Crowdfunding and IRBs: The Case of uBiome

IRBs and the Future of Citizen Science

uBiomeuBiome is a citizen science startup that sequences the microbiome, financed entirely by crowdfunding. Crowdfunding is a service where people contribute to a project that doesn’t exist, and in return, receive various perks when the product is created. Skipping ahead a bit in the story, we raised over $350,000, the largest successful single citizen science project in history.

In putting together our project, we had to consider new ethical and logistical questions that, to our knowledge, had never been considered before: How do you fund a science startup entirely without grants or venture capital? Do you get Institutional Review Board (IRB) approval for your research? How do you do it? And more.

Research projects involving human subjects are generally overseen by an Institutional Review Board (IRB). The purpose of an IRB is to ensure that an independent committee oversees the research to make sure that participants are treated with respect and informed of the risks and benefits of their participation. Vulnerable populations, such as prisoners, minors, and those with diminished capacity must be protected to a greater degree. For this reason, IRBs are used to cover most research that interacts with human subjects, with a few exceptions (such as those that only deal with anonymized data). IRBs are usually associated with an academic institution, and are provided free of charge to members of that institution.

Before we started our crowdfunding campaign, we consulted with our advisors at QB3, the startup incubator at UCSF, and the lawyers they provided us. We were informed (correctly) that IRBs are only required for federally funded projects, clinical trials, and those who seek publication in peer-reviewed journals. That’s right — projects that don’t want federal money, FDA approval, or to publish in traditional journals require no ethical review at all as far as we know. (No, that doesn’t sound like a great system to us either.)

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