The Principal Investigator

The Principal Investigator (PI) is the primary individual responsible for the ethical design and conduct of a research study including the supervision of co-investigators and study personnel. While the PI may delegate tasks to members of their research team, they remain ultimately responsible to ensure all research activities are designed and carried out in an ethical manner and in accordance with the IRB approved protocol application.

The PI must be qualified by education, training and experience in the area in which the research is being conducted. The PI must be familiar with the IRB approved protocol, all applicable regulations, guidelines, state laws, and institutional policies and procedures related to their human subjects research.

General Responsibilities of the PI:

  • Design and conduct the study in an ethical manner, including protecting the rights and welfare of human research participants, which includes practices such as:
    • Fair and equitable recruitment of participants.
    • Obtaining legally effective consent, documenting as approved by the IRB.
    • Protecting participant privacy and data confidentiality through appropriate data and safety monitoring.
    • Responding promptly to participant complaints, concerns, and/or requests for information.
  • Comply with all applicable regulations, laws, institutional policies and the guidance and determinations of the IRB.
  • Ensure there are adequate resources to conduct the research in a way that will protect human subjects.
  • Educate study personnel on sound research methods and ethical conduct of human subjects research.
  • Ensure study personnel are familiar with and comply with the approved IRB protocol.
  • For grant funded studies, ensure the IRB protocol application matches the funded grant proposal.
  • Notify the IRB if they become unavailable to actively monitor the study (sabbatical, retirement, etc.);
  • Promptly report any reportable incident to the IRB.
  • Obtain IRB review and approval prior to any changes being made or enacted to the approved IRB protocol or study materials.
  • Close the study in accordance to the IRB policy 6.4 Completion of Study / Study Closure.

Faculty Sponsor

A Faculty Sponsor (FS) is a UTD affiliated individual who is eligible to serve as a PI on a study and who sponsors an ineligible PI. As FS, this individual agrees to share the responsibility for the ethical conduct of the research and take on the following responsibilities:

  • Serve as a mentor to the PI.
  • Ensure the PI has the needed knowledge in the responsible conduct of human subjects research.
  • Ensure the PI has the needed knowledge of sound research methods.
  • Meet with the PI on a regular basis to discuss the conduct and progress of the research study.
  • Be available to the PI and research team should issues arise or if consultation is needed.
  • Review and certify all IRB related actions through Cayuse (initial application, modifications, renewals, closures, incident report, etc.).
  • Communicate with the HSR Office as appropriate.
  • Take over as PI of the study if deemed appropriate by the IRB.

Serving as FS for an unaffiliated PI

In rare instances the UTD IRB is contacted by a non-UTD affiliated individual wishing to conduct research on our campus (including the recruitment of UTD students / personnel). In these instances, a UTD-affiliated investigator or FS is required. By serving as a FS for an unaffiliated PI, the FS agrees to share the responsibility for the ethical conduct of the research and take on the following responsibilities:

  • Maintain knowledge of the research purpose, aims, and procedures.
  • Know all members of the UTD affiliated study team (if applicable) and be available should issues arise.
  • Review and certify all IRB related actions through Cayuse (initial application, modifications, renewals, closures, incident reports, etc.).
  • Communicate with the IRB as appropriate.
  • Take over as PI of the study if deemed appropriate by the IRB.