IRB DTC RFI

The Genomics Law Report is an interesting newish blog from the law firm of Robinson, Bradshaw and Hinson. Dan MacArthur pointed me there.

This week the direct-to-consumer genetics testing firm 23andMe announced a “do-it-yourself” initiative in gene-disease interaction research. The idea is that customers of the company can opt into participating in research projects, which would track their health characteristics and combine that information with their genetic profiles. It’s a logical thing to do – if you’re going to collect a lot of genetic material from thousands of people, you’ve got the kind of database that medical researchers dream about compiling. Today, Dan Vorhaus writes thoughts about the legal and practical angles for the research. Including, naturally, the lack of human subjects requirements for these companies:

That does not imply anything untoward about these emerging DTC genomic research projects. 23andMe provides a detailed Privacy Policy, Consent and Legal Agreement and Terms of Service that, collectively, serve many of the same functions that an informed consent agreement would serve in the academic research context. In the Consent and Legal Agreement, 23andMe spells out its research framework.

The DTC efforts are hoping for involvement by disease researchers outside the companies, with some success. I wondered while I was reading this: Will some IRBs decide it’s not kosher for researchers to collaborate with the direct-to-consumer companies – especially if they are also PIs on federal grants? There’s enough variation among institutions that I imagine they will arrive at different answers to that question – especially if it comes down to combining different databases collected under different consent scenarios. For that matter, some universities might look for ways to insist on intellectual property agreements.