Can I request a consult prior to applying?
Yes, please email Julie Sapp.
Can I apply before my protocol has been approved by the IRB?
Yes! In fact, we encourage you to do so that we can provide guidance on proper consent language.
What if my project is for exome/genome sequencing of more than 300 participants per year?
After reviewing the website, please contact Julie Sapp. We are willing to help you figure out possible workarounds.
What if I am investigating a gene on the ACMG 81 list?
Your protocol may still be applicable for secondary findings review but we will not confirm or return findings in the expected genes.
How will research teams know when SGFS has completed their analysis?
We will send your team a report of our annotation process and results.
My participants are enrolled on an intramural protocol but they have never been seen at the NIH. How do I register them as a clinical center patient?
Please follow the external-location patient registration process identified on the NIH CC intranet site.
My participants are not local but can be easily re-contacted. Can they mail in confirmatory samples?
Yes, SGFS can help coordinate obtaining confirmatory saliva samples via FedEx. SGFS can cover the cost of shipping.
Can I submit blood instead of saliva for a secondary sample?
No, we much prefer saliva as a secondary sample. SGFS can provide the Oragene DNA saliva kits. If there is some extenuating circumstance in which your patient physically cannot give saliva, please notify Julie Sapp prior to collecting blood as a second sample.
How long does it take to analyze results?
Every project is different, but it takes roughly 2-5 months from the time we receive your data to the time we return the annotation report that states which samples, if any, had a preliminary secondary finding. It then takes another 1-3 months to establish patient contact, receive saliva samples, CLIA validate findings, and return these results. We make our best effort to minimize the time between asking a participant for a sample and returning the results.
I don’t understand the data submission requirements. Who can help clarify this for me?
We recommend talking with your team’s bioinformatics staff or your collaborators whom perform the initial genetic analysis. They should be familiar with these terms (ex. VCF, GRCh38, etc.) in relation to your project.
I still have questions. Who can I ask?
Please email Julie Sapp with questions.