When Apple’s ResearchKit was announced, almost immediately some squawked about the problems of ethical research that may be raised by its use.  One argument suggested that because teens use iPhones, and because teens “aren’t supposed to take part in medical studies without parental consent” this would be bad.  The argument proceeds to describe how the study being implemented could be thwarted by a lying teen who indicates they are over 18.  Certainly we do not want to have children engaged in research without parental consent – but is ResearchKit the appropriate place to point our finger?

The Pew Research Center’s Internet & American Life Project in 2013 indicated that over 93% of 12-13 year olds, and 96% of 14-17 year olds use the Internet.  A 2012 study by the same team showed that 81% of online teens use some kind of social media.  With this prevalence online, a significant amount of research is already being conducted that is within reach of millions of teens.  And certainly, some of them have lied to participate in a survey that they would have otherwise been ineligible for.

Why is this a ResearchKit problem?  If a child intercepts a mail survey that is sent to a home, do we suggest that the postal service “has some growing up to do”?   Should the responsibility not lie with the researcher and their human subjects oversight to identify risks in the research design and require them to be resolved?

About two weeks after ResearchKit was announced, Apple released guidelines that would require researchers to provide evidence that they have Institutional Review Board (IRB) or Human Subjects oversight and approval for their study apps before they are published.

Apple should be applauded for this action, as for the first time ever, a technology company is forcing researchers to use an IRB.

Why is this significant?  Because a large amount of research conducted every day does not require an IRB review by law.  It turns out that IRB reviews are only required if your study involves federal funding or federal approvals (i.e. FDA) or the institution you work at has an internal policy to require an IRB review.  The Office for Human Research Protections in the U.S. Department of Health & Human Services provides many details and a guidebook about the laws.  A 2013 crowdfunding case with uBiome demonstrated the limitations of the current system.

Yes, you are reading this correctly: I am saying that independent or privately funded researchers, healthcare companies, market research companies, and likely others are routinely conducting studies without any IRB oversight.

But now, with ResearchKit, if researchers want to use the technology, they will have to obtain IRB approvals.  This is where real change will happen.  IRBs were designed to protect human subjects and foster more ethical research, and they will consider the risk/benefit trade-offs that are involved for each individual study and decide if a lying teen is something to worry about, or not.

It is time to see ResearchKit for what it is – a tool in the social / medical researcher’s tool belt.  That tool can be wielded appropriately or not – that is up to the researcher.

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.