Who Can Be a Protocol Director?
The Protocol Director (PD) is the individual responsible for the overall conduct of the human subjects research. The role of PD is more expansive from the Principal Investigator (PI), as it include students and other individuals when certain conditions are met, and is not determined by funding.
It is the PD’s responsibility to submit a written protocol to the IRB for review and the ongoing adherence to the determinations and requirements of the IRB for the duration of the research. At submission, the obligations of the PD with respect to oversight of the research protocol and research staff during recruitment, selection of study participants, and conduct of the study are stated in the application and must be agreed to by the PD. For more information, see HRPP Policy Manual, Section 15.3 Research Oversight.
Who Can Be Protocol Director?
The following table outlines who can serve as the PD on an IRB application. For any positions or titles not listed, please contact IRBeducation@stanford.edu.
| Position/Title(s) | Eligible to be a PD? | IRB Condition(s) for PD Eligibility |
|---|---|---|
Academic Council Professoriate - University Tenure Line (UTL)/University Medical Line (UML) Faculty
| Yes | N/A |
Academic Council Professoriate - Non-Tenure Line Faculty
| Yes | N/A |
| Senior Fellows and Center Fellows in Designated Policy Centers and Institutes | Yes | N/A |
School of Medicine (SoM) Clinician Educators
| Yes | N/A |
| Conditional | Requires a PI Waiver associated with funding source OR Academic Sponsor that is Faculty or a Clinician Educator. |
| MD/PhD at a Shared Facility/Service Center | Conditional | Requires a PI Exception for a project within the shared facility/service center. |
Students/Residents
| Conditional | Requires an Academic sponsor that is Faculty or a Clinician Educator. |
| Conditional | Requires a PI Waiver associated with funding source OR Faculty or Clinician Educator listed as a co-investigator. |
School of Medicine (SoM) Instructors
| Conditional | Requires a PI Waiver associated with funding source OR Faculty or Clinician Educator listed as an Academic Sponsor. |
| No | May be listed on the eProtocol application (e.g., investigator); however, they cannot serve as the PD. |
School of Medicine (SoM) Scholars | No | May be listed on the eProtocol application (e.g., investigator); however, they cannot serve as the PD. |
School of Medicine (SoM) Adjunct Clinical Faculty (ACF)
| No | May be listed on the eProtocol application (e.g., investigator); however, they cannot serve as the PD. |
| No | May be listed on the eProtocol application (e.g., investigator); however, they cannot serve as the PD. |
School of Medicine (SoM) - Other
| No | May be listed on the eProtocol application (e.g., investigator); however, they cannot serve as the PD. |
| Hospital Employees | No | May be listed on the eProtocol application (e.g., investigator); however, they cannot serve as the PD. |
Page updated July, 2025