Homework answers / question archive / Week 2 Ethical Issues in Research Class, in grading Week 2 assignment, please organize your paper or PP using the following headings

Week 2 Ethical Issues in Research Class, in grading Week 2 assignment, please organize your paper or PP using the following headings

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Week 2 Ethical Issues in Research Class, in grading Week 2 assignment, please organize your paper or PP using the following headings. Address each principle as it relates to your particular research study, not your research topic. Just defining them and applying them to research in general is not sufficient. • • • • • • • Social and clinical value Scientific validity Fair subject selection Favorable risk-benefit ratio Independent review Informed consent Respect for potential and enrolled subjects But you need to address each in relation to your particular research study. Just defining them and applying them to research in general is not sufficient. The following may be helpful in addressing each principle: FNIH_BioethicsBrochure_WEB.PDF Social and clinical value. Resources: (“the social value (for society) of an intervention lies in the nature and magnitude [6] of the improvement the intervention is expected to have on the wellbeing of patients, individuals in society, or society (but not research participant, for this we would call a direct benefit!). Habets, Michelle & Delden, Johannes & Bredenoord, Annelien. (2014). The social value of clinical research. BMC medical ethics. 15. 66. 10.1186/1472-6939-15-66. “The experiment should be such as to yield fruitful results for the good of society, unprocurable by any other methods or means of study, and not random or unnecessary in nature”. The Nuremberg Code. Reprinted from Trials of War Criminals Before the Nuremberg Military Tribunals Under Control Council Law 10, 181–182. 1949, Washington, D.C.: U.S: Government Printing Office Example: Research to improve sleep in the institutionalized older adult has the potential to improve sleep in this vulnerable population. Improved sleep has the potential to improved older adult’s quality of life and overall health. Clinically, sleep promotion interventions may assist the older adult to acclimate to the institutional setting. Scientific validity Resources: https://conductscience.com/research-methodology-validity/ Example: The research study will involve a random selected sample of institutionalized older adults residing in one long-term care facility ensuring results can be generalized to the population of older institutionalized older adults. The Fitbit Versa 2 will be used to measure the sleep patterns of the older adults. The Fitbit Versa2 has been proven to be a valid measure of sleep quality through a tri-wavelength sensor and a SpO2 sensor. The Fitbit Versa 2 produces a sleep score from sleep duration, restoration, heart rate data, blood oxygen and time tossing and turning. Sleep promoting interventions will be measured by two observers utilizing a check off sheet to ensure interrater reliability. Fair subject selection Subject selection should provide “formal equality of opportunity. According to this principle, investigators must treat all prospective participants the same unless differential treatment is warranted by the scientific goals of the study or the need to promote participants' medically related interests. All prospective participants (1) who meet the scientifically defined eligibility criteria and (2) for whom participation is consistent with their medically related interests should have an equal, formal opportunity to participate in the study. Prospective participants should not be excluded simply because they are more susceptible to risk than others”. MacKay D. Fair subject selection in clinical research: formal equality of opportunity. J Med Ethics. 2016 Oct;42(10):672-7. doi: 10.1136/medethics-2015-103311. Epub 2016 Jul 18. PMID: 27432910. Favorable risk-benefit ratio Resources: “Depending on the particulars of a study, research risks might be trivial or serious, might cause transient discomfort or long-term changes. Risks can be physical (death, disability, infection), psychological (depression, anxiety), economic (job loss), or social (for example, discrimination or stigma from participating in a certain trial). Has everything been done to minimize the risks and inconvenience to research subjects, to maximize the potential benefits, and to determine that the potential benefits to individuals and society are proportionate to, or outweigh, the risks? Research volunteers often receive some health services and benefits in the course of participating, yet the purpose of clinical research is not to provide health services.” One benefit of most research is the altruistic feeling of doing good. Patient Recruitment Ethics in Clinical Research. 2020. National Institute of Health. Downloaded from: NIH Clinical Center: Ethics in Clinical Research Independent review Resources: “Under FDA regulations, an Institutional Review Board is group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.” Most universities and healthcare facilities have an Institutional Review Board that approves all research. Institutional Review Boards (IRBs) and Protection of Human Subjects in Clinical Trials. 2019. Food and Drug Administration. Downloaded from: Institutional Review Boards (IRBs) and Protection of Human Subjects in Clinical Trials | FDA Frequently Asked Questions about Institutional Review Boards (apa.org) Informed consent sample-informed-consent-form-for-hofstra-irb-proposal.pdf Respect for potential and enrolled subjects Individuals should be treated with respect from the time they are approached for possible participation—even if they refuse enrollment in a study—throughout their participation and after their participation ends. This includes: 1. Respecting their privacy and keeping their private information confidential. 2. Respecting their right to change their mind, to decide that the research does not match their interests, and to withdraw without penalty. 3. Informing them of new information that might emerge in the course of research, which might change their assessment of the risks and benefits of participating. 4. Monitoring their welfare and, if they experience adverse reactions, untoward events, or changes in clinical status, ensuring appropriate treatment and, when necessary, removal from the study. 5. Informing them about what was learned from the research. Most researchers do a good job of monitoring the volunteers’ welfare and making sure they are okay. They are not always so good about distributing the study results. If they don’t tell you, ask Patient Recruitment Ethics in Clinical Research. 2020. National Institute of Health. Downloaded from: NIH Clinical Center: Ethics in Clinical Research Research Foundations NSG/456 Version 2 Morsal Wahaj NSG 456 05/03/2021 University of Phoenix Material Research Topic, Problem, and Question Complete this worksheet to develop your research focus for this course. To help you better understand the main parts of research, this topic will be the basis for other assignments in the course. Identify a Research Topic Grove, Gray, and Polit (2015) define a research topic as “a concept or broad issue that is important to nursing, such as acute pain, chronic pain management, coping with illness, or health promotion” (p. 131). Define your broad research topic in one to two sentences. A fall that results in injuries among older adults is a cause for concern since they lead to various complications. Interventions to prevent falls among the elderly can ensure older adults above 65 years old live healthy lives. Identify your Research Problem Grove, Gray, and Polit (2015) explain that a research problem “is an area in which there is a gap in the knowledge needed for nursing practice” (p.131). Write your research problem and explain the significance and background in a 175- to 260-word narrative. The National Council of Aging provides that the number of older adults 65 years and above is rising significantly in the US. For instance, estimates show that over 20% of the US population will be made up of people aged 65 years and above by 2040 (NCOA, 2021). The shift in demography is a concern since older adults are associated with high rates of falls. For instance, research shows that more than 800,000 older people are hospitalized due to falls annually (CDC, 2017). Also, over 32,000 fall-related deaths were recorded in 2018, making falls among the top causes of death among older people in the US ((Rubenstein, 2021). Falls are associated with various complications, including fractures, broken bones (ankles, wrists, arm, head injury, and over 95% of hip injuries). Age-related changes are the major causes of falls and are associated with impaired functional ability, making it challenging to maintain stability and balance among older people. Also, older people lose visual acuity and muscle power, leading to falls (Rubenstein, 2021). Other causes of falls are diseases such as COPD, diabetes, arthritis, and mental illnesses such as dementia, depression, delirium, and others. Some of the drugs used by older adults to treat chronic conditions may also cause dizziness increasing the risk of falls. The mental and neurocognitive conditions that affect older people have created concerns since patients with mental conditions experience high falling rates. This exacerbates the pre-existing conditions leading to increased hospital readmissions and deaths. Research indicates that physical exercises among older people reduce fall risk since they are associated with improved balance, alertness, and cognitive function (Finnegan, 2018). Develop your Research Question Copyright © 2016, 2018 by University of Phoenix. All rights reserved. 1 Research Foundations NSG/456 Version 2 Morsal Wahaj NSG 456 05/03/2021 Research questions should be short, probing, and take variables into account (Grove, Gray & Polit, 2015). Although the PICOS format is not required, your question should address patient, intervention, comparisons, outcomes for practice, and study design. Develop a one-sentence research question. Quantitative Research Question Among older patients 65 years and above in psychiatric units, do events of falls reduce as a result of physical exercises compared to no exercises in two months? Qualitative Research Question What factors do caregivers consider to be contributing factors for increased fall rates in psychiatric units? Copyright © 2016, 2018 by University of Phoenix. All rights reserved. 2 Research Foundations NSG/456 Version 2 Morsal Wahaj NSG 456 05/03/2021 References National Council of Aging. (2021). Get the facts on chronic disease self-management. Retrieved from https://www.ncoa.org/article/get-the-facts-on-chronic-disease-selfmanagement Finnegan, S., Seers, K., & Bruce, J. (2018). Long-term follow-up of exercise interventions aimed at preventing falls in older people living in the community: a systematic review and meta-analysis. Physiotherapy, 105 (2), 187-199. https://doi.org/10.1016/j.physio.2018.09.002 Rubenstein, L. Z. (2021). Falls in older people. MSD Manual. Retrieved from https://www.msdmanuals.com/professional/geriatrics/falls-in-older-people/falls-inolder-people CDC. (2017). Important facts about falls. Center for Disease Control and Prevention. Retrieved from https://www.cdc.gov/homeandrecreationalsafety/falls/adultfalls.html Copyright © 2016, 2018 by University of Phoenix. All rights reserved.