NUR 550 Topic 3 DQ 1 & 2 Discussion

NUR 550 Topic 3 DQ 1 & 2 Discussion

NUR 550 Topic 3 DQ 1 & 2 Discussion

Topic 3 DQ 1

Assessment Description

Discuss the ethical guidelines that would need to be implemented when conducting translational research. What are the ethical and legal considerations related to translating research into practice? Discuss what steps you would take as a member of a translational research team in order to establish ethical guidelines for conducting translational research.

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Topic 3 DQ 2

Assessment Description

Discuss the role of the Institutional Review Board (IRB). Discuss ethical research considerations specific to population health. How are respect for the persons, potential benefits and burdens of the research, and justice kept in balance? Provide an example.

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Topic 3 DQ 1: Translational Research Ethical Guidelines

Translational research promotes knowledge transfer from laboratory and preclinical research into clinical practice. As Gupta (2022) posited, critical ethical challenges characterize this process, particularly concerning the safety and dignity of human subjects. Ethical guidelines that should be implemented when conducting translational research include ensuring adherence to best practices, protecting participants, and awareness and adequately addressing possible conflicts of interest. According to Petrini et al. (2020), a conflict of interest emerges when a secondary interest, such as economic gain, influences the primary interest, like the patient’s health. Best practices include conforming to protocols and the expected data collection procedures, as well as conducting research in the right places and at the right time.

Ethical and legal considerations related to translational research are diverse and consider different factors. One of the key facets is the subjects’ safety and welfare, where researchers are obliged to prioritize patient welfare over other interests. Other considerations include integrity of research, proportionality between risks and benefits, and equality of access (Yarborough, 2020; Petrini et al., 2020). While explaining these considerations, Petrini et al. (2020) noted that translational research should comply with the established rules and professional standards, balance risks and potential benefits, and avoid discrimination. Special attention to the relationship between researchers and human subjects is crucial, established and maintained by promoting beneficence and autonomy.

As a translational research team member, I would take various steps to establish ethical guidelines for conducting translational research. The first step is to ensure the social and clinical value of research, accomplished by conducting research that improves scientific understanding of health and benefits patients. The second step is to ensure adequate measures to protect human subjects from potential risks. Thirdly, all research should ensure informed consent, respect for participants, and fair inclusion of subjects in a study. The requirements under each step should be explicit before the research commences.

References

Gupta, N. (2022). Ethical considerations in translational research. Perioperative Neuroscience, 215-228. https://doi.org/10.1016/B978-0-323-91003-3.00004-0

Petrini, C., Minghetti, L., & Brusaferro, S. (2020). A few ethical issues in translational research for medicinal products discovery and development. Annali dell’Istituto Superiore di Sanità, 56(4), 487-491. DOI: 10.4415/ANN_20_04_11

Yarborough, M. (2021). Do we really know how many clinical trials are conducted ethically? Why research ethics committee review practices need to be strengthened and initial steps we could take to strengthen them. Journal of Medical Ethics, 47(8), 572–579. https://doi.org/10.1136/medethics-2019-106014

DQ 2: The Institutional Review Board

Research involving subjects may pose significant risks to participants, hence the need for adequate control. Besides, individuals may participate in unbeneficial studies, and their protection is among the cardinal roles of Institutional Review Boards (IRBs). In the research context, IRBs are federally mandated boards that review research with human participants to ensure it meets the appropriate ethical guidelines (White, 2020). Under the FDA’s authorization, an IRB can approve, request modifications, or disapprove research. The decisions are made after the IRB’s group process of reviewing research protocols and materials (U.S. Food & Drug Administration, 2019). Generally, the advance and periodic review of research ensures adequate protection of human subjects’ rights and welfare.

Before proposing or commencing population health research, researchers should understand and adhere to its ethical considerations. The basic ethical considerations include respect for persons, beneficence, and justice. Respect for persons obligates researchers to promote autonomy and protect individuals with diminished autonomy (Gordon, 2020; White, 2020). Informed consent ensures autonomous decision-making and voluntary participation in research. Beneficence involves not harming participants and maximizing potential benefits (Mondragón Barrios et al., 2022). Justice is accomplished by fair participation and distribution of research benefits and burdens.

Before commencing research, the researchers and participants should look forward to studies benefitting patients, populations, and the broader society. One way of accomplishing this objective is balancing respect for the persons, potential research benefits and burdens, and research. For instance, after obtaining informed consent from participants in a study on mHealth apps and diabetes self-care, researchers should carefully examine who should receive the research benefits and bear its burdens. To ensure justice, the National Commission proposes equal share and distribution of benefits according to individual needs, effort, and societal contribution (White, 2020). Merit should also be a critical consideration when distributing research benefits and burdens.

References

Gordon, B. G. (2020). Vulnerability in Research: Basic ethical concepts and general approach to review. Ochsner Journal, 20(1), 34–38. https://doi.org/10.31486/toj.19.0079

Mondragón Barrios, L., Martínez Levy, G. A., Díaz-Anzaldúa, A., & Estrada Camarena, E. (2022). Rethinking benefits in health research, reflections of an ethics committee. The Yale Journal of Biology and Medicine, 95(3), 389–398. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9511940/

U.S. Food & Drug Administration. (2019). Institutional Review Boards (IRBs) and protection of human subjects in clinical trials. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/institutional-review-boards-irbs-and-protection-human-subjects-clinical-trials

White, M. G. (2020). Why human subjects research protection is important. Ochsner Journal, 20(1), 16-33. https://doi.org/10.31486/toj.20.5012