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IRB-HSR > Managing Protocol After Initial Approval >Keeping Data/Samples for Future Research

 

 

 

 

 

 

 

 

What do I need to do to keep data/specimens long term for future research that were collected under an IRB approved protocol including banking that is now being closed?

You have several options.

  • You may remove ALL HIPAA identifiers and any other information that may allow you to re-identify the subject.  You may then keep the data/specimens without any additional IRB approval.  If the subjects denied permission for their data/specimens to be kept long term for future research, this is the only option you may use.
  • If the subject provided permission for you to keep their data/specimens long term for future research and you wish to keep any of the HIPAA identifiers with the data/specimens you will need to do one of the following:
    • If you already have an IRB approved database protocol, you may submit a modification to that protocol noting that the data from the study you are now closing will be kept long term under the database protocol.
    • If you do not already have an IRB approved database protocol, you will need to open a new database protocol with the IRB-HSR.  Enter IRB Online, enter Protocol Builder and create a new application.  If you need help with this process please contact Margaret Ball at mnw2h@virginia.edu.
  • If the data/specimens were collected under a Waiver of Consent (e.g. no consent from the subject such as collecting left over clinical samples) you may either:
    • remove ALL HIPAA identifiers and any other information that may allow you to re-identify the subject.  You may then keep the data/specimens without any additional IRB approval
    • keep the data/specimens in an identifiable manner and request an approval of waiver of consent/ HIPAA authorization from the IRB with your database protocol application.