A. Ethical and policy issues in research involving human participants are grounded in Concordia University, St. Paul’s mission in the enlightened care of God’s creation and the safeguarding of human participants in all research under which the University is a part.
The University will comply with all federal regulations requiring the establishment and operation of an Institutional Review Board for the protection of human participants.
B. All research that can be defined as “a systematic investigation designed to develop or contribute to generalizable knowledge” (U.S. Department of Health & Human Services – 45 CFR 46) must be reviewed and approved by the Institutional Review Board for the
Protection of Human Participants (IRB).
C. IRB review is also required of research carried out under the sponsorship of an institution other than Concordia University, St. Paul, but which is performed on the premises of Concordia University, St. Paul, even if the research has already been approved by the IRB at the sponsoring institution or elsewhere.
D. Students and Faculty who are planning to conduct research are directed to use and follow FHB Section 8, Appendix D: Concordia University Saint Paul, MN Protocols and Procedures for Research Involving Human Subjects Application and Information Packet and Appendix E: Protocol Form Research Involving Human Subjects.
E. Faculty and student researchers must successfully complete Human Subjects
training through the Collaborative Institutional Training Initiative (CITI) program
prior to submitting protocol forms for IRB review. All researchers must maintain
valid (non-expired) certification of CITI training. The CITI certification is good for
three (3) years from date of successful completion.

Last modified: March 15, 2018