Topics
PI Responsibilities
Description
The IRB holds the PI responsible for the overall management of an approved study. Management of the study encompasses the ethical, technical, administrative, and fiscal elements of a project. The PI may delegate certain tasks (with documentation) but retains ultimate responsibility and accountability. Principal investigators are required to:
- Ensure the ethical conduct of the research study and protect the rights and welfare of research participants by complying with the IRB approved study protocol, and adhering to all University and State policies, and federal regulations, and applicable guidance,
- Ensure the training requirement for the protection of human participants in research are completed by all personnel working on the study,
- Supervise and ensure that all study personnel receive appropriate training, and conduct the study in accordance with the approved protocol (including approved amendments),
- Guide, mentor and advise student researchers,
- Ensure that all research activities have IRB approval and other approvals required by the institution before human participants are involved, and implement the research activity as it was approved by the IRB,
- Report any real or potential conflicts of interests of the PI or any study personnel in compliance with conflict of interest policies and management plans,
- Obtain informed consent from participants or legally authorized representative before participants are involved in the research, and document consent as approved by the IRB. A copy of the IRB-approved and validated informed consent document must be used to consent each participant. Participants must be provided with a copy of the form after it has been signed, unless the IRB has specifically waived this requirement. The consent process must include a discussion of the study between the person obtaining consent and the participants,
- Maintain written records of IRB reviews, decisions, research records and informed consent documents,
- Obtain IRB approval for and notify the sponsor (if applicable) of any proposed change to the research protocol prior to its implementation, except when necessary to eliminate apparent immediate hazards to the participants,
- Obtain re-approval by reporting progress of approved research to the IRB, in the manner prescribed by the IRB,
- Promptly report to the IRB any adverse events, protocol deviations or other unanticipated problems involving risks to participants or others. PIs should not undertake any action with an external funding agency regarding an unanticipated problem or noncompliance without first contacting OPRS to determine the correct course of action,
- Verify that IRB approval has been obtained from all participating institutions in collaborative activities with other institutions, and that continuing review by other institutions is maintained,
- Ensure the privacy of participants is maintained,
- Ensure all data are collected, transmitted and stored according to University data security policies
- Use the most current version of IRB forms and document templates
- Oversee the budget and expenditures related to the study to ensure that adequate resources are available, including staff, equipment supplies, participant incentives, storage space etc., to conduct the study at the University and any other performance site for which the PI is responsible,
- Provide the IRB with audit or inspection reports or findings issued by regulatory agencies, cooperative research groups, contract research organizations, the sponsor, or the funding agency,
- Maintain, when applicable, accurate records on the receipt, use and disposition of excess drugs/devices,
- Conduct the study in compliance with internal policies and federal regulations including 45 CFR 46 and 21 CFR 50 – Protection of Human Participants, 21 CFR 312 – Investigational New Drug Application and 21 CFR 812 – Investigational Device Exemptions; Good Clinical Practices and, when applicable, 21 CFR 210 – Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs and 21 CFR 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals, and the ethical principles outlined in the Belmont Report,
- Retain research records for length of time required by applicable oversight agency (see Record Retention Research Topic for more information)