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Medical Ethics Case 2 Informed Consent

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According to Nuremberg Code, research subject should give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved, as to enable him to make an understanding and enlightened decision (1). WMA Declaration of Helsinki indicates that study participants should be able to agree willingly and freely before enrolling in a research, he or she is also free to consult family members if the need arises and must be sufficiently educated on the aims, methods, expected benefits and future risk involved …show more content…

A respect for autonomy, beneficence and justice are ethical principles that guide the conduct of research involving human subjects. Regulations and policy require that this information be provided as part of the consent process. Any consent that lacks these major guidelines might be regarded invalid. Case 2 “Informed Consent “ has some ethical problems which are lack of ethical review and inadequate consent. The study did not receive an ethical review before it was started because there were few research institutions in the country. Consequently, this act violates guideline 23 of CIOMS which states that all proposals to conduct research involving human subjects must be submitted for ethical review of their scientific merit and ethical acceptability depending on the nature of the research and application of law (5). The inability of a researcher to give in research proposal for competent review leads to a serious breach of ethical principles. Ordinarily, If this study was submitted to the ethics committee before it was conducted, it might not be ethically acceptable considering the fact that the researcher withheld basic information from the patients. Although, there are

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Henrietta Lacks did not know that a tissue sample had been taken from her cervix, but the turning point in medical ethics was when researchers started injecting patients with cancer cells without their consent, so they could see how cancer spreads. After that, the government institutionalized medical review boards and informed consent laws. By law, informed consent means that the patient knows that the study involves research, the purpose of the research, the duration of their participation, procedure,

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Mr. Z is 86-years-old, Caucasian male that lives with his wife of 56 years. He values his independence, but recently he been struggling to care for himself. He has a long-standing history of diabetes mellitus, hypertension, and chronic kidney disease. His wife was concerned because she noticed her husband can no longer drive, is having difficulty walking, and managing his own care and daily medication. She explained that her husband is lethargic, sleepless, having poor appetite and difficulty maintaining his weight.

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In the study “Assessing the quality of informed consent in a resource-limited setting: A cross-sectional study,” researchers investigated the process of obtaining informed consent in clinical and public health research. The method of the study utilized interviews, in which research participants were asked a series of questions after they had been through informed consent procedures. 600 participants were interviewed, and the results show that 5.9% believed that they were not given enough information before deciding to participate. Only 5.7% of the participants said that they had not signed a consent form before making the decision to participate. Interestingly, 33.7% reported that they were not aware of their power to withdraw from participation

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The job of the “Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles.” (The National Commission for the Protection of Human

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However, the lack of informed consent has raised ethical concerns and led to the establishment of guidelines for obtaining consent in medical research. Today health care providers have a responsibility to obtain informed consent from patients before conducting any medical

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This can make the patient feel like they are in some sort of control (Privacy and Confidentiality). Making the patient feel like they are in control and respected will help establish the trust between the patient and the researcher. Therefore informed consent in the biomedical research is very important to have and should be

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Secondly, the report discuses that safety must be kept in mind. Scientific advancement cannot happen unless the experiments are safe. Thirdly, participants have to be chosen fairly, not from populations who could be coerced into participating, such as prisoners or institutionalized children. And, of course, consent is

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Informed consent involves the patient understanding “ all aspects of the trial, which are important for the participant to make a decision.... the participant voluntarily confirms his or her willingness to participate in a particular clinical trial and significance of the research for advancement of medical knowledge and social welfare”(Nijhawan 134). When provided informed consent, a patient might refuse to allow his or her doctor to take samples of what the medical professional believes is beneficial. Because of this refusal, the opportunity for potentially valuable research disappears. As a medical expert, you should take on the responsibility of deciding whether or not a patient’s condition becomes research. The research given by one person could become the breakthrough research that helps to save hundreds of lives.

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Ethical Research Frances Jeffcoat HSC: 320 2 December 2014   Abstract This paper explores the history and ethics of research. This paper will look at two different types of research that are commonly used today. The focus of the research is clinical and basic science. Clinical science is the use of humans in an experiment or study to further knowledge about a particular aspect.

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1 Ethical Issues of Informed Consent Waynesburg University Ethics PHL 205. March 9, 2024 The ethical principle of informed consent is a cornerstone of medical practice, as it empowers patients to make fully informed decisions about their healthcare. However, obtaining informed consent can be a complex process that requires careful consideration of various ethical challenges. These challenges include ensuring patients have sufficient information to make informed decisions, assessing patients' decision-making capacity, and mitigating power imbalances between healthcare providers and patients.

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My first week was primarily filled with professional training. This training included the background of the International Council for Harmonisation, Good Clinical Practice, CFR, and the evolution of the ethical and regulatory foundations of human subject research. Studying the Declaration of Helsinki provided education regarding the ethical principles of clinical research. A large portion of my training was centered on the ethical principles of clinical research: autonomy, beneficence, nonmaleficence, and justice. To have adequate knowledge of the informed consent process I studied CFR 21, part 50, Protection of Human Subjects.

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Judges in these trials found that certain principles must be observed to satisfy moral, ethical, and legal concepts (Jewish Virtual Library). Voluntary consent of the patient was necessary to be eligible to experiment of the subject. Experiments should result in good for the society and not in

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For instance, the practitioners are obligated to constantly inform the participants about plans that pertains to interventions (Reamer, 1987). In addition, it is essential for informed consent to include the following: “What is done, the reasons for doing it, clients must be capable of providing consent, they must have the right to refuse or withdraw consent, and their decisions must be based on adequate information” (Kirk & Wakefield, 1997, p. 275). One of the most dehumanizing incidents that occur is the researchers prohibit the participants’ self-determination. For example, the men were compliant with receiving treatment and to be examined by the physicians.

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Any study that involves subjects concerning human beings should be approved first from the ethics committee before being effected (Chiarelli & Cockburn, 2002). Further, if the paper ever sought for ethical approval is not being mentioned in any section of the article concerning its ethical issues. This is one of the pitfalls noticed at the beginning of the

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Medical Research has the potential to advance society and make life better for everyone in it. However, the ends cannot justify the means; the rights of the subjects of research cannot be violated no matter the possible benefit to mankind. Despite this, time and time again, it has been very easy for, at least allegedly well-meaning scientists to violate the rights of their research subjects because they wanted to help society as a whole. Such experiments were not performed in secret by a minority of scientists; they were often done “by respected investigators at leading medical institutions and were published in medical journals (Scandals and Tragedies 3). " It is vital that we understand the circumstances of these experiments and why they happened so

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