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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 CITI Program. 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.
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.
More information concerning this requirement can be found at NIH's notice page.
The next recommended step is to visit WVU's Kuali page and select the article that best addresses your training needs.
Important Note* Once you have access to the WVU+kc system, remember to complete Conflict of Interest disclosure and training by using the "COI" tab and following the prompts to either "Create" or "Update" your annual requirements. Key Personnel (Primary and Co-Investigators) listed on a submission must complete the Conflict of Interest dislcosure and training. 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 Director, Joy Edwards at 304-293-5475.
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 our KC portal .
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.