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Human Subjects

Overview of the KC IRB Protocol

The KC IRB Protocol is set-up using a system of Tabs. Within each tab, are “folders," which contain bits of information about the research protocol.

Moving from left to right, the first tab is the Protocol tab, where basic information about your protocol is captured.

The next tab is the Personnel tab, where research personnel who are engaged in the research are listed. The Principal Investigator (PI) information will automatically populate based on the information entered on the Protocol tab.

The third tab is the Permissions tab. This is where additional persons, who need access to the KC IRB Protocol, but aren’t directly engaged in the research, are added; for example, an administrator whose only role is to submit items to the IRB.

The Questionnaire tab is where the bulk of the research protocol information is collected. The Questionnaire “folders” in this Tab change based on the type item you are submitting. For instance, on an initial protocol submission, various Questionnaires will appear and need to be completed in order to submit your KC Protocol to the IRB for review. Likewise, when you create an Amendment to an approved KC Protocol, an Amendment Questionnaire, which includes questions asking you about the changes you are requesting, will appear on this Tab.

The Notes & Attachments tab is where documents are uploaded and maintained. This is where you will upload Informed Consent documents, HIPAA Authorization forms, data collection forms, e.g., surveys, interview questions, recruitment materials and any other required documents. This is where you should download the most current, IRB approved documents.

The Protocol Actions tab is where actions are taken by both the study team and HSO staff. This is also where pre-review comments and attachments, meeting minutes, and approval documents are located. Additionally, this tab contains a section showing the action history of your KC Protocol from creation to closure.