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 study participants 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 the research participants to take part in the respective research in full knowledge of the potential outcomes of the study. This concept has become a noteworthy area of development in the field of health research involving human subjects.
According to Gupta (2013) the concept of informed consent is based on three vital and essential elements; voluntarism, information disclosure and decision making ability. For an informed consent to be real and ethically valid, these elements are to be fundamentally employed. Voluntarism is defined as the capability of the potential participant to critically analyze the potential benefits and harms of the study he is subjected to in an independent and free manner. Voluntarism might be influenced by a number of factors such as emotional maturity, psychological effects of diseases, religious and cultural values and unjustified pressure or intimidation for research participation. Information disclosure is the provision of information for the participants regarding the research to be conducted. The information that is to be provided to the individuals is to include, but not limited to, the health issue for which research would be done, the purpose of the study, the nature of the experimental procedures, probable risks and benefits faced by the participants. Decision making ability is the capability of understanding and analyzing the consequences of the research and formulating decisions. Decisional capacity is dependent on the cognitive abilities as well as voluntarism.
Regulations governing informed consent are promulgated with the aim of protecting human subjects from any potential harm due to the research. The fundamental ethical principle lying behind legalities concerning informed consent is related to the protection of autonomy of individuals, 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 the betterment of society, must not be built after sacrificing of basic rights of participants (Grady 2015).
National and international guidelines have been documented that guide the process of informed consent for health research. These guidelines intend to help researchers ensure that the research carried out is valuable, ethically and legally appropriate, and scientifically rigorous. In Canada, the Canadian Institutes of Health Research (CIHR) has outlined the requirements for informed consent for health research. The association is initiated dialogue with key ethics committees and promoted health research in a suitable manner (DePoy and Gitlin 2015). As per the guidelines published by CIHR, informed consent is to be perceived as an ongoing process that initiates with the first contact between the researcher and the potential participant, and continues until the completion of the study or withdrawal of the individual. Three types of consent form templates are present that aligns with the research participant’s criteria. These are to be appropriately filled up for gaining informed consent appropriately.
There exists a growing body of literature discussing the different aspects of public and patient involvement (PPI), related to health science. Researchers have suggested that successful PPI is based on the dynamic interaction of various forms of transferable knowledge, professional and lay. One must note that the term ‘public’ includes individuals living in the community who are linked directly or indirectly with the patients, the potential patients, care providers and consumers of health and social care services, patient support groups and representatives of organizations delivering such form of care. Patient and public involvement are distinct from participation and engagement. It is to be noted that involvement refers to the activity in which individuals have an active association in the concerned process. In contrast, participation is the activity in which people take part in the respective process as a member. Further, engagement is the activity in which individuals contribute solely by sharing knowledge and information about the concerned process (Bowling 2014). Forms of participation are varied, and each of them has their own value. Examples of public and patient involvement are as co-applicants on a project; as members of a steering group; involvement in the identification of agendas; development of resource of information (Brett et al. 2014).
The concept of patient and public involvement and its relevance to health research has been documented extensively. Patient and public involvement in healthcare research are embedded in health policies across the globe (Carayon 2016). Such involvement has been justified on valuable ethical grounds that promote quality of health research. Clinicians and researchers might not be having the required skills and experience of the research topic considered for the study. PPI can thus help researchers with insights into how the research is supposed to be carried out and what the potential outcomes might be. Through PPI, the research would become more relevant to the comprehensive needs of the service users, care providers and patients. Patients and public can be involved in all stages of research, including prioritization of research, management of research, data collection and subsequent analysis and dissemination of findings. 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 is focused on ensuring that the appropriate research is done, and challenging research done as a result of interests of individual researchers. This would imply emergence of various research questions and research priorities; enabling researchers to understand the outcomes that are of more importance to the patients; challenging unnecessary or wasteful research and raising the profile of health conditions. However, there is more to this idea of patient and public involvement in health research, as pointed out by (Pollock et al. 2017). The researchers stated that the involvement is about making sure that the research is done in a right manner. Health research needs human participation, and input received from the public and patient can aid in ensuring that the communication between the researchers and participants is done in an efficient and safe manner.
The research paper selected for critical appraisal is titled “The BROAD study: A randomised 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 using the CASP Randomized Controlled Trial Checklist.
The study by Wright et al. (2017) is a randomized controlled trial that addressed a clearly focused issue. As per the researchers, there are limited randomized studies done with a whole food plant-based (WFPB) diet as the form of intervention for dyslipidaemia or elevated body mass index (BMI). On a global scale, the obesity epidemic is worsening, and an elevated BMI is related 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 study aimed at carrying out an investigation of the effectiveness of a community based WFPB dietary program in a population of New Zealanders. The program had a distinct characteristic of having the potential of enabling long-term behavioural changes through development of practical skills.
The study was a prospective, two-arm, parallel, superiority study where comparison of standard medical care and standard medical care plus a diet change program was carried out. The assignment of patients to treatments was randomized. 65 participants were randomized into two groups in the order of the interview taken previously by 1:1 sequence from random.org, which is an online tool for generating random numbers (Green and Thorogood 2018). The allocation was passed to another researcher who had been responsible for assigning groups. However, the allocation sequence was not concealed from the researchers and patients. Allocation concealment prevents selection bias having an influence on the decision-making process involving allocation of 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 of commencement of the trial, the researchers observed significant changes between the control and interventions groups. The intervention was therefore offered to the control group. The follow-up was extended up to 3 years in total.
As per the researchers, participant blinding was not feasible. While the researcher carrying out the measurements knew about the allocation, the statistician was blinded. The healthcare providers of the participants were not given information about the allocation. The study had participants recruited from a group general practice in Gisborne, a certain region in New Zealand’s where the rate of socioeconomic deprivation, obesity and type 2 diabetes is high. While the intervention group had 33 participants, the control group had 32. Apart from the experimental intervention, the groups were treated equally.
The primary outcomes for the study were cholesterol and BMI. The secondary outcomes encompassed changes in medication use, cardiovascular risk factors, quality of life, progression to surgery and transfer to a higher level of care. The initial end-point was six months. After six months, the mean mean BMI reduction was found to be greater with the WFPB diet as compared with normal care (4.4 vs 0.4, difference: 3.9 kg m− 2 (95% confidence interval (CI) ± 1), Po0.0001). Though the Mean cholesterol reduction was found to be greater with the WFPB diet, there was no significant differences when compared with normal care (0.71 vs 0.26, difference: 0.45 mmol l − 1 (95% CI ± 0.54), P = 0.1). Twelve-month mean reductions for the WFPB diet group were 4.2 (±0.8) kg m−2 BMI points and 0.55 (±0.54, P = 0.05) mmol l− 1 total cholesterol.
The study findings are not appropriate to be generalised to a wider population. Firstly, the study population has a higher number of females. Second, the rate of M?ori participants was less than that of Gisborne community, implying that the study findings might not be applicable to the indigenous population. Further, the participants had higher health literacy, indicating that the intervention would be appropriate for only those who have high literacy rate. The study considered all clinically important outcomes. The benefits of the study are worth the harm and the cost. The study laid the foundation of implementing WFPB diet for a safe and effective option for reduction in weight and cholesterol, without increasing exercise.
Quantitative research strategy puts emphasise on the quantification in data collection and analysis, which incorporates a quantitative outcomes from a research. This research utilises questions like how many, how much, and to what extent (Rasigner 2013; Bryman 2012). Quantitative method utilise deductive logic and tries to identify patterns in the study subject, and tries to separate the components into empirical factors (called variables) which can be quantified or measured (Rahman 2016).
Quantitative studies allow Generalizability since they are generally done on large samples which are selected randomly. Also the analysis of the data can be done easily using statistical software like SPSS. Furthermore, quantitative research is based on the philosophy of positivism in the measurement of variables (Rahman 2016). Studies by Polsky et al. (2016) utilised 7,079 adults from Canadian Community Health Survey living in Toronto to study the relation between the availability of Fast Food Restaurants and Diabetes among residents in the community. The study shows a probable unhealthy environment due to the presence of Fast Food Restaurants. The large sample data meant that the results could be generalised, while each of the components (like presence of fast food restaurants, distance from home, diagnosis of diabetes can be measured quantitatively.
The disadvantages of quantitative studies include the inability to incorporate meaning of different social phenomenon within the positivist and quantitative paradigm, and are unable to find deeper meaning or explanations. Quantitative approach tends to capture only a snapshot of the studied phenomenon. The positivist approach also is based on unresolved problems. The experiences and perspective of the participants are also not considered in a quantitative study, and there is often a lack of connect ion between the researcher and the subjects. The study done by Polsky et al. (2016) failed to incorporate any reasons behind the measured phenomenon, and how individual experiences can be related to the aetiology of the studied phenomenon.
The ethical and legal considerations for quantitative study includes the necessity for informed consent from participants, collection of sensitive information, confidentiality of participant and the disclosure about the possible effects/implications of the study, and the mental capacity of the participants, honesty, non-discrimination of participants, objectivity, social responsibility and respect to intellectual property. Most importantly, a strong code should exist against falsification or plagiarism of information (Cirt.gcu.edu 2018; Clifton 2012).
Qualitative studies are more challenging to define compared to quantitative studies, since there is no fixed theory of paradigm or even any fixed set of methods that can be used for all qualitative studies. Instead, each qualitative study can be one of a kind in its individual aspect. It can include a wide variety of methods spanning across various types of subjects and domains. It produces results that cannot be captured by statistical or other quantitative methods (Rahman 2016). This research strategy helps to capture the thoughts and feelings of the participants that can be useful to create an understanding and context to their experiences and behaviour (Sutton and Austin 2015).
The advantage of qualitative study can present a detailed explanation of the feelings and experiences of the participants, and help to understand reasons behind the actions of individuals. Their study utilizes a holistic approach to analyze human experience. The study can incorporate an interpretative philosophy that allows ideographic study of a given phenomenon. Data collection through personal interaction between the researcher and participant in the form of interviews and questionnaire allows attention on several interrelated factors for a complex phenomenon study. Additionally, qualitative studies are very flexible by design, and can be utilized in different types of setups and environments to study a variety of phenomenon (Rahman 2016). Studies by Pal et al. (2018) analyses how digital health interventions (DHI) can improve health outcomes of individuals suffering from diabetes. The study analyses the participant’s experiences to explain how can improve their experiences and support healthy lifestyle. The study also allows a holistic approach to study health related behavior and fosters a positive relation between participant and researcher.
Qualitative study can however leave out contextual sensibilities and put too much focus on the meanings and experiences. In addition, qualitative studies do not receive much credibility from policy makers. The smaller sample usually involved in qualitative study challenges the generalizability of the results. Interpretation and analysis of the data can also be complicated and data collection and analysis can take a long time (Rahman 2016). These limitations can be identified in the studies by Pal et al. (2018) that utilises only 20 individuals, and focuses on their feelings and opinions, which limits the generalizability of the results. Interpretation of the results was also complicated due to the diversity in the individual experiences.
The same ethical consideration can be applicable for qualitative study as for quantitative study, and revolves around the provision of anonymity, confidentiality and consent as well as impact on the participants (Sanjari et al. 2014).
The mixed method study integrates components of qualitative and quantitative study methods within a single study. This allows a more complete as well as synergistic use of information compared to just qualitative or quantitative approach. The study can involve both open and closed ended information through the simultaneous usage of qualitative and quantitative methods utilise rigorous processes for data collection and analysis and integrating the findings with the study (Wisdom and Creswell 2013).
Advantages of this model include the feasibility to compare quantitative and qualitative data, inclusions of experiences and reflections of the participants, develops scholarly communication, allows flexibility in the methodology, and provides a rich and comprehensive data (Wisdom and Creswell 2013). Studies by Valinejadi et al. (2016) used a mixed method approach on a research population that included 65 diabetic researchers and 14 research centers. The study allowed the presentation of the results in the forms of themes that provided a better understanding of the factors influencing the usage of knowledge in the management of diabetes.
Limitations of these kinds of studies include the increased complexity of the information, necessitates a multidisciplinary tem for the evaluation of data, as well as the need for additional resources, compared to either qualitative or quantitative study alone (Wisdom and Creswell 2013). A significant limitation in the study by Valinejadi et al. (2016) was the structuring and collection of data that which had both qualitative and quantitative relevance, and also in the analysis of such complex set of data.
The ethical and legal considerations applicable for mixed method study are the same as for qualitative and quantitative methods. The participants need to be briefed about the study aims after getting their consent. In addition, the confidentiality of the participants needs to be maintained at all times (Valinejadi et al., 2016).
References
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Bryman, A., 2015. Social research methods. Oxford university press.
Carayon, P. ed., 2016. Handbook of human factors and ergonomics in health care and patient safety. CRC Press.
Cirt.gcu.edu., 2018. Ethical Considerations – Center for Innovation in Research and Teaching. Cirt.gcu.edu. Retrieved 4 March 2018, from https://cirt.gcu.edu/research/developmentresources/research_ready/quantresearch/ethics
Clark, L., Fairhurst, C. and Torgerson, D.J., 2016. Allocation concealment in randomised controlled trials: are we getting better?. BMJ: British Medical Journal (Online), 355.
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Grady, C., 2015. Enduring and emerging challenges of informed consent. New England Journal of Medicine, 372(9), pp.855-862.
Green, J. and Thorogood, N., 2018. Qualitative methods for health research. Sage.
Gupta, U. C. 2013. Informed consent in clinical research: Revisiting few concepts and areas. Perspectives in Clinical Research, 4(1), pp. 26–32.
Pal, K., Dack, C., Ross, J., Michie, S., May, C., Stevenson, F., Farmer, A., Yardley, L., Barnard, M. and Murray, E., 2018. Digital Health Interventions for Adults With Type 2 Diabetes: Qualitative Study of Patient Perspectives on Diabetes Self-Management Education and Support. Journal of medical Internet research, 20(2), p.e40.
Pollock, J., Raza, K., Pratt, A.G., Hanson, H., Siebert, S., Filer, A., Isaacs, J.D., Buckley, C.D., McInnes, I.B. and Falahee, M., 2017. Patient and researcher perspectives on facilitating patient and public involvement in rheumatology research. Musculoskeletal care, 15(4), pp.395-399.
Polsky, J.Y., Moineddin, R., Glazier, R.H., Dunn, J.R. and Booth, G.L., 2016. Relative and Absolute Availability of Fast Food Restaurants in Relation to the Development of Diabetes: A Population-Based Cohort Study. Canadian Journal of Diabetes, 40(5), p.S17.
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Wisdom, J. and Creswell, J.W., 2013. Mixed methods: integrating quantitative and qualitative data collection and analysis while studying patient-centered medical home models. Rockville: Agency for Healthcare Research and Quality. From: https://pcmh.ahrq.gov/page/mixed-methods-integrating-quantitative-and-qualitative-data-collection-and-analysis-while
Wright, N., Wilson, L., Smith, M., Duncan, B. and McHugh, P., 2017. The BROAD study: A randomised controlled trial using a whole food plant-based diet in the community for obesity, ischaemic heart disease or diabetes. Nutrition & diabetes, 7(3), p.e256.
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