The DNP Project – IRB Process
Research projects usually involve the use of an intervention that can expose participants to various health risks. The intervention may be tested for its efficacy or to what extent it can benefit participants who may ultimately experience adverse health effects (Orimadegun, 2020; Rosenfeld, 2020). Thus, the Institutional Review Board (IRB) should examine any investigation to protect participants’ health and safety. The project under investigation focuses on the efficacy of Diabetes Self-Management and Education but does not require IRB screening since it is a case study.
The IRB pre-screening review at Chamberlain University evaluates any investigation and how it can affect participants, the population, and healthcare delivery. For example, the use of evidence-based interventions, the generation of new knowledge, the expansion of theory, or the use of protocols are evaluated in the IRB process. Additionally, the IRB process entails checking if a project utilizes the same approach as a previous study or if Chamberlain University staff is involved. My project involves using the DSME intervention, which can change the physiological status of patients (Hai et al., 2019; Sayeed et al., 2020). I may encounter challenges in receiving approval since I should explain how the intervention would not affect the participants. However, the project does not need the IRB to review the process since the DSME intervention is evidence-based with proven beneficial effects (Zheng et al., 2019). Moreover, this project is a case study. Therefore, a letter is not needed.
In conclusion, the Chamberlain University IRB provides specific steps that investigators should follow to protect research participants. For instance, it assesses the intervention, its effect on the participants, and the need for its approval. However, the anticipated project is a case study that utilizes an evidence-based intervention. Although I may have challenges trying to justify the need for the proposal, it may be approved since it is evidence-based. Overall, no letter is required since the project is a case study.
Hai, A. A., Iftikhar, S., Latif, S., Herekar, F., & Patel, M. J. (2019). Diabetes self-care activities and their relation with glycemic control in patients presenting to the Indus Hospital, Karachi. Cureus, 11(12), e6297. https://doi.org/10.7759/cureus.6297 (Links to an external site.)
Orimadegun, A. E. (2020). Protocol and researcher’s relationship with Institutional Review Board. African Journal of Biomedical Research: AJBR, 23(Suppl 2), 15–20. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7876614/ (Links to an external site.)
Rosenfeld, S. J. (2020). Institutional review board assessment – Balancing efficiency and quality. The Ochsner Journal, 20(1), 50–55. https://doi.org/10.31486/toj.19.0075 (Links to an external site.)
Sayeed, K. A., Qayyum, A., Jamshed, F., Gill, U., Usama, S. M., Asghar, K., & Tahir, A. (2020). Impact of diabetes-related self-management on glycemic control in type II diabetes mellitus. Cureus, 12(4), e7845. https://doi.org/10.7759/cureus.7845 (Links to an external site.)
Zheng, F., Liu, S., Liu, Y., & Deng, L. (2019). Effects of an outpatient diabetes self-management education on patients with type 2 diabetes in China: A randomized controlled trial. Journal of Diabetes Research, 2019, 1073131. https://doi.org/10.1155/2019/1073131
I appreciated your explanation of the site facility’s not requiring IRB approval. All projects required IRB approval from the school and practice site; therefore, if IRB approval is required, what specific steps will you need to take to prepare for the IRB submission for your site?