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 email@example.com.
- 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.