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Element of Ethical Conduct in Health

   

Added on  2021-04-21

24 Pages4174 Words49 Views
Data Science and Big DataDisease and DisordersNutrition and WellnessHealthcare and ResearchPhilosophy
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Running head: RESEARCH METHODSResearch MethodsName of student:Name of university:Author note:
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1RESEARCH METHODS1.Informed consent is known to be a chief element of ethical conduct in health research.The last few decades have witnessed researchers recognizing the moral rights of studyparticipants to self-determine and decide on their respective participation in diverse researches(Faden, Beauchamp and Kass 2014). Informed consent is defined as the agreement made by theresearch participants to take part in the respective research in full knowledge of the potentialoutcomes of the study. This concept has become a noteworthy area of development in the field ofhealth research involving human subjects. According to Gupta (2013) the concept of informed consent is based on three vital andessential elements; voluntarism, information disclosure and decision making ability. For aninformed consent to be real and ethically valid, these elements are to be fundamentallyemployed. Voluntarism is defined as the capability of the potential participant to criticallyanalyze the potential benefits and harms of the study he is subjected to in an independent andfree manner. Voluntarism might be influenced by a number of factors such as emotionalmaturity, psychological effects of diseases, religious and cultural values and unjustified pressureor intimidation for research participation. Information disclosure is the provision of informationfor the participants regarding the research to be conducted. The information that is to be providedto the individuals is to include, but not limited to, the health issue for which research would bedone, the purpose of the study, the nature of the experimental procedures, probable risks andbenefits faced by the participants. Decision making ability is the capability of understanding andanalyzing the consequences of the research and formulating decisions. Decisional capacity isdependent on the cognitive abilities as well as voluntarism.
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2RESEARCH METHODSRegulations governing informed consent are promulgated with the aim of protectinghuman subjects from any potential harm due to the research. The fundamental ethical principlelying behind legalities concerning informed consent is related to the protection of autonomy ofindividuals, which involves welfare, and interests of the individual taking part in the research.The idea is that research, which is done for the treatment advancements in health domain for thebetterment of society, must not be built after sacrificing of basic rights of participants (Grady2015). National and international guidelines have been documented that guide the process ofinformed consent for health research. These guidelines intend to help researchers ensure that theresearch carried out is valuable, ethically and legally appropriate, and scientifically rigorous. InCanada, the Canadian Institutes of Health Research (CIHR) has outlined the requirements forinformed consent for health research. The association is initiated dialogue with key ethicscommittees and promoted health research in a suitable manner (DePoy and Gitlin 2015). As perthe guidelines published by CIHR, informed consent is to be perceived as an ongoing processthat initiates with the first contact between the researcher and the potential participant, andcontinues until the completion of the study or withdrawal of the individual. Three types ofconsent form templates are present that aligns with the research participant’s criteria. These areto be appropriately filled up for gaining informed consent appropriately. 2.There exists a growing body of literature discussing the different aspects of public andpatient involvement (PPI), related to health science. Researchers have suggested that successfulPPI is based on the dynamic interaction of various forms of transferable knowledge, professional
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3RESEARCH METHODSand lay. One must note that the term ‘public’ includes individuals living in the community whoare linked directly or indirectly with the patients, the potential patients, care providers andconsumers of health and social care services, patient support groups and representatives oforganizations delivering such form of care. Patient and public involvement are distinct fromparticipation and engagement. It is to be noted that involvement refers to the activity in whichindividuals have an active association in the concerned process. In contrast, participation is theactivity in which people take part in the respective process as a member. Further, engagement isthe activity in which individuals contribute solely by sharing knowledge and information aboutthe concerned process (Bowling 2014). Forms of participation are varied, and each of them hastheir own value. Examples of public and patient involvement are as co-applicants on a project; asmembers of a steering group; involvement in the identification of agendas; development ofresource of information (Brett et al. 2014). The concept of patient and public involvement and its relevance to health research hasbeen documented extensively. Patient and public involvement in healthcare research areembedded in health policies across the globe (Carayon 2016). Such involvement has beenjustified on valuable ethical grounds that promote quality of health research. Clinicians andresearchers might not be having the required skills and experience of the research topicconsidered for the study. PPI can thus help researchers with insights into how the research issupposed to be carried out and what the potential outcomes might be. Through PPI, the researchwould become more relevant to the comprehensive needs of the service users, care providers andpatients. Patients and public can be involved in all stages of research, including prioritization ofresearch, management of research, data collection and subsequent analysis and dissemination of
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4RESEARCH METHODSfindings. As argued by Bowling (2014) contribution of patients and public is extremely valuable,as they provide alternative viewpoints and opinions from the researchers. According to Shippee et al. (2015) patient and public involvement in health research isfocused on ensuring that the appropriate research is done, and challenging research done as aresult of interests of individual researchers. This would imply emergence of various researchquestions and research priorities; enabling researchers to understand the outcomes that are ofmore importance to the patients; challenging unnecessary or wasteful research and raising theprofile of health conditions. However, there is more to this idea of patient and publicinvolvement in health research, as pointed out by (Pollock et al. 2017). The researchers statedthat the involvement is about making sure that the research is done in a right manner. Healthresearch needs human participation, and input received from the public and patient can aid inensuring that the communication between the researchers and participants is done in an efficientand safe manner. 3.The research paper selected for critical appraisal is titled “The BROAD study: Arandomised controlled trial using a whole food plant-based diet in the community for obesity,ischaemic heart disease or diabetes” by Wright et al. (2017). The appraisal would be done usingthe CASP Randomized Controlled Trial Checklist. The study by Wright et al. (2017) is a randomized controlled trial that addressed a clearlyfocused issue. As per the researchers, there are limited randomized studies done with a wholefood plant-based (WFPB) diet as the form of intervention for dyslipidaemia or elevated bodymass index (BMI). On a global scale, the obesity epidemic is worsening, and an elevated BMI is
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5RESEARCH METHODSrelated to morbidities such as cancer; osteoarthritis; obstructive sleep apnoea; type 2 diabetes(T2DM); cardiovascular disease; a shorter life expectancy and a lower quality of life. The studyaimed at carrying out an investigation of the effectiveness of a community based WFPB dietaryprogram in a population of New Zealanders. The program had a distinct characteristic of havingthe potential of enabling long-term behavioural changes through development of practical skills. The study was a prospective, two-arm, parallel, superiority study where comparison ofstandard medical care and standard medical care plus a diet change program was carried out. Theassignment of patients to treatments was randomized. 65 participants were randomized into twogroups in the order of the interview taken previously by 1:1 sequence from random.org, which isan online tool for generating random numbers (Green and Thorogood 2018). The allocation waspassed to another researcher who had been responsible for assigning groups. However, theallocation sequence was not concealed from the researchers and patients. Allocation concealmentprevents selection bias having an influence on the decision-making process involving allocationof participant to a particular group, control or intervention (Clark, Fairhurst and Torgerson,2016). The participants who entered the trial accounted for at its conclusion. After six months ofcommencement of the trial, the researchers observed significant changes between the control andinterventions groups. The intervention was therefore offered to the control group. The follow-upwas extended up to 3 years in total. As per the researchers, participant blinding was not feasible. While the researchercarrying out the measurements knew about the allocation, the statistician was blinded. Thehealthcare providers of the participants were not given information about the allocation. Thestudy had participants recruited from a group general practice in Gisborne, a certain region inNew Zealand’s where the rate of socioeconomic deprivation, obesity and type 2 diabetes is high.
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