Terms of Service (ToS)

Introduction

Welcome to SMART IRB (“Streamlined, Multisite, Accelerated Resources for Trials Institution Review Board”). These Terms of Service (“ToS”) govern your use of the SMART IRB web application (“the Application”). By accessing or using the Application, you agree to be bound by these ToS. If you do not agree to these ToS, please do not use the Application.

Definitions

• SMART IRB: A community of institutions that collaborate on research studies under a Joinder Agreement.
• Joinder Agreement: An overarching agreement that outlines how institutions in the SMART IRB community will engage each other for collaborative research studies.
• Institution: An entity that has signed the Joinder Agreement and is verified in the SMART IRB system.
• User: An individual associated with an Institution who has been granted access to the Application.
• Reliance Request: A site-to-site agreement with specific considerations for a particular study or trial.

Eligibility

To use the Application, you must:

• Be affiliated with an Institution that has signed the Joinder Agreement.
• Be authorized by your Institution to access and use the Application.

User Accounts

• Account Creation: Users are created once the Institution is verified and the Joinder Agreement is signed. Users must provide accurate and complete information during account creation. Users must use an individual email address for access to their account. Group email addresses are not allowed for use with individual user account access.
• Account Responsibility: Users are responsible for maintaining the confidentiality of their login credentials and for all activities that occur under their account.
• Account Termination: SMART IRB reserves the right to terminate or suspend a user’s account at any time for any reason, including but not limited to violations of these ToS.

Use of the Application

• Permitted Use: The Application is intended for creating and managing Reliance Requests and facilitating collaboration on research studies between Institutions.
• Prohibited Use: Users shall not use the Application for any unlawful purposes or in any manner that could harm the Application or interfere with any other party’s use of the Application.

Reliance Requests

• Creation: Only users with appropriate system privileges may create Reliance Requests.
• Approval: Reliance Requests must be reviewed and approved by authorized personnel at each involved Institution.
• Compliance: All Reliance Requests must comply with the terms of the Joinder Agreement and applicable laws and regulations.

Privacy and Data Security

• Data Collection: SMART IRB collects and uses personal data as described in its Privacy Policy, available at NCATS Privacy Policy.
• Data Security: SMART IRB implements reasonable measures to protect user data but cannot guarantee absolute security.

Intellectual Property

• Ownership: All content, features, and functionality of the Application are the exclusive property of SMART IRB and its licensors.
• License: Users are granted a limited, non-exclusive, non-transferable license to use the Application in accordance with these ToS.

Disclaimer of Warranties

The Application is provided “as is” and “as available” without warranties of any kind, either express or implied. SMART IRB disclaims all warranties, including but not limited to implied warranties of merchantability, fitness for a particular purpose, and non-infringement.

Limitation of Liability

In no event shall SMART IRB be liable for any indirect, incidental, special, consequential, or punitive damages, or any loss of profits or revenues, whether incurred directly or indirectly, or any loss of data, use, goodwill, or other intangible losses, resulting from (i) your use or inability to use the Application; (ii) any unauthorized access to or use of our servers and/or any personal information stored therein; and (iii) any other matter related to the Application.

Governing Law

These ToS shall be governed by and construed in accordance with the laws of the jurisdiction in which SMART IRB operates, without regard to its conflict of law principles.

Changes to the ToS

SMART IRB reserves the right to modify these ToS at any time. We will notify users of any changes by posting the new ToS on the Application. Your continued use of the Application after such changes have been posted constitutes your acceptance of the new ToS.

Additional Policies

As the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) hosts this Application, the following policies apply and are incorporated by reference into these ToS:

• NCATS Privacy Policy
• NCATS Comments Policy
• NCATS Accessibility Policy
• NCATS FOIA Policy
• HHS Vulnerability Disclosure Policy

Federal Records Retention

SMART IRB complies with federal records retention policies as outlined by the National Archives and Records Administration (NARA). For more information, please refer to the Federal Records Management Policy.

Access Limitations for Legacy Joinder Agreements

If an Institution has executed a legacy version of the Joinder Agreement and has not signed a subsequent version with updated provisions, the Institution’s access to the SMART IRB system may be restricted to read-only capabilities.

Contact Information

If you have any questions about these ToS, please contact us at:

SMART IRB
[Your Contact Information]
Email: [Your Email Address]
Phone: [Your Phone Number]