experiential data. Moreover, this endeavor gradually transfers the responsibility to preserve safety and ethics to lay experts, probing new ethical matters of concerns – from blurring boundaries between treatments and self-experimentation, peer-pressure to participate in trial, exploitation of vulnerable individuals or third parties (children), to a lack of regulation concerning quality control and risk of harm. Very little research currently focuses on adequate ways to adapt or design responsible governance and ethical standards tailored to citizen-driven biomedical research.

Notwithstanding ongoing challenges, we should not simply disregard medical research conducted outside of traditional institutions as de facto less safe, less reproducible, or unethical. Patients often have in-depth experiential knowledge of their conditions along with a vested interest in making sure that a treatment or device will be effective, safe, and beneficial. Yet, facing regulatory uncertainty, they might not overcome the “chill factor” – a phenomenon described by citizen scientists and DIY inventors as the fear to confront regulators by sharing the recipe for a new invention. The press has recently covered cases of biohackers who self-experimented with unregulated gene-therapies. However, the stories encountered in community bio-labs, such as Biocurious and Denver Bio-labs, are different: mentors, amateurs, and students want their proof of concept to be safe and reproducible, achieving specific standards in the research processes and evidences they rely on.

Towards the end of the workshop, participants were asked to write down ideas for what should be included in a tool kit for current and future bio-citizens. What should we put in it? What do you wish you would have had? What would you leave out? Many of these ideas stemmed from Boxes 1-3: Opportunities and Challenges. Building off those ideas and the discussions throughout the workshop, researchers and bio-citizens have begun compiling a tool kit for future bio-citizens that we hope will become a living tool-kit that evolves as the community of bio-citizens evolves.  The goal is to develop engagement channels between patients-innovators, crowdfunders, ethicists, and regulators to design adaptive oversight mechanisms that will foster a culture of empowerment and responsibility. Concretely, the authors of this report started building a taxonomy of different forms of innovations where you would also find, in parallel, an assessment of the risk-benefit trade-off defined in collaboration between bio-citizens and regulators.


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* Please see documents below for better viewing of project outputs.

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