Frequently Asked Questions
Do you have an Epi25 consent form I can use to consent participants?
To date, Epi25 has aggregated DNA samples collected under previously approved IRB protocols at the sites’ home institutions. If you are unsure if your participants have provided sufficient informed consent in order to be included in Epi25 sequencing and data sharing, please reach out to Felecia and Cate.
What is the NIH Genomic Data Sharing Policy and why does it matter in Epi25?
The NIH GDS Policy applies to all NIH-funded research (e.g., grants, contracts, and intramural research) that generates large-scale human or non-human genomic data, regardless of the funding level, as well as the use of these data for subsequent research. Large-scale data include genome-wide association studies (GWAS), single nucleotide polymorphisms (SNP) arrays, and genome sequence, transcriptomic, epigenomic, and gene expression data. Because Epi25 is funded by a branch of the NIH (the NHGRI), the Epi25 genomic data will be deposited into dbGaP. Therefore, the NIH Genomic Data Sharing Policy applies to Epi25 genomic data.
In brief, the NIH Genomic Data Sharing Policy requires that - for participants consented after the policy effective date of January 25, 2015 - participants provided informed consent for broad sharing of samples/data, future use of samples/data, and deposition of data into a repository.
If your site has samples collected after January 25, 2015, and you would like to contribute them to Epi25, it is required that your consent forms used to collect these samples contain this language.
If your site has samples collected before January 25, 2015, the consent form must not be in consistent with broad sharing, future use, and deposition of data into a repository.
An FAQ about the NIH Genomic Data Sharing Policy can be found here: https://osp.od.nih.gov/scientific-sharing/genomic-data-sharing-faqs/
If I can provide an IRB approval letter that dbGaP data deposition is allowed, why do you require a Data Use Limitations letter?
Because the Broad is using Epi25 samples in a secondary use manner and did not approve the sample collection activities themselves, we require Data Use Limitations letters to indicate that A) sharing samples and data with the Broad is allowed B) sharing data in a controlled-access repository is allowed and C) if there are any use restrictions associated with the data. We use the Data Use Limitations letters to complete the Institutional Certification form that is required to register samples/data in dbGaP.
What if my ethics committee will not sign the Data Use Limitations letters?
Contact the Broad Project Manager to discuss options for signatories in the letter.
Will the Broad accept more or less DNA than the recommended 50 ul at 80 ng/ul?
The requested amount of DNA is 80 ng/ul at 50 ul. This amount of DNA assures that there will be enough material for any downstream analyses. If you have samples that cannot meet these requirements, we still may be able to accept the samples. Contact Felecia with any questions about the sample input requirements.
What about family samples? Can those be sequenced?
At this time, Epi25 is sequencing one affected case per family. Unaffected or affected family members are not eligible for Epi25.
What about data? Is there a process for applying for and using data?
The data access process for Epi25 is described on our "Joining Epi25" page, here.