An IRB is only required if you are using the Stony Brook University Network AND require to download the dataset OR re-identify your cohort of SBU patients for chart review or recruitment.
Be aware that many publication entities require that you have received a determination from the SBU IRB that your research is Not Human Subjects Research, even when you are not using Stony Brook University Network datasets. You will want to verify if that is needed.
|
Use Case |
Need IRB? |
Reason |
|---|---|---|
|
Study design and feasibility |
No |
Done only in platform, no individual patient data |
|
In-platform data analysis |
No |
Done only in platform, no individual patient data |
|
MRNs for Subject recruitment |
Yes |
PHI access needed |
|
MRNs for Chart Review |
Yes |
PHI access needed |
|
SBM patients Limited Dataset Download |
Yes |
Limited Datasets include dates of visits, dx, procedures, etc. |
|
Research or Linked Network Dataset Download |
No |
Not possible to identify individual patients |
A template protocol for research using a TriNetX Limited Dataset or Chart Review is available in Documentation and Resources section of this site.
See the documentation section of this site for a template HIPAA Waiver of Authorization for the use of TriNetX for recruitment. With IRB approval, you can use those patient MRNs to request data from SBM IT or do chart reviews. For these requests, the SBM TriNetX Administrator and Honest Broker will first review your IRB documentation and protocol to ensure compliance.