This document is intended to provide principal investigators (PIs) with the IRB’s expectations about their role in mentoring student researchers who conduct research with human participants. This document is meant to compliment the “Responsibilities of Research Investigators” document given to researchers with every IRB approval and re-approval letter.

The Importance of Mentorship

• Helps students work within an often unfamiliar federal regulatory environment
• Contributes to the success of a student’s research experience
• Prepares students for future research endeavors
• Fosters professional development

 

PI Mentorship Responsibilities

• • Consider whether you have the time to mentor the student and oversee the research study.
    • Meet with the student prior to the development of a research project to discuss basic principles of ethical research design. Develop appropriate strategies for:
      • Recruitment/retention
      • Consent process
      • Data and safety monitoring plan
      • Writing scholarly papers and reports
    • Complete/renew required CITI human subjects training.
    • Ensure that the student researcher understands and abides by the ethical principles, professional standards and codes of conduct within the research discipline.
    • Assist the student in determining whether IRB review/approval is required. Contact IRB if unsure.
    • Assist the student in preparing the protocol application, consent document, recruitment material, etc. Student researchers should not complete the entire protocol submission solely on their own. The mentor is ultimately responsible for the integrity of the research.
    • Review and proofread the completed protocol application prior to IRB submission.
    • Guide students in the work habits necessary for success (planning, record keeping, disciplined work habits, procedures to protect participants’ privacy and confidentiality, etc.).
    • Be available. Provide supervision, guidance, and oversight for entire duration of study and at intervals described in the data safety monitoring section of the IRB-1. Hold regular meetings, if possible.
    • Ensure that the student researcher obtains proper approvals from all required organizations including those that are off-site.
    • Ensure that protocol deviations and adverse events are reported to the IRB as soon as possible.
    • Ensure that the protocol is re-approved according to the time-frame set forth in the approval letter.
    • Ensure that amendments are submitted before changes are made and that changes are not implemented before the changes are approved.
    • Ensure risks are minimized for research participants AND for the student researcher
      • Based upon the PI’s experience, is the research environment safe?
      • Has the student researcher been trained in how to address problems that may arise?
      • For field settings, particularly international research, are there travel advisories that may affect safety? PI and student researchers must be aware of university polices for foreign travel/research activities. PI must be sure that students are aware of local customs and regulations. Establish a communication plan with students. Develop effective plans for data security.
    • Ensure that the student researcher abides by the ethical principles of respect for persons, beneficence and justice, as outlined in the Belmont Report.
    • Ensure that the student researcher conducts the study in accordance with the approved protocol (including approved amendments).
    • Share responsibility with the student researcher for the conduct of the research.

 

As PI and as a mentor you MUST…

• Be available for the student
• Be involved in the research
• Be supportive
• Be knowledgeable about research rules, regulations, and policies
• Be aware of who to contact should an issue arise

 

Finally, the mentor is ultimately responsible for ensuring protection of human participants.

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