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Scenario: You have been asked to help complete an ethics application for an organisation or group so they can begin a research project. Select one of the following options (topics) as the subject of your assignment (they are all based on actual projects):
1. Evaluating a self-empowerment program aimed at reducing re-offending at the Youth Unit of Melbourne’s Port Phillip Prison.
2. Conducting a survey among staff and patient families in the Intensive Care Unit at the AlfredHospital, aimed at improving patient experiences.
3. Evaluating outcomes from programs aimed at reducing domestic violence with participants from culturally and linguistically diverse (CALD) communities at various inner-city community health centres, facilitated by staff from the Centre for Culture Ethnicity and Health, Richmond.
4. Monitoring and evaluating Aboriginal tobacco control by conducting a survey aimed at identifying smoking rates in remote Indigenous towns, as requested by the Lowitja Institute.
5. Evaluating outcomes from peer-education programs aimed at increasing safe sex education and practices among youth aged between 18-26 years.
As the ethics advisor, you will need to a) identify key ethical implications associated with the proposed research based on associated/similar studies, b) relate these issues to the relevant items in the ethics application form, and c) suggest effective strategies for addressing them so that the ethics application will be approved for the project to go ahead.
Research involving individuals, in clinical and intervention settings, is highly sensitive and an important issue. Intervention refers to any form of “Therapeutic regime”, clinical treatments and protocols, psychotherapy, supportive interventions, psycho-counselling sessions which improve the physical and psychological health of an individual. We want to understand, the existing effectiveness of Palliative Care provisions, in “Intensive Care Unit” of Sydney Hospital. Understanding the proper research ethics, in relation to treatment plans, will help me to design specific research plan and methodologies, aimed at improving care in these patients. Like other Human Research Ethical Approval Committees, the hospital also runs on certain guiding principles. A research is only eligible to be conducted in care settings, if the potential benefits of such study or research, are likely to outweigh the risks and burden placed on participants (Shaw et al, 2009).
Researchers may collect or analyse such data, which are generated from patients as a consequence of normal interventional practices. There should be total concealment of self- identity of a patient, and data collections must comply with Electronic Medical Record system privacy guidelines. The primary data analysis may include haematological, radiological, and histological findings, along with pharmaceutical and surgical treatments that were implemented. The secondary data which may be collected includes ongoing assessment and interventions, the health condition of a patient from time to time, on the aspects of physical and psychological grounds (Shaw et al, 2009). Data may be also collected from worksheets or journals, which are aligned to the patient population of interest, undertaken in the research study. The secondary data which may be collected is any data, which is generated from routine and regular intervention strategies (Shaw et al, 2009).
Wherever possible retrospective studies must be carried out, like undergoing secondary analysis of clinical records. This will provide a large sample size and hasten the process of data analysis to arrive at research conclusions, much faster than prospective study designs. For example, one could obtain the end points of palliative care treatment in last 100 patients, for analysis planned. Further, phenomenological studies may be incorporated, to understand treatment experiences of individuals, who have already received palliative care at Sydney hospital. In case the patient is not available, the physicians, care providers and their family members may be surveyed for data collection and analysis (AIAA, 2007) ( Creswell,2003).
Research designs must be substantiated by proper statistical analysis. The ethics and reproducibility of data analysis is an important issue. It is not only important for concluding a current research but may provide further research avenues in the same direction, saving cost and time for both patients and researchers. The statistical analysis must select appropriate tests like regression analysis, Anova, chi-square tests or t tests to compare between the experimental and control groups, as per the research plan (Creswell, 2003).
Regression analysis may be helpful, in both retrospective and prospective studies. It helps to find out, significant predictors affecting the criterion variable. For example, in our case study, the predictors can be care facilities, addressing vomiting problems in cancer patients and quality of life improvement, which can be regressed on efficacy in palliative care. The study can be either conducted on a qualitative ground as described or it can also be conducted on a quantitative scale. This can be done by noting the haematological parameters ( like WBC count, c-reactive protein levels), fever grades and physiological endpoints as a predictor variable to measure the efficacy of palliative care(criterion variable) in cancer patients (Creswell,2003).
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