IRBs and the Future of Citizen Science

uBiome 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.)

Although we are incubated in the UCSF QB3 Garage, we were told that we could not use UCSF’s IRB process and that we would have to pay thousands of dollars for an external IRB. We didn’t think it made sense (and in fact, we had no money) to pay thousands of dollars on the off chance that our crowdfunding campaign was a success. At that point, we didn’t know if we were going to raise $5 or $5 million dollars.

One of our advisors is a co-founder of 23andme, which was founded in 2006 and received IRB approval in June 2010. Although their case was somewhat controversial, it seemed a reasonable model to follow. However, we wanted to go even further, and get IRB approval once we were funded -- in case we wanted to publish, and to ensure that our customers were well-informed of the risks and benefits of participation. It seemed the right thing to do.

So, we decided to wait until after crowdfunding and, if the project was successful, submit for IRB approval at that point.

Criticism from Bloggers

In February, there were several posts about the ethics of this choice from a variety of bloggers. (See links from Boundary Layer Physiology (here, here, here) Comradde Physioprof (here, here, here), Drugmonkey (here), Janet Stemwedel (here), Peter Lipson (here).) We greatly appreciate the comments, suggestions and criticisms that were made. Some of the posts threw us off quite a bit as they seemed to be personal attacks rather than reasoned criticisms of our approach.

At the time of these posts, we had not collected any samples, we had not analyzed any data -- and we hadn’t even manufactured our product. What we had done at that point was fund our project; according to Indiegogo’s terms of service, we had not even sold a product (Before you click to buy, Indiegogo has this text: “By clicking ‘Continue’, you acknowledge that you understand that you are contributing to a work-in-progress and not making a direct purchase.”)

We thought it was a bit... much, shall we say, to compare us to the Nazis (yes, that happened, read the posts) or to the Tuskegee Experiment because we funded our project without first paying thousands of dollars for IRB approval for a project that had not (and might never have) happened.

IRB Approval

We are happy to say that we have completed IRB review and that our protocol has been approved. The process was extremely time-consuming, and expensive. We went back and forth for months to finally receive approval, exchanging literally hundreds of pages of documents. We spent hundreds of hours on the project. Members of the certified IRB board included doctors, epidemiologists, certified IRB practitioners, and experts in public health.

Some might criticize the fact that we are using a private firm, one not connected with a prestigious academic institution. We beg to differ. This is the same institution that works with academic IRBs that need to coordinate multi-site studies, as well as private firms such as 23andme and pharmaceutical companies doing clinical trials. We agree that it’s kind of weird to pay for ethical review, but that is the current system, and the only option available to us.

We don’t regret the time and effort spent to get IRB approval. We agree that ethical review is extremely important. What we would like to do is think carefully about the process going forward, and whether the existing structure is the right one for citizen science in the future.

IRB 2.0

There are many problems with the existing structure of IRBs that citizen science makes clear: the lack of consistency between IRBs (meaning that the University of Minnesota may approve something that the University of Wisconsin would not), speed (or lack thereof), and lack of transparency (IRB protocols are private and institutions will not reveal them for fear of litigation). All of these structures would probably have been designed differently if IRBs were reinvented today.

So the question becomes: What is IRB 2.0?

The cost of IRB approval and the difficulty of obtaining it outside of an institutional setting will continue to be an issue as citizen science grows. How should DIYBio hackers, Quantified Self researchers, and others at the frontier make sure that they are doing research ethically?

IRBs are structured for the Old World of scientific inquiry: there is a Principal Investigator, a home institution, and a particular protocol for communication. But what happens when a participant tweets at you? What about when the citizen scientists want to choose what to research? Citizen science blurs the lines between the researcher and the research subject: the subjects are studying themselves.

Citizen science has enormous potential for moving science forward and improving human life -- but it does require us to rethink some assumptions. To move the debate forward, here are a few suggestions. We offer these here as a way of opening debate and encouraging dialogue. We’d love to hear more of your thoughts on how to make this system better for all of us.

1) Mini-IRB. A publicly available IRB for citizen scientists, which would ensure that the creators had undergone ethics training, had considered how their project would affect the participants, that was available at a fairly low (and fixed) cost and could be achieved within a finite amount of time. This “mini-IRB” would not be a full review, but would ensure that it was clear who was responsible for the project, that they had done their due diligence, and that participants were informed of the risks and benefits. This could be paid for by funding agencies such as NIH or NSF, or by crowdfunding platforms specific to science, such as Microryza or Medstartr, in partnership with crowdfunded projects, or some other scheme.

2) More transparent IRBs. We could also set up a more transparent process for getting existing IRBs. We were shocked to discover that IRB protocols are not public documents. We could not see protocols for similar projects and were urged not to reveal ours because of risk of litigation. Wouldn’t it be a better system if we could all learn from each other?

3) Public debate on IRBs. Finally, let’s involve the public in creating IRB 2.0. There are many stakeholders: researchers, clinicians, ethicists, biotech startups, universities, and regulators. Let’s all come together to discuss the best ways of structuring IRB 2.0. And let’s involve the public, of course.

We’ve learned a lot by going through this process. We want to use this knowledge to help others and to promote the cause of citizen science for everyone. Let’s do that together.