The Institutional Review Board (IRB) determination at the University, has the goal to assist students in the preparation for transition into the NR 705 course, Project and Practicum II. The IRB is an administrative body established to protect the rights and welfare of the subjects participating in research or project activities conducted under the auspices of the institution with which it is affiliated (Harris, Roussel, Dearman, & Thomas, 2020). For the majority of students in the DNP program, a full IRB review will not be required. Reflect on the IRB prescreening process by answering the following questions: Concisely describe the process for the IRB prescreening review at the university. What barriers could you face as you progress through the IRB prescreening process? *I’m doing a case study, so no full IRB is required, but I need to submit the application for the committee review and I need to follow all the steps created to protect human life and rights. Will you need to gain IRB approval from your organization? *No (unfortunately I’m doing a case study, no implementation or clinical site) If so, what is the schedule for the organization’s IRB meetings? What is the process you will expect? If you do not need site IRB review, have you arranged to get a letter from your organization that confirms you do not need IRB approval? What is the purpose of the IRB process, Do you find that it is important? Use an . Provide The scholarly source needs to be: 1) evidence-based, 2) scholarly in nature, 3) Sources should be no more than five years old ( citations and references are included when information is summarized/synthesized and/or direct quotes are used, in which standards apply. Include the

The Institutional Review Board (IRB) process is a vital component in ensuring the protection of human subjects involved in research or project activities conducted under the auspices of an institution. At this university, the IRB prescreening review is the initial step in determining whether a full IRB review is required.

The process for the IRB prescreening review involves several steps. First, the student must submit an application to the IRB committee. This application includes a detailed description of the proposed research or project, the intended participants, the data collection procedures, and any potential risks or benefits to the participants. The application must also include relevant documentation such as informed consent forms and data collection instruments.

Once the application is submitted, it undergoes a review by the IRB committee. The committee assesses the proposed research or project to determine whether it meets the ethical guidelines and regulatory requirements for human subjects research. This assessment includes considerations of the risks and benefits to participants, the adequacy of informed consent procedures, and the protection of participant privacy and confidentiality.

During the IRB prescreening process, there are several potential barriers that a student may face. One barrier could be a lack of clarity or understanding regarding the ethical guidelines and regulatory requirements of the IRB. Students may also encounter challenges in obtaining informed consent from potential participants, especially if they are working with vulnerable populations or conducting research in sensitive areas.

Another potential barrier is the need for revisions and clarifications to the research or project proposal. The IRB committee may request changes to the study design, data collection procedures, or informed consent materials in order to ensure the protection of participants. This iterative process of revisions and resubmissions can be time-consuming and may delay the progression of the research or project.

In the case of a case study, where no implementation or clinical site is involved, there may not be a need to gain IRB approval from an organization. However, it is important to confirm this with the institution and obtain a letter that confirms that IRB approval is not required. This letter serves as documentation and demonstrates adherence to ethical standards even in the absence of a full IRB review.

The purpose of the IRB process is to protect the rights and welfare of human subjects involved in research or project activities. It ensures that potential risks are minimized, that participants provide informed consent, and that their privacy and confidentiality are safeguarded. The IRB process also helps to maintain the integrity and ethical standards of research conducted within the institution.

In conclusion, the IRB prescreening process at this university involves the submission of an application to the IRB committee for review. Potential barriers can include a lack of understanding of ethical guidelines, challenges in obtaining informed consent, and the need for revisions to the research or project proposal. In the case of a case study, it may not be necessary to gain IRB approval from an organization, but it is important to obtain documentation confirming this. Overall, the IRB process plays a crucial role in protecting the rights and welfare of human subjects, and it is important for researchers and students to adhere to its guidelines and requirements.