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BACKGROUND/RATIONALE:
For over forty years, organizations have used institutional review boards (IRBs) to oversee research involving human subjects. Most research organizations have created their own institutionally-based IRB (a "local" IRB). In recent years, federal regulators have temporarily halted research at several organizations for human subjects violations. One alternative system that has been suggested by researchers and ethicists is the use of centralized IRBs. The VA has decided to design its own CIRB and we are proposing to assess the costs and benefits of the VA CIRB relative to local review.
OBJECTIVE(S):
Our specific aims are:
1)To assess whether the CIRB reduces researcher's effort for IRB related work,
2)To assess whether the CIRB reduces effort for IRB and R&D staff,
3)To investigate whether a CIRB reduces the time it takes to approve a protocol, amendments, and continuing reviews
4)To estimate the shape of the CIRB's learning curve over time.
5)To estimate the costs of IRB related effort and compare the costs of the CIRB model to the local IRB model
METHODS:
We will prospectively follow multi-site research protocols to understand effort and timing for IRB-related work. We will use these data to estimate costs for our analysis.
FINDINGS/RESULTS:
No results at this time.
IMPACT:
We expect this information will provide researchers and policymakers with greater information on how to best protect human subjects while simultaneously expediting research.
PUBLICATIONS:
None at this time.
DRA:
Health Services and Systems
DRE:
none
Keywords:
none
MeSH Terms:
none
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