Patient Advocacy and Autonomy: Belmont Report Ethical Principles
Read "The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research" (1979):
http://www(dot)hhs(dot)gov/ohrp/humansubjects/guidance/belmont.html
Write a 1,250-1,500 word paper that addresses the significance of autonomy, patient advocacy, and informed consent. Your paper should include:
A description of the concepts of autonomy, patient advocacy, and informed consent.
A discussion of the Nuremberg Code and the Declaration of Helsinki and a summary of the events that led up to the development of ethical guidelines for conducting human clinical trials, including Institutional Review Boards (IRB).
Three examples of ways "The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research" works to protect special populations (e.g., minors, prisoners, persons with mental illness).
A minimum of three references are required.
Prepare this assignment according to the APA guidelines found in the APA Style Guide, located in the Student Success Center. An abstract is not required.
Belmont Report
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Description of Belmont Report Ethical Principles
Respect for persons
This principle is pegged on the presumption that all people have the autonomy to do their own decisions. The Belmont report defines ‘respect autonomy as to give weight to autonomous persons' considered opinions and choices while refraining from obstructing their actions unless they are clearly detrimental to others.’ Hence, anyone who voluntarily enters into research as a subject is entitled to autonomy to make his/her own decisions especially on whether to participate in the research or not. in the event that the subject is incapable of self-determination, a legal representative assumes the role of self-autonomy. The capacity of self-determination can be affected by illnesses, genetic conditions, age, etc. and therefore a legal representative assumes the responsibility to make autonomous decisions on the behalf of the subject.
Beneficence
CITATION Mue06 \l 1033 (Mueller & Hook, 2006) defines beneficence as ‘the principle of beneficence requires that investigators act to secure the well-being of human research subjects, maximize benefits and minimize risks and harm.’ The two main rules of this principle are; do not harm and should be aimed to maximize possible benefits and minimize possible harms. Since it is nearly impossible to determine that the subject may not be harmed, there is a grey area in this principle and it is fairly subjective in that the researcher weighs the possible risks to ascertain whether the subject will be harmed. The researchers have to determine when benefits should be foregone because of risks and when benefits should be sought despite the risks.
Justice
The principle of justice refers to the equitable distribution of the benefits and burdens of research. The general idea of justice is the fairness of distribution. No one should have unfair advantage because of his/her societal status and neither should anyone with low societal ranking be subjected to unfair terms or procedures because he/she cannot afford the advantage or innovations of a research study. Thus, the selection of subjects must be fair and that no class of people should be unfairly targeted or manipulated for their availability or compromised availability rather than for reasons directly related to the problem being studied.
The Nuremberg code & Helsinki Declaration
During World War II, the Nazi Germany government used unethical approaches to human medical exploration. The tyrannical government of Nazi Germany targeted specific pool of people who were coerced to agree to participate in some scientific experiments. The selection process was subjective and was inclined towards advancing the eugenic practices of the Nazi Germany government to create a master race, the Aryan race CITATION His17 \l 1033 (History.com, 2017). During this time, the medical explorations targeted mainly the mentally sick, people living with physical disabilities, specific ethnicities, etc. the experiments had nothing to do with the background of these people, rather, the Nazi Germany government targeted them because they were vulnerable and lacked equal protection of rights as other Germany citizens. When the war ended, the allied forces began trials into the medical personnel who were complicit with the Nazi Germany government to carry out these human experiments which left many disabled, emotionally troubled and fatalities in some cases. Mostly, the defendants pegged their innocence or lack of clear guidelines on conducting human trials and this prompted Drs. Andrew Ivy and Leo Alexander who worked with the prosecution to come up with six guidelines for ethical medical research. The guidelines were later expanded to 10 and they became the Nuremberg code after the place where the doctors were tried for their unethical approach to medical exploration under the Nazi Germany government.
The Nuremberg code came up with the following resolutions to guide human clinical research CITATION Uni \l 1033 (United States Holocaust Memorial Museum Online Exhibitions)
1. The voluntary consent of the human subject is absolutely essential.
2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.
3. The experiment should ...
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