The one-sentence rule
An IRB is only required if you are using the Stony Brook University Network AND need to download the dataset OR re-identify your cohort of SBU patients for chart review or recruitment.
By use case
| Use case | IRB required? | Key details |
|---|---|---|
| Study design & feasibility | No | Platform-only work; no individual patient data accessed |
| In-platform data analysis | No | Platform-only work; no individual patient data accessed |
| MRNs for subject recruitment | Yes | Requires PHI access; include a HIPAA Waiver of Authorization |
| MRNs for chart review | Yes | Requires PHI access to patient records |
| SBM patients limited dataset download | Yes | Limited datasets contain dates, diagnoses, procedures; include the Limited Dataset form |
| Research or Linked Network dataset download | No | Individual patient identification is not possible |
Publishing
Many publication venues require an IRB determination that the research qualifies as “Not Human Subjects Research”, even when Stony Brook datasets aren't used. Verify with the venue before submission.
Help with the paperwork
- Template protocols for TriNetX limited-dataset or chart-review research (see Documentation & Resources)
- Template HIPAA Waiver of Authorization for recruitment purposes
- The SBM TriNetX Administrator and Honest Broker review IRB documentation for compliance