Ethical Research: IRBs and ResearchKit

When Apple's ResearchKit was announced, almost immediately some squawked about the ethical problems 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 research 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 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.