Risks Associated With A Clinical Trial

This temptation happens when the research question, such as a cure for cancer, is extremely important and the answer could save lives. If the investigators cared more about the scientific or medical advancement than the well-being of their participants, they would cross a line that prohibits treating human subjects as a means to an end. When this line is crossed, there is little left to protect patients from a callous disregard of their welfare for the sake of research goals. Informed consent would not matter because of the unbalanced relationship between the knowledge and authority among the researcher and the subject. Approval by an institutional board, although it is important, can be subject to change in its responsiveness to patients’ interests when they conflict with the welfares of the researchers. Going back to Paul’s case, he agrees to enter a clinical trial which was suggested by his oncologist. The study, that Paul has agreed to enter, has claimed that this research team has created a new drug that may be on its way to cure cancer. Obviously to a father and husband, this trial looks very appealing. However, the researchers knowingly form two groups that will compare two treatments. What Paul doesn’t know, is that one of the treatments is better than the other. One group will receive this new drug and the other group will receive a placebo. Comparing this new treatment

Respect for human dignity includes two rights; the right to self-determination and the right to full disclosure. When conducting a research study these two rights must be maintained to ensure that the participants are not coerced into participation and that they are making the choice of their own free will. Patients must be provided with all the information necessary to make an informed decision and voluntarily participate. No deception or concealed data collection can be done because it will violate the patients’ rights.

The research ethics, especially with the human subjects, is a very complex topic, and the completion of the certification opened my eyes on many aspects of research process. I learned how important it is to fully understand the research purpose and the methodology especially when selecting participants. I learned which populations are considered vulnerable, how to balance risk and potential benefits of research, and the importance of obtaining an informed, voluntary consent. I learned how important it is for researchers to ensure subjects confidentiality and privacy. Hardicre (2014) said that the research would be impossible without volunteers, and that the researchers “must act as patient advocates to ensure that every stage of the research

Our study will comply with standard ethical research procedures. We will obtain informed consent from our participants before they participate in our study. Our potential participants will be fully informed about what will happen during our study; in addition, they will understand the effects that our study will have on them and our research (Grinnell, Unrau, and Williams, 2014). We will not use bribery, deception, threats, or any other forms of coercion in order to gain participants for our study. The physical/emotional safety of the participants will come before the research; therefore, we will adhere to all ethical research procedures.

In healthcare, it is important to establish an informed consent. Informed consent is a process by which a client or client legal representative and the healthcare provider engage in a discussion about a course of medical treatment. It includes the risk of treatment, benefit, possible harm and consequences as well as alternatives provided by the healthcare practitioner or physicians in an understandable manner (Blais, K. & Hayes, J. S., 2016, p.85). Informed consent takes into consideration the safety of the patient. It allows the patients to ask questions about the procedures and discuss any concerns; by doing so can help improve patient outcomes and prevent medical errors.

Review Ethics boards should be considerate of the patient’s they are using to conduct their research by first having them fill out an agreement to participate in the research. This idea is reinforced by a field researcher who had to get the patients to sign permission slips before interviewing them and the research wouldn’t reveal their identity. The field researcher found this was an effective way to make the patients whom the experiment is being conducted on comfortable and willing to participate. It allows the patients to have a say on whether they are willing to have specific research done on them whether related to psychological reasons such as asking questions or to have biological research

The author believes that biomedical research is the way of better understanding medicine and without randomized clinical trials the field of medicine will have insufficient information. He argues that randomized clinical trials are the most scientifically sound and ethically correct means of evaluating new therapies. The belief of a physician being unethical when running randomized clinical trials is rejected by this article because previous trials on patients can have a better outcome on future patients. This article stresses that randomized clinical trials must be carefully designed that has an intended purpose of gathering data to improve the wellbeing of patients. If the patient is to endure a clinical trial he/she must be properly informed of the risks of the trial and the health of the patient should be high priority. Overall this article explains the importance of randomized clinical trials and debunks the idea of randomized clinical trials as being unethical. This article uses a utilitarian point of view and gives reasons why these trials can be in the best interests for both the patient and society.

Informed consent means that the psychologist or researcher must make every effort to be sure the patient understands the purpose, benefits, risks, and other options of the test or treatment. Then the doctor or nurse must get the patient’s consent before starting (American Cancer Society,2014). The reason why this is required for every experiment, is because the participants has to understand the risks of the experiment so they are willing to agree on, or in other words, give consent to participate the experiment.

Informed consent explains in detail to all patients the potential risks involved, when moving forward with the procedure. This form of content has become the standard in daily practice at every medical institution. (Post, 2007) The federal government is pursuing a set of studies, that will permit researchers to conduct medical experiments without obtaining the patients consent. (Post, 2007)

Out of 20 randomly selected adults surveyed, 9 of these adults are diagnosed with a heart-related problem. This is quite a big number considering that it is 45% (9/20 x 100) of the adults interviewed (almost half of the sample size). I am now aware that heart-related problems are common amongst adults and according to cdc.gov heart disease is said to be the leading cause of death for both men and women – further justifying my research. According to my survey analysis these ailments are slightly more common amongst women considering 5 adults out of the 9 diagnosed were women while only 4 were men. However according to livestrong.com my statistics gathered were not credible as men are at higher risk for heart disease as opposed to women as a result of their sex hormones – estradiol and estrone were proven to be linked to

It is hard to believe that in a first world country women are more likely to die of heart disease than men are because clinical researchers conduct more health studies on men and then release the research to the public claiming that the studies apply to both genders. Sadly, the problem of women not being equally represented as men in clinical studies is a reality in the United States of America and puts women at risk for their health; however the problem can be fixed by creating awareness, incorporating more females in health research, and establishing a dedicated Food and Drug Administration (FDA). Each of the three solutions is necessary as they would work best together to fix the problem. Society needs to bring awareness to women and inform them what is and is not healthy for them so they can speak out and require that more women need to be tested on to then better provide the FDA with more reliable information which should create a safer health system. In order to understand why these solutions should be put into effect, it is essential to fully understand what the issue is and just how dreadful it can be.

Clinical research trials can be traced as far back as biblical times, though in those days the researchers used legumes and lemons1. As medicine advanced, so did clinical research techniques. The first double blind controlled trial which occurred in 1943, was for a drug to treat the common cold. By 1946, the first randomized trial began for Streptomycin. It didn’t take long for leading researchers to discover the need for regulatory framework1. The ethical framework that formed our healthcare delivery system is rooted in the Hippocratic Oath, which states that the prime duty of a physician is to avoid harming the patient. However, this oath has not been shown the same respect in the clinical research world1. The FDA, founded in 1862, was designed to be a scientific regulation institution that quickly became a law enforcement organization in

When Pharmaceutical companies are trying to develop a new drug they begin the process of a clinical trial. A clinical trial in drug testing is when researchers test a new drug on live participants and record information such as side effects and results. Recently, pharmaceutical companies are trying to increase their profits so they have been outsourcing. Outsourcing is when clinical trials go to a clinical research organization (CRO), which are big businesses. One crucial step in a clinical trial is informed consent. The participants must know they are part of a research study, the possible risks, and outcomes. This information should be presented in a manor in which the individual can understand. However, after watching the videos this crucial step is sometimes overlooked or not taken seriously during overseas drug testing. Often times testing is done overseas in areas that are over populated and have a large gap between the wealthy and the poor. When researchers are conducting the trial they have been known to just completely skip over this step or they give individuals the information on the clinical trial but the participants are illiterate and unable to understand any part of it. This is seen as unethical practice. Ethically, all participants are required to know they are part of a clinical trial and they need to know all risks and outcomes projected before participating.

Innovation and the “Change” process have gripped the clinical research Industry in the last few years. Evolution in technology and Risk Management processes consequently lead to release of the latest International Council of Harmonization (ICH) Good Clinical Practice (GCP) E6 R2 step 4 in Nov 2016. Change in the Clinical Research landscape also lead to revisions towards modernization and reinforcement of the “Common Rule” in Jan 2017 besides the Food and Drug administration’s (FDA) ongoing initiatives for paperless trials with the release of multiple guidance documents including electronic informed consent (Federal Register, 2017 and Mitchel & Helfgott, 2017). Other highlights of the Research Industry are FDA propagating

Interviewer: (11:10) That’s a good idea, having a conference, because I know some people I’ve spoken to say, “Look. We don’t really have time for things like this,” but they do go to conferences. So that’s a good suggestion. In terms of other types of professional activities, do you undertake trials with companies? I know you’re a scientific expert.