Human Subjects Research

In accordance with SMU Policy 10.10 Human Subjects in Research, the use of Human Subjects in research activities will be performed in accordance with applicable federal and state laws and regulations, and guided by the principles in the Belmont Report. Review of research activities involving human subjects will be provided by the Institutional Review Board (IRB) in order to minimize the risks to, and to promote protection of the rights and welfare of, human subjects.

Electronic IRB Management Software: Axiom Mentor

The electronic IRB management system, Axiom Mentor, is ready for researcher use. This replaces the current system of emails and PDF forms. We transitioned exclusively to this system for all IRB activity on September 1, 2021.

If you would like to schedule an individual or group training session, contact Research Compliance to schedule an appointment. You will find SOPs for several common Mentor functions in the Research Handbook.

Watch a recorded Mentor training here.

Mentor IRB Management System

Researcher Guidance on COVID-19 and IRB Review

Please see the guidance on the Resumption of Research site.

Research Handbook

Details about the IRB committee and review process and guidance for compliance with the Common Rule can be found in the Research Handbook.

External Collaborations

SMU as a Study Site

If an external researcher would like recruit members of the SMU community, they must first request permission from the SMU IRB. This is not a full IRB review.

To begin the process, the external researcher must secure a Letter of Support from a member of the SMU community. This SMU community member should be familiar with the details of the research and confirm that SMU is a suitable site. A Letter of Support template may be found here.

Once the external researcher has secured a Letter of Support, they should submit a request to the SMU IRB by emailing Research Compliance. The approved study documents (application, recruitment materials, consent forms, data collection instruments, approval letter, Letter of Support) should be attached to the email request.

Reliance Agreements

If SMU researchers will collaborate with external researchers on projects involving human subjects, the pertinent IRBs may help reduce administrative burden by entering into Reliance Agreements. These agreements establish an IRB of Record, which is responsible for oversight all research activities, and Relying IRBs, which cede oversight to the IRB of Record. SMU participates in the SmartIRB system to facilitate this process.

If you would like to discuss a Reliance Agreement, please email Research Compliance.

Guidance

We offer guidance for planning your research project. To discuss your specific research plans, please email Research Compliance or call at 214-768-2033.