Concordia College, Moorhead, MN

Institutional Review Board

CC IRB-Required Education for Principal Investigators, Key Research Personnel, IRB Members, and IRB Delegates

The CC IRB requires that Investigators, Key Research Personnel, and all CC IRB members and IRB delegates (chairpersons or their appointed representatives) educate themselves on ethics in human research by:

• Reviewing the 8-page Guidelines for Ethical Human Subjects Research document available on the CC IRB web page, and
• Reviewing the 3-page Summary of the Belmont Report document available on the CC IRB web page.
• Completing the on-line course sponsored by the NIH "Human Participants Protection Education for Research Teams" within the last five years. The on-line course takes about 2 hours to go through and can be completed over several sittings. Those who have completed equivalent human subjects research training within the last 5 years may qualify for a waiver of the requirement to complete the on-line course. An “IRB 101” workshop offered during a scientific conference and a CC IRB summer workshop qualify as equivalent training.

Individuals who are not at all familiar with the IRB, its function, and the federal regulations that guide its decisions, might find it beneficial to begin by viewing an IRB video prepared by the NIH and the FDA titled “Protecting Human Subjects: Three Instructional Films.” Several copies of this video are available in tape format and in DVD format on 2-hour reserve in the CC library under “IRB 1” for videotapes and “IRB 2” for DVD’s. In addition, most academic department chairs have a copy in either the video or the DVD format for use by their department.

All investigators and key research personnel submitting new research protocols (even if the protocols are exempt from continuing review and only require approval of the chairperson of the appropriate department) are required to complete the on-line course and submit a certificate of completion (dated no earlier than 5 years from the date the protocol is submitted). If the principal investigator has not completed the education requirement, research protocols will not be accepted and will be returned to the investigator. If there are co-investigators or key research personnel who have not completed the education requirement, the new research protocol will be accepted; however, final approval of the research protocol may be withheld until the education requirements have been met. Participation of the co-investigators or key research personnel in the conduct of the research is not allowed until the education requirement has been met.