Effective Date: September 1, 2008

Policy

Every investigator conducting a research project involving human subjects must successfully complete WCU’s Investigator Training course. Training is required regardless of the study’s funding source or the location of the research. All investigators, including faculty, staff, subcontractors, students, research supervisors, and affiliated investigators, are covered by this policy. Training is renewed every five years, and investigators must have current certification as a condition of study approval by the IRB.

To access the required online training website, click here:  http://www.citiprogram.org/

For a short user's guide that explains how to register for the site and start the course, click here.  (PDF)

Investigators conducting federally-funded research should also comply with the funding agency’s guidelines regarding additional investigator training requirements (e.g., NIH course located at http://phrp.nihtraining.com/users/login.php). WCU does NOT monitor compliance with umn subjects training requirements set by external agencies.  These federal requirements do not exempt the investigator from completing WCU’s designated course.

Procedures

1. All investigators conducting research with human subjects must have current certification in order for studies involving human subjects to be approved.
2. Any member of the WCU community can complete the course at any time, even if no IRB request has been submitted. Instructors who wish for their students to learn about human subjects protections may also require their students to complete the course.
3. Investigators will pass the training course with a minimum score of 80% on all modules. Once successfully completed, certification is effective for five years. Renewal may be completed at the investigator’s convenience or no later than the submission of the next IRB request after the expiration date of the previous training.
4. Any investigator who takes the course unsuccessfully may retake it as many times as necessary in order to obtain a passing score.
5. It is strongly recommended that previously certified investigators who undertake a new type of research (e.g., studies involving vulnerable subjects, internet-based research) complete the relevant, optional training modules. The IRB may recommend or require completion of these modules on a per-study basis. No minimum score is required for successful completion of optional modules.  
6. Monitoring of the investigator database is the responsibility of the IRB Project Specialist. When an IRB request is submitted for review, the Project Specialist will review the training database to confirm all investigators have current training. If one or more investigator does not have current certification, the completion of training will be a condition for IRB approval.
7. The contents and/or requirements of the training course are subject to change depending on federal guidance and locally-identified needs. Revisions to the training course content, passing score, and other procedural elements will be recommended by the IRB, reviewed by the Research Council, and approved by the Dean of the Graduate School and Research.