WIRB Eligibility Criteria
The criteria for studies from USA investigators to be eligible for review by the WIRB include:
- Research meets the NIH definition of a clinical trial. “A prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices)”.
- Research is a Phase II/III/IV clinical trial.
- Protocol must be written and designed by sponsor.
- The sponsor is a for-profit entity or company.
- The sponsor holds all INDs/IDEs.
- The research has not previously been submitted to the USA IRB for review.
Studies which involve any of the following are not eligible for submission to WIRB:
- Phase I Studies (including I/II, studies).
- Planned emergency research.
- Single patient emergency use or compassionate use situations.
- Embryonic stem cell or gene therapy research.
- Federally funded protocols.
- Investigator-initiated research.
- Industry sponsor that refuses to pay WIRB fees and/or the USA IRB fees.
- Research involving prisoners.
USA may also require dual review by the USA IRB when the institution deems that the rights and welfare of subjects would be better served by local review.