Can we use a single-IRB model with CH as the relying institution?
Yes. We have a reliance agreement template (v3) that cedes review to your IRB. We add a CH addendum scoped to enclave usage and the analytic-plan pre-registration. About 60% of our active studies use sIRB.
What if our IRB requires more than the standard DUA?
Common, especially at large academic medical centers. We accept reasonable amendments — most often around publication rights, IP, indemnification scope. If your ORA wants something we can't do, we'll tell you in 48 hours; no surprise stalls at signature.
Are pediatric studies handled differently?
Yes. Pediatric protocols go to a second-tier IREB review with a patient-advocate seat. Approval typically takes 21 days instead of 14. Output k-thresholds rise from k≥11 to k≥20. Pediatric school-affiliation graphs require explicit guardian consent at the source.
What about behavioral-health and substance-use disorder cohorts?
BH and SUD cohorts are governed under our 42 CFR Part 2 + state-BH-statute policy (in active development for the BH clinic surface). Until then, BH/SUD studies are reviewed case-by-case with patient-advocate seat at IREB and require additional consent at the source.
Can we run an interventional study, not just observational?
Not directly through the enclave. Interventional studies require a partner clinical site to deliver the intervention; CH provides the cohort frame and outcomes telemetry. We've co-built two such studies. Email researchers@conceptualhealth.com for the interventional addendum to the DUA.
What's the appeals path if IREB doesn't approve our analytic plan?
You get the rejection memo with specific cited concerns. You can revise and resubmit (no fee, no penalty); usually a single revision resolves it. If you disagree with a decision, written appeal to the IREB chair triggers a second-look by an external bioethicist within 14 days.
Do you charge for IRB review?
No. IREB review is free. The data-access pricing kicks in at step 5 — see the pricing page. Academic / non-profit tier is substantially below commercial.
Can our results be embargoed?
No. We require any aggregate output that leaves the enclave to also be queryable as a chain-attestation by the affected patient population. You can embargo against the press, but not against the participants whose data made it possible.