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Ethics in biomedical research
Ethics in biomedical research
Ethics in biomedical research
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Introduction:
Clinical trials are studies made by assigning human participants either individually or by groups to evaluate the outcomes of the new treatment and how it does effect humans in terms of health. The purposes of clinical trials are mainly for treatment registration, and availability for public use. Clinical trials are not limited to drug use only, but also they include surgical procedures, radiology procedure, etc. Clinical trials have been used for a long time to test treatments. It dates back to 500 BC as recorded in the biblical descriptions. The “Book of Daniel” in the bible has the first recorded clinical trial. Compared with the past, clinical trials now differ in the addition of governmental influences and ethical environments.
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Before releasing any new medicine, we must ask ourselves how safe is it? The main for this phase to acquire more information about the maximum doses of this “medicine” humans can be exposed to while minimizing the serious side effects of the drug. Doctors therefore study how the drug and the human body react to each other. Usually studies in this phase are done on a small group of people from 20 to 80 persons but are given very small doses of it. The doses of drugs are increased until doctors find the dose that’s most likely to work while having an acceptable level of side effects. Overall, phase I trials are the ones with the most potential risk but might help some patients. For those with life-threatening illnesses, weighing the potential risks and benefits carefully is …show more content…
It is designed to question the potential effects of treatments. These studies involve thousands of people in order to come up with the most accurate data possible to be analyzed later on when evaluating the drug. Phase IV studies are by far the most secure type of studies, since the treatment has already been administered to many people and was already studied thoroughly by medical and trial labs. This phase defines the importance of the future engagements of an approved treatment, taking into consideration the potential risks and effects that might arise when the drug is consumed.
Phase IV studies allow researchers, doctors and academicians to evaluate how the treatment or drug has affected the life of the patients whom the medicine was administered to. It seeks to understand whether the living conditions of the consumers have improved or not, and whether the creation of the drug and its pricing was cost effective in terms of return on investment.
Conclusion:
In conclusion, clinical trials can mainly give better opportunities for people who are diagnosed with cancer. Clinical trials hand us the key to innovative treatments. But clinical trials can sometimes involve risk taking, and it’s not meant for everyone. Decisions and judgments made in clinical trials must be made on basis of accurate understanding of what might happen after applying the treatment in terms of risks
This paper discusses pharmacology and terminology related to “Pharmacology” which is the branch of medicine concerned with the uses, effects, and modes of action of drugs“ pharmacology. 2015. In Merriam-Webster.com. The study of different classes of drugs, routes of absorption, and drugs have effects on those consuming them. There are drugs that are necessary for illnesses and healing but, there are medicines that cause concern regarding interaction and harming the body.
This module of study has focused on many aspects of human health, anatomy, and the disease process. It has included such topics as the human organ systems, the mechanism of disease and the resulting disruption of homeostasis, the integumentary system, and the musculoskeletal system. The following case studies explore how burn classification will affect treatment, how joint injuries can disrupt mobility, and last, how a sedentary lifestyle can contribute to a decline in a person’s health status. The importance of understanding disease and knowing when to seek treatment is the first step toward enjoying a balanced and healthy life.
The IRB is an administrative body which has been established to make sure research participants' rights are protected. IRBs review all aspects of the researchers' project: the study design, the recruitment process, the participant population, the informed consent document and process, the risk/benefit ratio, privacy and confidentiality, data storage and protection, and safeguards for vulnerable participants (University of St. Francis, n.d.). In this way, participants' rights are protected because the effort is made even before the research begins. The review process ensures that participants are chosen fairly and informed adequately and the information collected during research is safeguarded through collection, use, and storage. Research using human participants is such an important part of medicine that it is imperative it is performed in a way that its intrigue is not compromised.
It is essential that when using evidence-based practice guidelines to choose a treatment, that variety of research methods are applied so that the best relevant data can be produced. Such methods include qualitative/quantitative research, randomised controlled trials and systematic reviews. Both qualitative and quantative methods produce valuable data. Quantative research produces numeric evidence that is necessary for practice and can be measured and qualitative research produces descriptive data about the subject by using patients views etc. which can also be applied to clinical practice (Broeder et al, 2010)
In the United States, the basis for ethical protection for human research subjects in clinical research trials are outlined by the Belmont Report developed in the late 1970’s. This document, published by the Nation Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, highlights three important basic principles that are to be considered when any clinical trial will involve human research subjects. They are; respect for persons, beneficence, and justice. (Chadwick & Gunn, 2004)
Background: Merck & Co. is an American pharmaceutical company and one of the largest pharmaceutical companies in the world. In 1971 the United States approved the use of an MMR vaccine made by Merck, containing the Jeryl Lynn strain of mumps vaccine. In 1978 Merck introduced the MMR II, using a different strain of the rubella vaccine. In 1997 the FDA required Merck to conduct effectiveness testing of MMRII. Initially it was over 95%; to continue the license; Merck had to convince the FDA that the effectiveness stayed at a similar rate over the years.
... be in the patient’s best interest and getting the best results for the trial.
Pre-clinical testing is performed to Good laboratory practice (GLP) and covers pivotal toxicology & safety pharmacology studies. In preclinical research, scientists test their ideas for new biomedical prevention strategies in laboratory experiments or in animals.
both the benefit and risk of all medication before approval.. In addition, FDA makes the labeling
Disputes are almost unavoidable between people when there are disagreements or misunderstandings. In the construction industry, contractual relationships could lead to dispute. To resolve disputes, construction disputes are most likely encouraged to use Alternative Dispute Resolutions such as arbitration, mediation, and mini-trials to resolve their disputes faster and keep the dispute confidential and at lower cost (Ray, 2000). The construction case presented in this paper first resorted to negotiation; however, it could not give the parties a resolution which led to a mini-trial.
With the increased cost of manufacturing, pharmaceutical companies have been divesting in their smaller or less profit making operations and focus on large segments. Many Pharmaceutical companies sold their manufacturing sites to contract manufacturing organizations. The dynamics of interfacing with contract manufacturing organization added intricacy in pharmaceutical supply chain network of pharmaceutical companies.
Clinical trial is biomedical or health related research studies in human being that follow a pre-defined protocol. Research is an activity designed to test a hypothesis that helps in concluding and developing knowledge. It is a protocol that has an objectives and procedures to reach those objectives (1). There are two types of clinical studies. One is interventional studies in which the research subjects are assigned by the investigator to a treatment or other intervention, and their outcomes are measured. Second is an observational study in which individuals are observed and their outcomes are measured by the investigators.
Introduction Clinical trials are a gateway to proven practical medical treatment, so it requires accuracy and validity of the outcomes. Placebo control trials are therefore employed in clinical trials as nearly half of academic physicians have answered in a questionnaire that they had used a placebo in their clinical trials (Sherman and Hickner, 2007). To have the higher scientific validity of results on the clinical trials requires that prospective, carefully selected subjects and endpoints, a control group, randomly allocated subjects into a treatment group and a control group, blinded both subject groups and investigators, sufficient sample size, and an approved independent ethics committee and monitoring by data safety and monitoring board to have stronger the scientific validity on the clinical trials (Brody, 1997). The use of placebos will enable more scientifically reliable outcomes. However, unnecessarily or ineffectiveness of placebo use is also claimed, therefore considering appropriate conditions and suitable cases would be needed for placebo use. .
Mayo Clinic is a hospital that is as well-known by many to be a haven of caring and concerned doctors whos’ sole focus is to give their patients the type of care they would want their families to receive if they were patients. According to Colquitt, LePine, and Wesson (Mayo Case Study, 2014), Mayo Clinic has established a customer service, patient first culture that puts the needs of those whom they serve ahead of other focuses, such as profit or patient quotas. This corporate culture has lead the hospital to become one of the most successful and iconic medical centers in the United States. Colquitt, LePine, and Wesson (Mayo Case Study, 2014) propose several very interesting questions at the end of the reading that they ask readers to ponder.
“In one scientific trail eight healthy men volunteered to take part in this drug trial. Two of them were given a placebo while the other six were given the experimental drug. All six men who were given the drug TGN 1412 are now ill, two of whom are in a critical condition. The other four became seriously ill” (Nordqvist 1). “There was another medical trial reported where Two men who took part in a clinical trial for an experimental drug to treat chronic inflammatory