Responsibilities of Research Investigators and Study Coordinators

Responsibilities of the Research Investigator

  1. Research investigators acknowledge and accept their responsibility for protecting the rights and welfare of human research subjects and for complying with all applicable provisions of this Institution’s IRB. The Principal Investigator is responsible for the compliance of all co-investigators, student investigators, and research associates with the IRB decisions, conditions, and requirements.
  2. Research investigators are responsible for conducting studies in accordance with the protocol.
  3. Research investigators are required to complete periodic training in the protection of human subjects, as required by Federal regulations and IRB policy.
  4. Research investigators are responsible for obtaining consent and for providing a copy of the IRB-approved and signed informed consent document to each subject at the time of consent.
  5. Research investigators are responsible for ensuring that only authorized research staff will conduct the consent process.
  6. Research investigators will promptly report changes in previously approved human subject population or research activities to the IRB. Changes will not be initiated without IRB review and approval, except where necessary to eliminate apparent immediate hazards to the subjects.
  7. Research investigators are responsible for reporting progress of approved research to the IRB, as often as and in the manner prescribed by the IRB, on the basis of risks to subjects, but not less than once per year.
  8. Research investigators are responsible for notifying the IRB of any change in financial relationships of any investigators that may result in a conflict of interest that was previously undisclosed.
  9. Research investigators will promptly report to the IRB any injuries or other unanticipated problems involving risks to subjects or others no later than 5 working days after their occurrence.
  10. Research investigators are responsible for notifying the IRB and providing a final report when a study is closed.
  11. Research investigators are responsible for notifying the IRB of any gaps in investigator involvement in a study.
  12. Research investigators are responsible for ensuring, whenever necessary, that the trial is properly registered with clinicaltrials.gov  
  13. Research studies have the resources necessary to protect human subject participants.
  14. Researchers are qualified to conduct the research.
  15. Adequate time is allotted for the researchers to conduct and complete the research. There are also an adequate number of qualified staff and adequate facilities.
  16. Researchers have access to populations that will allow recruitment of the necessary participants.
  17. The researchers are provided with the availability of medical or psychosocial resources that participants may need as a consequence of the research.
  18. Researchers will follow good clinical practice guidelines.
  19. Researchers must disclose significant financial interests including those of the Researcher, and the Researcher’s spouse and dependent children (refer to Investigator Conflicts of Interest in Funded Research policy).