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.
Details about the IRB committee and review process and guidance for compliance with the Common Rule can be found in the Research Handbook.
Electronic IRB Management Software: Axiom Mentor
SMU employs the Mentor Electronic Management System to administer the IRB oversight process. If you would like to attend an individual or group training session on the use of the Mentor system, 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.
Researcher Guidance on COVID-19 and IRB Review
Please see the guidance on the Resumption of Research site.
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.
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.
Training for External Key Personnel
SMU Protecting Human Research Participants course materials and quiz
Research Personnel not affiliated with SMU may study the Protecting Human Research Participants course materials provided by the NIH Office of Extramural Research and complete a proficiency quiz. Trainees must score 80% or better on the quiz to earn credit, and the quiz may be repeated if needed. A completion certificate will be provided by Research Compliance. Training is valid for 3 years and then must be renewed. This option is intended for external key personnel on SMU research involving human subjects.
Office of Human Research Protections
Another option available to research Personnel not affiliated with SMU is the Human Research Protection Training offered by the Office of Human Research Protections. It takes about 5 hours to complete the training. A completion certificate will be generated and must be provided to Research Compliance. Training is valid for 3 years and then must be renewed. This option is intended for external key personnel on SMU research involving human subjects.
Research Compliance may also be able to accept training completed at other institutions. Send any external training certificates to Research Compliance for review.
The Institutional Review Board (IRB) meets on the first Wednesday of every month.
Christopher Dolder, MFA