The creation of any research project with human subjects (clinical trials) is characterized by a number of steps that have to be taken before direct contact with participants and during cooperation. One of the goals is to get approval from the Institutional Review Board (IRB). According to the U.S. Food & Drug Administration (2019), the IRB possesses the authority to approve or disprove research and offer modifications to protect the rights of research subjects. Pre-screening turns out to be an integral part of the study, during which inclusion/exclusion criteria are discussed before informed consent is obtained. In addition, eligibility tests are administrated and discussed via phone, personally, or online. During this particular research, no pre-screening procedures were organized, and no IRB approval was necessary because of the restrictions due to COVID-19. To find credible background information, the school provided the case for review. Instead of pre-screening activities and cooperation with the IRB, more attention was paid to the process of finding the material about a mindfulness program for nurses.
The replacement of regular student activities during the pre-screening stages was explained by the impossibility of students to reach hospitals and cooperate directly with administrators, nurses, or patients. Therefore, no letter from an academic facility was required by the IRB. The coronavirus situation introduced new working conditions for millions of people worldwide, and academic researchers or students had to identify some new ways of work. To identify the main aspects of the study, it was important to choose human subjects for analysis. The school provided the case for evaluation, which created a solid opportunity to learn the idea of mindfulness meditation for nurses, and consider the impact of a pandemic on nurses’ responsibilities. On the one hand, such a way of getting access to research results seemed easier and time-saving. On the other hand, students were deprived of a chance to strengthen their communication skills, develop collaboration with healthcare employees, and check the validity of ideas within a real setting.
The barriers to the IRB pre-screening process were removed, as well as some worries about obtaining a letter from the organization for IRB approval. Still, there were several complications, and my intention was to minimize the number of problems and achieve positive results. Firstly, an appropriate case about a mindfulness meditation program for nurses should be found. The school offered several options for students and explained their responsibilities while using this information. The main challenge at this stage was following referencing policies and understanding what data to cite or represent with the help of personal words and interpretations. Secondly, the case study review focused on the connection between the already made achievements in the nursing field and the current situation and nursing practice. Although it was difficult to establish the relationship between the past and present findings, online cooperation with a tutor and peers’ recommendations became a helpful source of inspiration.
In general, the absence of special research protocols and reviews of pre-screening activities facilitate student work and remove significant barriers. At the same time, new responsibilities and expectations could not be ignored because of the importance of clinical trials and research studies. To answer research questions and assess the effectiveness of a mindfulness meditation program for nurses, it was crucial to find a credible case study. Students were not able to visit hospitals and ask to review real cases due to COVID-19. Therefore, the school participated in research preparations and supported students in their intentions to investigate mindfulness meditation for stress reduction.
Reference
U.S. Food & Drug Administration. (2019). Institutional review boards (IRBs) and protection of human subjects in clinical trials. FDA. Web.