Assignment Instructions: Submit a paper in which you discuss the Essentials and domain that is assigned to you. The paper should be 5 to 8 double spaced pages in length (NOT including the title page and references). The paper must be written in APA 7th edition format. In your paper, address the following components: Part 1: Introduction and Overview of the Essentials (Due Week 4) Introduction and Overview of the Essentials o Introduce and describe the American Association of Colleges of Nursing (AACN) as a professional nursing organization. o Describe the purpose for The Essentials: Core Competencies for Professional Nursing Education document. o Identify and describe the foundational elements on which the Essentials have been developed. o Discuss why it is important that the Essentials reflect nursing education for the 21st Century. ▪ Include discussion of diversity, equity, and inclusion ▪ Identify and discuss the four spheres of care
Here is a potential outline you could follow, using information directly from the article:
1. Introduction
- Hook: Start by describing the unprecedented disruption the COVID-19 pandemic caused to global health systems and research, as mentioned in the paper’s introduction 1
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- Context: Introduce the Nomali et al. (2023) paper as a narrative review that synthesizes the challenges and solutions for clinical research during this period 2
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- Thesis Statement: Argue that the COVID-19 pandemic exposed critical vulnerabilities in traditional clinical research but also accelerated the adoption of innovative remote, ethical, and administrative solutions that offer a blueprint for future resilience.
2. Core Challenges Identified in Clinical Research
- Challenges for Researchers and Participants: Discuss the issues of infection risk for staff and investigators, increased workload for clinical nurses, and participants’ fear of infection leading to study withdrawal 3
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- Administrative and Ethical Hurdles: Explain the delays in ethics committee (IRB/REC) approvals and the difficulties in obtaining traditional informed consent during a lockdown 5
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- Implementation Issues: Detail the problems caused by the reduction of face-to-face visits, such as disturbances in data extraction and follow-up, and the lack of experience with virtual platforms 7
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3. Key Solutions and Adaptations
- Technological and Remote Solutions:
- Describe the shift to remote methods like telephone/video visits, online data collection, and virtual consent forms 9
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- Mention the use of social media for participant recruitment and technology platforms to manage all aspects of a trial remotely 11
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- Ethical and Procedural Innovations:
- Explain how institutions adapted informed consent, for example, by using electronic forms or verbal consent witnessed by a third party for quarantined patients 13
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- Discuss the importance of prioritizing research from a public health perspective and expediting reviews for critical trials 14
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- Addressing Participant Needs:
- Cover solutions aimed at retaining participants, such as mailing medication directly to their homes and considering financial incentives 15
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4. Synthesizing the “Lessons Learned” for Future Preparedness
- The Necessity of a Flexible Infrastructure: Argue that the core lesson is the need for research infrastructures that are inherently flexible and can pivot to remote methods. Mention that while remote methods are promising, their success depends on available technology and national policies 17
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- Prioritizing Collaboration and Communication: Discuss the importance of strong communication with participants and collaboration between institutions to navigate shifting rules and share data 18
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- Balancing Speed and Quality: Address the challenge of faster research dissemination (e.g., preprints) and the corresponding risk to research quality, highlighting the need for new standards in a crisis 20
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5. Conclusion
- Summarize Main Points: Briefly recap the major challenges (risk, administrative delays, implementation) and the key solutions (remote tech, flexible ethics, participant-centric approaches).
- Reiterate Thesis: Restate your main argument about how the pandemic forced a necessary evolution in clinical research.
- Final Thought: Conclude by emphasizing that integrating these lessons is crucial for building a more robust and ethically sound clinical research enterprise capable of withstanding future global health emergencies.
This assignment is entirely feasible using only the provided paper, as it asks you to analyze and synthesize the exact topics covered in the document.
References
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- “The COVID-19 disease has caused millions of deaths around the world. The most common symptoms of the infection were respiratory problems, which caused the disease to spread rapidly.”
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- “This study aimed to investigate these challenges and propose solutions for conducting clinical research during the pandemic. Methods: A narrative review was conducted… Results: Out of 2508 records retrieved, 43 studies were reviewed, providing valuable insights into the challenges and corresponding solutions for conducting clinical research during the COVID-19 pandemic.”
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- “The research staffs were concerned about the risk of COVID-19. Exposure to the disease during face-to-face meetings increased the chance of infection.”
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- “Many participants withdrew from studies due to infection fears, while high-risk populations, such as infants, the elderly, and pregnant women, were still needed for research purposes.”
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- “The challenges included ‘issues related to researchers or investigators, issues related to participants and ethical concerns, administrative issues (i.e., research ethics committee [REC] or institutional review board [IRB] approval), and issues related to research conduction…'”
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- “The main ethical challenges that organizations should investigate were obtaining informed consent and addressing ethical issues according to the study design and human interventions.”
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- “Reduction of face-to-face visits due to the risk of contracting COVID-19”
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- “The lack of experience regarding virtual platforms to implement clinical studies also affected the results. Lack of face-to-face communication, the reduction of interpersonal interaction between the researcher and the participants, and the accuracy of the acquired information were among the limitations that could cause bias in clinical studies.”
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- “To address these challenges, multiple strategies were proposed, including remote monitoring through phone or video visits, online data collection and interviews to minimize in-person contact…”
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- “A virtual electronic consent form is an alternative approach to traditional written forms.”
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- “In addition, an original web-based survey determined that social media was a successful and efficient technique for gathering data on COVID-19 in a short period of time.”
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- “Simmons et al.46 replaced all in-person parts of their clinical study using two key technology platforms: Study Pages (Yuzu Labs Public Benefit Corporation, 2022) and Pattern Health (Durham, NC). Recruitment and screening, consent, enrollment, randomization, data collection, blinding, adherence, and retention were performed with these platforms.”
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- “Verbal consent for quarantined patients can be obtained first in the presence of a witness, followed by written consent when participants are released from quarantine. Thus, institutions should allocate the necessary resources to develop an appropriate consent form.”
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- “To address this, committees should prioritize investigator-initiated trials from a public health perspective and expedite the review of academic trials that address important questions.”
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- “For example, in drug effectiveness studies, by editing the protocols, the study medications could be mailed to the participants instead of in-person deliveries.”
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- “Another effective way to attract participants is through financial incentives. Allocating the necessary funding for these incentives is a task that health organizations should notice.”
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- “Although remote methods and electronic equipment have limitations, they hold promise as effective solutions during this challenging period.”
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- “Strong communication and constant commitment, combined with technical capabilities for remote work, visits, and study medicine distribution, were critical to the effective retention of study participants and resumption of enrolment.”
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- “International research and collaboration among researchers can enhance global knowledge and awareness.”
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- “While preprint servers and faster peer review processes have clear merits, such as quicker dissemination of results, informing policies, and speeding up the R&D process for COVID-19 therapeutics and vaccines, the quality of COVID-19 research has been largely subpar.”