A Novel and Flexible Reliance Model:
- Free to join and use
- Open to any institution with a Federalwide Assurance (FWA) with OHRP
- Single reliance agreement allows use with any multisite study regardless of disease type and funding support
- Available to studies at any level of review (expedited or full committee)
- Does not require changes to local IRB database
- No additional regulatory burden for the Lead IRB
- Maintain local IRB oversight while streamlining IRB review
- Increased transparency between IRBs leading to improved review quality, more consistent determinations, and best practices
- Secure IRB access to confidential and proprietary documents
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When should IRBshare be Used?
IRBshare can be used with any study with two or more sites regardless of the disease type, funding source (or lack thereof), location of study sites, and study characteristics (e.g., level of risk, size, phase). Additionally, these scenarios are uniquely well suited for using IRBshare to streamline IRB review and approval:
- When study sites are widely dispersed across the US or otherwise have highly disparate populations or state/local laws: Since the local IRB reviews the local context and maintains oversight of the study, IRBshare allows IRBs to minimize the duplicative regulatory review, but maintain local autonomy and control of the study.
- When there is not a coordinating center to help with study coordination and communication: IRBshare staff can help create a ROCKET workspace to help manage all study-related documents in a way that provides secure access and clearly communicates version changes and updates.
- N of 1/Rare disease studies: For example, many cancer studies/protocols are very specific to rare cancers with or without specific genetic mutations. An investigator may never see a patient who qualifies. However, in order to be prepared, the investigator often obtains IRB approval to expedite the enrollment process should a qualified present. With IRBshare, the study can be approved by the lead PI’s IRB and other sites can use the Shared Review Process to obtain approval in a short amount of time when a patient who qualifies arrives at the site. Similar to using a “just in time” approach.
- When sites are recruited on a rolling basis: IRBs of newly recruited sites can start the Shared Review process as soon as the required study documents are submitted.