ResearchKit: will Apple change social science research? Geolocation, iSperm, and DNA

by | Jul 24, 2015 | Fun, Genetic Testing, Human Subjects / IRB, Innovative Methodologies, Opinion / Editorial, Survey Methodology, Survey Operations

It seems that every few days, an announcement brings forth a new use for Apple’s ResearchKit.  My first reaction was one of excitement, mixed with horror.  The excitement stemmed from the fact that we are heading in a direction where the survey question may not always be the best way to get the data you need.  Platforms like ResearchKit provide easier access to such tools.  The horror followed the trajectory of the do-it-yourself surveys that exploded when easy to use web survey systems made it possible for anyone anywhere to conduct a survey.  Would this increase the poorly designed studies that happen when those who are not trained in research methods attempt to conduct research?

Only time will tell – and until then, I choose to remain on the excited side of my initial reaction.  I can’t imagine a more exciting time!

The science is evolving, and evidence is being gathered on the best methodologies for using the new tools provided by mobile devices.  In recent experiments, we have begun to understand the best practices for consenting to capture and capturing geolocation data.  But the field is largely untested – for years to come the technologies that are emerging today will be used, largely without much consideration for data quality, until slowly the field gets a handle on the error sources and costs involved.

Devices to capture blood pressure, blood oxygen levels, pulse rates, mobility, and sleep patterns are already on millions of wrists and belts.

Will the capture of DNA in ResearchKit studies truly integrate genetic and social data collection into one?

Will fertility studies have a new tool with the newly announced iSperm?  Just a year ago, had the iSperm article been posted on April 1, it would have been considered a beautiful prank – but today this is a real tool that is being used by farmers to evaluate non-human (boar) sperm.

Hold on to your mobile devices – this is far from over.

Currently, the FDA only regulates true direct-to-consumer (DTC) genetic tests, which have no health care provider involved either before or after testing. Consumer-initiated, physician-mediated genetic tests are considered lab developed tests (LDTs), which currently do not require FDA oversight. 

 

Our Study Design

Our study was designed to simulate the experience of an everyday person who is considering doing a health-related genetic test. For this reason, we only reviewed website contents presented to a consumer before ordering a test. By limiting our data collection to pre-test content, instead of digging around or contacting the companies to fill in missing data points, gaps in public-facing information that consumers use to make ‘informed’ decisions were revealed.  

Also, while a genetic counselor supervised the project, a research assistant (RA) conducted most of the website investigations. The RA was familiar enough with genetics and genetic testing to understand and identify the information presented on the websites, but has not had the clinical exposure that might create bias from knowing how specific tests work “behind-the-scenes”. 

 

To Sum Up

We set out to understand the landscape of health-related consumer genomics testing from the public perspective. By limiting our research (by design) to public-facing pre-test website content, we could not complete our data collection as set out in the protocol. However, this uncovered an important observation: consumer genomics websites are highly variable in content, readability and ease of use. 

This begs the question, if we can’t find basic test information on a consumer genomics website, how does a consumer have enough information to make an informed choice about testing? 

Stay tuned for Part 2 in this series, where we will dig into our study findings and reveal our most interesting observations.  

 

 

As experts in FDA user comprehension studies for consumer genomics companies seeking 510(k) clearance, we are interested in how everyday people access and understand health content that is meant for them. If you need help optimizing your consumer-directed health communications, we’ve got the in-house expertise and experience to meet your needs. Let’s chat

About the Author

Scott D. Crawford

Scott D. Crawford is the Founder and Chief Vision Officer at SoundRocket. He is also often found practicing being a husband, father, entrepreneur, forever-learner, survey methodologist, science writer & advocate, and podcast lover. While he doesn’t believe in reincarnation, he’s certain he was a Great Dane (of the canine type) in a previous life.