Policies and Expectations

policies and expectations

Faculty and trainees (Fellows, Residents, and Students) involved in research must adhere to Duke's guidelines for research and data integrity. All studies must obtain IRB approval before initiation. Below is a guide outlining some specific departmental expectations. Please refer to the links provided for a comprehensive list of Duke's research policies.

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Primary Investigator and Research Mentor Responsibilities

Every clinical research protocol submitted to the IRB at Duke University requires a faculty member to serve as the Primary Investigator (PI).

The PI holds full responsibility for all aspects of the research protocol, including:

  • Defining the research hypothesis and specific aims,
  • Securing funding for tests, data collection, and salary support for research personnel,
  • Overseeing the day-to-day conduct of the study with support from the CRU and RPM.

The PI also carries a special responsibility when supervising medical students, residents, or fellows conducting research activities. These individuals are referred to as "learners." In this context, the PI acts as a research mentor for the learner, who is typically responsible for much of the work on the project. The PI’s role as a mentor includes several essential responsibilities:

  1. Authorship Responsibilities

    • The PI determines which research team members will be included in authorship roles.
    • Ideally, authorship should be agreed upon at the beginning of the project, with a clear understanding of each individual's role.
    • "Gift authorship" between trainees is inappropriate.
    • The PI may also provide a limited dataset when publishing in a journal requiring data sharing.

  2. Research Protocol Execution

    • The PI is ultimately accountable for the proper execution of the study and for ensuring all critical tasks are completed following the study protocol.
    • This includes adhering to all approved IRB procedures and following general principles of responsible conduct in research.
    • A protocol deviation must be reported to the IRB if any task is not completed within the required timeframe.
    • While the PI may delegate some tasks to a CRC or learner, they remain responsible for ensuring all tasks are completed as required.

  3. Regular Meetings with Learners

    • The PI should meet regularly with each learner to review the progress of their project and assist in addressing any challenges.

  4. Funding Responsibilities

    • The PI should provide funding or identify opportunities for funding the proposed research.

  5. Responsibilities When a New Learner Joins the Research Team

    • The new learner must be listed as key personnel on the IRB protocol to gain access to the protocol in iRIS.
    • The PI must ensure that the learner reads the IRB protocol thoroughly, covering the hypothesis, experimental methods, patient population, data sources, inclusion criteria, study dates, and the research data security plan for data storage.
    • The PI should ensure the learner can access the secured location specified in the research data storage plan (RDSP). If not, the PI should notify the relevant personnel with access (e.g., RPM, CRC).
    • The PI should clarify which critical research tasks they want to delegate to the learner. Some tasks, such as patient consent for a clinical trial, require additional training to ensure they are performed correctly.

  6. Responsibilities When a Learner Leaves the Study or Duke

    • When a learner leaves a clinical protocol, the PI must request that the learner be removed from the key personnel list on the IRB protocol.
    • If a learner leaves Duke, the PI must ensure that research data for Duke patients remains at Duke. Allowing Duke patient data to leave the institution without proper approval can have serious consequences.
    • The PI may allow the learner up to one year to complete their manuscript after leaving Duke, provided the appropriate agreements are finalized and the learner is listed as external key personnel. After this period, the PI should assume full responsibility for completing, closing, or transitioning the study to another learner.

  7. Key Considerations for Study Transitions

    • All prospective clinical trials that require patient consent to collect data must include a CRC as part of the study team. The School of Medicine considers internally funded studies that require patient consent among the highest-risk studies at Duke, as they lack external monitoring typically associated with federally or industry-funded studies.
    • Transitions in study design—such as moving from a non-patient contact design (e.g., data pull or chart review) to requiring patient contact (and consent)—constitute a major shift in the IRB protocol. Planning this transition through a preparatory data review can help avoid significant delays.

  8. Closing the Study

    • Upon completion of a study, the PI must ensure the timely closure of the IRB protocol. Retrospective studies typically require only a few weeks to obtain approval. Studies should not be left open indefinitely "in case" a similar analysis is conducted. Keeping protocols open unnecessarily can lead to IRB violations due to discrepancies in study end dates and patient enrollment numbers.