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Biobanking Consent Document

Consent Document for Sample Storage and Additional Genetic Analyses

By choosing to have 23andMe store either your saliva sample or DNA extracted from your saliva, you are consenting to having 23andMe and its contractors access and analyze your stored sample, using the same or more advanced technologies (such as genetic sequencing), in a manner consistent with our Terms of Service and Privacy Statement. Unless we notify you otherwise, we will store your sample for a minimum of one year and a maximum of ten years, at our CLIA-certified laboratory. We may contact you in the event we need to re-analyze your sample. All of the same safeguards to any further use of your sample will be provided as in our Terms of Service and Privacy Statement.

Additional DNA Analyses of Stored Participant Samples

In addition, a subset of research participants may have their DNA reanalyzed using another technology, such as sequencing. The sequencing may focus on particular genes or regions, on the coding portions of the genome (also known as the exome), or on the whole genome. While the field of large-scale sequence analysis is still in its early stages, we can use methods that are being developed to compare sequence data with large public databases of genetic variation to identify and characterize functional genetic variation. The sample sizes needed for sequencing vary considerably depending on the type of study. To identify the causal mutation for a rare recessive disease may only require a nuclear family of four people. Identifying less penetrant rare modifiers of risk will likely require significantly more people. The studies with whole exome and whole genome data thus far have been mainly descriptive and better estimates of appropriate sample sizes will come as the methods for analysis are established. In the short term, sample sizes may mostly be limited by the cost and capacity of current high-throughput sequence providers.

If additional data are collected, their use will follow the scope of topics currently approved by 23andMe's IRB. For example, research on sensitive topics using these data will not be performed unless specific IRB approval and participant consent has been obtained.

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