Evaluating Consent: Random Controlled Trial (RCT)

The purpose of this paper is to critique a quantitative study and to present a critical analysis on its research findings. The paper will discuss the elements influencing believability and robustness of research, including writing style, research problem, literature review, conceptual framework, research question, hypothesis, study sample, methods, data analysis and results, and discussion of the relevance and future directions.

* The data was collected through questionnaire. The responds from the respondents may not be accurate.

This write appreciates facts and data mostly, thus would choose a quantitative method of research. They are concise, the sampling size can be larger and the limitations to human subjectivity usually are less. It is believed that the accuracy of the study is greater and more

I made an informed consent form. In the informed consent form, I explained the purpose of the study, the methodology of the study and that I will ensure confidentiality by having no identifying information on the questionnaire. None of the participants raised concerns about their rights as a participant. One participant did ask about the purpose of the informed consent.

The author states, “Should specific informed consent be sought from a patient enrolled in the study? If so, then what should be done if the patient chooses not to participate” (Truog et al. 1999)? In this scenario the patient does not give their consent to participate in the trial so the dilemma of what to do with the patient rises. Should no data be collected on the patient or should they be moved out of the program and if that happens, what was the point of having the trial in the first place? If you have to collect informed consent from patients in the trial it is going to make the data polls smaller and harder to collect.

Informed consent is the current guiding principle for the ethical conduct in medical research and originated after the 1947 Nuremberg Code and the 1964 Declaration of Helsinki (Nguyen et al., 2015). The purpose of the informed consent process is to provide potential research subjects information about the nature of the clinical trial, the risks, benefits, underlying procedures, and alternative treatments (Bloswick & Skowron, 2015). The research team must provide the patient with sufficient information so the participant can fully make an informed, uncoerced choice about whether to begin or continue participation in a clinical trial. This process is an ongoing exchange between the subject and the research team throughout the research study.

The chapter examines the background of the study, statement of the problem, objectives of the study, research questions, significance of the study, scope of the study, limitations of the study and conceptual framework adopted for the study.

The research began by Using the library database such as CINAHL, to six peer-reviewed research article, ensuring that they were both qualitative and Quantitative. Then the writer was given the opportunity to review one done by a quantitative and a qualitative method. The quantitative study

Diener and Grandall (1978) defined the notion of informed consent as the procedures within which informants have the choice to take part in the research under investigation after providing them with facts that would impact their decisions (Cited in Morrison, Cohen, and Manion, 2011, p. 51). This definition includes four major principles, which are competence, voluntarism, complete facts, and comprehension. Thus, it is really necessary to consider the informed consent before starting to gather data. This involves preserving and respecting the participants’ rights and it is also vital to mention that the participants have the right to refuse to participate or to withdraw once the research has started (Frankfort-Nachmias and

Boswell and Cannon (2014) states that “the core ethical issue in medical research is the need for voluntary consent of the potential research subject so that a fully informed individual participates” (p. 93). It is important to make sure that all ethical concerns and specifications of the person giving consent for participation in the research should be detailed (Hoe & Hoare, 2012, p. 54). Guidelines have been made to follow, in regards to informed consent, to help ensure that any participant in any research be given the best information in the best way for the participant to make an informed decision. In combination with a participant being informed, it is equally important to make sure that the participant is not vulnerable.

A major strength of this research is the large sample size that was including in the study. Six-hundred participants were included. Randomization was also utilized. The included patients were randomly assigned to the study groups using simple randomization based on a computer-generated list of random numbers. This allowed for an unbiased selection of the participants by the

In modern medicine, informed consent is a principal factor considered when treating patients. In the past, informed consent was not the fundamental requirement that it is today, because patients were viewed as objects for research, not as whole persons (Jewson, 1976, p. 235). Consequently, when wartime anxieties amplified the desire to advance scientific research, minorities were targeted as suitable objects for this research as a result of pre-existent prejudices, which justified human experimentation (Baader, et al., 2005, pp. 229-230). Over time, nonconsensual practice has come to be seen as unacceptable following the emergence of the Nuremberg Code, patient activism, and official medical reforms.

This chapter includes the methodology and research design of the study. The chapter is organized in the following sections: (a) research design and design appropriateness;

Participants were thoroughly informed beforehand about the potential impact of the investigation. During the interview process caution was taken in order to do little to no harm to the participants and it was emphasized that the participant could withdraw from the study at any stage and did not have to answer any questions they were uncomfortable with.

The objective of this chapter is to describe the procedures used in the analysis of the data and present the main findings. It also presents the different tests performed to help choose the appropriate model for the study. The chapter concludes by providing thorough statistical interpretation of the findings.