Responsibilities of Researchers

Any individual who is engaged in human subjects research that is under the jurisdiction of the KSU is responsible for carrying out sound ethical research consistent with research plans either approved by the IRB or determined exempt. All faculty, staff, students, or other agents of KSU who are engaged in human subjects research are required to comply with all IRB determinations, appropriate KSU policies and procedures, and all applicable laws and regulations.

All KSU researchers are responsible for the following:

  • Completing required training on human subject research prior to commencing any research activities that involve interaction or intervention with human subjects or their identifiable private information or identifiable biospecimens. 
  • Disclosing financial conflicts of interest. 
  • Obtaining IRB approval or an exempt determination before involving human subjects in research. This is generally a responsibility of the Principal Investigator (PI). 
  • Using subject selection and recruitment processes that are fair and equitable.
    1. See Guidance: Subject Selection
    2. See Guidance: Recruitment
  • Obtaining and documenting informed consent of subjects or subjects’ legally authorized representatives prior to the subjects’ participation in the research unless these requirements have been waived by the IRB.
    1. See IRB Policy: Informed Consent
  • Monitoring research subjects for potential harm and taking steps to minimize or mitigate those harms when possible.
  • Promptly reporting any activities or circumstances that affect the rights and/or welfare of research subjects, including subject complaints or questions, directly to the IRB or to the PI. 
  • Promptly reporting suspected or confirmed non-compliance to the IRB. Reportable Information Reports are submitted via Cayuse.  Reports can also be directed to the IRB Office by phone or email Attn: IRB Chair.   
  • Maintaining, managing, and retaining research data and records relating to the research as required by applicable policies and regulations.
    1. See overview of KSU data security
    2. See KSU data storage matrix
  • Contacting the IRB if there are any questions about whether an activity involves human subject research.
    1. See IRB Policy: Determination of Engagement in Human Subject Research
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