My understanding is that there is currently no situation where genomic data can be deposited publicly without "explicit consent" (regarding the data deposit). I think that is discussed in this Genomic Data Sharing (GDS) PDF, but I am trying to double-check if there is something that specifically says "explicit consent" for deposit (in regards to the informed consent document) and "public" data deposit.
That PDF linked above also provides the following sentence: "“NIH expects that informed consent for future research use and broad data sharing will have been obtained even if the cell lines or clinical specimens are de-identified"
This is important because I think there has been some confusion in regards to de-identified data and data deposit: using de-identified data is not sufficient to be able to deposit the data publicly (even though you might be able to get an IRB exemption, such as with archived patient samples).
If the samples were collected before January 25th 2015, you can submit those as controlled access. That (along with the term "explicit consent") is mentioned here:
https://www.genome.gov/about-nhgri/Policies-Guidance/Genomic-Data-Sharing/informed-consent-for-GDS
For a dbGaP submission, you need institutional certification (IC). I have been talking to very helpful people internally, and my understanding is that there can sometimes be exceptions with a "compelling scientific reason" (which is also shown in flow chart for the above link). However, in most situations, I don't think Post-2015 data will be accepted into dbGaP, if there wasn't consent for data deposit.
I've already encountered a few projects where I either need to avoid public data deposit (preferably submitting to controlled access to meet data deposit requirements), convert a previous public data deposit to controlled access, and/or figure out what to do if a study has a mix of Pre-2015 and Post-2015 samples (without consent for data deposit). I might also encounter a dataset of entirely Post-2015 samples (without consent for data deposit), but I am having to sort out all of the details for each individual project (and I have not yet assisted with any project that has gone through a successful dbGaP submission).
I don’t believe I have encountered a 2017 or later sample without consent for deposit, but I am also often not provided the collection date in the metadata.
Since I believe this affects multiple projects, does anybody know if there are any controlled access options other than trying to get an exception for each project for a dbGaP submission (for Post-2015 patient samples collected without consent for genomic data deposit)? If so, I think this will be very helpful to pass along (and it is important that we get the right consent in the future).
Thank you very much for your help.
