Advancing research together.

SMART IRB is a platform designed to ease common challenges and burdens associated with multisite human subjects research. Through a flexible master IRB reliance agreement, standard operating procedures, as well as complementary tools and resources, SMART IRB helps streamline human subjects research while maintaining strong protections for participants. The SMART IRB Agreement eliminates the time and effort typically required to negotiate an IRB authorization agreement for each new study; a Reviewing IRB as well as relying institutions can then be designated on a study-by-study basis via the electronic Reliance system. This model can be used for a range of research, from large clinical trials to two-site collaborations. Clinical investigators can obtain trial results faster, and ultimately speed development of new diagnostics, treatments, and preventative measures for patients.

Institutions participating in SMART IRB enjoy the following benefits:

  • A single IRB Authorization Agreement to participate in the SMART IRB platform
  • Standard operating procedures (SOPs) for establishing and implementing reliance
  • Assistance joining and implementing the SMART IRB agreement from a team of experts
  • Access to online tools

Online Tools

A series of open-source, web-based systems to support the SMART IRB Agreement are in development. Two tools are currently under development:

  • Joinder (in beta)

    The Joinder tool facilitates the process for an institution to request to join the SMART IRB platform, as well as the administrative process to confirm eligibility and establish points of contact, and institution profiles.

  • Reliance (piloting)

    The SMART IRB Reliance system facilitates and documents the decision-making process on a study-by-study basis. Through this system, an investigator (or designee) requests IRB reliance, and the institutions involved reach a reliance determination. The system tracks who needs to take action, automatically notifies the next person when a handoff occurs, and provides a central location for the reliance determination.

Seeking Pilot Studies for Reliance

The Reliance tool is designed to facilitate and document the decision-making process for selecting the Reviewing IRB and Relying Institutions for a given study. We are currently seeking volunteers who would like to gain early access to the tool, and provide feedback and input for future development.

Please for more information about the pilot studies or our software.

 

Funded by the NIH Clinical and Translational Science Award (CTSA) program, grant number UL1TR001102-04S1.
SMART IRB is a joint initiative of Harvard Catalyst, Dartmouth Synergy, and the University of Wisconsin-Madison.