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Informed Consent Analysis

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The creation of an informed consent I believe is pivotal asset in random control trials. Patients in North, Guinea Pigs in South provided the history in which informed consents were not obtained by participants in several studies. There were clinical trials mentioned in the movie that had harmful affects due to lack of consent and ethical issues. I believed the movie highlighted that informed consent is not only important in the United States, but internationally. Furthermore, there is even more procedures in place when clinical trials are done on foreigners. The purpose of this paper is to explained how the movie provided several advantages of informed consent. Finally, how the elements of informed consent that were discussed in class could …show more content…

The concept of transparency would have been valuable in the controversial clinical trials described in the movie. In the Tuskegee Experiment if the men were being told the implications and ramifications of the study could have reduced long-term consequences for the participants. Moreover, for patients in the Nigerian clinical trial transparency would have allowed many parents to become aware of all aspects of the study before agreeing to allowing their children to participate. As Dr. Francis Tremolliere noted, in clinical trails it is important that participants are not just signing a consent, but there should be ongoing and stable communication between researchers and …show more content…

One issue with informed consent that was showcased in the Nigerian study was the participants not explaining the study and lack of simplicity. The parents in the Nigerian study lacked the knowledge on the side effects of trovan and were not aware of everything that Pfizer were doing to their children. One parent mentioned in the movie stated that the researchers were isolated and they were not invited to see their child. Therefore, I believe participants whether children or adults should be privy to all information in a detail and simplistic way. The last element I believe that was highlighted in Patients in North, Guinea Pigs in South is the concept of voluntarism. I think in each of the clinical trials participants did volunteer, but there was an element of coercion. As it was mentioned in the movie many international participants who are poor, often times willingly participate due to being informed they will receive incentives such as free medication. Secondly, many patients may participate because of power of the medical authority. Thus, in any clinical trial it is important that participants are not involved because they are guaranteed

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284 Words | 2 Pages

Faden and Beauchamp discuss two definitions of informed consent, which are labeled sense1 and sense2. First, sense1 informed consent is defined as “autonomous authorization”. (Vaughn, p. 191). The key aspect of sense1 is that the patient has the autonomy to consent, or refuse consent. Faden and Beauchamp state four defining characteristics of sense1 informed consent: complete understanding of the consent, individual desire for the consent, intent to consent, and authorizing consent.

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1217 Words | 5 Pages

Those who live on a very low income, who are from developing countries or are part of the lower classes agree to participate for financial reasons, and usually were not fully informed about all of the risks and side effects (Moreno). In the United States the more vulnerable segments of the population have continuously been the subjects of medical experimentation, but African Americans, including children, assumed a unbalanced burden and suffered the most brutal, and invasive of the medical experiments. In the article written by Jonathan D. Moreno, “Master Sergeant James B. Stanley volunteered to be a subject in a study advertised as developing and testing measures against chemical weapons, but Stanley was never told that the clear liquid he drank for the test contained a psychoactive drug, nor was he debriefed or monitored for the hallucinations that followed, nor did he understand the source of the emotional problems that disrupted his personal life, leading finally to his divorce in

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646 Words | 3 Pages

Likewise, the best treatment should not refer to local treatment standards, but the best standards available to maximize the beneficence and justice applied to participants already undertaking the burden of participating in a clinical trial. Unfortunately, ethical principles can sometimes be neglected due to competition in the field and the increase of regulations. This has resulted in some ethically questionable trials based in third world countries that violate justice, autonomy, and beneficence to obtain faster results. Harold Varmus and David Satcher’s perspective on what standards and guidelines should be implemented in clinical trials in third world countries differs from that of Angell’s arguments. They make the argument that compared to other approaches, a placebo is the most justified way to obtain clear and rapid results from clinical trials regardless of what treatments may currently be available.

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479 Words | 2 Pages

This is a problem in the documentary and is very disrespectful. What is "informed consent?" Informed consent is a common litmus test for many of the ethical issues. Participants in a study should be told the consequences.

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1937 Words | 8 Pages

“Simple Definition of medical informed consent a formal agreement that a patient sign to give permission for a medical procedure (such as surgery) after having been told about the risks, benefits, etc. Full Definition of informed consent consent to surgery by a patient or to participation in a medical experiment by a subject after achieving an understanding of what is involved.” (merriam-webster Dictionary) The first laws for informed consent was made in 1974 they called it the National Research Act. They the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

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1023 Words | 5 Pages

We need to be able to understand what the nature of the procedure is and what it details. It’s also good to discuss other types of alternatives. Informed consents can also bring up certain topics about the risk that can be involved with the procedure. As healthcare professionals it is part of our job to help look after the patient and make sure that all legal documents are in order.

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1035 Words | 5 Pages

Participants in the study were not subject to any physical harm, discomfort or psychological distress during the research. Towns people were grieving the loss of community members and openly spoke about what they knew to have happened, and shared their losses with Capote and Lee in a casual conversation format. Eventually, Capote does question Perry Smith about the night of the murders, and physical distress does come through in reliving what had happened. I do believe beneficence was withheld throughout the research phase of Capote’s writing. While watching the movie I do not believe there were any major risks associated with the research being

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546 Words | 3 Pages

First of all, the investigators should have respected the people they were going to conduct by obtaining an informed consent, letting the men decide if they want to be a participant after all. Second of all, medical researchers should not have lied to the people about how long this study was going to last. Third of all, both the risks and the benefits of it should have been stated to them so that the men could decide if this experiment is any beneficial to them or not. Lastly, the participants should have been randomly assigned to the control or experimental group without considering their race, class, and gender. Also, the medical researchers should not have the right to give the favored participants the helpful treatment rather than the riskier

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520 Words | 3 Pages

It has now been a quarter of a century, and yet the images and heartache that still evolve when the words "Tuskegee Syphilis Study" are brought up, still haunts people around the world and touches upon many professionals such as social workers, medical examiners, and so forth. Sometimes people hear about this disgusting human experiment in a highly visible way directed to the entire country as an example of what we as a country and people, in general, should not do. This occurred when the study first made national news in 1972, when President Clinton offered a formal apology, or when Hollywood actors star in a fictionalized television movie of the story. On the other hand the audience may become fainter: kept alive only by memories and stories told in the African American community, in queries that circulate over the world wide web and radio talk shows, or even in courses such as this one being taught by social workers, historians, sociologists, or bioethicists. This is neither the first nor the last unethical human experiment done under the human study for the medical purposes umbrella, basically stating it is ok to sacrifice a few people in the name of medical research.

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379 Words | 2 Pages

INFROMED CONSENT ARE PATIENTS TRULY INFORMED??? Informed consent gives a competent patient the freewill to make his decisions about his health after getting informed adequately about the procedure, its alternatives, pros &cons and uncertainties related the procedure and its alternatives. Above all the patient’s consent must be voluntary and without any kind of pressure whatsoever. There are few fundamental question

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930 Words | 4 Pages

Informed consent. A.2.b. Types of information needed. A.4.a. Avoiding harm.

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894 Words | 4 Pages

Similarly, confidentiality and informed consent are generally perplexed. Because parents are included in the treatment plan of children, it is important for them to fully understand the purpose of informed consent. Conversely, times may arise when cases are presented with extreme difficulty where individual analysis is warranted on a case by case. For example, a referral for a hyperactive child, who is assessed, diagnosed, and treated. For treatment to take place consent from the parents must be given, however, the child's views and wishes must also be considered when a child is included in their own treatment plan particularly in teenagers.

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1109 Words | 5 Pages

In fact they were being harmed. An example from the movie is when the participants in the experiment were told entering the program by Nurse Evers that they were all being treated for bad blood when in fact they were being solely experimented on for the benefit of the government. The men were receiving free treatment that was not even designed to better their health. The benefits for the participants did not outweigh the risks. Matter of fact one may argue that there were many risks and little to no benefits.

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1034 Words | 5 Pages

Participants must be warned of all the potential problems that can arise during the study such as additional costs, extra procedures, and or extra treatments needed. Having informed consent sounds nice and sweet but that was not always the case; for a long time physicians had a problem with giving consent because they felt that it only complicated the matter of the study by adding more bias views to the study slowing down the research progress. Some physicians feel that it is their job to use good judgement to recommend treatments that are best for their patients; that being said, physicians would not recommend doing a clinical trial if it was not good for them. On the other hand patients feel that the people involved in the study should be able to choose what goes on in their lives especially when they are being used as research “guinea pigs”. Today it is highly recommended that clinicians work with their patients throughout the study to constantly reaffirm each individuals’ goals in the study; it is key that they do this to make sure that patients understand the research process.

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973 Words | 4 Pages

They think the level of risks increase on patients especially because the one who are conducting the trials are the same as the ones who are being experimented. But what these people don’t know is that these ethical concepts are no longer acceptable. Nowadays researches won’t be conducted unless the participants are fully aware of the potential risks that they might encounter and they should be informed of the kind of treatment they will receive. Another important point is that the researcher should of course focus on making the experiment work no matter what, but his duty falls in the first place on taking care of the patients regardless the medical

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