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To begin your study review process with the IRB, your first step should be to complete the appropriate ethics training via the CITI Program.
If you have not already done so, you will need to register an account at http://www.citiprogram.org. During the registration process, you will be prompted to select the ethics training courses that you plan to complete.
All researchers who will be listed on the protocol should complete the training.
All researchers should complete either the Biomedical Research Investigators (if you are in a medical field) or the Social and Behavioral Research Investigators course. These courses can be found under the Human Research section of the course registration screen.
Once you have completed the required courses with a score of 80% or better, you can proceed to the next step. Please note that you do not need to send ethics training documentation to the IRB office.
In addition, all Key Personnel (Primary and Co-Investigators) listed on a submission must complete the Conflicts of Interest CITI Program course. This course can be found under Question 2 of the ‘Add a Course’ area of your CITI account. The completion of the conflict of interest training will be a requirement for WVU IRB protocol approval.
For more information regarding this requirement, please contact the Conflict of Interest in Research Officer, Joy Edwards at 304-293-5475.
**NIH Good Clinical Practice Training Requirement**
The National Institute of Health (NIH) has established a new directive regarding the training of investigators and staff involved in the conduct, oversight, or management of any NIH funded clinical trial. Anyone that is involved with NIH funded research, regardless of the nature of the research (biomedical or social science related) must be trained in Good Clinical Practice (GCP).
West Virginia University provides GCP courses through the CITI Program. Courses offered can be found under the Question 7 section of the ‘Add a Course’ area of your CITI account. Individuals needing to complete this training can take the course titled GCP (Good Clinical Practice) (Human Subject Research).
This training requirement is effective January 1, 2017. Therefore, any clinical research conducted under the auspices of WVU and funded by NIH, will not receive approval until the NIH GCP training requirement is met.
For more information concerning this requirement for NIH funded trials, please visit the following link: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-148.html
The next step is to complete the KC IRB submission system training that best suits your needs. Self-train by visiting kuali.wvu.edu, click on the WVU+kc Training tab, and go to IRB Protocol Training. You will find a link to a training video on this page. Please watch the video then complete the short test in order to submit your request for access to create protocols.
Once you’ve completed the ethics and system training steps, you can begin creating your protocol. To do so, you’ll need to login using your WVU MyID and password at kc.wvu.edu.
Remember your system training and start your protocol creation by clicking Create Protocol from the main menu. If you have any questions along the way, please feel free to contact our office for help.