Principal Investigator Responsibilities

PIs have additional responsibilities for the oversight and conduct of human subject research studies, including hiring qualified staff, ensuring that the staff have current training on ethical human subject research and applicable rules, following the IRB-approved research study, promptly reporting any potential non-compliance or unanticipated problems, maintaining IRB approval throughout the duration of the research, and maintaining oversight over the recruitment, consent, and research procedures. 

Specific responsibilities of PIs include, but are not limited to:

  • Obtaining IRB approval or an exempt determination before involving human subjects in research.
  • Ensuring that individuals conducting human subject research (e.g., research staff) receive appropriate training prior to contact with research subjects or their identifiable private information. 
  • Maintaining adequate and appropriate oversight over the conduct of the research study. Co-investigators and other members of the research team must adhere to appropriate policies and ethical standards related to the protection of human subjects. The PI is held responsible for the conduct of the research personnel (e.g., co-investigator, investigators, and research staff).
  • Using sound scientific study design in the research protocol and obtaining peer review of the research study as appropriate (e.g., thesis committee review, sponsor peer review, academic unit review). 
  • Using research designs that appropriately protect human subjects’ privacy and confidentiality of their information. 
  • Ensuring adequate resources are available to protect human subjects during the proposed research. 
  • Ensuring informed consent is sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by, 45 CFR 46.116 and/or 21 CFR 50 Subpart B.
  • Keeping a log documenting oral consent process if applicable.
  • Obtaining appropriate permissions at non-KSU recruitment and/or research sites. 
  • Reporting any of the following to the KSU IRB:
    1. Adverse events or unanticipated problems involving risks to subjects or others.
    2. Subject complaints.
    3. Potential or confirmed non-compliance with the regulations or the requirements of the IRB. 
    4. Emergency use of investigational drugs or devices. 
    5. Any other circumstance that affects the rights and/or welfare of research subjects.
  • Obtaining approval from the IRB prior to making any modifications to the previously approved non-exempt research, except those necessary to eliminate apparent immediate hazards to subjects. 
  • When continuing review is required, submitting a Renewal Request form for renewed approval to the IRB in sufficient time to allow for IRB review prior to the expiration date of current approval. 
  • Keeping records relating to the research as required by applicable regulations after completion of the research study for a minimum of three years, or longer depending on the funding agency and type of record. This requirement also applies to research records for student research conducted under the supervision of the PI. 
  • Posting clinical trial consent forms, when required. 
  • Submitting a study closure when the research is complete.
     
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