October 19, 2010
I am a strong supporter of self experimentation and citizen science, particularly when it comes to health (full disclosure: I’m CoFounder of CureTogether.com
). Since our bodies all differ to varying degrees, we need to experiment with foods, lifestyles and medications to find out what will work best for each of us. And pooling our individual data can guide us in choosing intelligently, rather than randomly, which experiments will have the highest chance of yielding answers that will help us.
It will come as no surprise that I’m a great fan of fellow QS member Seth Roberts – a modern pioneer and champion of self-experimentation. At a recent QS Meetup, Seth drew lots of attention from the crowd when he discussed the results of his Butter-Arithmetic experiment
. In fact, there was so much interest, that some people decided they wanted to run the same experiment on themselves and pool the data to see if they could replicate his results. This led to Eri Gentry’s Butter-Mind… and Coconut-Mind Study
, in which she outlines a good, scientific protocol and writes: “I am currently looking for Butter Mind participants.”
And this is when I became concerned.
In a subtle shift, we went from one person reporting on an experiment he ran on his own body, to a group of people deciding they want to try the same thing, to a public call for participants.
Some would argue that such a call qualifies as an advertisement for a human interventional study, which creates ethical, if not legal, responsibility to establish proper oversight. Specifically, it would require assessment and disclosure of any potential risks of participating and verification that all participants have given voluntary and fully informed consent.
Personally, I think the Butter-Mind experiment is quite safe, and most members of the QS community are likely sufficiently sophisticated to be fully aware of whatever risks it may present. But some might reasonably challenge this, particularly for certain potential participants, and especially when the details of the study are communicated to a wider audience. We already had a cardiologist express concern to Seth about the risks to cardiovascular health of increasing saturated fat consumption.
Most importantly, it is not up to the designers of a study to make the determination of whether research is ethical, whether potential risks and benefits have been properly communicated, and whether informed consent is sufficient. This is the job of an ethical review board.
As the QS movement ventures from simple self-tracking to more sophisticated social experimentation, which offers compelling scientific rewards, there are a couple of options for proceeding.
If there are going to be public calls for participation, then I would strongly urge the QS community to assemble its own ethical review board, according to federal regulations, and to review all studies that in any way seek to actively recruit others to participate.
If we alternatively decide this would pose too great a burden on us self-experimenters, then we need to figure out how to help people with similar interests come together and share data, without anyone “advertising” their study such that it binds us to play by the same rules that were established long ago for pharmaceutical companies.
I am not at all an expert in this, but I think it’s an important distinction that we need to understand and develop rules against.
It would be truly tragic if the nascent QS movement, and its promise for social benefit, became overburdened with regulatory oversight for failure of its pioneers to take appropriate safety precautions. The best way to avoid this is to demonstrate that we have considered the ethical issues and can responsibly regulate ourselves.
For those who might think this is excessive, consider what might happen if, in some future experiment, someone who was not fully informed of potential risks ends up seriously harming themselves.