IRB HUMAN SUBJECTS POLICY & PROCEDURE
Summary of the Policy:
The University policy is in accordance with the federal government regulations 45 CFR 46 - Federal Policy for the Protection of Human Subjects. The regulation defines research as “systematic investigation, including research, development, testing and evaluation, designed to develop or contribute to generalized knowledge.” Projects involving human subjects must receive prior approval from the University’s Institutional Review Board for the Protection of Human Subjects (IRB). In addition, faculty, staff and students having access to information obtained from human subjects must complete CITI training before engaging in such a project.
MISSOURI STATE & MERCY HEALTH SPRINGFIELD COOPERATIVE IRB AGREEMENT
Summary of the Agreement:
To reduce redundant reviews and to lessen unnecessary burden to investigators, members, and staff of the University and Mercy, a cooperative IRB agreement has been established. Only when protocols meet the criteria outlined in the agreement, will the IRB for either the University or Mercy serve as the IRB of record and will perform the initial review as well as required continuing review and review of amendments per 45 CFR 46.101-46.409. The agreement defines a mechanism to determine if a protocol review will be conducted by the University or Mercy.