When conducting human subjects research there are certain expectations that the research team must meet. The roles of the research team and their corresponding responsibilities are outlined below.
As outlined in HRP-103: Investigator Manual, the PI is ultimately responsible for the conduct of the research. Research responsibility may be delegated to research staff; however, PIs must maintain oversight and retain ultimate responsibility for the conduct of those to whom they delegate responsibility.
CU-Boulder IRB recognizes faculty/staff members with University-paid appointments or students (under the direction of a faculty advisor) as PIs. Protocols that require skills beyond those held by the PI must be modified to meet the investigator's skills or have one or more additional qualified faculty as co-investigator(s).
For eRA purposes, once the Initial Application is approved the PI will have ability to create, modify and submit all submission types.
The IRB holds all study personnel responsible for meeting certain obligations. For the purpose of eRA, key personnel should be classified as one of the following roles:
|Co-investigator||Role: Individual involved in the scientific development or execution of a project.
eRA Study File Access: There are two choices:
|Research Coordinator||Role:Individual contributing to the submission and research process, but not involved in the scientific development of a project.
eRA study file Access: Individual may create and modify submissions; cannot send submissions
|Faculty Advisor||Role: Individual is ultimately responsible for monitoring all aspects of the student's research.
eRA Study File Access: Individual may only view study file; cannot edit or send submissions
CU-Boulder students (graduate or undergraduate) may conduct research involving human participants only under the direction of a CU-Boulder faculty advisor. When submitting a study for IRB review, the student is responsible for completing all eRA applications and identifying their faculty advisor.