Healthcare research can be challenging in that it calls researchers to more stringent ethical measures relative to what is expected of researchers in other fields. El-Saiedi (2013) conducted one such study. A randomized controlled trial calls for even greater adherence to specific ethical concerns as it directly involves people. The study conducted by El-Saiedi was motivated by the desire to understand to what extent myocardial damage is mediated by immunological mechanism. The study was conducted on children undergoing the onset of acute dilated cardiomyopathy and/ or myocarditis. The objective was to establish whether the administration of intravenous immune globulin (IVIG) enhanced the left ventricular fractional shortening (LVFS) and reduced the left ventricular end diastolic volume (LVED). The trial was conducted over two consecutive days during which the affected children were placed on 2 g/Kg of IVIG or placebo. The children underwent echocardiographic examination before admission and had a repeat at one and six months after the initiation of the intervention.
During each examination, the LVED dimension and the fractional shortening were read and recorded. The results of the tests showed no significant differences between the children who were treated using the IVIG and those who were placed under placebo. From these results, the author concluded that for young patients with cardiomyopathy, the conventional therapy resulted in poorer outcomes compared to IVIG treatment. The study methodology entailed a total of 86 patients (44 for the placebo control group and 42 for the IVIG treatment). All these patients were children under 15 years old and who had been admitted at Cairo General Hospital for a variety of cardiomyopathy related symptoms. The study provides no indication that the children and/ or their parents were aware of their participation in the trial.
The study presents an opportunity to explore several ethical concerns in healthcare research. Fouka and Mantzorou (2011) described some of the major ethical issues in healthcare research. Some of the issues include beneficence (doing no harm), informed consent, respect for privacy, respect for confidentiality and anonymity and working with vulnerable groups of people. For a randomized controlled trial in healthcare, the participants are in most cases vulnerable people (patients). In the case of this particular study, the participants are even more vulnerable since they are children. Ethical research practice requires researchers to be skilled at working with such participant populations. Working with vulnerable people may be construed as a violation of their rights such as in the case of this study by El-Saiedi (2013). In particular, opponents of conducting healthcare research on vulnerable people refute experimenting with such populations, which is essentially what an RCT does.
Secondly, the study is subject to the principle of conducting research under informed consent. This is one of the major ethical concerns in research across all fields and is considered critical regardless of the participant populations. In this particular study, informed consent was to be sought from the parents of the children who were to be involved in the study. They should be asked to provide their written consent to their children’s participation based on information about how the RCT would affect the conventional treatment of the patients as well as the expected outcomes whether placed on placebo or IVIG. Considering the described research methodology, there is no indication that this consent was given either by the parents or by the children, violating a critical ethical norm. Other issues that would be looked at while evaluating the key ethical issues in the study include respect for privacy and confidentiality. In this regard, it would be necessary to understand to what extent the researchers protected the participant information, who was allowed to access the information and how the research findings were presented. Based on the findings as reported, the researcher respected the concept of confidentiality by not revealing personal details about participants.
Ethical issues can influence research outcomes significantly in different ways. The adherence to ethical issues can enhance the validity of research findings and also promote the researcher’s capacity to share the findings publicly. The integrity and reliability of research findings also depend to a large extent on the adherence to ethical principles in research. Factors such as honesty, objectivity, non-discrimination and confidentiality, which are the cornerstone of reliable and valid research, are founded in a combination of ethical codes of conduct set by organizations and ethical principles outlined for research practice. If followed, ethical principles provide a guarantee that all human subjects have not only chosen to participate in the research out of free will, but also one of respect to the dignity of those subjects. In this way, research not only becomes founded in integrity but also becomes acceptable within the moral confines of the society.
Social responsibility is also shown by the provision of required information to all potential participants, who make the choice to engage in the research through their own will and after understanding all the risks involved. Through a written and/ or verbal consent provided by the participants, researchers can provide proof that the participants are competent enough to provide information that would be used in the study and also that the information is not provided under participant duress. Vanclay, Baines and Taylor (2013), report that providing information for a research following coercion can result in lack of objectivity, biasness and dishonesty on the part of the participant, which affect the credibility and the reliability of the information provided. When such information is used to formulate research findings, the reported findings are likely to be skewed and inaccurate. This thus means that following ethical principles during research increase the capacity of the researcher to deliver high quality research reports as much as it promotes social responsibility.
Research validity is one of the core concepts used to define the acceptability of a study. Alongside the reliability and credibility of research, validity is an essential indicator of the quality of research, which also determines its clinical and statistical applicability. The concept of validity relates to the soundness of a research study and is evaluated based on the methodology and the design of the study. As such, a research can only be termed as valid if the methods as well as the research design used are sound, which translates to valid results.
In the study by El-Saiedi (2013), an exploration of the research methodology and the research design can help to determine whether the study was sound or not. In particular, the research methodology is explored under concepts such as the choice of approach, the participant choice, data collection procedures and analysis procedures implemented. In this case, the researcher adopted a randomized controlled trial study design. The choice of participants for the study also augurs well with the intended objective. Similarly, the data analysis was conducted using a statistical software package (SPSS) that is known for its reliability in describing comparative data. When conducting research, biasness can hamper research validity in various ways. One of the common outcomes of biasness during research is lack of objectivity in data collection and analysis. This can result in significantly negative outcomes in research in that the researcher would be skewed in reporting, data analysis and actual data recording.
Stakeholders in healthcare research range from government institutions, hospital/ healthcare facility administrations and even researchers. In most cases, stakeholders influence research outcomes due to their ability to influence extrinsic factors to the research. For instance, government regulations on handling certain drugs and conducting certain medical procedures can inhibit the propensity of researchers to explore various drug options through experimentation. Similarly, other stakeholders such as healthcare providers can affect accessibility to potential research participants through quarantines and confinement. One of the key ethical concerns that comes to mind when involving stakeholders in healthcare research initiation is the impact of the proposed research on the patient populations. The level of exposure that the research would subject patients to is one of the imperative aspects considered particularly when conducting research that uses patients as participants such as that by El-Saiedi (2013). Other factors that are commonly considered include the appropriateness of the methods used in the study. For instance, drugs that have not undergone preliminary testing procedures cannot be used during an RCT for fear of potential harm to patients. This is in line with the principle of beneficence in research, which posits that no harm should be done to participants. Each of these factors when considered in detail raises more specific reasons why healthcare researchers must adhere to stipulated research ethical principles.
El-Saiedi, S. (2013). Randomized controlled trial on the use of intravenous immune globulin in acute pediatric myocarditis. Journal of Clinical Research & Bioethics, 5(1). Retrieved from www.longdom.org/open-access/randomized-controlled-trial-on-the-use-of-intravenous-immune-globulin-2155-9627-5-170.pdf
Fouka, G. & Mantzorou, M. (2011). What are the major ethical issues in conducting research? Is there a conflict between the research ethics and the nature of nursing? Health Science Journal, 5(1), 5-14. Retrieved from www.hsj.gr/medicine/what-are-the-major-ethical-issues-in-conducting-research-is-there-a-conflict-between-the-research-ethics-and-the-nature-of-nursing.pdf
Vanclay, F., Baines, J.T., & Taylor, N.C. (2013). Principles for ethical research involving humans: ethical professional practice in impact assessment Part I. Impact Assessment and Project Appraisal, 31(4), 243-253. Retrieved from tandfonline.com/doi/full/10.1080/14615517.2013.850307