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 ensure 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 ensure 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 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:

• Approving, requiring modifications to secure approval, or disapproving all research activities overseen and conducted by faculty, staff, and/or students of Missouri State University involving human subjects, based on its consideration of the risks and potential benefits of the research and whether the rights and welfare of the subjects are adequately protected.
• Determining 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.
• Reviewing proposed changes in research activities to ensure the protection of human research subjects.
• Investigating any actual or suspected adverse event or incident of noncompliance regarding research involving human subjects.
• Observing research activities at any point to ascertain whether human subject protections are implemented in a manner to reduce the likelihood of an adverse event or noncompliance.
• Making recommendations to the president, IO, or other designee regarding any aspect of research related to the protection of human subjects.
• Suspending or terminating approval of research that is not being conducted in accordance with approval requirements or that has been associated with unexpected serious harm to subjects.

All research conducted by Missouri State University students, staff, and/or faculty 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 all required training has been completed.

Missouri State University Office of Research Administration will maintain records regarding Human Research Protocol Applications and file reports to maintain compliance with applicable laws and regulations pertaining to human research.

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

Reason or purpose for policy

Missouri state University recognizes its responsibilities in conducting research involving human subjects.  These responsibilities include protection of the rights and welfare of human subjects participating in research at Missouri State University, the need to educate faculty, staff and students of the importance of human subjects’ research protections, and compliance with all applicable laws and regulations.

Entities affected by this policy

This policy is applicable to all Missouri State University faculty, staff, students, and visiting researchers and educators that will be involved with research involving human subjects.