Research Involving Human Subjects (IRB) Policy

Op4.01-6 Research Involving Human Subjects (IRB) Policy

The protection of the rights and welfare of human subjects involved in research is part of Missouri State University’s commitment to ethical conduct of research. Missouri State University will conduct matters related to all research involving human subjects in compliance with federal and state laws and implementing regulations including, but not limited to, 45 CFR 46, also known as the Common Rule, and the Belmont Report.

Missouri State University will also assure that the University’s faculty, staff, and students understand the importance of protecting the rights of human subjects involved in research and the University will implement practices to reduce risks associated with human subjects’ involvement in research.

The President will establish an Institutional Review Board (IRB) that has the authority to develop and implement standard operating procedures (SOP) to assure research involving human subjects is compliant with this policy and applicable laws. Individual members of the IRB will be nominated and selected via the process outlined in Section A.1 of the SOPs. The President will also appoint an Institutional Official (IO) to have University system-wide responsibility for oversight of the implementation of this policy.

The functions of the IRB include, but are not limited to:

  • Conduct initial and continuing review of research with human subjects and report the findings and actions to the investigator(s) in writing.
  • Review and approve, require modifications in (to secure approval) or withhold approval of those components of activities related to human subjects involved in research.
  • Determine which projects require more than an annual review and which projects require verification (from sources other than the investigators) that no material changes have occurred since the previous IRB review. Considerations used to make these determinations include the absolute risk to the subject, whether the risks outweigh the benefits, and prior conduct of the investigator(s) regarding the protection of human research subjects.
  • Review proposed changes in research activities to insure that the protection of human research subjects is maintained.
  • Investigate any actual or suspected adverse event or incident of noncompliance regarding research involving human subjects.
  • Observe project activities at any point to ascertain whether human subject protections are implemented so as to reduce the likelihood of an adverse event or noncompliance.
  • Make recommendations to the President, IO, or other designee regarding any aspect of the program related to the protection of human subjects involved in research.
  • Suspend or terminate approval of research that is not being conducted in accordance with the requirements or that has been associated with unexpected serious harm to subjects.

All research conducted by Missouri State University students, staff, and/or faculty Missouri State University that involves human subjects must be reviewed by the IRB before implementation.

The University shall provide training for all personnel involved in research that involves human subjects. Persons are not permitted to be involved in projects involving human subjects until they have been certified as completing appropriate training.

Missouri State University Office of Research Administration will maintain all records necessary and file reports as required to be in compliance with applicable federal law and implementing regulations.

Missouri State University’s IRB will develop and maintain SOPs described elsewhere to enable implementation of the University policy described above.