...CITI - Collaborative Institutional Training Initiative 8/5/14 9:56 PM English Text size: A A Aubrey Burklin ID: 4276982 Log Out Help Search Search Knowledge Base Main Menu My Profiles CE Credit Status My Reports Support Main Menu › Quiz Results Defining Research with Human Subjects - SBE Quiz Results - Defining Research with Human Subjects - SBE You correctly answered 4 of 5 and received 4 of 5 possible points. Scroll down to review the quiz questions and the explanation of the answers. Question 1 Question : Which of the following studies is linked most directly to the establishment of the National Research Act in 1974 and ultimately to the Belmont Report and Federal regulations for human subject protection? Your answer : The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male. Correct Answer : The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male. Comment : Points Earned : 1 Question 2 Question : The Belmont principle of beneficence requires that: Your answer : Risks are managed so that they are no more than minimal. Correct Answer : Potential benefits justify the risks of harm. Comment : Points Earned : 0 Question 3 Question : Humphreys collecting data for the Tearoom Trade study under the pretense that he was a lookout is an example of a violation of the principle of: Your answer : Respect for persons. Correct Answer : Respect for persons. Comment : Humphreys collecting...
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...Belmont Report: Informed Consent and Subject Selection In the famous Belmont Report, several guidelines regarding informed consent, assessment of risk and benefits, and selection of subjects in addition to ethical practice and procedure in the area of human research are outlined. The Belmont Report attempts to summarize the basic ethical principles identified by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (Belmont Report, 1979). In particular I would like to discuss the standards for informed consent, assessment of risk and benefits, and selection of test subjects drawn out by the Belmont Report. These three areas of interest are said to be the applications of the general principles of research. Informed consent is broken down into three checkpoints: information, comprehension, and voluntariness. Assessment of Risks and Benefits has two similar components: identifying the nature and scope of the risks and benefits, and then the systematic assessment. Then there is the selection of subjects which is just an evaluation of the appropriateness of a group used in a research study. I will discuss these concepts as they apply to the infamous artificial heart case study. Informed consent is the application of the general principle of respect for persons. Remember, respect for persons requires that subjects be given the opportunity to choose what will or will not happen to them (Belmont Report, 1979). The first tier...
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...1. Respect for Persons. -- Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy. An autonomous person is an individual capable of deliberation about personal goals and of acting under the direction of such deliberation. To respect autonomy is to give weight to autonomous persons' considered opinions and choices while refraining from obstructing their actions unless they are clearly detrimental to others. To show lack of respect for an autonomous agent is to repudiate that person's considered judgments, to deny an individual the freedom to act on those considered judgments, or to withhold information necessary to make a considered judgment, when there are no compelling reasons to do so. However, not every human being is capable of self-determination. The capacity for selfdetermination matures during an individual's life, and some individuals lose this capacity wholly or in part because of illness, mental disability, or circumstances that severely restrict liberty. Respect for the immature and the incapacitated may require protecting them as they mature or while they are incapacitated. Some persons are in need of extensive...
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...1964 and subsequently revised. This document built on both the Nuremberg Code and physicians' code of ethics known as the Declaration of Geneva by adapting the existing guidelines to address the growing field of clinical research. In the U.S., news that researchers deceived and withheld treatment from subjects in the Tuskegee Study, led to the creation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The National Commission was charged with the establishing a code of research ethics for U.S. research with human subjects. In 1979, the Commission issued the Belmont Report, the foundational document of the current system of U.S. human subjects protections. The Belmont Report outlines three key ethical principles for conducting research with human subjects: respect for persons, beneficence, and justice. The Belmont Report, in turn, informed the U.S. Department of Health and Human Services' (HHS) Code of Federal Regulations (45 CFR 46), created...
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...Research Act in 1974 and ultimately to the Belmont Report and Federal regulations for human subject protection? The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male. 2. The Belmont principle of beneficence requires that: Potential benefits justify the risks of harm. 3. Humphreys collecting data for the Tearoom Trade study under the pretense that he was a lookout is an example of a violation of the principle of: Respect for persons. 4. According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of: Justice. 5. Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects? Ensuring that risks are reasonable in relationship to anticipated benefits. 1. Which of the following are the three principles discussed in the Belmont Report? Respect for Persons, Beneficence, Justice. 2. Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects? Determining that the study has a maximization of benefits and a minimization of risks. 3. All of the following are true regarding the Belmont Report, EXCEPT: The Belmont Report defines and delineates the differences between "Practice" and "Research". The Belmont Report describes the concept of "Respect for Persons". The Belmont Report indicates that it is necessary to rigorously...
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...Helsinki, published in 1964 and subsequently revised. This document is built on both the Nuremberg Code and the physician's code of ethics known as the Declaration of Geneva. In the U.S., news that researchers deceived and withheld treatment from subjects who suffered from syphilis in the Tuskegee Study led to the creation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission or "the Commission"). The Commission was charged with establishing a code of research ethics for U.S. research involving human subjects. In 1979, the Commission issued the Belmont Report, the foundational document of the current system of U.S. human subjects protections. The Belmont Report outlines three key ethical principles for conducting research with human subjects: respect for persons, beneficence, and justice. The Belmont Report, in turn, informed the U.S. Department of Health and Human Services (HHS) Code of Federal Regulations...
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...Foreign Languages * American Government * History * Literature * Management * Math * Sciences * Test Prep * Writing 13 What principles of the Belmont Report were violated in the Tuskegee Syphilis Study? The Tuskegee Syphilis Study was conducted from 1932 to 1972 around Tuskegee, Alabama. Six hundred poor — and mostly illiterate — African-American males, 400 of whom were infected with syphilis, were monitored for 40 years. Free medical examinations were given; however, subjects were not told about their diagnosis. Even though a cure (penicillin) became available in the 1950s, the study continued until 1972 with participants being denied proper treatment or given fake treatments and placebos, instead. In some cases, when subjects were diagnosed as having syphilis by other physicians, researchers intervened to prevent treatment. Many of the subjects died slow and painful deaths of syphilis during the study, which was stopped in 1973 by the U.S. Department of Health, Education, and Welfare only after its existence was publicized and became a political embarrassment. Congressional intervention eventually led to the publication of the Belmont Report in 1979, which is now required reading for everyone involved in human subject research. The Belmont Report identifies three basic ethical principles regarding all human subject research: respect for persons, beneficence, and justice. * Respect for persons requires medical researchers to obtain...
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...medicines that heave cure and protected the health of millions of people. The National Institute of Health (NIH) is the federal Government’s primary agency for advancing knowledge in the biomedical and behavior sciences in order to understand and treat human disease. In the past, research process often involved many unethical practices where the research participants lacked adequate protection. To protect human research participants from undo harm, biomedical researchers must follow the four basic ethical principles on which standards of ethical research are based: autonomy, beneficence, nonmaleficence, and justice. Such ethical requirements on biomedical research are found in documents such as the Declaration of Helsinki or the Belmont Report. The four principles and Institutional Review Boards (IRBs) are the principal regulations and ethical protocols when conducted human research. In the United States, the National Institute of Health (NIH) is the primary agency responsible in enforcing ethic in human research but the IRBs falls within the authority of the Food and Drug Administration (FDA). In other countries, different names might be used, such as research ethics committees or ethics review committees. Where ever human research is conducted, either within the US regulations or internationally, it should be conducted only after an appropriate ethical reviewed has occurred. Whether ethical standards are practice according to...
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...questions available 5 on exam Sequential Cluster Name: Question Cluster 1 Exam Text: None Question Order Question Stem, Answers, Feedback for Correct and Incorrect Answers Question Type Active? 1 (ID: 17285) Question Stem: Which of the following studies is linked most directly to the establishment of the National Research Act of 1974 and ultimately to the Belmont Report and updated federal regulations for protecting research subjects? Answers: The "Public Health Service study of untreated syphilis in the Negro male" (Correct) The Tearoom Trade study The Wichita jury study Obedience to authority study (Milgram study) Feedback for correct answer: Although the other studies are clear instances of human subjects abuse, it was the publicizing of the Public Health Service study that triggered congressional action. Feedback for incorrect answer: Although the other studies are clear instances of human subjects abuse, it was the publicizing of the Public Health Service study that triggered congressional action. Multiple Choice/Single Answer Inactive 2 (ID: 51762) Question Stem: According to the Belmont Report, implementing the principle of respect for persons involves Answers: Providing compensation that is commensurate with time requirements. Ensuring that subject selection is fair. Ensuring that risks to subjects are no more than minimal. Making it clear to subjects that they may withdraw from a study. (Correct) Feedback for correct answer: The principle of...
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...research. Zimbardo’s Stanford Prison Experiment and Milgram’s Obedience experiment were ridiculed for the lack of ethics involved. Although these experiments caused unnecessary harm to their subjects they also acted as the foundation for the establishment of the Belmont Report, which in itself, would change research forever. Ethics in the Name of Science Two very controversial experiments have been dissected a thousand times over by some of social science’s most amazing minds as well as the academic populous worldwide. Though the Milgram experiment of 1962 and the Stanford Prison Experiment in 1971 were entirely different, they both shared the groundbreaking task of identifying the affects of “Obedience to Authority” (Milgram, 1974). Both social scientists believe they had identified the possible risks but fell short in their attempt to alleviate any ethical repercussions. This paper will address the attempts made to ensure moral and ethical studies were accomplished as well as identify where both experiments had major flaws in their plans to ensure no physical or emotional harm came to it’s subjects. To establish a baseline for this paper we must first define the basic principles of ethics. The Belmont report of 1979 states “Three basic principles (among those generally accepted in our cultural tradition) are particularly relevant to the ethics of research involving human subjects: the principles of respect of persons, beneficence and...
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...The federal government engaged a panel of experts to evaluate the study and it found out that the study was “ethically unjustified”. Based on the report of the panel, the study was terminated. In the summer of 1973, a class-action suit was filed on behalf of the men against the PHS resulting in nine million dollars being given to the participants as settlement. The Tuskegee Syphilis Study raised many ethical questions regarding medical research. Is it ok to involve human subjects in medical research? What should be the level of information that should be provided to subjects of the study? Considering the uncertainty of research outcomes, what is the level of risk that the researcher should allow the subjects to take? Is the researcher at liberty to choose one group over the other when administering treatment? Following the public outcry over the Tuskegee Syphilis Study, the United States congress established a commission which submitted its report called as the Belmont Report in 1979. The Belmont report laid out principles which are considered as ground-rules for modern day medical research. The Federal Government established the Office for Human Research Protections (OHRP). The OHRP ensures the rights of human subjects involved in research in the United...
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...Anti-Bullying Programs Maryann Johnston DeVry University Anti-Bullying Programs “You may have noticed that this years’ trendy trauma is bullying, which replaces last years’ obesity.” (Nachman, 2011). In his article Gerald Nachman recounts how years ago it was a part of being a kid in school to be teased at some point and it made you a stronger person to come through school surviving the process. There has been an increase in the sensational media coverage of violence attributed to bullying. Almost weekly, there are headline news items concerning acts of violence committed on school grounds, which involve shootings of innocent students by disgruntled gunmen. The underlying cause is portrayed to be a result of some sort of bullying at the hands of peers. One such incident which occurred in an Ohio High School resulted in the death of three students. The gunman’s motives were not clear but, “Yet even as police worked to secure the crime scene, one word quickly attached to the unfolding drama: bullying.” (Cloud, 2012). Further investigation discovered a connection to one of the victims through a former girlfriend of the shooter. The gunman had a troubled family situation which may have contributed to his resorting to violence as a solution. His case was one of bullying his classmates while being a victim of his rough childhood. As a result of these news items there has been a furor which has reached all the way to the President, who has urged school officials to push for legislation...
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...The Ethics of Fieldwork If we are going to conduct a research project including some interviews, we have to know the history of how to take interview by rules. “In 1974, the National Research Act established the National Commission for the Protection of Human Subjects of Biometrical and Behavioral Research. In 1979, the Commission published what’s commonly called “the Belmont Report,” which identifies three basic principles relevant to the ethics of research involving human subjects: respect for persons, beneficence, and justice” (Sunstein and Chiseri-Strater 121-122). All informants should be volunteers in any research projects. They also have to have enough information about the research and then to decide if they would like to be a part of this research. First of all, if we decided to take an interview for our research study, we have to ask our informant to sign formal permission or at least an informed consent form. For example, before I took an interview with Dasha, she gave permission to me to interview her for my English class research paper. I explained the project to Dasha, and she even did not ask me to read the final draft with all information she provided. The only thing Dasha asked me to use a pseudonym instead of her real name. It would not be ethical if I did not protect the anonymity of my informant. To be a good researcher we have to show a respect for person. “Researchers should protect informants against risk from harm and also...
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...The Merchant of Venice opens on a street in Venice, where Antonio, a Venetian merchant, complains of a sadness he can't quite explain. His friends suggest they'd be sad too if they had as much merchandise to worry about as Antonio. Apparently all of his money is tied up in various sea ventures to exotic locales. But Antonio is certain it's not money that's bothering him. Antonio's friend Bassanio enters the scene, and we learn that Bassanio has been at the forefront of Antonio's mind. Apparently Bassanio just got back from a secret trip to see an heiress named Portia in Belmont. Bassanio financed his trip (and in fact, his entire lifestyle) by borrowing tons of money from Antonio. Portia is beautiful, intelligent, and, most important, rich. If Bassanio could only get together the appearance of some wealth, he would be in a good position to compete with all the other guys vying for Portia's attention. If they marry, he's all set financially. Antonio would be happy to lend Bassanio the money he needs to woo Portia, except, as we know, all of Antonio's money is at sea. The two friends part ways, agreeing that they'll try to raise the funds on Antonio's credit around town. Meanwhile, even rich heiresses have their troubles. Portia is plagued by suitors from the four corners of the earth but isn't allowed to choose the one she wants. Instead, her father, before his death, devised an unusual test. Three caskets – one gold, one silver, and one lead – are laid out before each suitor...
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...Merchent of venice The Merchant of Venice opens on a street in Venice, where Antonio, a Venetian merchant, complains of a sadness he can't quite explain. His friends suggest they'd be sad too if they had as much merchandise to worry about as Antonio. Apparently all of his money is tied up in various sea ventures to exotic locales. But Antonio is certain it's not money that's bothering him. Antonio's friend Bassanio enters the scene, and we learn that Bassanio has been at the forefront of Antonio's mind. Apparently Bassanio just got back from a secret trip to see an heiress named Portia in Belmont. Bassanio financed his trip by borrowing tons of money from Antonio. Portia is beautiful, intelligent, and, most important, rich. If Bassanio could only get together the appearance of some wealth, he would be in a good position to compete with all the other guys vying for Portia's attention. If they marry, he's all set financially. Antonio would be happy to lend Bassanio the money he needs to woo Portia, except, as we know, all of Antonio's money is at sea. The two friends part ways, agreeing that they'll try to raise the funds on Antonio's credit around town. Meanwhile, Portia is plagued by suitors from the four corners of the earth but isn't allowed to choose the one she wants. Instead, her father, before his death, devised an unusual test. Three caskets – one gold, one silver, and one lead – are laid out before each suitor, and whoever picks the right one gets the girl. Portia...
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