Ethical Dilemma On Randomized Clinical Trials

Placebos have been used in clinical trials since the eighteenth century but did not become a research topic until the late twentieth century (van Haselen, 2013). Most often when using placebos in clinical trials it is to determine whether or not the active agent has more effect on a patient than the placebo by providing each to the same number of recipients. The trials are almost always double blinded, this means that both person giving the drug and the person receiving it are unaware whether or not it is active so that good care and relationships must be present in the recipients at all times (Tavel, 2014). Ovosi, Ibrahim, & Bello-Ovosi (2017) declared “The choice between placebo and active controls in clinical trials affects the quality of the result as well as the ethical and scientific acceptability by both the public and regulatory bodies. It has, therefore, continued to generate discuss among researchers” (para. 3). This goes against the autonomy of a patient which is the right for a person to

In the same study, it is stated that 24% of participants were what they called “healthy participants”. These participants are individuals that are typically enrolled in phase 1 trials. Because they have no prior health concerns researchers use these participants to test the general safety of certain products. The use of healthy individuals is one of the biggest ethical debates in paid research. Those that argue that paid research on healthy individuals should be allowed claim that it is up to each individual to decide whether or not they are willing to risk their health. Those that argue against healthy paid research subjects claim that it is against a doctors Hippocratic oath to do anything that may cause harm to a healthy individual.

The Second Best Method involves giving one half of the test group the research drug and the other half a placebo. Any beneficial results or side effects the former group exhibits that the control group does not can be attributed to the research drug. Since the control group merely receives a placebo, the members are unlikely to receive any benefits other than more personalized attention from the physician-researchers.

This design’s randomization and blinding of the study ensures the researcher and participations are unaware of the group they are assigned and assists with decreasing the risk of bias or overstating the findings of the experiment (Watson, 2015). Weaknesses of the design are often found in studies evaluating the effectiveness of health care interventions secondary to the study only being a single blind study in which the researcher is knowledgeable of the participants in the experimental group. While double blind is ideal a single blind study can create bias, and skew the results (Watson, 2015).

First, I would try and convince the nurses by pointing out that the randomized controlled trials are not perfect but they are objective and eliminate the responsibility and difficulties of making a more subjective decision. Any other alternatives would take longer, and this research is time-sensitive: the sooner we know the most effective intervention, the better for all the patients.

This Report enforces the private institutions to uphold a certain ethical standard in regards to human subjects research (HHS.gov, 1979). The APA is only entitled to live up to these principles set by the commission, but not entitled to do any follow up investigations of their biomedical research to ensure, develop, and uphold their biosafety and biosecurity of their medical and human subject research. What is interesting about these two policies is that both NIMH and APA must enforce the Belmont Report by law, but since the NIH is a government institution, it is supposed to live up to the new criteria for biosafety and biosecurity. These differences of the policies of biomedical research between governmental and private institutions can be

In recent years, the number of clinical trials increased significantly. With an increasing number of clinical trials, the ethical issues related to clinical trials have also increased. Furthermore, the ethics of the clinical trials were violated on several occasions in last few decades. Nazi experiments with World War II initiated the world leaders to implement a code of conduct that protects the autonomy of the clinical trial subjects. Therefore, the Nuremberg Code was initiated in the year of 1949. However, this Code failed to protect the human subjects in clinical trials. Tuskegee syphilis trial was one of the few incidents that were exposed in front of the entire country. The regulatory agencies and the government then realized that there should be better regulations to protect the human subjects in the clinical trials. A series of codes and regulations were established to protect the subjects in the clinical trial after the Tuskegee incident. The Belmont report (1979), International Conference on Harmonization guideline for Good Clinical Practice (1996), the Declaration of Helsinki (2000), and CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002) are the main guidelines in recent years. There are also federal regulations to protect human subjects in the clinical trials. They are USCFR Title21 Part 50, 56 (Protection of Human Subjects and Institutional Review Boards, 1991), and USCFR Title 46 (The Common Rule, 1981). These federal

Governmental and professional societies have developed provisions that are deemed necessary in the process of biomedical research. “In leading clinical examination, the specialist ought to exhibit the same concern and alert for the welfare, security, and solace of the individual included as is needed of a doctor who is outfitting medicinal consideration to a patient autonomous of any clinical examination” (Baillie et al., 2013). The principal concern should reliably be the security of the human subject. Also an informed consent is a required document needed in order to conduct the study. The patient must be aware of the risks involved and the reasons why the experiment is being

Clinical trials are essential for the development of effective medical treatments and vaccnies1, but conducting clinical trials in only one setting severely limits the ability to generalise results to the entire population. To ensure a drug is safe and works in the same way across different populations, it is necessary to conduct clinical trials in multiple ethnic and geographic locations1. There are other clear benefits to conducting clinical trials in multiple locations, particularly in developing countries. Globalisation of clinical trials promotes positive relationships between clinicians and researchers2, raises research and ethical standards in developing countries1, improves health care on a global scale1, and reduces the cost of and time taken to implement the trial drug2. Despite the benefits of global clinical trials, globalisation raises serious ethical concerns, particularly in low income countries, whose ethical and scientific frameworks are underdeveloped. Without stringent ethical guidelines, global clinical trials experience major criticism, and must address these ethical concerns before the trial drug can be appropriately implemented.

The third and final phase of drug trials involves a large number of volunteers in well-controlled settings. A variety of ways can be used to test the drug; however, placebo is the standard comparator for the drug (Wing et al.).

In conclusion, clinical trial is essential to minimize major health condition, but it does has it own negative impact on researches and patients. That is why it is important that experimenter are following proper protocol and guidelines to avoid any problem from arising. Specifically, elderly population who participate in clinical tend to be more fragile and sensitive than a younger population. The researchers have to be careful and respectful when experimenting with this population, they should be able to evaluate the capability of their patients and not pressure them too much. Although, elderly population are beneficial to research there should be a certain age limit to participate. Any participant above 75 should either not be included or

Conducting a trial in a biased manner will lead to inaccurate and unreliable research outcomes. From this module, I determined that randomization, blinding, sample size, control groups, analysis of intent to treat population, selection of appropriate endpoints and statistics all are essential while designing a clinical trial in order to eliminate the bias.

cross? In this paper, we will look at the ethical reasoning for which doctors should or should not

Clinical trials are medically based experiments undertaken on human subjects to systematically determine the effectiveness and/or safety of therapeutic interventions. Formal definitions of clinical trials are numerous, but they capture the concept of an organized, systematic study of human subjects in a treatment environment that is consistent.245 Studies are created to measure different things, such as determining whether a treatment is effective compared to a placebo or determining whether one treatment is more effective than another. Increasingly, the cost of therapy is also being added into the studies to create what are called cost effectiveness analyses, in which the effectiveness of various

These trials involve random allocation of patients to either a treatment group or a control (placebo) group, and this allows us to compare the effects of the intervention and draw conclusions based on the differences between the groups. The advantages of using randomised controlled trials include the fact that it reduces selection bias, as patients are randomly selected for either the intervention or placebo; other variables are kept constant, ensuring as much as possible that there are no other factors or conditions that may affect the outcome; and they allow the use of statistics to show that any differences observed are due to chance, which helps the researchers and clinicians gain confidence in the study. An example of when this type of trial has been used is in a study published in 1991, to test whether folic acid supplements had any positive effects on pregnancy, and whether they could reduce the risk of neural tube defects. The study involved 1817 women who had a high risk of these defects. The study concluded that the folic acid had a positive effect on pregnancy, and is recommended as a supplement to pregnant women today (Wald et al. 1991). Studies such as this show that using randomised controlled trials is a good way to gain knowledge of causation because links are able to be made by observing whether or not the pregnant women who took supplements had children with neural tube defects and compare it to those who did not have an