Important Update: April 22, 2025
On April 14, the NIH sent Harvard University a Stop Work Order for the SMART IRB federal funding contract. We were told to cease all work on the SMART IRB federal contract immediately. The order did not include a reason or explanation. While we have been trying to reinstate the work order, to date, we have not been successful. The Agreement, however, remains operative, and we will continue to support its enablement as we are able.
Moving Forward
From the beginning, SMART IRB has been a collaborative, grassroots effort: SMART IRB was built by and for the community. It is not owned by Harvard, NIH, HHS, or any other entity.
At this time, Harvard is supporting us to maintain the SMART IRB Agreement and assist Participating Institutions to the best of our abilities. It is our intention to continue to provide this vital support to advance collaborative research.
Importantly, the SMART IRB Agreement is an independent legal agreement between the Participating Institutions; as such, SMART IRB Agreement V3.0 remains available for use by current signatory institutions, and the existing arrangements under the prior Legacy Agreements remain valid.
Supporting our Community
The majority of the staff who have supported the SMART IRB platform continue to be employees of Harvard Medical School; others are employed elsewhere. Since no one is being funded or supported by the SMART IRB federal funding contract at this time, we will communicate only as employees of the university or through our relevant institutional affiliations.
In our role as Harvard employees, staff will resume responding to Help Desk tickets, activate new joinder agreements, and perform other tasks as needed.
Ambassadors and other team members are unable to be paid for their SMART IRB work as of April 14, 2025, and until further notice from NIH. Any work on SMART IRB performed during this time is voluntary. Please be considerate of their time.
Advancing Research Together
The following are important facts about our initiative’s impact:
- SMART IRB supports research for over 1,350 institutions across the nation, including the NIH, universities, academic medical centers, community hospitals, commercial/independent IRBs, and others.
- SMART IRB supports over 12,000 researchers and, additionally, over 2,000 IRB and HRPP staff members.
- The SMART IRB Reliance System has been used to document IRB reliance for nearly 12,000 studies that are tackling pressing and complex health conditions and diseases that impact individuals, families, and entire communities across the country.
Please help us spread the word about SMART IRB and this important update.
Importantly, thank you for your support, cooperation, and community, and for all your efforts to protect and advance the health of all Americans.
