Investigator Responsibilities

Responsibility of All Research Personnel

(Includes Principal Investigators (PI), Co-Investigators (Co-I), Coordinators, and Research Assistants (RA) who are either students, faculty or staff) 

The IRB holds all research personnel responsible for meeting certain obligations.  All research personnel are required to:

• Acknowledge and accept their responsibility for protecting the rights and welfare of human research participants, including the equitable selection of research participants, ensuring that risks to participants are minimized, and that the risks are reasonable in relation to anticipated benefits,
• Conduct the research in compliance with internal policies including IRB policy, regulations including 45 CFR 46, and other applicable federal and state laws,
• Report any real or potential conflicts of interests in compliance with the conflict of interest policies,
• Fulfill the training requirement (CITI: www.citiprogram.org) and understand the ethical standards and regulatory requirements governing research activities with human participants (Note, specific sponsors may require additional training),
• Use the most current version of IRB forms and document templates,
• Provide a thorough explanation of the research in lay terms to the subject during the consent process,
• Provide the subject with an opportunity to ask questions and have them answered when obtaining informed consent and throughout their participation,
• Obtain informed consent from subjects before they are involved in the research, and document consent as approved by the IRB.  A copy of the IRB-approved informed consent document must be used.  Participants must be provided with a copy of the form after it has been signed, unless the IRB has specifically waived this requirement.  Documented evidence of informed consent of the subjects or their legally authorized representative and/ or witness is to be retained in a manner approved by the IRB.  The consent process involves two required elements: 1) a discussion of the research by the person obtaining consent and the subjects, and 2) an opportunity for subjects to read the consent form.  Please note that it is never appropriate to forgo the discussion, even if subjects will then read the consent form.  Subjects must be given the opportunity to have the consent form read to them if they have difficulty reading,
• Document contact with subjects, e.g., obtaining informed consent or informing subjects of changes that may affect their willingness to continue participating,
• Ensure the confidentiality and security of all information obtained from and about human subjects, and the privacy of subjects is maintained, and
• Be familiar with and follow the adverse event, unanticipated problem, and protocol deviation reporting requirements.

Additional Responsibilities of the Principal Investigators (PI)

(Includes student Principal Investigators)

In addition to the responsibilities outlined (above) for all research personnel, the IRB also holds the PI responsible for the overall management of an approved research protocol. Management of the research encompasses the ethical, administrative, fiscal, and applied elements of a project. The PI may delegate certain tasks, but retains ultimate responsibility and accountability. Principal investigators are required to:

• Supervise all research personnel, as specified in the approved protocol, and ensure that all personnel abide by the ethical principals as outlined in the Belmont Report,
• Ensure that all research personnel are knowledgeable of, and conduct the research in accordance with the approved protocol (including approved amendments),
• 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,
• 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, but not less than once per year,
• 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 the IRB Office in order 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,
• Oversee the budget and expenditures related to the research to ensure that adequate resources are available, including staff, equipment supplies, storage space etc., to conduct the research 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, and
• Communicate, when applicable, the investigator's plans to meet with representatives of the community from which individuals will be recruited, about community concerns, values and expectations.