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Establishing a Research Program in the ICU

  • Laurence W. BusseEmail author
  • Alex Hall
  • Jonathan Sevransky
Chapter

Abstract

The creation of a critical care research program is a challenging endeavor that requires an understanding of important concepts in trial design and execution, as well as the local research landscape, including key stakeholders, regulatory bodies, and potential funding sources. It is important for the investigator to be able to identify the type of study (randomized controlled trial or retrospective chart review), the setting in which the research will occur (in a community hospital or an academic medical center), and the scope of the contemplated effort (single-center, multicenter, or as part of a research consortium). It is also necessary to assemble the research team, which consists of a clinician-scientist and a research coordinator, and potentially other contributors, including a research pharmacist, nurse educator, and project manager. Patient, ICU, and hospital demographics will dictate which disease processes can be adequately studied at the local level. The investigative team needs to plan for the design of the protocol and its submission, the budgeting process, patient recruitment, and reporting and publication strategies, as prudence at this stage can lead to future success and sustainability. Finally, the team needs to focus on ethical issues such as how to determine whether a critically ill patient is competent to make an informed decision about participation, as well as other variables such as co-enrollment and recruitment when the investigator is acting simultaneously as the clinical attending.

Keywords

Research Investigator Critical care coordinator Clinical trials 

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Copyright information

© Springer Nature Switzerland AG 2020

Authors and Affiliations

  • Laurence W. Busse
    • 1
    Email author
  • Alex Hall
    • 2
  • Jonathan Sevransky
    • 1
  1. 1.Department of Medicine, Division of Pulmonary, Allergy, Critical Care, and Sleep MedicineEmory University School of MedicineAtlantaUSA
  2. 2.Department of Emergency MedicineEmory University School of MedicineAtlantaUSA

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