DNP 825 Describe the purpose of the Institutional Review Board (IRB) and the types of determinations the board makes
Institutional Review Board (IRB) or research ethics committee approval is designed to protect the rights of an individual subject, wherein ethical guidelines in conducting research protect the integrity of the research process (Oermann et al., 2021). IRB reviews all research studies involving human subjects to meet the regulations and ethical standards.
Categorizing a project by the QI oversight committee or project team members will depend on the decision to submit a project for IRB review and approval, which is done before starting a project (Gautham & Pearman, 2021). All processes may vary, but Institutional Review Board (IRB) has mechanisms to evaluate a project proposal, including validating A QI project with good use of its resources and does not cause harm to any patients.
Any QI projects not involving human subjects do not need IRB approval. Research topics in relation to patient safety and quality should be subject to IRB review and approval, ensuring privacy, safety, and confidentiality to protect the patient’s welfare (Gautham & Pearlman, 2021). Quality improvement activities such as implementing a practice to improve the quality of patient care and collecting patient or provider data regarding the practice for clinical, administrative, or practical purposes do not meet the definition of research and do not need IRB review (Oermann et al., 2021). Sepsis alert is a QI project to improve diagnosis and treatment requiring IRB approval. Outcomes are reviewed on how often a patient receives antibiotics and intravenous fluids and draw blood cultures and lactate levels. The alert was designed to supplement other institutional initiatives to improve sepsis outcomes.
Reference
Gautham, K.S. & Pearlman, S. (2021). Do quality improvement projects require IRB approval?
Journal of Perinatology, 41 (6).
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Oermann, M.H., Barton, A., Yoder-Wise, P.S., & Morton, P.G. (2021). Research in nursing education and the institutional review board/ ethics committee.
Journal of Professional Nursing, 37 (2), 342- 347.
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