Principal Investigator

Only certain persons may be designated as the Principal Investigator on a human subject research study. Eligibility to act as the University Principal Investigator on a sponsored research project is a privilege that is typically limited to University employees (generally faculty members). Non-faculty University Principal Investigators must hold an appropriate position or provide key expertise, and should at least have a master’s degree to serve as a: Principal Investigator, Project Director, Co-Principal Investigator, or other senior personnel on a sponsored project.

Students, staff, and individuals holding other appointment titles, such as research associate, specialist, post-doctoral fellow, visiting, adjunct, or clinical faculty, may be designated on the IRB application as an additional investigator, but not as the PI.

In the case of graduate student research for theses or dissertations, the student’s advisor or another faculty member should be designated on the IRB application as the PI and the graduate student as an additional investigator.

Those holding positions that are transient by nature, including Postdoctoral Research Associates (Postdocs) and other limited-term appointees are not eligible to serve as a PI because these positions are temporary. These categories of employees are often not able to commit the level of resources necessary to carry out a program of research.

Visiting faculty may serve as Co-Principal Investigator in accordance with the approval requirements.

Retirees who are not employed by the University but who wish to serve in the role of a Principal Investigator must petition the department head for approval. Except as provided in the case of retirees, all individuals who serve in the role of a Principal Investigator on University sponsored projects must be employed by the University.

The unit head with final approval by the dean shall determine the eligibility of an individual to serve as a Principal Investigator, in compliance with the eligibility criteria of a potential sponsor. In any case, where there is no reporting relationship to a college dean or director, the appropriate vice president or designee will make eligibility determinations.

An exception to the limitations discussed above may be granted in special circumstances. Approval is required for the unit head and the Vice President of Research and Innovation.

700.04 Form, PI Eligibility Exception

When an individual accepts the role of PI on a human research study, he/she accepts the responsibility for the proper execution of the research and is accountable for the conduct and oversight of the study.

No. The IRB does not have a specific limit on the number of studies for which a person accepts the role of PI. However, the individual should not accept this role unless he/she has the time, effort, and ability to maintain adequate oversight over the conduct of the study.

The PI is responsible for assessing the overall workload and resources to determine if he/she has the ability to oversee the study. However, the IRB may review the number of open studies for which an individual is the PI on a case-by-case basis, particularly where adequate supervision is questioned.

Assessments should include the number of studies in active enrollment, number of local subject enrollment, complexity of the research studies overseen, risk level, overall number of studies overseen by the PI, and additional time commitments to other university activities by the PI.

Yes. Delegation is permissible. However, delegation of tasks to study personnel does not relieve the PI of the responsibility for ensuring that the rights, safety and welfare of human participants in the study are protected and that the study is conducted correctly and in accordance with the signed agreement, the IRB-approved protocol, Federal regulations, and TAMU-CC HRPP policies and procedures.

The PI cannot delegate the task to ensure the study is performed in compliance. The PI, regardless of what study staff actually created the non-compliance or error, will be responsible for corrective actions.

The PI is responsible for ensuring that tasks are delegated to appropriately trained, experienced and licensed personnel.

Study tasks must never be performed by persons not participating in the study or not approved by the sponsor and/or the IRB.

When research tasks are delegated, the PI should:

• Properly document the delegation.
• Make study staff aware of terms and conditions of the award, requirements of the sponsor, federal, state, local laws, regulations, guidelines and TAMU-CC policies that apply to the research activities to which staff are performing.
• Engage in education and make available resources to aide in staff performing their duties as assigned in compliance with all of the above, such as copies of the approved protocol, regulations, etc.
• Maintain proper supervision and oversight of the duties as assigned to ensure they are being performed properly.
• Keep an open line of communication for staff to raise questions, ask for additional training, and/or discuss and resolve issues that arise in the conduct of research activities.