STEP 1: Complete Data Protection and Determination*
Data Protection and Determination is required for all human subjects research projects. Depending on your answers and the assessed risk of the data, you will be emailed a Data Protection Certificate that will include the approved storage plan, and information related to notifications sent to other departments. Information and guidance is available. Please note: The form is required for all Initial and New Protocols.
Data Protection and Determination Form
Data Protection and Determination is also used to determine if your project is considered human subjects research (under the federal definition of research and human subjects) and to provide an official Letter of Determination for projects that do not require IRB review. Use the Data Protection and Determination above to start the process or click below for additional guidance.
STEP 2: Determine the Protocol Type for the Project
If your project is considered human subjects research or a protocol submission is recommended, click on the link below to access the decision tool for determining the protocol type. This information will assist you in understanding the information needed for your protocol submission.
STEP 3: Complete the Required Training
STEP 5: Submit a Protocol Application to the WVU IRB
Before submitting the protocol application for human subjects research, review the requirements for the protocol type and the protocol submission prep checklist.
Protocol Types and Requirements
Protocol Submission Prep Checklist
Create the protocol application and submit to the WVU IRB. Access to the WVU+kc electronic protocol submission system is automatic for students and all employees. There is no need to request access.
NOTE: Human Subjects Research CANNOT begin until the protocol submission is approved and all other approvals are received (data agreements, software licenses, export control approvals, participant payment method approvals).
STEP 6: Conduct the Research
Amendments, renewals, and event reporting may be required throughout the project for some protocol types.
STEP 7: Close the Research Project
At the conclusion of the project, complete the closure process and dispose of data as required by agreement and institutional policy.
Closure Process*WVU Health System only employees (no dual appointment with WVU) must following specific instructions to access the electronic submission system/tools.