Scaling citizen health science and ethical review

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

Blood tests 2.0: finger-stick and microneedle array

The farther future could include smartpatches - non-invasive, invisible, continuously-worn health self-monitoring skin patches. In the nearer future, a killer app for synthetic biology and other new chemistry and biology 2.0 methods could be the ability to create one's own vitamin supplements, and possibly innovate low-cost, non-prescription based finger-stick blood tests, and saliva and urine panels for self-testing.

Barrier to Citizen Science
A significant barrier to the wide-scale adoption of citizen science in the context of health self-management, intervention exploration, and preventive medicine implementation is the high cost, inconvenience and discomfort involved in obtaining traditional lab tests. While many tests may be ordered in a direct-to-consumer fashion through DirectLabs, the Life Extension Foundation, and other websites, it still costs ~$100 per test.

The challenge is to identify the requisite chemistry and processes involved and see if it may be possible to make simple consumer-friendly finger-stick blood test cartridges, similar to the glucose and HDL measurement kits sold at drug stores, which self-experimenters may perform at home or at community biolabs. Continuous monitoring via microneedle arrays would be useful for self-tracking glucose levels and other markers. For example, there could be consumer-targeted versions of the devices being developed by Orsense.

Figure 1. Non-invasive glucose monitoring device from Orsense

Community labs and high-end home labs may include the (CLIA-waived) Cholestech LDX machine (~$2,000 for the machine + ~$5-10 per measurement cassette) which can assess eight different lipid profiles.

Figure 2. Cholestech LDX finger-stick lipid measurement device

There is an urgent opportunity to expand the range of finger-stick measurement tests. Below is a Wish List of basic tests for one-off or comprehensive panel delivery.

Traditional Blood markers:

• Homocysteine
• Vitamin B-12
• Folate
• Vitamin D
• Creatinine
• eGFR
• Cortisol
• Calcium
• Iron
• Aldosterone

Hormones

• Estrogen
• Progesterone
• Testosterone
• Estradiol