PI Responsibilities

At WSU, only a faculty member (or staff who have a research requirement associated with their position) may serve as the Principal Investigator (PI) or as the sponsor on a research project involving human subjects. Other individuals, such as research scientists or post- doctoral fellows may be allowed to be the PI at the discretion of the VPR/DRA/ADRA.

WSU students may not serve as the PI but may serve as a Co-I. They must have an eligible faculty sponsor who fulfills the PI eligibility criteria and who will serve as PI and faculty advisor on the study.

PIs are ultimately responsible for the conduct of research. PIs may delegate research responsibility; however, investigators must maintain oversight and retain ultimate responsibility for the conduct of those to whom they delegate responsibility. As such, PIs on student projects should carefully assess if they will be able to provide meaningful mentorship and oversight on student projects before agreeing to serve in this role.

Investigators who conduct research involving human subjects must:

  • Develop and conduct research that is in accordance with the ethical principles in the Belmont Report;
  • Develop a research plan that is scientifically sound and minimizes risk to the subjects;
  • Have sufficient resources necessary to protect human subjects, including:
    • Access to a population that would allow recruitment of the required number of subjects.
    • Sufficient time to conduct and complete the research.
    • Adequate number of qualified staff.
    • Adequate facilities.
    • A process to ensure that all persons assisting with the research are adequately informed about the protocol and their research-related duties and functions.
    • Availability of medical or psychological resources that subjects might require as a consequence of the research.
  • Assure that all procedures in a study are performed with the appropriate level of supervision and only by individuals who are licensed or otherwise qualified to perform such under the laws of Washington and the policies of WSU;
  • Ensure that all personnel are educated in the regulatory requirements regarding the conduct of research and the ethical principles upon which they are based;
  • Protect the rights and welfare of prospective subjects;
  • Ensure that risks to subjects are minimized: (i) By using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk; and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes;
  • Recruit subjects in a fair and equitable manner;
  • Obtain and document informed consent as required by the IRB and ensure that no human subjects are involved in the research prior to obtaining their consent;
  • Monitor the data collected for the safety of research subjects;
  • Protect the privacy of subjects and maintain the confidentiality of data;
  • When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, include additional safeguards in the study to protect the rights and welfare of these subjects;
  • Have a procedure to receive complaints or requests for additional information from subjects and respond appropriately;
  • Ensure that pertinent laws, regulations, and institution procedures and guidelines are observed by investigators and research staff;
  • Ensure that all non-exempt research involving human subjects receives IRB review and approval in writing before commencement of the research;
  • Comply with all IRB decisions, conditions, and requirements;
  • Ensure that protocols are submitted for timely continuing IRB review and approval, when required;
  • Report unanticipated problems involving risk to subjects or other and any other reportable events to the IRB;
  • Obtain documentation of IRB review and approval before changes are made to approved protocols or consent forms; and
  • Seek IRB assistance when in doubt about whether proposed research requires IRB review.