Stop Work Order for SMART IRB

• • Raise your Voice:
    • Essential Research Infrastructure is at Risk! Tell your friends, family, colleagues, and senators and representatives about the current situation, how SMART IRB has impacted your work, and why SMART IRB matters.
    • Spread the Word: Share through your social networks, and with colleagues on LinkedIn. Consider writing an op-ed or a letter to your local/regional news outlet.
  • Build our Capacity for Collaborative Research:
    • Now is the time to join SMART IRB Agreement V3.0 and to encourage your affiliates, collaborators, and colleagues to join ASAP. Regardless of what happens in the future, the SMART IRB Agreement remains an independent legal agreement between signatory institutions. For this reason, it will always be available for use among the current signatories.
    • Become (or continue to be) an active member of the SMART IRB community: Continue to use the SMART IRB Agreement, the Reliance System, and our supportive resources. Invite others to become active members.

To Support Outreach Efforts

The template language below includes a summary of the current situation and background on SMART IRB and how we work to support and advance research across the country. We welcome you to use and adapt this language. We also strongly encourage you to add your own take on why SMART IRB matters and how it has made a difference in your work.

Sample messaging:

Essential research infrastructure is at risk. SMART IRB needs our help!

On April 14, the NIH sent Harvard University a Stop Work Order for the SMART IRB federal funding contract. From the beginning, SMART IRB has been a collaborative, grassroots effort dedicated to easing challenges associated with multisite research. SMART IRB was built by and for the community: It is not owned by Harvard, NIH, HHS, or any other entity.  Harvard is temporarily supporting the core team to provide vital support for single IRB review and advance collaborative research across the country, but the future is uncertain. We must help ensure the long-term sustainability of this vital resource – for the benefit of all.

About SMART IRB

SMART IRB eases challenges associated with multisite research by providing free, comprehensive support for single IRB arrangements. 
From small collaborations to large clinical trials and research networks, SMART IRB is designed to make multisite research work better, streamlining the initiation of studies addressing pressing and complex issues that affect all of us, from dementia to cancer.

SMART IRB is not an IRB; rather, it is a free platform offering a roadmap for single IRB review and fostering a community dedicated to collaboration and process improvement. SMART IRB supports tens of thousands of studies and as many investigators, study teams, and IRB/HRPP professionals at more than 1,350 institutions across the country, including universities, academic medical centers, community hospitals, commercial/independent IRBs, the NIH, and more.

By providing a legal framework for IRB reliance, along with free education, tools, and guidance, SMART IRB harmonizes and streamlines the ethical oversight of health research. In short, SMART IRB is an essential resource that the research community has come to depend on to improve efficiency and reduce burden, while ensuring the safety and wellbeing of research participants and advancing research for the benefit of all Americans.

FAQs

During this time, can we continue to use the SMART IRB Agreement?

Yes, please do. The SMART IRB Agreement is an independent legal agreement between the Participating Institutions.

• • SMART IRB Agreement V3.0 remains available for use by signatory institutions.
  • Existing arrangements under the prior Legacy Agreements remain valid.
  • Resources, Harmonization materials, and the Reliance System remain available to support your reliance arrangements.

As a reminder, starting March 17, 2025, any new reliance arrangements (including adding sites to an existing study) must use SMART IRB Agreement V3.0. Learn More.

Can we join SMART IRB Agreement V3.0? Can our collaborating sites join?

Yes. For the time being, Harvard team members are reviewing and activating new Joinder Agreements, allowing institutions to join and use SMART IRB Agreement V3.0. The future, however, is uncertain, so we strongly encourage institutions to join now to ensure they can use the Agreement to support their research moving forward.

If you have any questions about the status of your Joinder or how to join SMART IRB Agreement V3.0, please contact us.

Can we still use the Reliance System to coordinate and document our arrangements?

Yes. While the system remains optional for documenting reliance arrangements, it is a key means for us to provide data that demonstrate broad use of the SMART IRB Agreement.

If you have any questions about how to access or navigate the Reliance System, we invite you to explore the system User Guides, or contact us for assistance.

Note: The Reliance System remains under the NIH Information Technology Resources Branch (ITRB) and is not contracted through Harvard. While some corrective actions are possible right now, we cannot substantively change or update the system until the current situation resolves.

I need help. Who do I contact?

At the present time, Harvard team members are available to assist you with questions about joining the Agreement, troubleshooting login issues and navigating the Reliance System, and using SMART IRB resources for your studies. Please contact us; we will get back to you as soon as possible. Thank you for understanding if there are any delays.

Note: During this time, any SMART IRB work undertaken by Ambassadors and other team members not employed by Harvard is pro bono; please be considerate of their time.

Will you be hosting SMART Talks, Single IRB Boot Camp, and other events or posting new videos and resources?

Not at this time. The uncertainty of the current environment affects events, project planning, collaboration, and operations.

What would a full pause in funding look like?

While Harvard is temporarily allowing for the continuation of some activities, if NIH does not reinstate the federal funding contract, or if we are unable to secure long-term funding through other means, there will be significant disruptions to the mechanisms that support the SMART IRB Agreement and its Participating Institutions:

• • Institutions will be unable to join SMART IRB Agreement V3.0, which is the only version of the Agreement that may be used to facilitate new reliance arrangements – this has the potential to significantly delay or disrupt the initiation of research studies across the country.
  • Institutions won’t be able to join the optional Indemnification Addendum.
  • SMART IRB staff, Ambassadors, and other team members won’t be able to assist institutions and study teams in the implementation of the SMART IRB Agreement and use of resources.
  • The help desk will not be available to provide technical and regulatory support in the Reliance System.
  • No workshops or trainings will be held, i.e., Office Hours, SMART Talk, Single IRB Boot Camp, and other events.
  • No new harmonization guidance, templates, checklists, or other resources will be developed, posted, or disseminated.
  • No newsletters, timely messages, and other communications will be sent from SMART IRB to the research community.

However, the SMART IRB Agreement is an independent legal agreement between the Participating Institutions; as such, SMART IRB Agreement V3.0 will remain available for use by current signatory institutions; existing arrangements under the prior Legacy Agreements will remain valid. SMART IRB’s existing tools, templates, and resources will also remain available for use, but will not be updated.

At this time, the SMART IRB website and Reliance System remain operational under a small team in the NIH Information Technology Resources Branch (ITRB), but we are unclear about the future of these systems.