Institutional Review Board

Principal Investigator's Responsibility

  1. General Responsibilities of Principal Investigators

    The principal investigator (PI) is responsible for personally conducting or supervising the conduct of human-subjects research and for protecting the rights, safety, and welfare of the subjects enrolled in the research. The PI must ensure that all human¬ subjects' research is conducted in an ethical manner and in accordance with all federal, state, and local laws and regulations, institutional policies, and requirements or determinations of the IRB.

    1. Supervising the conduct of human-subjects research

      The PI may delegate study-related tasks, but must adequately supervise study personnel to whom tasks are delegated. When supervising the conduct of human subject's research, the PI must ensure that:

      1. Study personnel are qualified by training and experience to perform study related tasks that have been delegated to them
      2. Study personnel have an adequate understanding of the research
      3. Study personnel follow the IRB-approved protocol, including the recruitment and consent procedures described in the protocol summary

      The PI should have a plan for supervision and oversight of the research. The intensity of the supervision should take into consideration the study personnel conducting the research, the nature of the research, and the subject population.

      When tasks are delegated by the investigator, the investigator is responsible for providing adequate supervision of those to whom tasks are delegated and the investigator is accountable for violations resulting from failure to adequately supervise the conduct of the study.

    2. Protecting the rights, safety, and welfare of research subjects

      When protecting the rights, safety, and welfare of research subjects, the PI must ensure that:

      1. S/he or other identified, qualified individual( s) provides study subjects with reasonable medical care for any adverse events, including clinically significant laboratory values, related to the research
      2. S/he or another specific qualified individual is available to study subjects to answer questions or provide care during the conduct of the research
      3. S/he and all research staff conducting the study adhere closely to the research plan, such as inclusion/exclusion criteria, safety assessments, safety monitoring and reporting of unanticipated problems, and procedures to protect privacy of subjects and confidentiality of identifiable data, in order to minimize risks to subjects.

      The PI should not commence the research without adequate resources to protect subjects participating in the research and should stop the research if the resources necessary to protect subjects become unavailable. These resources might include research personnel, space, equipment, time, and availability of medical or psychological care for problems that arise during participation in the research.

  2. More Specific Responsibilities of Principal Investigators
    1. The PI must ensure that:
      1. IRB approval is obtained prior to initiation of the research
      2. The research is conducted in accordance with the IRB-approved protocol, including, when applicable, the approved recruitment and consent procedures
      3. When informed consent is required, informed consent is obtained prior to the initiation of any study-related procedures
      4. When written informed consent is required, informed consent is obtained and documented using the current IRB-approved research consent form
      5. When drugs, biological products, and devices are being investigated or used, they are managed and controlled as required by institutional policy and, when applicable, FDA regulations 21 CRF 312 and 21 CFR 812
      6. Changes to the IRB-approved protocol and/or the research consent form are not initiated without prospective IRB approval unless necessary to eliminate apparent immediate hazards to the subject
      7. Unanticipated problems involving risks to subjects or others (including adverse events) are reported promptly to the IRB in accordance with IRB policy
      8. When applicable, Data and Safety Monitoring Board/Data Monitoring Committee or other monitoring group reports are submitted promptly to the IRB for review
      9. Continuing review is conducted prior to expiration of IRB approval in accordance with IRB policy
      10. Should IRB approval lapse, research procedures, such as recruitment and enrollment of subjects, study procedures on currently enrolled subjects, review of health/medical records, collection of tissue or other samples, or analysis of data, are not conducted until the IRB re-approves the research or until special permission is obtained from the IRB to continue previously enrolled subjects because it is in their best interests to do so
      11. When the research has been completed or is being closed out prior to completion, a final continuing review report is submitted to the IRB
      12. Adequate and accurate research records are kept and retained as required by the IRB and, when applicable, by the sponsor or FDA
      13. Research records are made available to the IRB, the sponsor, and when applicable, the Office for Human Research Protections (OHRP), and the Food and Drug Administration (FDA) upon request for monitoring and oversight of the research