Today, 23andMe is pleased to announce that we have received institutional review board (IRB) approval for our research protocol and an accompanying revised Consent Document. This approval reaffirms that all 23andMe research efforts intended for publication protect the interests of our customers. Our absolute commitment to privacy has not changed.
An IRB is an independent panel charged with ensuring that every step of a study’s protocol follows federal guidelines on research protections for human subjects. IRB approval is required when individuals directly interact with researchers and/or individual, identifying information is made visible to researchers or third parties.
Because the 23andMe protocol excludes individual identifying information (e.g. name, email address, user ID, Password, payment information, etc.) and our analysts do not interact directly with customers during data collection, our research technically does not require IRB review. This would be true even if the federal government funded our work.
While IRB approval is not required, we sought IRB approval for our research protocols and customer consent language to ensure that our work is in line with scientific research best practices. This has taken some time because 23andMe’s innovative new model of research was not originally anticipated by traditional IRB guidelines.
So what has changed?
The new IRB-approved consent process lets customers use our service and access their own data, regardless of whether or not they want to be part of research that will be published in a peer-reviewed scientific journal. Previously, customers opted into this research by purchasing our service, then completing and submitting surveys. Now, however, customers must explicitly choose to allow their genetic and survey data (in an aggregated and de-identified form, as always) to be used in published research.
What hasn’t changed:
23andMe remains committed to furthering personalized medicine. As such, we use data from all customers (including those who have not consented to be part of published studies) for company research aimed at making new discoveries and developing new features and products. This research is not intended for publication and is sometimes undertaken in association with our partners. We believe consumer-driven research will lead to significant findings that will benefit us all in the future.