Required Human Subjects Research Education

The University of North Dakota is committed to the protection of human subjects in research. To ensure that all investigators and research personnel receive adequate education in human subjects protection, the UND Institutional Review Board requires all researchers to complete human subject education, as required by the federal guidelines.

One form of human subject education must be completed at least once every three years. The IRB will not release the approvals for new or continuing protocols until all individuals involved with the project, including student advisers and key personnel, have completed the training. Key personnel are defined as persons in contact with human subjects or persons that have access to identifiable data.

Initial Education

1. On-Line Educational Modules

Individuals may register to complete the required modules at the CITI website by clicking on the "Register Here" link. Users should select "University of North Dakota" under "Participating Institutions" on the select your institution or organization page, and then click submit. On the next page, users will need to select a user name and password that will be used each time the user enters the CITI site to work on the modules.

There are two sets of modules, and Principal Investigators and key personnel should choose which group best fits the type of research they wish to conduct, the Biomedical Research track or the Social & Behavioral Research track. If you are taking the IRB education for the first time, be sure to indicate that you "have not previously completed an approved Basic Course" on the "Select Groups" page.

All required modules must be completed. Depending on the type of research to be conducted, one or more of the optional modules may need to be completed as well. Each Module takes 10 to 30 minutes to complete. The total required time is estimated to be two to three hours; the course does not have to be completed in one sitting. The passing score required is 80%.

• Biomedical Researchers - Printable instructions to register for the online IRB training.

• Social/Behavioral Researchers - Printable instructions to register for the online IRB training.

2. In-Class IRB Basics Workshop

The IRB Coordinator is available to present human subjects research education for students requiring IRB training. Instructors may call 701.777.4279 to schedule a workshop for an entire class that will be completing research projects. The length of the workshop will be approximately two and a half hours and will include a quiz for students to complete at the end of the training.

Continuing Education

The Collaborative IRB Training Initiative (CITI) and the University of Miami have developed a re-certification set of modules designed to meet the need for ongoing education. The required modules for the Refresher Course must be completed to meet the continuing education requirement. Registration for the modules is available at the CITI website.

Education at Another Institution

Occasionally, researchers may have completed human subject education at another institution. The researcher must provide a copy of the certification indicating the type of education and the date of completion to the UND IRB for review. The researcher will be informed if the human subject education is acceptable and meets the UND IRB requirements.