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 firstname.lastname@example.org.
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.
Last Modified: Wednesday, 12-Jul-2017 13:03:14 EDT