IRBshare

IRBshare is a new joint or shared IRB review model for multi-site studies that facilitates the sharing of full board review documents and enables a temporary reliance between IRBs for the initial study review to reduce duplicative IRB reviews. While the primary goal of sharing review documents within the IRBshare System is to allow for utilization of a new shared review model, use of the IRBshare System solely to share key review documentation will naturally result in positive secondary outcomes as well. Examples of such worthy outcomes are promoting consistency and compliance, facilitating IRB cooperation, and providing shared access to data amongst IRBs participating in a multi-site investigation – all of which have great potential to improve participant safety, quality, and timeliness of results.

IRBshare is supported by a single, universal agreement (IRBshare Master Agreement (IMA)) that satisfies 45 CFR 46.114 and 21 CFR 56.114 as an appropriate model for joint study review, as well as a secure web-based document sharing system. Visit IRBshare.org for more information, including

• Participating Institutions
• Resources
• IRBshare Studies
• Frequently Asked Questions
• IRBshare Master Agreement (to join IRBshare)

Visit the Tool Shop Webinar page to view a system overview and demonstration (here).

What Institutions Can Use IRBshare and How Much Does it Cost?

IRBshare is available to any institution with an active Federalwide Assurance with OHRP. To join, an institution's Institutional Official must sign the IRBshare Master Agreement and an IRBshare Liaison must be identified for the institution. There is no cost to join IRBshare.

What Studies Can Use IRBshare?

IRBshare can be used with any multisite study that is greater than minimal risk study (i.e., studies that require full board review) and either investigator-initiated or industry-sponsored. At this time, the study must also be undergoing the initial round of reviews conducted by the respective participating IRBs. Future phases will  allow institutions to utilize IRBshare for continuing review and amendment reviews (estimated to be available in late 2013/early 2014). To view the names of current studies in IRBshare, go here.

Contact:

IRBshare Project Manager

Related Links:

IRBshare.org