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Principles in biomedical research ethics
Importance of ethics in clinical research
Principles in biomedical research ethics
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In Marcia Angell’s article, “The Ethics of Clinical Research in the Third World,” she strongly argues the use of clinical placebo-controlled trials done in developing countries are unethical if an effective treatment already exists. Angell believes studies that compare potential new treatment with a placebo controlled group is ineffective and unnecessary. All research studies should offer the best standard of care and give participants the most beneficial outcome and treatment possible. The main priority of a study is not the goals of the research itself, but the well-being of the participants. Angell uses many sources to defend her argument, such as WHO. At times, the goal of the researcher might seem more important due to the importance …show more content…
When doing any studies with human subjects, “the safest and most reasonable position is that people everywhere are likely to respond similarly to the same treatment” (300). With third world countries, Angell states there are dissimilarities between population, but that cannot be anticipated. The local of standard care should not be different, the best treatment and care should always be given regardless of where the study takes place and who the subjects are. As clinical trial studies are becoming more popular, researchers need to understand the same protection goes to the people rather they are aboard or at home. Studies done in third world countries are unethical because they cannot afford the same effective treatment. If people volunteer, it is not because they are willing to for their own interest, but they need to in order to improve their health and well-being. She wishes for researchers in the future to reconsider their ethical standards. She ends her argument stating we really have not come far from the Tuskegee study after …show more content…
As long as participants were not coerced into participating in the trials and later given any treatment provided then clinical trials are allowed. Brody defends his argument by using successful statistics from past clinical trial studies. For example, he brings up the success of introducing Zidovudine to reduce the transmission of HIV from mother to child during birth. Because of the clinical trials, effective and inexpensive antiretroviral drugs can be tested to help less developed countries find better treatments. Brody then goes into details about what critics have been saying that clinical trials are unethical. Therefore, he states he wants to “focus the paper on the arguments offered in support of the claim that these trials were unethical,” (302). The first criticism states,” injustice was done to the control group…second, the participants in the trial were coerced into participating…third, the countries in question were exploited,” (302). Against the first criticism, he argues that if the clinical trials were not conducted the participants would not have received proper treatment. For the second criticism, he states that coercion, “involves a threat to put someone below their baseline unless they cooperate with the demands of the person
Those who were affected by the testing in hospitals, prisons, and mental health institutions were the patients/inmates as well as their families, Henrietta Lacks, the doctors performing the research and procedures, the actual institutions in which research was being held, and the human/health sciences field as a whole. Many ethical principles can be applied to these dilemmas: Reliance on Scientific Knowledge (1.01), Boundaries of Competence (1.02), Integrity (1.04), Professional and Scientific Relationships (1.05), Exploitative Relationships (1.07, a), Responsibility (2.02), Rights and Prerogatives of Clients (2.05), Maintaining Confidentiality (2.06), Maintaining Records (2.07), Disclosures (2.08), Treatment/Intervention Efficacy (2.09), Involving Clients in Planning and Consent (4.02), Promoting an Ethical Culture (7.01), Ethical Violations by Others and Risk of Harm (7.02), Avoiding False or Deceptive Statements (8.01), Conforming with Laws and Regulations (9.01), Characteristics of Responsible Research (9.02), Informed Consent (9.03), and Using Confidential Information for Didactic or Instructive Purposes (9.04), and Debriefing (9.05). These particular dilemmas were not really handled until much later when laws were passed that regulated the way human subjects could be used for research. Patients
Ethical violations committed on underprivileged populations first surfaced close to 50 years ago with the discovery of the Tuskegee project. The location, a small rural town in Arkansas, and the population, consisting of black males with syphilis, would become a startling example of research gone wrong. The participants of the study were denied the available treatment in order further the goal of the research, a clear violation of the Belmont Report principle of beneficence. This same problem faces researchers today who looking for an intervention in the vertical transmission of HIV in Africa, as there is an effective protocol in industrialized nations, yet they chose to use a placebo-contro...
The study took advantage of an oppressed and vulnerable population that was in need of medical care. Some of the many ethical concerns of this experiment were the lack of informed consent, invasion of privacy, deception of participants, physical harm, mental harm, and a lack of gain versus harm. One ethical problem in this experiment was that the benefits did not outweigh the harm to participants. At the conclusion of the study there were virtually no benefits for the participants or to the treatment of syphilis. We now have
Southam’s practice, beginning with the Code’s number 1 rule, “The voluntary consent of the human subject is absolutely essential.” Other rules under the Nuremberg Code were broken as well, however all of these egregious behaviors of researchers, more so than just Southam, have influenced the tight research protocols in place today. As Dr. Hardy shared information on research protocols, she consistently referred back to a strict system of regulations that, at times, may seem a little extreme. The alternative, a system permitting researchers like Southam, would be a far harder bullet to bite. In the end, I am glad these systems are in place to try to ensure a trust between patients and
Article two entitled “Clinical trials: are they ethical?” is written by Eugene Passamani discusses the importance of randomized clinical trials. Passamani rejects the argument that the physician-patient relationship demands that physicians recommend ...
Fellow psychologists pointed out whether the welfare of the participants was thought of in the experiment (Brace and Byford). Levels of stress endured by the participants were viewed by some to be excessive and the experiment shoulder been stopped. In the cause of Hofling, such anxiety was not reported. However, both cases used some form of deception towards the participants which would be questioned extensively today. In addition, the right for the participant to stop the experiment by Milgram was not exercised because of prompts to continue the experiment. Some argue the both Milgram and Hofling studies could have caused psychological harm. Both studies of obedience by Milgram and Hofling have had similar critique regarding the ethics of the trials. Psychologists of today would have viewed theses studies as unethical and indeed, would have questioned its validity. (Brace and
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)
A person’s belief or disbelief in a medication or medical procedures changes the effect of the treatment as exhibited by placebos, which are medical treatments that have no physiological effect. This phenomenon is known as the placebo effect. The placebo effect is not merely regression; it is the body’s physical response to the mind. For this mind-body relationship to work to it’s greatest potential, a physician must con their patient’s into believing a prescribed placebo does have a physiological effect. There are respectable laws currently in place that physicians must follow, which state that a physician cannot use deception, and must provide patients with correct medical information. The administration of placebos can be beneficial to patient even though it seems as if dishonesty is necessary from a position where deception is unlawful, but there are ethical methods to use the placebo effect justly, and without wrong doing.
Though the research seems pretty sound in the ethical department, one could say that placebo controlled studies could be unethical in themselves. Accepting someone into a clinical trial gives him or her hope of improvement, but they may not ever get that chance. If they were placed in the control group, they would only receive a sugar pill that would have no health implications. Though part of many successful and effective experiments, it could be raised as an ethical issue.
Looking beyond the Nuremberg Code and applying it to modern medical research ethics, there are many challenges that it poses. Many have argued that the Code tries to provide for all unforeseen events, which restricts the researcher by requiring him to anticipate every situation, demanding the impossible. The most important contribution of the Code is the first principle, which says that voluntary consent of the human subject is absolutely essential. The subject involved should have legal capacity to give consent, should have free power of choice, as well as sufficient knowledge and comprehension of the experiment. This restricts that populations upon which some experiment may be conducted, since many do not have “legal capacity”. For instance, studies of mental illness and children’s diseases have been curtailed because neither of these populations has the legal capacity to give consent. Another group of people, prisoners, are never really able to give voluntary consent since they might be enticed by financial rewards, special treatment, and the hope of early release in exchange for participating in the human experimentation projects. British biostatitcian Sir Austin Bradford Hill also questioned whether it was important to inform a research subject who was receiving a placebo since it does...
...f patients’ doctors recruited participants, patients may not ease to refuse participating a trial. Therefore recruitment may be better to be done by a person who does not normally treat the patients.
First, the participants should be given the chance to decide if they want to partake in the experiment. The participants could be under age or concerned for their safety which are valid reasons for them not to participate in the study. It does not matter if the study was single blinded, it was vital to tell the participants that they are being studied (Cicarelli and White, 2015, p. 33). Second, participants are not allowed to withdraw from the study. Due to the participants not being informed of the study they are unable to withdraw. Third, investigators do not inform the participants of any risks. While the researchers do not use equipment that could cause bodily harm the participants can suffer a greater risk that involves their privacy. Privacy helps people maintain who they are as an induvial and when that is violated they lose the ability to trust not only others, but themselves in certain situations. Lastly, the investigators do not debrief participants. Debriefing is a critical part of any experience because it not only allows the experimenter to share their findings, but it gives participants the opportunity to ask questions. Due to the importance of ethics in an experiment I would correct the four violations that were discussed
Looking back at my memories, I can safely say that I enjoyed two things during primary school; science and reading. Although biomedical science is hardly “plant a seed and watch it grow”, small observations such as the plant certainly sparked some interesting questions for a 10 year old. “How does the seed know which way is up when it’s in the soil? Why does the plant grow towards the sunlight?” It often frustrated me that I could never get the answers to all my questions. Growing up, I still have multitudes of questions without an answer, ranging from science specific questions such as “How can the pandemic of obesity and its related diseases be prevented in the Western World?” to ethical debates; “the gene for converting yellow fat to brown
Code of ethics serves as the moral compass that directs and guides the integrity, values, and beliefs of an organization. A code of ethics clarifies to employees what the company stands for and its expectations for employee conduct (Daft, 2013). A well-written code is a true commitment to responsible business practices in that it outlines specific procedures to handle ethical failures. Within the research enterprise, the code of ethics ensures that research projects involving human subjects are carried out without causing harm to the subjects involved. Research ethics also ensure researchers conduct research in an ethical manner. This paper will focus on the regulations and guidelines that govern ethics in research, a study where research ethics were violated and recommendations to improve ethics within the research enterprise.
Ethics is the study of moral values and the principles we use to evaluate actions. Ethical concerns can sometimes stand as a barrier to the development of the arts and the natural sciences. They hinder the process of scientific research and the production of art, preventing us from arriving at knowledge. This raises the knowledge issues of: To what extent do moral values confine the production of knowledge in the arts, and to what extent are the ways of achieving scientific development limited due to ethical concerns? The two main ways of knowing used to produce ethical judgements are reason, the power of the mind to form judgements logically , and emotion, our instinctive feelings . I will explore their applications in various ethical controversies in science and arts as well as the implications of morals in these two areas of knowledge.