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Informed consent in clinical setting cit quiz
Informed consent in clinical setting cit quiz
Informed consent in clinical setting cit quiz
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Complete the NIH “Protecting Human Research Participants” course. Include a copy of the certificate of completion and add to your post as an attachment for proof of completion. Once you have completed, respond to the following:
Share your reaction to this course.
The NIH “Protecting Human Research Participants” course is very informative and interesting. It provided a detailed information on the historical background of behavioral and biomedical research, basic concepts, principles, and issues related to research involving human subjects. This course helped me to understand the researcher’s responsibility in protecting the rights of human participants involved in research, with additional protection for pregnant women, children, fetuses, neonates, prisoners and persons with diminished autonomy. The three principles essential to the ethical conduct of research with humans are beneficence, justice, and respect for persons and one should follow these principles when doing research. Also, the Institutional Review Board (IRB) play a major role in safeguarding the rights and
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For example, is there an IRB or ethics committee? If so, do they review proposals? Next, find out the composition of the members and discuss if they meet federal guidelines.
The Organization I work is a magnet certified hospital and is conducting clinical trials in many areas of medicine such as cancer, pulmonology, neurology, cardiology and orthopedics. The institution has several procedures in place, as part of the protocols, to protect the safety of the participants (El Camino Hospital, 2016). Informed consent is a process designed to protect potential participants through detailed description of important facts about a specific clinical trial. Two groups that oversee the safety procedures are the:
• Organization that sponsors the study, for example, the National Cancer
Belmont Report (1979). The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research. Retrieved from hhs.gov/ohrp/humansubjects/guidance/belmont.html
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.
Anonymous. "Human Experimentation: An Introduction to the Ethical Issues." The Physicians Committee. N.p., 22 June 2015. Web. 28 Apr. 2017.
Informed consent is the basis for all legal and moral aspects of a patient’s autonomy. Implied consent is when you and your physician interact in which the consent is assumed, such as in a physical exam by your doctor. Written consent is a more extensive form in which it mostly applies when there is testing or experiments involved over a period of time. The long process is making sure the patient properly understands the risk and benefits that could possible happen during and after the treatment. As a physician, he must respect the patient’s autonomy. For a patient to be an autonomous agent, he must have legitimate moral values. The patient has all the rights to his medical health and conditions that arise. When considering informed consent, the patient must be aware and should be able to give a voluntary consent for the treatment and testing without being coerced, even if coercion is very little. Being coerced into giving consent is not voluntary because others people’s opinions account for part of his decision. Prisoners and the poor population are two areas where coercion is found the most when giving consent. Terminally ill patients also give consent in hope of recovering from their illness. Although the possibilities are slim of having a successful recovery, they proceed with the research with the expectation of having a positive outcome. As stated by Raab, “informed consent process flows naturally from the ‘partnership’ between physician and patient” (Raab). Despite the fact that informed consent is supposed to educate the patients, it is now more of an avoidance of liability for physicians (Raab). Although the physician provides adequate information to his patient, how can he ensure that his patient properly ...
Truog, Robert D., Walter Robinson, Adrienne Randolph, and Alan Morris. "Is Informed Consent Always Necessary For Randomized, Controlled Trials?" The New England Journal of Medicine 340, (March 1999): 804-807.
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)
Informed consent is the authorization by the patient of services based on the principles of autonomy and privacy; this has become the requirement at the center of morally solid decision making in health care and research. (Farlex,
The basic significance of Belmont Report is to summarize the guidelines and ethical principles regarding the protection of human subjects involved in the research. The significance in terms of principles that guide human research today is as follows.
In conclusion, obtaining informed consent is a vital part of respect for the patient and safeguarding of self-determination. The consent to participate in research or treatment should be informed, comprehensible, and free of coercion. There is not a clear black and white answer because no matter what is done to assure informed consent there is always a moment of doubt on the end of the patient as to whether what is going to take place is fully understood and their true wishes honored.
Englewood Cliffs: Prentice Hall, 1976. Call Number: HV4711.A56. American Medical Association. The “Animal Experimentation Benefits Human Health”. Animal Rights Opposing Viewpoints?
Unethical experiments have occurred long before people considered it was wrong. The protagonist of the practice of human experimentation justify their views on the basis that such experiments yield results for the good of society that are unprocurable by other methods or means of study ( Vollmann 1448 ).The reasons for the experiments were to understand, prevent, and treat disease, and often there is not a substitute for a human subject. This is true for study of illnesses such as depression, delusional states that manifest themselves partly by altering human subjectivity, and impairing cognitive functioning. Concluding, some experiments have the tendency to destroy the lives of the humans that have been experimented on.
The history of medical research in the twentieth century provides abundant evidence which shows how easy it is to exploit individuals, especially the sick, the weak, and the vulnerable, when the only moral guide for science is a naive utilitarian dedication to the greatest good for the greatest number. Locally administered internal review boards were thought to be a solution to the need for ethical safeguards to protect the human guinea pig. However, with problems surrounding informed consent, the differentiation between experimentation and treatment, and the new advances within medicine, internal review boards were found to be inadequate for the job. This led to the establishment of the National Bioethics Advisory Commission by President Bill Clinton in the hopes of setting clear ethical standards for human research.
In this case, a conflict arises from the use of the term “effective” (Davis, 2002). On the other hand, all researches that involve human participation should adhere the four basic ethical principles, namely autonomy, beneficence, maleficence, and
It has long been debated as to whether it is ethical to use animals for experimentation. When considering whether animal research is ethically acceptable or not two main concerns must be raised. The first issue is whether it is absolutely necessary to use animals in order to acquire information that may contribute to the improvement of people’s health and well-being. The second issue is whether the use of animals is defendable on a moral ground.