DNP 825  Clinical Sit QI IRB Research Paper

DNP 825  Clinical Sit QI IRB Research Paper

DNP 825  Clinical Sit QI IRB Research Paper

            Research is an important role of nurses prepared at the doctoral level. Research enables them to discover new aspects of nursing care, management, and education that can be adopted to improve outcomes. They also implement quality improvement interventions in their practice sites to address inefficiencies in performance. Institutions have institutional review boards that oversee the research and quality improvement initiatives that nurses prepared at the doctoral level undertake (Aldridge, 2022; Slutsman & Nieman, 2018). Consequently, it is important to understand the processes utilized in getting institutional review board approvals in different institutions.

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            Nurses intending to undertake research or quality improvement initiatives in my practice site are expected to undergo the processes laid by the institutional review board. The first step is the submission of the research proposal or quality improvement proposal to the organization’s quality assurance team. The quality assurance assesses the proposals to determine their need in the organization. They also determine if the proposal meets the requirements of being considered as either quality improvement or research projects in the hospital. In some instances, they reach out to the researcher to obtain more insights on the proposed projects. The quality assurance team provides feedback on the next course of action for the researcher. For example, if approved at this stage, one is allowed to submit the proposal to the institutional review board. If not one has the opportunity to revise the proposal according to the comments that the quality review team gives the researcher. Any proposal must be approved by the quality assurance team before being submitted to the institution review board.

            The second step in the process is the submission of the proposal to the institutional review board. This is achieved by submitting it through the online system that has been developed for this purpose. One must ensure that the proposal meets the set requirements by the board. The requirements include addressing the crucial needs of the organization, scientific, and developed according to the structure that is approved by the board. Once submitted, the researcher waits up to two months for the initial response from the board. The board is expected to convene a meeting within this period to review the proposal. The board can either approve the proposal directly, request for a revision of some aspects of the proposal, or reject it.

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            The board has developed timelines that must be met if a proposal is to be revised. In most cases, the researcher has up to two months to respond to any concerns the board raises about the research or quality improvement initiative. Any delay will translate into the need for the researcher starting from the initial stages involving the submission of a proposal to the quality assurance department. If approved, the researcher is allowed to proceed with the project undertaking as proposed in the research or the quality improvement initiative. The institutional review board has been inexistence for long in the hospital. It ensures that the researches or quality improvement initiatives undertaken by the practitioners safeguard the rights of the study participants. They also ensure that they promote safety, quality, and efficiency in the patient care (Duffy et al., 2020; Grady, 2019; Rodriguez et al., 2021).

Conclusion

            The submission of a research or quality improvement initiatives in the hospital is a two-step process. One must be approved by the quality assurance department before being submitted to the institutional review board. The institutional review board assesses the ethical nature of the proposals and makes decisions about them. Therefore, researchers and healthcare providers should be informed about the processes utilized in the organization to enable them undertake their projects efficiently.

References

Aldridge, M. D. (2022). Maneuvering the Institutional Review Board Process: A Guide for Critical Care Nurses and Researchers. Dimensions of Critical Care Nursing, 41(1), 24–28.

Duffy, K. A., Ziolek, T. A., & Epperson, C. N. (2020). Filling the regulatory gap: Potential role of institutional review boards in promoting consideration of sex as a biological variable. Journal of Women’s Health, 29(6), 868–875.

Grady, C. (2019). Bioethics in the oversight of clinical research: Institutional review boards and data and safety monitoring boards. Kennedy Institute of Ethics Journal, 29(1), 33–49.

Rodriguez, E., Pahlevan-Lbrekic, C., & Larson, E. L. (2021). Facilitating Timely Institutional Review Board Review: Common Issues and Recommendations. Journal of Empirical Research on Human Research Ethics, 16(3), 255–262.

Slutsman, J., & Nieman, L. (2018). Institutional review boards. In Principles and practice of clinical research (pp. 47–61). Elsevier.

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Assessment Description
This purpose of this assignment is to increase familiarity with the IRB submission process.

In this assignment, you will create a mock GCU Quality Improvement (QI) IRB submission. You will be required to submit your actual DPI-Committee-Approved DPI Project Proposal to iRIS in the DNP-960 course, and so to prepare, you will begin reviewing the submission process and all requisite IRB documents in this assignment. However, you will not be submitting an IRB proposal for your DPI Project at this point in time. This assignment is a practice opportunity to ensure you are aware of the QI-IRB submission process at your clinical/practicum site and that you are familiar with the types of documents required.

General Requirements:

Use the following information to assist you in executing the correct procedures for timely, successful completion of the assignment:

This assignment uses a rubric. Please review the rubric prior to beginning the assignment to become familiar with the expectations for successful completion.
Doctoral learners are required to use APA style for their writing assignments. The APA Style Guide is located in the Student Success Center.
You are required to submit this assignment to LopesWrite. A link to the LopesWrite technical support articles is located in Class Resources if you need assistance.
Procedures:

Use the following information to ensure successful completion of the assignment:

Work with your preceptor/mentor at your clinical/practicum site to understand the DPI Project approval process for IRB and quality improvement projects. This includes timelines, committees involved (IRB, Nursing Research, Quality Improvement), and the authorizing signatures required. Ensure you address timeframes and submission documents required in addition to the approval process for a quality improvement DPI Project to be conducted at your clinical/practicum site.
Review the resources within the IRB Documents folder, located in the DC Network. Navigate to the IRB Documents folder by selecting DNP Community, DNP Program Documents, DNP-960, and then the IRB Documents folder.
Read the “IRB Documents Checklist for DNP Learners,” located in the DNP-960 folder.
Review the IRB Submission Training Videos for iRIS.
With your instructor, determine which documents you will need to submit for your IRB application based on the “IRB Documents Checklist for DNP Learners,” located in the DNP-960 folder.
Use the following document templates as needed: informed consent, site authorization letter, recruitment script, confidentiality statement, conflict of interest form, and HIPAA authorization form, located in the DNP-960 Folder/IRB Documents folder.
Directions for Submission:

Construct a 250-500-word Clinical/Practicum Site QI-IRB Report that outlines the steps in the DPI Project approval process for IRB and quality improvement projects at your clinical site.

Upload the following to the assignment dropbox: Your completed DNP-10 Strategic Points document (including all updated required revisions from your DNP-815A course), sample site authorization letter, (identifying the authorizing official), DNP Committee Approval Form, QI Determination Form, and any other IRB documents that pertain to your DPI Project.

Learners will submit this assignment using the assignment dropbox in the digital classroom. In addition, learners must upload this deliverable to the Learner Dissertation Page (LDP) in the DNP PI Workspace for later use.

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