Category Archives: regulation

Scaling citizen health science and ethical review

(cross-posted at Broader Perspective)

Many things are needed to scale citizen science from small cohorts on the order of a few individuals to medium and large-sized cohorts. Building trust in online health communities, motivating sustained engagement from study participants, and lower-cost easier-access blood tests are a few things that are needed.

Legal and ethical issues are also a challenge. Independent ethical review is appropriate but the current IRB (Institutional Review Board) requirement for funding and journal publication is a barrier to crowdsourced study growth. In 23andMe’s early studies, there was a definitional debate as to whether their research constituted ‘human subjects research,’ and whether there was a difference in interacting with subjects in-person versus over the internet.

The U.S. HHS (Health and Human Services) definition of ‘humans subjects research’ is research that “obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.” (45 CFR 46.102(f)) The strict reading is that any research obtained by ‘interacting’ with a human subject (e.g.; likely all personalized health collaboration community research) would require an IRB for the funding needed to do it at scale.

Acknowledgement: Thank you to Thomas Pickard for providing background research