Roles & Responsibilities

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.

¶¶Òõ¶ÌÊÓƵ Boulder IRB recognizes faculty and staff members with University-paid appointments 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.

¶¶Òõ¶ÌÊÓƵ Boulder students (graduate or undergraduate) may conduct research involving human participants only under the direction of a ¶¶Òõ¶ÌÊÓƵ Boulder faculty member who is the Principal Investigator for the research.

Key Personnel

The IRB holds all study personnel responsible for meeting certain obligations. For the purpose of defining personnel activities in eRA, key personnel should be classified as one of the following roles:

Role

Individual involved in the scientific development or execution of a project.

eRA Study File Access

There are two choices: 

  • Co-investigator: Individual may only view study file; cannot edit or send submissions.
  • Co-investigator with Edit: Individual will be able to create submissions (Amendments and Continuing Reviews), upload documents in submissions, and send submissions to the IRB on behalf of the PI.

Role

Individuals involved in execution of project and interaction with subjects or subject data.

eRA Study File Access

Individual may only view study file; cannot edit or send submissions.

Role

Individual contributing to the submission and research process and interactions with subjects, but not involved in the scientific development of a project.

eRA study file Access

Individual will be able to create submissions (Amendments and Continuing Reviews), upload documents in submissions, and send submissions to the IRB on behalf of the PI.

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