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 Online 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 web-based systems to support the SMART IRB Agreement are available:

  • Joinder

    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

    The SMART IRB Online 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.

Please for more information about our software.

 

Funded by the NIH National Center for Advancing Translational Sciences through its Clinical and Translational Science Awards Program, grant number UL1TR001102-04S1.
SMART IRB is a joint initiative of Harvard Catalyst, Dartmouth Synergy, and the University of Wisconsin-Madison.

 

AMIA Poster

Presented at AMIA 2018 Informatics Summit, March 12-15, San Francisco.

AMIA 2018 Poster

 

System usage as of August 2, 2019:

Who is using the ORS?

512 institutions registered
3002 users

How many requests?

622 in-progress
1409 reliance reached

Current People

Ankit Panchamia Ankit Panchamia Technical Lead Anupama Maram Anupama Maram Senior Business Analyst Bill Murphy Bill Murphy Senior Web Technology Architect Bill Simons Bill Simons Director of Engineering and Technology Douglas MacFadden Douglas MacFadden Chief Informatics Officer, Harvard Catalyst Eric Dias Eric Dias Software Engineer Katherine Sao Katherine Sao Senior Business Analyst Michael Cherry Michael Cherry Senior Release Operations Engineer Nikolay Akhmetov Nikolay Akhmetov Software Engineer Paul Fricker Paul Fricker Project/Content Support Coordinator Perminder Singh Perminder Singh Software Quality Assurance Engineer Santiago Alvarez-Vargas Santiago Alvarez-Vargas Senior Software Engineer Simone Biver-LeBlanc Simone Biver-LeBlanc Project Manager Andrew Dion Andrew Dion DevOps Engineer

Past People

Genoa Polumbo Genoa Polumbo Senior Project Coordinator Isha Johri Isha Johri Software Quality Assurance Engineer Sophia Cheng Sophia Cheng Technical Lead and Principal Engineer Thomas Naughton Thomas Naughton Software Quality Assurance Engineer Adhiraj Rankhambe Adhiraj Rankhambe Senior Software Engineer Adriano A. Paiva Adriano A. Paiva Senior Informatics Project Manager Bhanu Bahl Bhanu Bahl Director, CTSC Informatics Program Management Chris Pallotta Chris Pallotta Senior Software Engineer Christine Sloane Christine Sloane Senior Quality Assurance Analyst Dan Russotto Dan Russotto Software Engineer Co-op David Hummel David Hummel Principal DevOps Engineer Drew Teter Drew Teter Software Engineer Greg Polumbo Greg Polumbo Technical Lead – Harvard Catalyst Web Portal Jillian Dudek Jillian Dudek Senior Project Manager Katherine Lau Katherine Lau Senior Business Analyst & User Experience Designer Lisa Finch Lisa Finch Senior UI/Graphic Designer Maria Cervone Maria Cervone Informatics Director, SMART IRB Nandan Chhabra Nandan Chhabra Software Quality Assurance Engineer Narendra Negi Narendra Negi Software Quality Assurance Engineer Patrick Watrous Patrick Watrous Software Engineer Co-op Remlee Green Remlee Green Senior User Experience Analyst Sherry Seibel Sherry Seibel Software Engineer