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.
- Assure that all members of the study team of non-exempt protocols have submitted a financial interest disclosure with the Conflict of Interest Office.
- 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.);
- Follow reporting requirements for problems that require prompt reporting.
- When PI is the lead researcher for a multi-site study, applications must include information about the management of information that is relevant to the protection of research participants, e.g., interim results; protocol modifications; how unanticipated problems involving risks to participants or other unanticipated problems will be managed; how communication of unanticipated problems to all sites will occur; how protocol modifications will be managed; is there a formal agreement in place delineating each site’s roles and responsibilities.
- If the PI holds an IDE/IND, adhere to sponsor responsibilities in addition to investigator responsibilities per FDA regulations.
- If appropriate, assure applicable clinical trial and NIH sponsored clinical trials are registered on ClinicalTrials.gov.
- Obtain IRB review and approval prior to any changes being made or enacted to the approved IRB protocol or study materials.
- Submit requested data at specified times for continuing review of ongoing research activities. Close the study in accordance to the IRB policy 6.4 Completion of Study / Study Closure.
- Retain records as required by regulations, the sponsoring entity and institutional policy.
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. The FS must be actively involved in the research (from protocol design to data analysis and report preparation) and agrees to share the responsibility for the ethical conduct of the research. The following FS responsibilities are not all inclusive:
- Serve as an active 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.
- Ensure the PI is provided with, or has access to, information on UTD policies relating to the administration of their protocol.
- 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 consultation needed.
- Review and certify all IRB related actions through Cayuse (initial application, modifications, renewals, closures, incident report, etc.).
- Ensure all study documents and data are archived at the end of the study in accordance with federal, state, and UTD policy and regulations.
- Communicate with the Human Subjects Research (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.
Medically/Psychologically Responsible Investigator
If research procedures involve clinical elements and the PI is not qualified in the appropriate clinical area, does not hold an applicable license, or does not have privileges to practice where the research will occur, a licensed and institutionally credentialed clinician appropriately qualified by education, training, experience, and background and appropriate privileges must be designated as the Medically/Psychologically Responsible Investigator.
The Medically/Psychologically Responsible Investigator must manage or appropriately delegate all clinical elements of the research such as physical examination, psychological testing, providing counseling services, conducting any drug administrations, follow-up examinations, evaluating lab values, test results and reviewing all adverse events.
Clinical elements of a study are considered any event, procedure, test, or intervention that would require performance by a licensed/credentialed professional in a non-research setting.
During review of human subjects research, the IRB can determine that a Medically/Psychologically Responsible Investigator must be identified. The Medically/Psychologically Responsible Investigator should be noted by name in the research proposal and listed as research personnel in UTRMS-IRB. A copy of the Medically/Psychologically Responsible Investigator’s CV should be uploaded in “Other Attachments” in UTRMS-IRB. The Medically/Psychologically Responsible Investigator’s contact information should also be included in the informed consent document(s).