1st peer- IRB approval is a crucial step in the research process, ensuring that studies involving human subjects are conducted ethically and responsibly (Barrow et al., 2022). To determine if a research project requires IRB submission, several key components should be evaluated. The involvement of human subjects is a primary consideration; if the research collects data from or about living individuals, IRB review is typically necessary (Barrow et al., 2022). This includes studies involving surveys, interviews, observations, or any form of direct interaction (Barrow et al., 2022). Projects that present more than minimal risk to participants—whether physical, psychological, social, or legal—require IRB review (Barrow et al., 2022). Minimal risk is defined as harm or discomfort anticipated in the research not greater than what is encountered in daily life or routine examinations. Any research involving interventions, such as medical procedures or behavioral treatments, or interactions with participants requires IRB oversight (Barrow et al., 2022). The informed consent process must also be examined to ensure participants are fully informed about the study’s nature, any potential risks, and their right to withdraw. Confidentiality concerns must be addressed, ensuring that sensitive or private information is handled securely (Barrow et al., 2022).
An example illustrating the need for IRB approval can be found in the review by Rarani and Kramer, which discusses critical strategies for preventing surgical site infections. The review emphasizes evidence-based guidelines, such as patient optimization, antimicrobial prophylaxis, and meticulous wound care, which have significantly reduced SSI rates when consistently applied (Rarani & Kramer, 2023). It also highlights the importance of effective multidisciplinary collaboration, including surgeons, nurses, anesthesiologists, infection prevention specialists, environmental services, and IT professionals, to maintain high compliance with these practices and improve patient outcomes (Rarani & Kramer, 2023). The study further examines continuous quality improvement initiatives like Lean Six Sigma and Plan-Do-Study-Act cycles, which are recognized for their role in reducing SSIs through targeted interventions and data analysis (Rarani & Kramer, 2023).
Given that the research involves collecting and analyzing data from healthcare professionals and potentially patients, IRB approval is necessary to address the ethical considerations related to handling sensitive information and ensuring participant privacy. The study’s focus on the roles of APRNs in infection prevention also underscores the need for clear protocols and advocacy for evidence-based practices. By obtaining IRB approval, the study ensures that ethical standards are upheld, protecting participants’ rights and enhancing the research’s integrity and quality.
2nd peer- The required components one should look for in a project to determine if IRB submission is needed are the following: Involvement of human subjects, generalizability of findings, intervention or interaction, use of private information, vulnerable populations, risk to participants, funding and institutional requirements. (Stark L, 2018) An example of a research study in one of my literature review articles that needed IRB approval wasthe study conducted by Ceccarelli et al. (2024). This study involved human subjects—specifically nursing staff—who were surveyed to assess their knowledge of delirium diagnosis, identification of complications, and management of the condition. IRB approval was necessary for this study because it involved collecting data from participants, which could potentially involve privacy concerns and ethical considerations. Why IRB approval was needed in this instance was because of the human subjects, the confidentiality and privacy, the risk to participants, and the generalizability of findings.
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