Essay On Human Subject Protection

The Food and Drug Administration, also known as the FDA or USFDA, is responsible for protecting and advocating public health. They are the official government agency that ensures our drug supply is safe and effective. This is achieved through the regulation and supervision of food safety, dietary supplements, veterinary products, cosmetics, vaccines, biopharmaceuticals, medical devices, prescription and pharmaceutical drugs that can be purchased over- the- counter.

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.

The process used to pool the data together was clinical trial decision making. The main factors influencing this process consist of patient, provider, and treatment. Two studies specifically explored decision making by the patient. Education requirements impacted decision making since understanding the risks and benefits of clinical trials was the most important factor taken into consideration by the patient. Educational interventions were noted to have increased patient enrollment. (Biedrzycki, 2010).

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.

This measure is a reliable indicator of trial quality and is based on each trial’s reporting and quality of randomisation and blinding attribution (CASP 2006).

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

Describe the roles of different agencies involved in the safeguarding the welfare of children and young people.

The author considers the simplest way of finding out best practice is by using guidelines. According to Field & Lohr (1992) guidelines are “systematic developed statements to assist practitioners and patients decisions for specific clinical circumstances.” Evidence is always current and a generous collection of many different systematic research reviews with multiple random control trials are available (AGREE, 2000). These types of trials are graded at the top level of hierarchy (Guyatt et al 2002).Nevertheless in contrast Devereaux and Yusuf (2005) argue that top level hierarchy is not a guaranteed deviation from the truth in randomized trials. The clinical guidance used is the National Institute of Clinical Guidance (NICE 2009) is based in the author’s homeland and is an independent organisation responsible for providing guidelines. The ethos behind NICE (2009) is to promote and prevent poor health nationally involving the public, health professionals and patients in the process (NICE 2009).

a. The study was conducted in accordance with the ‘Recommendations Guiding Physicians in Biomedical Research Involving Human Subjects’ in the 1989 Declaration of Helsinki.

Patients who are eligible for the study and provide written informed consent will randomized to one of two groups, 90 mg dose of Dextromethorphan (twice a day) or the placebo on a 1:1:1 basis. The trial will utilize Clinstat, a free, statistical software, to perform randomization of patients. The random number generation will assign all the participants to the treatment or placebo group by generating a number that corresponds with Dextromethorphan or the placebo. An outside committee that has no interest in the study and is not connected to anyone conducting the study will be responsible for the allocation of participants. This will limit the risk of introducing bias into analyses and results.

The present study was conducted after obtaining ethical permissions from the Ethics Committee of Shahid Beheshti University of Medical Sciences (IR.SBMU.REC.1396.51). In addition, the research data were recorded in the Iranian Registry of Clinical Trials (IRCT) with registry number of IRCT20150825023753N6.

The study conducted was done in the form of a random controlled trial (RCT). A RCT was the optimum methodology of choice as it is used to compare two or more treatment procedures (Farrelly 2013 p.43), as this study is demonstrating. By selecting the method of RCT the researcher is enhancing the validity and possibility of application of the study, as RCT it is “considered the strongest research design for evaluating

There are six methods used to analyse trial design; of which are discussed as follows.

Safeguarding - is to protect all the children against abuse, maltreatment, neglect, unfair treatment and violence.

Pharmaceutical sciences combine a broad range of scientific rules that are critical to the discovery and development of new therapies and drugs, and so in that saying, knowing this kind of information can help people around the world greatly in the future.