Essay Double Blind Randomized Controlled Trial

In the famous Belmont Report, several guidelines regarding informed consent, assessment of risk and benefits, and selection of subjects in addition to ethical practice and procedure in the area of human research are outlined. The Belmont Report attempts to summarize the basic ethical principles identified by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (Belmont Report, 1979). In particular I would like to discuss the standards for informed consent, assessment of risk and benefits, and selection of test subjects drawn out by the Belmont Report. These three areas of interest are said to be the applications of the general

In order to develop nursing knowledge and establish evidence-based practice (EBP) in nursing, there needs to be a "concept model, one or more theories and one or more empirical indicators" (Fawcett & DeSanto-Madeya, 2013, p. 26). The theoretical framework can be advantageous in guiding and supporting the design and execution of an EBP change. Using a conceptual model (C) theory (T) and empirical research (E) provides the foundation for an intervention to an identified clinical problem. Known as C-T-E structure, the application of this system in nursing practice involves an elevated level of critical reasoning, which assists in knowing what data is important and how it relates to practice change (Chinn & Kramer, 2011; Fawcett & DeSanto-Madeya, 2013; Mazurek Melnyk & Fineout-Overholt, 2015). The doctoral level of nursing necessitates the need to combine the understanding and knowledge gained from using the C-T-E structure, and then integrate the concepts and theories into daily practice.

Misconception with equipoise will make the barrier between therapeutic and research null. Its goal in producing reliable and generalizable knowledge is coiled in with ethical difficulty. That’s why on an ethical standpoint, benefiting a collective group needs to be weighed with the rights of the participant patients in the clinical research. However, the goal of equipoise is beneficial since its main priority is extracting epistemic information from the randomized clinical trials. The useful information is needed since equipoise follows the principle of having “a state of genuine uncertainty.” This affects both theoretical and clinical. So, trials that are redundant can be marked out by taking equipoise into account since the trials have already been run where there is already certainty of the outcome. So, to detail what equipoise allows underneath the principle of “non-exploitation” is that there will be no exploitation of participants or patients with a needless trial that holds no useful outcome. Equipoise becomes a necessary condition in order for a trial to become ethical since trials must be reviewed to be deemed of value. But, there’s an underlying factor that equipoise’s uncertainty trials do not bring about and that is the health of the patients. Participant patients will undergo trials of uncertainty so there is a possibility that the patient may be harmed during the process. If the trial proceeds, then the health of the patients will be even more at risk, disregarded and exploited in order to grasp epistemic information. The moral principles between medical therapy and those that guide clinical research is different. Though, equipoise is valuable in a collective sense – it is exploitative of participant patients by failing to consider the balance with the subject and societal

Occupational functioning: Rosa isn’t currently employed. She did work as a waitress but she mostly prostituted and sold drugs to bring in the income for her family. For Rosa Lee not having much education she doesn’t have any job perspectives. Due to the lack of knowing how to read, Rosa made money the best way she could.

Replication, external review, and data recording and sharing, are important to the scientific method because it helps support the hypothesis even more. By replicating the experiment and sharing the data, it increases the validity of the experiment. Semmelweis included these concepts in his experiment by repeating the experiment multiple times, he showed a third party (other scientists) his experiment, and he shared his data and results to multiple sources, but scientists dismissed it.

Double-blind Procedure- An experimental procedure in which both the research participants and he research staff are ignorant (blind) about whether the research participants have received the treatment or a placebo. Commonly used in drug-evaluation studies.

19. The text points out a common misconception about the term “controlled experiment”. In the

Clinical trials, or a test before a treatment is approved to be safe for human consumption, have been dated back to the biblical times. Recorded in the “Book of Daniel” a king and military leader performed the first known clinical trial (Evolution of Clinical Research). Although his experiment was nowhere near what we conduct in today's society scientist, doctors, and other researchers before them have learned through trial and error, and they have used clinical trials to study diseases. In 1774 James Lind followed through with the first clinical trial of the modern era studying scurvy.

scientists kept this information to themselves in order to carry out the study without regard to the well being of

Jona’s definition of identification is that “the most educated and motivated members of society should be the candidates for research, and their agreement must be autonomous and informed to be valid.” He believes that people who are being experimented on should have a better understanding of what exactly is being done as well as all the details behind it. Patients should not be the guinea pigs in these experiments “the most highly motivated, highly educated, and the least captive members of the society” should be the ones who are being experimented on. With any case this is only justifiable if the experiment relates to the disease. The belmont report states that there are three core principles identified, respect for persons, beneficence,

The first article is entitled “of mice but not men: problems of randomized clinical trials,” is written by Samuel Hellman and Deborah S. Hellman discusses the issues of randomized medical testing and experiments on patients. The article describes the role of the personal physician and how the physician can take an ethical or unethical path of treating his/her patients. The relationship between the patient and physician is greatly emphasized because according to the article trust is very valuable in medicine especially when a patient’s life is at risk. A Kantian and a Utilitarian view of randomized clinical trials are debated but the authors clearly steers towards a Kantian point of view.

While to what extent this bias affects the outcome is not measured, the effect certainly is there. Mainly, there exists a restriction in the generalizability of the finding, especially those trials that relate to alternative medicine (Hróbjartsson et al., 2014). When patients are more aware of their treatment, the way they report their symptoms may vary, adversely even the quality of the doctor-patient relationship is reduced. This also leads to disproportionate rates of attrition and the placebo effect. The rates of attrition of patients are always found to be higher where they are non-blinded (Hróbjartsson et al., 2014). Bias has mainly reported occurring due to a combination of response bias, placebo effect, and attrition. Response bias refers to the methods in which the patient response to the intervention. For example, the patient may be disappointed to know that he is in the control group and hence may become disinterested and more inclined to leave. This leads to attrition of the participants. Further, the patient may experience the “placebo effect” (Sedgwick, 2013). The placebo effect refers to the presumed benefits of the placebo drug, which is not caused by the drug itself, but is due to the patient’s belief in the treatment (Colloca & Benedetti,

The opposing side of this argument states that testing is inhumane, unethical and wasteful. In “Animal Experimentation is Unethical”, Robert Garner (2002) expresses concern that “animal experimentation is justified provided any suffering inflicted in the laboratory is perceived to be necessary” (p. 2). Garner (2002) disagrees with animal experimentation because if any researcher says that a test is necessary, all pain inflicted in the laboratory will be deemed humane and justifiable.

Denis Diderot once said, “There are three principal means of acquiring knowledge... observation of nature, reflection, and experimentation. Observation collects facts; reflection combines them; experimentation verifies the result of that combination.” Denis Diderot discusses the overall way to obtain information. When wanting to know statistics, numerous experiments need to be performed in order to provide accurate results. Through the abundant of experiments performed, human experimentation is one of those tests. Upon hearing the words “human experimentation,” individuals automatically assume grotesque, immoral, and unethical tests being conducted on people. However, this is untrue because experimenting on humans is beneficial to the citizens

It is now accepted worldwide that before a drug is brought into routine use its efficacy, safety, and the balance between two need to be formally demonstrated. The efficacy of new drugs nowadays is almost invariably established with a technique known as ‘randomized controlled trial’.