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Ethics In Qualitative Research
Prompt #1 – What does Creswell say about the ethics of data collection? Compare and contrast that
with the ethics of data collection one might encounter in the fields of intelligence, counter–
terrorism, and protection.
The forms of data collection are often grouped into four basic categories such as journals, blogs, e–
mail, and video. These four forms, as defined by John W. Creswell (2013) are interviews,
observations, documents, and audiovisual materials (pg. 152–162). The author mentioned about the
challenges with qualitative research can include protecting sources, storing data, informing and
receiving subject consent for participation in the study. Among those, ?Informed consent or
voluntary? is one of the biggest ethical challenges in ... Show more content on Helpwriting.net ...
American Anthropological Association (TheAAANet.org). October 31, 2007.
http://www.aaanet.org/about/Policies/statements/Human–Terrain–System–Statement.cfm, accessed
19 Aug 2011.
?U.S. Military, Oblivious of Iraqi Culture, Enlists Anthropologists for Occupation.? Alternet.org.
January 19, 2008. http://www.alternet.org/world/74326/?page=entire
?Welcome to the HTS Page.? Army.mil. Last updated: March 24, 2011.
http://humanterrainsystem.army.mil, accessed 18 Aug 2011.
Johnson, Eric Michael. ?AAA Honors Franz Boas, After Shunning While Alive.? The Primate
Diaries, A Scientific American Blog. July 9, 2009.
http://scienceblogs.com/primatediaries/2009/07/aaa_honors_franz_boas_after_sh.php, accessed 14
Aug 2011.
O?Connor, Tom, Dr. ?Research Ethics.? MegaLinks in Criminal Justice. Last updated: July 17,
2011. http://drtomoconnor.com/3760/3760lect05.htm, accessed 17 Aug 2011. ?The Evolution of the
U.S. Intelligence Community–An Historical Overview.? U.S. Government Printing Office. 1 Mar.
1996. ?Preparing for the 21st Century: An Appraisal of U.S. Intelligence; Appendix A.?
http://www.access.gpo.gov/intelligence/int/int022.html, accessed 6 Mar.
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Analysis Of Chinese Health Promotion Hospitals
Several recent natural disasters have occurred in China including the Wenchuan earthquake in 2008
(8.0 on the Richter scale), the Yushu earthquake in 2010 (7.1 on the Richter scale), the Yuliang
earthquake in 2012 (5.7 on the Richter scale), the Yaan earthquake (6.5 on the Richter scale), and the
Ludian earthquake in 2014 (6.5 on the Richter scale). The Chinese government has increased its
focus on public health in post–disaster areas and has provided sufficient funding to support
construction of local hospitals. Additionally, the government has attempted to improve medical
services to promote public health [1, 2]. In 2013, the Chinese government proposed the Chinese
Health Promotion Hospitals (CHPHs) programme [3].The Health–Promoting ... Show more content
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Disaster conditions also challenge their physical and mental endurance [9]. Healthcare professionals
may have increased risks of post–traumatic distress due to their work. For example, Shrestha R
reported that health professionals working in the Nepal earthquake of 2015 were at significantly
higher risk of developing post–traumatic stress disorder (PTSD). The overall prevalence rates of
PTSD were 21.9% and 17.1% using cut off scores and diagnostic criteria, respectively [10]. A study
by Oglodek E. showed that 40% of medical rescuers experiencing PTSD reported that the
dissociation was caused by the death of a patient being rescued [11]. Additionally, Yu YM et al.
revealed that during the Wenchuan earthquake in 2008, more than 50% of medical staff
demonstrated several of the following signs of stress: grief, fear, depression, anxiety, fatigue,
headache, and dizziness [12]. Therefore, health quality of healthcare professionals after disasters is a
significant issue [9, 13].
To our knowledge, the data regarding how medical staffs promote healthy lifestyles after a disaster
are unclear. We hypothesized that additional data could provide reliable empirical evidence for
health promotion in health workers and the public in post–disaster areas as well as for the
development of CHPHs. The primary goal of this study was to determine whether healthcare
workers took healthier lifestyles than other
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Medical Ethics As A Moral Compass
Medical Ethics as a Moral Compass
I work for a government run medical center. As an organization we are run by government
oversight, rules and regulations and high–powered patient complaints. If a provider is not ethically
oriented they will be found out and dismissed quickly. The flip side of the coin, most people work at
this medical center because they enjoy their work and the patient population. We work well with one
another and come together overall for the common good. There are no incentives which can lead to
ethical misconduct. Additionally, physicians have their own code of ethics. The Hippocratic Oath, is
a set of principles for physicians' conduct, which aim to protect the rights of the patient and oblige
the physician voluntarily to behave in an altruistic manner towards patients (Riddick, 2003). The
four basic principles of medical ethics (autonomy, justice, beneficence and non–maleficence) form
the foundation for health professionals to guide and decide what practices are ethical. These basic
ethical principles are based on the major documents of healthcare ethics (Hippocratic Oath,
Nuremberg code and Helsinki declaration). Future doctors and nurses are expected to learn and
abide by these ... Show more content on Helpwriting.net ...
We are only human after all, and we are likely to make mistakes when it comes to the gray areas of
ethics. One way to assure we do the best we can is keep the lines of communication open and the
feeling of a safe zone ever present. If employees feel like they are in a safe environment and can
question a practice, or even a superior, than we are less likely to have unethical issues get out of
control. Finally, ensuring clarity in the organizational ethical culture promotes higher work
engagement, less emotional strain and exhaustion, and lower turnover rate. These all lead to a
decrease in unethical activity and a healthier work environment (Huhtala et al.,
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Ethical Principles Of The Tuskegee Study
Ethical principles were established to help protect the human population from being unlawfully
treated when involved in any type of treatment, research study, or medical decision–making. Miss
Evers' Boys provide examples, to how ethical principles were neglected to be used throughout the
study. The Tuskegee study lasted a brutal 40 years and ethical principles where pushed aside, to
obtain the evolution of syphilis in African American males. Anyone who is involved in some type of
medical treatment or research deserves to be treated with respect and dignity. As healthcare
professionals it is imperative to understand ethical principles and morals and be able to apply them
to every day practice. The Tuskegee study was an eye opener to many individuals, leading to laws
and reconstructed ethical principles. According to Ogungbure, The aim of research ethics is to
ensure that research projects involving human subjects are carried out without causing harm to the
subjects involved. (Ogungbure 2011) As a nurse it is important to follow the ANA code of ethics.
Being aware and practicing ethical principles will help with treating the Patient and keep them
informed with their healthcare choices. Nursing in itself can be challenging and everyday you can be
faced with ethical dilemmas.
Overview of the Tuskegee study
The Tuskegee study was an experimental study composed of Doctors, Nurse, Government officials
and the U.S Public Health Service. The study was performed to recognize
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D5 Disclosure Analysis
The invention claimed in claim 1 does not involve an inventive step when the disclosures of D5 and
D6 are combined: D5 discloses: A system for predicting a health outcome of a subject in an
environment (Abstract). In animal husbandry, it is considered a body temperature and weight of a
livestock is associated to the health of the livestock. comprising: – a camera (Item 1) situated within
the environment configured to capture one or more images and/or a video sequence including at
least a portion of a feature of the subject (Para.0025); and – a processor (Col.4, Lines 52–65),
configured to identify and segment at least a portion of the feature from the one or more images
and/or video sequence to form one or more segmented features (Col.2, Lines 46–Col.3, Lines 10), to
calculate one or more metrics from the segmented features (Col.2, lines 61–Col.3 lines 10). D5
disclose using a thermographic screening of livestock to recognize animal health (Col.4 lines 22–51
and thus is able ... Show more content on Helpwriting.net ...
The problem to be resolve in the application is reducing time and constraint in determining a health
and wellbeing of livestock in animal husbandry. D6 discloses a method of utilize infrared
thermography for early detection determines several disorder of a livestock, for example:
inflammation, infection disease, mastitis (Para.0020). D6 also discloses comparing the rate of
change in temperature of the same animal from the previously obtained infrared thermographic
result (Para.0064). The rates of change of temperature are monitor, measuring over a period of time
(Figures 1–9, Para.0071). It is considered the analysed results of the changes in temperature in the
livestock are considered as risk value
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Good Clinical Practice
Good Clinical Practice (GCP) is important because, 1– It is an international ethical and scientific
quality standard for the conduct of clinical research. 2– Compliance with this standard provides
public assurance that the rights, safety and well–being of trial subjects are protected, consistent with
the principles that have their origin in the Declaration of Helsinki. 3– It assures the quality,
reliability and integrity of the data collected. Q2– What are the three principles of Belmont report?
The three basic ethical principles are; respect for persons, beneficence, and justice. Respect for
persons involves a recognition of the personal dignity and autonomy of individuals, and special
protection of those persons with diminished autonomy. Beneficence entails an obligation to protect
persons from harm by maximizing anticipated benefits and minimizing possible risks of harm.
Justice requires that the benefits and burdens of research be distributed fairly. Q3– What specific
areas of the ICH–GCP did the investigator not follow? The study in this scenario was conducted and
the results was published. However, the study had not been approved by the Spanish Agency for
Medicines and Health ... Show more content on Helpwriting.net ...
The investigator informed the participants that he had his hospital ethical approval for the study. The
subject in this situation, had given their consent base on a false/incomplete information making their
given consent not valid. Furthermore, the investigator in this study, tested an approved medication,
but in an unapproved regimen on a large number for HIV patients, exposing them to the possibility
of all the medication and trial related risks, without having an ethics board approval and without any
monitoring or auditing of the trial. In my opinion such investigator's behaviour, is both illegal and
un ethical. The investigator also, did not obtain insurance for the
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Tuskegee Model Case For Unethical Research Practices
In the case of the Public Health Service (PHS) experimenting on inmates at the Terre Haute Federal
Penitentiary for prophylaxis in gonorrhea, it was clear that the study was abandoned at a critical
stage in its develop where a line would have been crossed, exposing and crossing moral/ethical
boundaries set about in countries such as the U.S. as far as research on human beings is concerned.
The decision to continue the same research beyond boarders and use subjects from a Guatemalan
National Penitentiary with the mere consent of their supervisors and not from the subjects
themselves, along with the differences in human rights policy in this nation, ultimately allowed the
study to be undergone with less regulation, whereby human rights to justice ... Show more content
on Helpwriting.net ...
Ultimately, the investigators are responsible for the well–being of the patients and that only when
there is no effective treatment know, it is ethical to compare a potential new treatment with a
placebo, however, when effective treatment is known, the the control group must be given the best
treatment. In this case, an effective treatment was in fact known (penicillin), however, as it was not
standard procedure to treat in prisons and was not given to the control group. Meanwhile, those who
were seen to have the illness outside of this study in both Guatemala and the U.S. were treated with
penicillin. Clearly, violating the investigator's state of equipoise and the human rights of the
subjects. All of this can be summed up with a point made saying: "a problem inherent in research
that must be balance and rights of individuals and the group benefit is not social good but global
good," (EHC,
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Xenotransplantation Essay
Moral, Environmental and Cultural Issues
From the beginning, xenotransplantations have been an ethically controversial procedure and for
many diverse reasons. Diverse groups are fervently opposed to it: animal rights groups, for instance,
are undoubtedly against butchering animals to collect their organs for some human's sake. Although,
most major religions aren't resistant to the use of genetically modified xenografts to save human
lives, the proscription of pig consumption poses some dilemmas for the Jewish and Islamic
communities. "When divine providence is not being used to justify the genetic engineering of
animals, then some evolutionary ethic of 'the strongest calls the tune' or 'might is right' seems to
obtain" (Sherlock & Morrey, 2002, ... Show more content on Helpwriting.net ...
Patients, in that case, must be entirely aware of what the procedure implies, without any outside
influence affecting their choice, and must, themselves, understand the risks and benefits of this type
of transplantation.
Also, some have suggested that family and close friends of the patient should also give consent
because of the magnitude of repercussions xenografts imply; the great possibility of diseases and
viruses crossing over to humans make the patients' closest contacts at risk as well. Therefore, it is
important that those contacts be monitored to assure that a xenozoonosis is not happening. This
proposal arise another ethical question: the consent of the patient can turn out to be narrowed down
if the family and friends don't agree with putting themselves at risk and the confidentiality principles
would also be broken.
Evidently, the public's safety remains a significant element to be measured. Procedures must be in
place to protect the public from any risk due to possible outbreaks. Ergo society must understand the
risks and benefits of xenograft and consent to its application. This societal response is a very
important ethical issue according to the Ethics Committee of the International Xenotransplantation
Association and it will be hard to overcome until researches proves the achievement of a low risk
graft, resulting from genetically modified
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Nuremburg Code Of Ethics Essay
The rights of research participants became a topic of concern as a result of the Nuremberg Trials in
1945. After World War II and the Holocaust it was discovered that Nazi soldiers conducted
experiments on prisoners of war. Informed consent from the prisoners was not granted and they
became participants against their wishes. These prisoners of war were not given a choice whether or
not to participate. People all over the world were outraged and the Nuremburg Code of Ethical
Human Subjects Research Conduct came into being. This code of ethics is the first of its kind in our
society to highlight the necessity of voluntary participant consent when conducting research and
investigations. Declaration of Helsinki In 1964 the World Medical Association ... Show more
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This study again demonstrates the need for informed participant consent. In this study participants
were not provided with proper information regarding the study. Although the subjects consented to
being part of the study they were not told of the true intent or purpose of the research. Participants
did not receive the implied treatment they needed to survive the illness. The men involved in the
study were in fact misled and were not presented with factual information to make an educated
decision regarding their participation. Subsequently, the news media broke the story forty years
later. Public uproar demanded an investigation. As a result the study ended immediately and a higher
need for informed consent came to light once more (Centers for Disease Control and Prevention,
2017). The need for satisfactory moral and ethical laws was now at stake. The result of the
Nuremburg Trials and the Tuskegee Study resulted in the National Research Act (Pub. L. 93–348).
This act was signed into law on July 12, 1974. The passing of this law produced the National
Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
(Department of Health, Education, and Welfare, 1979). The job of this commission was to pinpoint
principles which involved human participants and to provide the rules and procedures necessary to
insure the safety of research participants. As a
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Biostatistics Student Journal Club
Biostatistics Student Journal Club Questions and Answers 10/17/2016 Group #12: Jenna Nixon, Vu
Le, Sarah Jacob, Kajri Shah, Andres Brito, Isis Sanders Question #1: What was the null hypothesis
of the study and was it accepted or rejected? Answer: The null hypothesis was that there is no
association between lower blood sugar and taking the oral glucagon receptor antagonist LY2409021
in healthy and diabetic individuals. The study found that taking the glucagon receptor antagonist
does indeed help lower blood sugar in healthy and diabetic individuals with very limited
hypoglycemia; therefore, the null hypothesis was rejected Question #2: What ethical guidelines, if
any, were used during this research study? Answer: The study used the Declaration ... Show more
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Answer: The primary objective was to test if the glucagon receptor antagonist use is safe and if
study participants will be able to tolerate the drug. Also, they wanted to test the therapeutics effect of
the LY2409021 drug on the study participants and how the participants' body will affect the drug.
Question #4: What measurements were conducted during the study to ensure that the participants
were safe? Answer: The subjects in the study were regularly tested on their vital signs,
echocardiogram and clinical laboratory tests. Question #5: Was this journal peer reviewed and what
was its impact factor? Answer: The journal (Diabetes, Obesity, and Metabolism) had a journal
impact factor of 6.198 in 2015, according to InCites. The journal, however, is not peer–reviewed per
Ulrich's Periodicals Directory. Question #6: How were the participants selected for the studies?
Answer: The study participants for the studies were selected based on the following criteria: For
Type 2 Diabetes Study Participants: Hemoglobin A1C level that 11.1/1, following an oral glucose
tolerance test For Healthy Study Participants: BMI 18.5–29.9 kg/m2, Fasting blood glucose level of
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The Pros And Cons Of The Declaration Of Kosovo
A unilateral declaration of independence by Kosovo's February 17, 2008 has caused mixed reactions
in the international community. To date, Kosovo's independence from Serbia was recognized by 110
states out of 193 (56.9%), the United Nations Member States (the United Nations). At the same
time, other states – members of the United Nations (more than 1/3), including two permanent UN
Security Council members (China and Russia), refused to recognize the independence of Kosovo or
declared neutrality. In order to take a seat at the UN, country must have the support of 2/3 of the
states – members of the UN (129 out of 193) and the approval of the UN Security Council, in
particular, the absence of a veto of any permanent member of the Security Council ... Show more
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Of course, the UN Security Council resolutions can be changed, but as long as it remains applicable
legal act, and its non–compliance is a violation of international law. Referred to in resolution 1244
in 1999, but we should not forget that the current document does not contain a single word about
independence (the more independence from Serbia Serbian same territory) can argue about the legal
identity is now a legal entity. On the contrary, the text of resolution 1244, and its applications on
several occasions expressed the commitment of all Member States to the sovereignty and territorial
integrity of the Federal Republic of Yugoslavia (Muharremi, 2014).
Kosovo precedent would undermine the role of the UN and enhancing the role of the EU and
NATO. The role of the observer, which is assigned before the UN Mission in Kosovo (1999 to 2008)
is now transmitted to the representation of the EU International Steering Group for Kosovo,
composed of 15 European countries to recognize Kosovo's sovereignty. Creating Group is contrary
to UN Security Council resolution 1244 and internationally agreed principles of settlement of the
Kosovo (Peters,
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Code of ethics serves as the moral compass that directs...
Code of ethics serves as the moral compass that directs and guides the integrity, values, and beliefs
of an organization. A code of ethics clarifies to employees what the company stands for and its
expectations for employee conduct (Daft, 2013). A well–written code is a true commitment to
responsible business practices in that it outlines specific procedures to handle ethical failures. Within
the research enterprise, the code of ethics ensures that research projects involving human subjects
are carried out without causing harm to the subjects involved. Research ethics also ensure
researchers conduct research in an ethical manner. This paper will focus on the regulations and
guidelines that govern ethics in research, a study where ... Show more content on Helpwriting.net ...
Within the research enterprise, ethics serve as the moral compass in to ensure that research projects
involving human subjects are carried out without causing harm to the subjects involved. In addition,
it provides a governing structure which ensures that human participants in research are not exploited
either physically or psychologically. In addition, research ethics educates and monitors scientists
conducting research to ensure that they are adhering to the guidelines and regulations associated
with research. Ethics also ensures that researchers can use the knowledge obtained to oversee
clinical research and insure its conduct in a safe, scientifically sound and ethical manner (Tremaine,
Carlson, Isaacs, Motil, Robuck, & Wurzelmann, 2005).
This research paper will provide a brief history of ethical guidelines associated with research, one
research tragedies where research ethics were violated, and recommendations to ethics are
maintained with the research enterprise.
Brief History on Research Ethics
There are several regulations and guidelines that govern the research enterprise. They provide the
foundation for research ethics. These regulations and guidelines were formulated to ensure
researchers conduct research in an ethical manner and to ensure that no human subject is harmed or
violated. There are three key guidelines that have been implemented to ensure that
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Nazi Medical Experiments Research Paper
Nazi medical experiment: 1933 to 1945, the program of the Nazi regime included sterilization,
euthanasia, and medical experimentation for the purpose of producing a population of "racially
pure" Germans who were destined to rule the world. The medical experiments were conducted on
prisoner of war and those that were considered racially valueless such as Jews. They were confined
to concentration camps, exposed to high altitudes, freezing temps, malaria, poison spotted fever, and
untested drugs and surgical procedures without anesthesia. Nuremberg code: involved in the Nazi
experiments. Mistreating of human subjects in these studies led to the development of the
Nuremberg code in 1949. The code included guidelines that should help with consent
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Tuskegee Case Study
Introduction The Tuskegee Syphilis experiment was an unethical scientific study funded by the US
Public Health Service that was performed on African American men in Macon County, Alabama that
took place from 1932– 1972. The purpose of this experiment was to study the progress of untreated
syphilis in African American men; a total of "600 black men – 399 with syphilis, 201 who did not
have the disease." (U.S. Public Health Service Syphilis Study at Tuskegee, 2013) The study was
conducted under false pretenses, in that the scientist lied to the patients saying they were being
treated for "Bad Blood" while being provided a placebo. In 1945 penicillin was discovered to be an
adequate treatment for syphilis, and everyone who could get ... Show more content on
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This provides a guideline that ensures that researchers minimize the amount of risk a study may
impose to a participant. When planning a study, it is also important that each of the participants are
provided with a sense of security and not placed at a disadvantage. When participants enter into a
study, a level of trust is established, and their identities and the information they provide must be
protected and never be used against them or exploited for any reason. Respect for human dignity
includes two rights; the right to self–determination and the right to full disclosure. When conducting
a research study these two rights must be maintained to ensure that the participants are not coerced
into participation and that they are making the choice of their own free will. Patients must be
provided with all the information necessary to make an informed decision and voluntarily
participate. No deception or concealed data collection can be done because it will violate the
patients' rights. Justice represents two rights; the right to fair treatment and the right to privacy. The
right to fair treatment consists of being treated in a nonjudgmental, nonprejudiced manner and with
respect. Those that do not complete the experiment cannot be denied treatment that may be
established from the information gathered, nor can they be denied treatment if they seek outside
treatment. The right to privacy provides limits that "their research is not more intrusive than it needs
to be, that
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Keynote-024 Case Study
The KEYNOTE–024 trial was designed by Merck representatives and academic advisors. According
to European legislation, Merck, as the Sponsor, designated, per country, a national principal
coordinator, responsible for coordinating the work of the principal investigators at the different trial
sites in each member state of the multicentre trial, according to national regulations. Each
coordinator agreed to allow: 1) the respect of local laws, rules and regulations relating to the
conduct of the clinical trial; 2) a regulatory authority inspection of trial–related documents and
procedures and 3) the access to all trial–related source data and documents. The Code of Conduct, a
collection of goals and considerations that govern the ethical and scientific
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Guatemalan Pharmaceuticals
In the case of the Public Health Service (PHS) experimenting on inmates at the Terre Haute Federal
Penitentiary for prophylaxis in gonorrhea, the study was abandoned at a critical stage in its
development where a line would have been crossed, exposing moral and ethical boundaries set
about in countries such as the U.S. as far as research on human subjects is concerned. The study was
undergone with less regulation as a result of the decision to extend the research beyond borders to
study syphilis, use subjects from a Guatemalan National Penitentiary with the mere consent of their
supervisors (not from the subjects themselves), along with the differences in human rights policy in
this nation, whereby human rights to justice and moral obligation issues were jeopardized. The
questions would therefore be: can it be well argued that the actions of the PHS and the OverNow
study were morally justifiable under the given circumstances while conducting their research
abroad? ... Show more content on Helpwriting.net ...
All actions taken by the researchers and their constituents (the pharmaceutical co–sponsoring the
study, Healthy People Pharmaceutical) should evaluated according to the principles set about by
Rawlsian justice and from a deontological perspective that is concerned with the moral obligations
one has to the betterment of society as a whole and the morality of individual action. Through this
essay, I seek to prove that the conducted research was unethical and a clear violation of human
rights. Thus, further examination has revealed clear violations of the principles of Rawlsian Justice
from a deontological perspective, and a multitude of internationally recognized legal principles that
directly address cases of human research subject injustice that were observed in the past were also
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Research Ethics : Animal And Clinical Research
Research Ethics: Animal and Clinical Research When it comes to clinical research, many people
think of clinical trials, but that's only merely a small portion of a process towards a medical
development involving a process call bench to the bedside. Clinical research outline scientific
investigation involving animal or human subjects helping translate basic research into new
treatments that would be valuable to patients. Clinical trials can contain a variety of research under
the departments of physiology and pathophysiology, health services, and mental health.
Furthermore, the process of developing new treatments from the bench to the bedside come in three
stages: basic research, transitional research, and clinical research. First ... Show more content on
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Phase III Trials usually randomize compared trials, test efficacy compared to standard of care, once
again test for further safety, and conclude to an effective dosage. Animal studies would be necessary
based on the animals and the trials scientist are trying to conduct. Every animal is different,
especially when compared to humans, but there are some in different animals that can help test
based on the compound for the trials. Over time there has been numerous ethical violations in
clinical research; some more significant than others. In 1906, when the Pure Food and Drug Act was
passed, there were no regulations regarding the ethical use of human participants in research. There
were no consumer regulations such as the Food and Drug Administration, Common Rule and
Institutional Review Boards. One of the most significant events in research history involved human
participants was the Nuremberg Code on December 9, 1946. American military opened criminal
proceedings against several leading German physicians for their willing participation in crimes
against humanity. German Physicians were charged for conducting medical experiments on
thousands of concentration camp prisoners without their consent; in most of which the participants
as a result either died or were permanently damaged physically. In conclusion of the trial, in 1948
the Nuremberg Code was established, making it known that participants should give consent.
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Therapeutic Disorders: A Case Study
Case 9F In this case study we are introduced to a discovery from the 1980s. In the 1950s and 1960s
patients from a state–operated mental health facility from Illinois underwent "therapeutic surgery."
Therapeutic surgery is a treatment used to treat existing diseases. These surgical procedures were
done without the consent of the patients undergoing these procedures. The purpose of this surgery
was to improve the symptoms of schizophrenic patients. This surgical procedure consisted of the
removal of the adrenal glands. The background behind this surgical procedure was that by removing
the adrenal glands this could help correct a hormone imbalance that could help cure schizophrenia.
The problem in this case study is that these surgeries were ... Show more content on Helpwriting.net
...
This research project main focus was to find a way to reduce the disappearance of specific brain
tissue that most people with Parkinson's disease had been suffering from. The people performing
these research studies thought that the central nervous system could reduce the disappearances of the
brain tissue if they regrowth the specific brain tissue. One of the methods that they would use was to
place fetal tissue to desired locations within the brain. They would do this by drilling wholes in the
skull and placing the tissue inside specific areas of the brain. The problem in this case study is to
determine whether it was ethical for this study to use a control group that would not receive the
treatment of the fetal tissue, but they will still have holes drill in their skull. When it comes to
clinical trial there must always be a control group to show the progression of the study. However,
the fact that these people with severe Parkinson disease were not going to have the opportunity to
have the fetal tissue inject, but will still have holes drill in their skulls is unethical. By drilling holes
in the control group skull their human rights would be violated and many of the laws that now
protect individuals right when undergoing a research study would be broken. According to the RIB,
" ....we have posited in conjunction with the goal of human flourishing, namely, never to allow
scientific inquiry to trump the interest and inherent value of the irreplaceable human being enrolled
in such research." Throughout history we have seen many human right violated when it comes to
using human for experimental research. For example, the cruel way that the Nazi concentration
camps used Jews as part of unethical experiments, or other research projects that use humans as an
experimental tool without thinking about that persons feelings. This why law as like the Nuremberg
Code, Belmont
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Carl Gustaf Emil Mannerheim Analysis
When the topic of significant historical figures from the mid–17th century to present arises, people's
minds typically gravitate towards a handful of usual suspects. Some examples might include George
Washington, Abraham Lincoln, Winston Churchill, Franklin Delano Roosevelt, to include villainous
figures such as Benito Mussolini, Joseph Stalin, and of course, Adolph Hitler. While these impactful
historical characters are indeed intriguing, as there are countless books, articles, documentaries, and
other literary pieces telling their respective stories, it is also important to learn and become further
educated on other, less known historical figures. We all are pieces that eventually fit into our world's
grand historical puzzle. And without historical education and learning about the people that paved
the path for the world today, we can never truly understand today's world. Carl Gustaf Emil
Mannerheim is a sizable piece of our historical puzzle, and his story is one that deserves recognition.
Born on June 4, 1867, Carl Gustaf Emil Mannerheim was born into a wealthy family. He was son to
a Swedish nobleman who was highly regarded in his society. Carl Gustaf spoke better in Swedish
and Russian tongue than he could in Finnish, but this would prove obsolete in his ability to accel in
Finland later in life.1 Mannerheim started his military education at the Hamina Cadet School,
though he was eventually expelled from the institution due to disciplinary reasons.2 Following
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Examination Of Past And Present Ethical Guidelines On...
Eilidh Cowan
Ethics of Biomedical Science Research
Ioan Alexandru Beldean
Examination of past and present ethical guidelines on biomedical research
Ethics can be defined as a set of moral values informing one's decisions. But this set of moral values
can be influenced by many different things, such as various cultures, religions, and even
technological advancements. This is called moral relativism, the idea that there are no real truths in
ethics and what is right or wrong varies person by person. That is why before there was any codes or
set of rules regarding what was ethical put in place, people were able to get away with doing all
sorts of scientific research, that would now be deemed unethical. Biomedical research is to be done
to eventually better the health of humans.
Biomedical research has been going on for many years, it is how we have knowledge of many
deadly diseases as well as the discovery of vaccines and antibiotics! These things seem so common
today, but infact went through lots of stages of research to get to the technologies we have today.
However, before 1947, there were no codes of ethics or regulations to ensure that research being
done was ethical. The smallpox vaccination, although the first successful vaccine to ever be
developed, would be considered highly unethical today. Edward Jenner experimented on a healthy
young 8 year old boy without consent. In today's society, this study would never have been allowed
to continue. There are many other
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Unethical And Criminal Behavior During The Prussian...
The experiment with human subject was brought to an attention to the Prussian Parliament, when
several unethical and criminal behaviors were traced in the field of research in Germany in the
nineteenth century. The research was mainly conducted unethically in the hospitals, mainly without
any informed consent. The turning point for the establishment of universal rule regarding human
experiment was done after the case of Neisser, where in 1898, Albert Neisser, who discovered the
gonococcus and professor of dermatology at university of Breslau, conducted "clinical trials on
serum therapy in patients with syphilis. In order to find a method of syphilis prevention, he injected
cell free serum from patients with syphilis into patients who were admitted for other medical
conditions. Most of these patients were prostitutes, who were neither informed about the procedure,
nor asked for consent." After several discussions in the Prussian parliament about the case, attention
was given to the need of participant's autonomy and beneficence. The criticism of unethical human
experiments in the media and in the parliament, the Reich government issued detailed 'Guidelines
for new therapy and human experimentation' in 1931 (Vollmann, & Rolf, 1996).
Nuremberg Code (1946) Since, the post–World War I gave a way for Nazis to rise to power in
Germany and that had led to an era, where all basic human rights of the citizens were ceased, the
research sector was also greatly affected as 'the Nazi
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The Pros And Cons Of Bioethics
In healthcare, bioethics is studied to improve patient outcomes and treatment. Research is conducted
by bioethicists on ethical, social, and legal issues that have come about in biomedicine (National
Institute of Health). Since the beginning of time, much knowledge has been gained through
experimentation. Healthcare is an everchanging field in which experimentation is a key aspect.
Some research can be done without using humans as test subjects, however, others must be tested on
humans. The primary purpose of medical research involving human subjects is to understand the
causes, development and effects or diseases and improve preventive, diagnostic and therapeutic
interventions (World Medical Association). Accordingly, there are fundamental boundaries that
should be respected, relating to the principles of beneficence, nonmaleficence, autonomy, and
justice. The World Medical Association (WMA) originally adopted the Declaration of Helsinki in
1964, which protects the ethical principles involving human subjects. It serves as a statement of
ethical principles for medical research involving human subjects, as well as research on discernable
human substance and data. The document provides guidelines to ensure that the life, well–being,
dignity, integrity, privacy, autonomy, and confidentiality of subjects are protected (WMA). Though
the declaration is not a legal document, it has been integrated into laws governing medical research
across the world. Before a research
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Application Of Individual Voluntary Consent
Despite many ethical guidelines, various issues stay debatable, including the relevance,
prioritization, and application of individual voluntary informed consent in developing countries. The
practical problems of informed consent in developing countries are huge due to several factors,
including relatively low levels of formal education, lack of access to good quality health care
services, and in some circumstances, diverse values, knowledges of health and illness. HIV research
in developing countries has caused in amplified arguments of ethical concerns, mainly the subject of
the quality of informed consent. The ethical dilemmas in the standards of informed consent applied
by research institutions and pharmaceutical companies of HIV clinical trials in developing countries
will be discussed. 2. Vulnerability and Informed Consent in Research and Health Care a)
Vulnerability and Vulnerable Populations "Vulnerability" term is a fairly new one in the discourse of
bioethics; it was used in the Belmont Report in 1979 for the first time. The meaning of the concept
has gradually evolved over time. At first, vulnerability was reflected as a special deliberation in the
application of the bioethical principles of respect for persons, beneficence, and justice, mostly
applicable in the framework of research with human beings. In the 1993 CIOMS guidelines, the
notion of "vulnerability" developed to include a distinctive application of the principle of justice and
the principle of respect
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There Should Be Guidelines To Human Experimentation
The modern understanding of medicine was created by the many people who were subjected to
medical testing without their consent. There should be guidelines to human experimentation. Human
experimentation should only be performed on consenting adults that understand what is going to
happen. In other words, the doctors should get informed consent from their patients. There have
been many unethical human experimental trials performed on people that had no idea what was
happening to them. This is unethical and very dangerous for the people. There also have been
different guidelines and codes for human experimentation, such as the Nuremberg Code and the
Declaration of Helsinki. An example of such unethical human experimentation is The Tuskegee
Syphilis Experiment. This happened in Alabama and was performed by the U.S government in
1932. The men that were in the trial were given free health care, meals and burial insurance. 399
men had syphilis beforehand and 201 did not. Funding was cut for the experiments but they still
continued to study these men even though the antibiotic penicillin had come out in 1947. They told
the men that they had something called "bad blood" and they refused to tell the men that they had
syphilis. This trial was continued until 1972 when the ... Show more content on Helpwriting.net ...
The nazis performed experiments involving torture, disabling injury, and death.The Nuremberg code
is a set of guidelines in which doctors must follow. The Nuremberg code was published in 1947. The
Nuremberg Code was created after the Nuremberg trials where high ranking Nazi members and
doctors were put on trials for their heinous acts during the World War II. The Nuremberg Code was
not the first guideline for human experimentation. The Nuremberg Code was based on the
Guidelines for Human Experimentation of 1931. The Nuremberg code is not regularly reviewed or
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Ethical Research: Should Research Be Informed Consent?
Before any research is conducted, as stated by the NHS Health Research Authority (2015) it is
essential that the researcher ensures all relevant permissions are sought. Long & Johnson (2006)
argue, any research can be harmful to both its participants and or researchers, therefore as per the
guidance issued by the Royal College of Nursing (RCN) (2011), the researcher should ensure
research governance is adhered to and permission is sought from the local and university ethics
committee. Additionally, it is expected researchers should comply with the Declaration of Helsinki
(American Medical Association, 2013). Interestingly, Hammersley & Traianou (2012) question
whether the Declaration is fit for its purpose as it is not compulsary for researchers to adhere to this.
However, as stated by Gerrish & Lathlean (2015) it is considered the Declaration of Helskini is the
foundation on which all ethical research is built upon. Thus to comply with the declaration, as
stipulated by the RCN (2011) the researcher should address six key ethical points ... Show more
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Therefore in order to address this key issue, the author proposes to breif students of the intended
research aims at the beginning of a lecture and provide the benefits and potential harms of taking
part in the study. Additionally, participants will also be informed of the right to withdraw from the
study at anytime without prejudice or impact on their studies. As Dyson & Norrie (2013)
recommends the explanation should be carried out in a simplistic way, so that participants can
understand and ask questions, in order to provide informed consent. It is important to note as per the
RCN (2011) guidelines, at no point will the researcher make the individuals feel pressured or
coerced into taking part in this study. The next paragraph will now consider how this carrying out
this research is relevent to
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10 Principles Regaarding Ethical Clinic and Set of...
Nuremberg Code is a set of 10 sophisticate principles regarding ethical clinical research on human
being (Grodin, 1994). It is mainly for protection of subjects' human right (Shuster, 1997), such as
compulsory of informed consent and the equal authority of subjects as the physician–researcher to
end the experiment.
1.2 Helsinki Declaration (1964)
Helsinki Declaration is a set of guidelines on clinical research for physician as their responsibility
toward protection of their research subjects (Williams, 2008). World Medical Association (WMA)
also encourage it is used as reference by other parties in conduction of clinical research (Bădărău,
2013). Compared with the Nuremberg Code, which mainly focuses on safeguard of the subjects, its
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The vile medical crimes during the WW II had raise the awareness on the need of a world body
which able to define and promulgate medical ethnics around the world (Tyebkhan, 2003). Thus, the
World Medical Association (WMA) was set up in 1947 with 1st Annual Meeting of General
Assembly in September 1947, Paris (Human and Fluss, 2001). WMA is an international
confederation composed of national medical associations that seek to promote medical ethics and
professional standards (Human and Fluss, 2001).
Helsinki Declaration was first developed and promulgated in June 1964 by World Medical
Association General Assembly in Helsinki after more than a decade of debate and discussion among
the members of WMA (Williams, 2008).
Since the first adoption, revision and amendment were done several times on the Helsinki
Declaration for refinement. The Helsinki Declaration had been revised 8 times at meeting of WMA:
Tokyo 1957, Italy 1983, Hong Kong 1989, South Africa 1996, Edinburg 2000, Washington 2002,
Tokyo 2004, Seoul 2008 and Brazil 2013 (Association, 2013).
3 Importance of Nuremberg Code and Helsinki Declaration
In my opinion, Nuremberg Code and Helsinki Declaration play an important role as guideline in
clinical research involving human being. Both Nuremberg Code and Helsinki Declaration protect
the clinical subjects in term of their right and safety. By referring to them before performing of the
protocol,
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Obtaining Ic in Er Situations
Obtaining Informed Consent in Emergency Situations Introduction As research advances in finding
answers and treatment for diseases, the process of obtaining a patient's informed consent becomes
more detailed required. The informed consent is known as the cornerstone of Good Clinical Practice
for ensuring patient safety. In a normal clinical paced environment, time is given to ensure patients
are provided all the required information and the time to make a rational and voluntary decision to
participate in a study. At times this process is not feasible do to emergency situations, such as when
a patient arrives in the emergency room in a compromised mental and physical state that does not
permit ample time for this process. Such cases ... Show more content on Helpwriting.net ...
The Belmont is based on three basic principles: 1) Respect for persons. Autonomous subjects,
subjects have the right not to participate and withdraw their participation at any time. 2)
Beneficence. To prevent and do no harm; the risks should not outweigh the benefits. 3) Justice. All
subjects should be treated equally regardless of their race, age or economic status7. Exception to
Emergency Informed Consent Form In 21 CFR 50.24, federal regulations allow for emergency
research to be conducted without an informed consent. The Consent is designed to exempt the
subject's normally required signature due to the following reasons below: (1) The patient is in a life
threating condition, requiring treatment outside of the standard of care. The study treatment may be
unproven and require data on safety and effectiveness. (2) The patient's mental and/or physical state
does not permit them to give their consent. (3) The treatment in question will need to be
administered before a family member or a Legally Authorized Representative (LAR) is able to
provide consent. (4) There is no way to determine prospectively if patients would be eligible and
provide their consent to participate in the trial. (5) The benefits associated with the investigational
product
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The Need To Safeguard The Practice Of Research Ethics
Research Ethics
This essay is aimed at my fellow students and tries to explain using some different case studies
firstly what research ethics are and what happens when you don't stick to these same ethics.
Research ethics involves concepts and principles of right conduct within the research being carried
out. Oxford dictionary defined ethics as 'Moral principles that govern a person's behaviour or the
conducting of an activity' (Oxford). This is especially true within research ethics as this research is a
public trust that must be ethically conducted, trustworthy, and socially responsible if the results are
to be valuable and be believed.
The need to safeguard the practice of research ethics within all fields of sciences and engineering is
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Research should be carried out only by medically/scientifically qualified individuals and in
appropriate laboratories.
5. Risks should not exceed benefits that will potentially result from the experiment.
(Research & Economic Development)
During the World Summit on Sustainable Development (WSSD) in Johannesburg in 2002, held on
the, the then UN Secretary–General Kofi Annan (2002) stated that "And more and more we are
realizing that it is only by mobilizing the corporate sector that we can make significant progress. The
corporate sector has the finances, the technology and the management to make this happen" (Annan,
2002, para. 5–6).
This shows that assessing the compatibility of business ethics and sustainable development is
important and is encouraged at the highest level.
A basic ethical dilemma that commonly takes place with many engineers has to be the duty to report
a to the proper responsible authorities if a client or employer is failing to follow the engineer's
directions and/or designs causing possible harm. This duty should annul all or any duty to a client or
the employer as it may put people in harms way. As an engineer they may face some penalties, or
have their license taken away, if something unethical has occurred (Engineers,
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Ethics of the Nuremberg Code Essay
From 1946 to 1947, the Nuremberg War Crime Trials took place, withfifteen of twenty–three
German physicians and research scientist–physicians found guilty of criminal human
experimentation projects. The trial court attempted to establish a set of principles of human
experimentation that could serve as a code of research ethics. The result was the Nuremberg Code,
which attempted to provide a natural law–based set of universal ethical principles. Looking beyond
the Nuremberg Code and applying it to modern medical research ethics, there are many challenges
that it poses. Many have argued that the Code tries to provide for all unforeseen events, which
restricts the researcher by requiring him to anticipate every situation, demanding the ... Show more
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Hence, a proxy was given to those who did not have legal capacity allowing researchers to expand
their population for experimentation.
The term informed has also been criticized because sometimes even the researcher is not aware of
the risks associated with the experiment or they are too technical for the subject to understand. Thus
scientists have argued that only adequate information should be released to the patient and a full
understanding is not necessary. In this clause, responsibilities are placed on the individual who is
initiating, directing, or engaging the experiment but there is no place for the researcher to be
reviewed for his actions. The scientist is in full control of making any necessary ethical
deliberations. The Declaration of Helsinki added a clause stating experimental protocols should be
transmitted to a specially appointed independent committee for consideration and comments. The
third principle of the Code addresses the justification of the performance of the experiment based on
previous studies done on animals. This may be challenged because the researcher cannot always
guarantee success of the experiment even though it has been successful on animals or in previous
studies. Uncertainties in the experiment will always be present. The Declaration of Helsinki does not
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Ethics of Offshoring: Novo Nordisk and Clinical Trials in...
Ethics of Offshoring: Novo Nordisk and Clinical Trials In Emerging Economies
Offshoring is a highly debatable topic throughout the country and the world. Many people base their
opinions on different aspects of offshoring. Some people are against offshoring because they feel as
if the working conditions in other countries aren't up to par and are unethical. Some people are
against offshoring because they feel it is taking jobs away from people within their own country.
Some people are for offshoring because they feel there is greater profit involved or that they can get
harder workers in other countries. No matter what side of the debate, everyone can agree on a few
things like there needs to be better standards for working conditions, ... Show more content on
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Another question that needs to be addressed is if trials are conducted in an emerging economy, how
should they be managed and which standards should apply? I think medical ethics is a big issue
when it comes to trials being conducted in an emerging economy. One famous incident of this was
the Tuskegee syphilis study. This study left 400 African Americans untreated in order to research
how they obtained the disease. The cure for syphilis, penicillin, had already been found in the 1940s.
To prevent this from happening again, professional medical organizations developed guidelines and
principles of ethics to guide their research, notably the Helsinki Declaration. I believe Novo Nordisk
does a great job of adhering to these guidelines by putting safety measures in place. Emerging
economies like India and China are attractive places to have clinical trials because of how much
cheaper it is, the willingness to try new things as an emerging economy, and because a possible lack
of standards. Novo Nordisk only conduct trials in countries where they have affiliates with
necessary competence to arrange and monitor the trials. Also, they conduct clinical trials globally to
test the safety and efficacy of new drug candidates in order to obtain global marketing authorization.
These trials always have the same standards at all trial sites. The standards in
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Informed Consent In Medical Research
Informed consent is the current guiding principle for the ethical conduct in medical research and
originated after the 1947 Nuremberg Code and the 1964 Declaration of Helsinki (Nguyen et al.,
2015). The purpose of the informed consent process is to provide potential research subjects
information about the nature of the clinical trial, the risks, benefits, underlying procedures, and
alternative treatments (Bloswick & Skowron, 2015). The research team must provide the patient
with sufficient information so the participant can fully make an informed, uncoerced choice about
whether to begin or continue participation in a clinical trial. This process is an ongoing exchange
between the subject and the research team throughout the research study.
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Ethical Research In Australia
Australia's policy on research ethics is very similar to most developed nations' policies, in that it
aims to ensure that the people on whom studies are conducted are treated fairly and are afforded
basic rights and their freedoms are protected. Australia also sets forth guidelines for researchers with
the goal of managing the ways that researchers use and share data, attribute other authors and
conduct effective peer reviews. A relevant document is the Australian Code for the Responsible
Conduct of Research which is a "guide [to] institutions and researchers in responsible research
practices". This document provides a basic reference for the development of policies that ensure
ethical practices. This document and many others in Australia define ... Show more content on
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Additionally, the government is responsible for providing grants to researchers and institution, and
thus must have stringent policies on making sure that research is ethical before providing grants as
well as having an ethical review committee for assessment of the ethicality of potential research.
Moreover, in the case that research is being conducted abroad, domestic ethics review committees
may need to work in conjunction with the ethics committees in the host nation, or in some
circumstances even help in creating such a committee. Ethical ramifications of research done
outside one's nation will be extensively discussed further in this paper. The next level of research is
the research institution, specifically dealing with private institutions, as public ones are generally
covered under the governmental level, institutions' are responsible for disseminating governmental
decrees as well as educating their staff on all tenets of ethical research and make sure that
researchers have a conducive environment for researching, so that they may advance human
knowledge and health. The final level is the researcher, for whom these standards are addressed to
and whose responsibilities include being aware of laws in
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Project Case
Obtaining Informed Consent in Emergency Situations Introduction As research advances in finding
answers and treatment for diseases, the process of obtaining a patient's informed consent becomes
more detailed required. The informed consent is known as the cornerstone of Good Clinical Practice
for ensuring patient safety. In a normal clinical paced environment, time is given to ensure patients
are provided all the required information and the time to make a rational and voluntary decision to
participate in a study. At times this process is not feasible do to emergency situations, such as when
a patient arrives in the emergency room in a compromised mental and physical state that does not
permit ample time for this process. Such cases ... Show more content on Helpwriting.net ...
The Belmont is based on three basic principles: 1) Respect for persons. Autonomous subjects,
subjects have the right not to participate and withdraw their participation at any time. 2)
Beneficence. To prevent and do no harm; the risks should not outweigh the benefits. 3) Justice. All
subjects should be treated equally regardless of their race, age or economic status7. Exception to
Emergency Informed Consent Form In 21 CFR 50.24, federal regulations allow for emergency
research to be conducted without an informed consent. The Consent is designed to exempt the
subject's normally required signature due to the following reasons below: (1) The patient is in a life
threating condition, requiring treatment outside of the standard of care. The study treatment may be
unproven and require data on safety and effectiveness. (2) The patient's mental and/or physical state
does not permit them to give their consent. (3) The treatment in question will need to be
administered before a family member or a Legally Authorized Representative (LAR) is able to
provide consent. (4) There is no way to determine prospectively if patients would be eligible and
provide their consent to participate in the trial. (5) The benefits associated with the investigational
product
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Grimes Vs Kennedy Krieger Institute Case Summary
What comes to your mind when you hear the word ethics? Do you think of morals, right or wrong,
Ten Commandments, Hippocratic Oath, The Golden Rule, or a little bit of everything? Ethics can be
described as a philosophy dealing with the actions, beliefs and decision–making of an individual or
groups of individuals and what may be seen as good or bad. Ethics and ethical decision–making can
be found in all aspects of society, professions, culture, human development, institutions, law and
religion. This paper will examine the case of Grimes v. Kennedy Krieger Institute and the Lead
Abatement Study and how ethics, legal theory and law plays a vital role in the institution of human
research, specifically on children. What follows will evaluate how this case violated or conformed to
the assigned ethics documents: The Nuremberg Code, Helsinki Accord, Belmont ... Show more
content on Helpwriting.net ...
The Belmont Report is a summary and outline of ethically guided principles of justice, respect for
the individual and beneficence. Consent, assessment of risks and benefits, and selection process of
individuals are also mandatory. The Belmont Report had already been in place prior to the John
Hopkins study. All aspects of the report were violated as a result of the research. A complete and
informed consent was not absent, children were harmed and not treated as other children, perhaps
being used individually for the good of children as a whole. All of the possible risks were not
disclosed, the benefits of the research for the children if any, were unclear and the selection process
may have been unjust. Kennedy Krieger's Chief Executive argued however, that most children
benefited from the study. He stated that if they had not moved into the homes of the study, things
could have been
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The European Union ( Eu )
The European Union (EU), as a supranational organization, has increased its stock of importance
within the international realm through increased integration. Sector after sector has been targeted in
attempts to create a more perfect union where all European member states are represented equally.
That quest for deeper integration ultimately brought the founders of the EU at the threshold of
defense and foreign policy. No one knows for sure the collective direction of the EU, only to say
that the goals of the organization tends towards creating a federal state. That would mean that the
EU would be the voice over all pertinent matters including foreign and security policy. It also
happens to be that those two areas are held in high regard by ... Show more content on
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By suggesting that the safety of European Community would be bolstered only in the cooperation of
the European states in the rebuilding of Germany, these gentlemen put forth the theoretical
beginnings to what the European Union is today. The idea was that the individual nations within the
European Community would relinquish a portion of their state's sovereignty in a massive effort to
avoid the chance of another tragic war on the continent. More than any other continent on earth, the
European continent had experienced, what seemed like, constant war between relatively close states.
Because of this, it is definitely understandable the need for some significant peace time on the
continent, and the utilization of this fragile moment in European history as a time to create a new,
more interconnected community. Monnet, while wanting eventually, this collection of European
states under a central authority, realized the time restraints:
"Jean Monnet had understood that any attempt to introduce a comprehensive institutional structure
in one go would bring a huge outcry from the different countries and was doomed to failure. It was
too early yet to envisage wholesale transfers of sovereignty. The war was too recent an experience in
people 's minds and national feelings were still running very high (Schuman, 1950)."
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Ethics of Offshoring Novo Nordisk Essay
To: Anders Dejgaard From: Jennifer Tsai Subject: Ethics of offshoring Date: 05/23/2011 Critical
issued of the appropriateness of conducting clinical trials in emerging countries has arisen over
years. Being a leading company in biopharmaceutical industry, Novo Nordisk faces the critiques of
whether it is justice to offshoring their clinical trials in developing economies. With the consistency
of ethical principles brought up by Novo Nordisk, the company would be able to move their trials
into emerging economies with the best interest for stakeholders. I will also propose ideas to Mr,
Dejgaard for possible approach to media as well as the practices that Novo Nordisk could have
changed over time at the end. Conducting Clinical ... Show more content on Helpwriting.net ...
Firms definitely need to incorporate their highest moral standards to build trust and reputation for
themselves in order to better off in long run. Novo Nordisk always follows the regulation from
Helsinki Declaration with other international ethical guidelines. They made sure that the interest and
well–being of the trial subject should always transcend over the interest of science, society and
commerce. Decision Principles Even though I think conducting clinical trials in emerging
economies is beneficial to the firm, Novo Nordisk should still follow below guidelines for this major
decision to protect its own reputation and serve the best interest for every stakeholder: Execute
clinical trials when the internal organization is well established and external environment is proper
regulated in emerging countries. Conduct placebo clinical trials when they are scientifically and
ethically justified. Ensure the human rights of the participants in emerging countries associated with
the predictable risks Responses to The Media I understand that Mr. Dejaard holds a high ethical
stands, and is not interested in misleading the public or ethical dissembling in the response. It is also
important to clear up the actions Novo Nordisk has taken for the past years and give public a clear
picture of how the firm is operating. If a journalist is inviting for an interview, Mr. Dejaard should
present himself
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Ethical Issues During The Nuremberg Trial
Some may say it is ethical to use information from an unethical study, but I believe that it is
unethical to use information that was obtained in an unethical way. However, the Nuremberg Trial
shows why it is unethical to use information from studies that are unethical. The Belmont Report
and Declaration of Helsinki both allow for researchers to understand what is considered ethical and
unethical before starting their research. Unethical research has been characterized by the Nuremberg
trials and other research that has been done in the past to cause harm to an individual that is
participating in research. According to Neutens, children are considered a vulnerable population
along with the elderly. Although children and elderly are both considered ... Show more content on
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Now we have the Belmont Report and the Declaration of Helsinki to guide researchers in the most
ethical direction when they are conducting their research for studies. Luckily now researchers have
to basically write out their entire plan throughout the study step by step. They must write out any
way that the human subject may be harmed, what they will do if someone is harmed, any potential
costs, and much more. Once all of this is written out researchers then have to get their study
approved before they can move forward with their study (Neutens & Rubinson, 2014). The steps
that have to be taken to conduct research may seem like a lot, however, it may save a lot of time and
energy in court if something happens to go wrong during the trial. The Nuremberg Trials may have
been awful but now researchers are aware of the difference between right and
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The Provision Of Fair Benefits
The question 'does the provision of fair benefits counter a claim that communities have been
exploited in the context of international research?' opens discussion to a complex topic on ethics in
international research. The question asks whether the provision of fair benefits protects research
communities, defined as communities on whom the research is conducted, from exploitation. In
order to discuss this question, it is necessary to first understand what constitutes fair benefits and
exploitation in the context of international research. Whilst several divergences of the definition of
"exploitation" in international research exist, exploitation in the context of this discussion is defined
as the unfair distribution of risks and benefits ... Show more content on Helpwriting.net ...
Whilst low income nations most commonly take on the risks of research, the majority of benefits
achieved through research are shared with communities in high income countries3,6. Poor
healthcare, poverty, illiteracy, cultural and linguistic differences, limited scientific understanding
and lack of or inefficient research regulations and independent monitoring contribute to the
vulnerability of communities in low income countries to exploitation. Over the last ten years there
has been an increased interest by organisations and sponsors from wealthy countries to conduct
research in low income countries due to reduced costs3,7,8. Emanuel et al. claim that the prevention
of exploitation of study participants and their communities demands the provision of "fair benefits"
to these communities7. The fair benefits framework aims to protect communities from exploitation
in international research through the fair distribution of burdens and benefits between involved
parties9. The framework asserts that research participants and their communities are entitled to a
"fair level" of benefits which balance the burdens and risks participants experience during the
research. As the benefits attained by sponsors and researchers increase, so
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Informed Consent
Mark A. Puno
Instructor: Craig Bartholomaus
English 102
27 March 2013
Informed Consent
What is an informed consent? What do we know about it? Where did it come from? What purpose
does it serves? These days, there is a variance in what informed consent means. Its definition
depends on what specific manner it accentuates in accordance with the pertinent setting of
application. The American Medical Association (AMA) has definitions on a clinical setting and on
the field of research. However it is defined, informed consent was the product of a period of work
and experience.
Informed consent is the cornerstone of human subject research protection. (Rowbotham et al.)
The principles of informed ... Show more content on Helpwriting.net ...
HeLa cells are considered the first immortal human cells ever grown in culture – they divide
indefinitely and that is what sets them apart from other cell lines. HeLa cells have been used in
various important medical research, i.e. cancer research, culturing and growing cells, cloning, gene
mapping, and development of vaccines. The most recognized vaccine created is the polio vaccine.
HeLa cells also helped found or create the field of Virology – the study of viruses. However,
Henrietta Lacks' and her HeLa cells story is far more about her contribution to medical research, it
was about the unethical process of the collection of her tissue sample and what came after it.
Rebecca Skloot had written a best–selling book about her life story and her cells. (Skloot)
With human health experiments steadily exposed people to conditions beyond the boundaries of
medical evidence, the United States Congress passed the National Research Act in 1974. The
National Research Act then created the National Commission for the Protection of Human Subjects
of Biomedical and Behavioral Research. Among the Commission's most significant work was the
formulation of the Belmont Report and the Institutional Review Report. The Belmont Report is one
of the primary report in health care research and ethics. The report comprises of three (3) basic
ethical principles; which are justice, respect for persons,
... Get more on HelpWriting.net ...

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Ethics In Qualitative Research

  • 1. Ethics In Qualitative Research Prompt #1 – What does Creswell say about the ethics of data collection? Compare and contrast that with the ethics of data collection one might encounter in the fields of intelligence, counter– terrorism, and protection. The forms of data collection are often grouped into four basic categories such as journals, blogs, e– mail, and video. These four forms, as defined by John W. Creswell (2013) are interviews, observations, documents, and audiovisual materials (pg. 152–162). The author mentioned about the challenges with qualitative research can include protecting sources, storing data, informing and receiving subject consent for participation in the study. Among those, ?Informed consent or voluntary? is one of the biggest ethical challenges in ... Show more content on Helpwriting.net ... American Anthropological Association (TheAAANet.org). October 31, 2007. http://www.aaanet.org/about/Policies/statements/Human–Terrain–System–Statement.cfm, accessed 19 Aug 2011. ?U.S. Military, Oblivious of Iraqi Culture, Enlists Anthropologists for Occupation.? Alternet.org. January 19, 2008. http://www.alternet.org/world/74326/?page=entire ?Welcome to the HTS Page.? Army.mil. Last updated: March 24, 2011. http://humanterrainsystem.army.mil, accessed 18 Aug 2011. Johnson, Eric Michael. ?AAA Honors Franz Boas, After Shunning While Alive.? The Primate Diaries, A Scientific American Blog. July 9, 2009. http://scienceblogs.com/primatediaries/2009/07/aaa_honors_franz_boas_after_sh.php, accessed 14 Aug 2011. O?Connor, Tom, Dr. ?Research Ethics.? MegaLinks in Criminal Justice. Last updated: July 17, 2011. http://drtomoconnor.com/3760/3760lect05.htm, accessed 17 Aug 2011. ?The Evolution of the U.S. Intelligence Community–An Historical Overview.? U.S. Government Printing Office. 1 Mar. 1996. ?Preparing for the 21st Century: An Appraisal of U.S. Intelligence; Appendix A.? http://www.access.gpo.gov/intelligence/int/int022.html, accessed 6 Mar. ... Get more on HelpWriting.net ...
  • 2.
  • 3. Analysis Of Chinese Health Promotion Hospitals Several recent natural disasters have occurred in China including the Wenchuan earthquake in 2008 (8.0 on the Richter scale), the Yushu earthquake in 2010 (7.1 on the Richter scale), the Yuliang earthquake in 2012 (5.7 on the Richter scale), the Yaan earthquake (6.5 on the Richter scale), and the Ludian earthquake in 2014 (6.5 on the Richter scale). The Chinese government has increased its focus on public health in post–disaster areas and has provided sufficient funding to support construction of local hospitals. Additionally, the government has attempted to improve medical services to promote public health [1, 2]. In 2013, the Chinese government proposed the Chinese Health Promotion Hospitals (CHPHs) programme [3].The Health–Promoting ... Show more content on Helpwriting.net ... Disaster conditions also challenge their physical and mental endurance [9]. Healthcare professionals may have increased risks of post–traumatic distress due to their work. For example, Shrestha R reported that health professionals working in the Nepal earthquake of 2015 were at significantly higher risk of developing post–traumatic stress disorder (PTSD). The overall prevalence rates of PTSD were 21.9% and 17.1% using cut off scores and diagnostic criteria, respectively [10]. A study by Oglodek E. showed that 40% of medical rescuers experiencing PTSD reported that the dissociation was caused by the death of a patient being rescued [11]. Additionally, Yu YM et al. revealed that during the Wenchuan earthquake in 2008, more than 50% of medical staff demonstrated several of the following signs of stress: grief, fear, depression, anxiety, fatigue, headache, and dizziness [12]. Therefore, health quality of healthcare professionals after disasters is a significant issue [9, 13]. To our knowledge, the data regarding how medical staffs promote healthy lifestyles after a disaster are unclear. We hypothesized that additional data could provide reliable empirical evidence for health promotion in health workers and the public in post–disaster areas as well as for the development of CHPHs. The primary goal of this study was to determine whether healthcare workers took healthier lifestyles than other ... Get more on HelpWriting.net ...
  • 4.
  • 5. Medical Ethics As A Moral Compass Medical Ethics as a Moral Compass I work for a government run medical center. As an organization we are run by government oversight, rules and regulations and high–powered patient complaints. If a provider is not ethically oriented they will be found out and dismissed quickly. The flip side of the coin, most people work at this medical center because they enjoy their work and the patient population. We work well with one another and come together overall for the common good. There are no incentives which can lead to ethical misconduct. Additionally, physicians have their own code of ethics. The Hippocratic Oath, is a set of principles for physicians' conduct, which aim to protect the rights of the patient and oblige the physician voluntarily to behave in an altruistic manner towards patients (Riddick, 2003). The four basic principles of medical ethics (autonomy, justice, beneficence and non–maleficence) form the foundation for health professionals to guide and decide what practices are ethical. These basic ethical principles are based on the major documents of healthcare ethics (Hippocratic Oath, Nuremberg code and Helsinki declaration). Future doctors and nurses are expected to learn and abide by these ... Show more content on Helpwriting.net ... We are only human after all, and we are likely to make mistakes when it comes to the gray areas of ethics. One way to assure we do the best we can is keep the lines of communication open and the feeling of a safe zone ever present. If employees feel like they are in a safe environment and can question a practice, or even a superior, than we are less likely to have unethical issues get out of control. Finally, ensuring clarity in the organizational ethical culture promotes higher work engagement, less emotional strain and exhaustion, and lower turnover rate. These all lead to a decrease in unethical activity and a healthier work environment (Huhtala et al., ... Get more on HelpWriting.net ...
  • 6.
  • 7. Ethical Principles Of The Tuskegee Study Ethical principles were established to help protect the human population from being unlawfully treated when involved in any type of treatment, research study, or medical decision–making. Miss Evers' Boys provide examples, to how ethical principles were neglected to be used throughout the study. The Tuskegee study lasted a brutal 40 years and ethical principles where pushed aside, to obtain the evolution of syphilis in African American males. Anyone who is involved in some type of medical treatment or research deserves to be treated with respect and dignity. As healthcare professionals it is imperative to understand ethical principles and morals and be able to apply them to every day practice. The Tuskegee study was an eye opener to many individuals, leading to laws and reconstructed ethical principles. According to Ogungbure, The aim of research ethics is to ensure that research projects involving human subjects are carried out without causing harm to the subjects involved. (Ogungbure 2011) As a nurse it is important to follow the ANA code of ethics. Being aware and practicing ethical principles will help with treating the Patient and keep them informed with their healthcare choices. Nursing in itself can be challenging and everyday you can be faced with ethical dilemmas. Overview of the Tuskegee study The Tuskegee study was an experimental study composed of Doctors, Nurse, Government officials and the U.S Public Health Service. The study was performed to recognize ... Get more on HelpWriting.net ...
  • 8.
  • 9. D5 Disclosure Analysis The invention claimed in claim 1 does not involve an inventive step when the disclosures of D5 and D6 are combined: D5 discloses: A system for predicting a health outcome of a subject in an environment (Abstract). In animal husbandry, it is considered a body temperature and weight of a livestock is associated to the health of the livestock. comprising: – a camera (Item 1) situated within the environment configured to capture one or more images and/or a video sequence including at least a portion of a feature of the subject (Para.0025); and – a processor (Col.4, Lines 52–65), configured to identify and segment at least a portion of the feature from the one or more images and/or video sequence to form one or more segmented features (Col.2, Lines 46–Col.3, Lines 10), to calculate one or more metrics from the segmented features (Col.2, lines 61–Col.3 lines 10). D5 disclose using a thermographic screening of livestock to recognize animal health (Col.4 lines 22–51 and thus is able ... Show more content on Helpwriting.net ... The problem to be resolve in the application is reducing time and constraint in determining a health and wellbeing of livestock in animal husbandry. D6 discloses a method of utilize infrared thermography for early detection determines several disorder of a livestock, for example: inflammation, infection disease, mastitis (Para.0020). D6 also discloses comparing the rate of change in temperature of the same animal from the previously obtained infrared thermographic result (Para.0064). The rates of change of temperature are monitor, measuring over a period of time (Figures 1–9, Para.0071). It is considered the analysed results of the changes in temperature in the livestock are considered as risk value ... Get more on HelpWriting.net ...
  • 10.
  • 11. Good Clinical Practice Good Clinical Practice (GCP) is important because, 1– It is an international ethical and scientific quality standard for the conduct of clinical research. 2– Compliance with this standard provides public assurance that the rights, safety and well–being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki. 3– It assures the quality, reliability and integrity of the data collected. Q2– What are the three principles of Belmont report? The three basic ethical principles are; respect for persons, beneficence, and justice. Respect for persons involves a recognition of the personal dignity and autonomy of individuals, and special protection of those persons with diminished autonomy. Beneficence entails an obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks of harm. Justice requires that the benefits and burdens of research be distributed fairly. Q3– What specific areas of the ICH–GCP did the investigator not follow? The study in this scenario was conducted and the results was published. However, the study had not been approved by the Spanish Agency for Medicines and Health ... Show more content on Helpwriting.net ... The investigator informed the participants that he had his hospital ethical approval for the study. The subject in this situation, had given their consent base on a false/incomplete information making their given consent not valid. Furthermore, the investigator in this study, tested an approved medication, but in an unapproved regimen on a large number for HIV patients, exposing them to the possibility of all the medication and trial related risks, without having an ethics board approval and without any monitoring or auditing of the trial. In my opinion such investigator's behaviour, is both illegal and un ethical. The investigator also, did not obtain insurance for the ... Get more on HelpWriting.net ...
  • 12.
  • 13. Tuskegee Model Case For Unethical Research Practices In the case of the Public Health Service (PHS) experimenting on inmates at the Terre Haute Federal Penitentiary for prophylaxis in gonorrhea, it was clear that the study was abandoned at a critical stage in its develop where a line would have been crossed, exposing and crossing moral/ethical boundaries set about in countries such as the U.S. as far as research on human beings is concerned. The decision to continue the same research beyond boarders and use subjects from a Guatemalan National Penitentiary with the mere consent of their supervisors and not from the subjects themselves, along with the differences in human rights policy in this nation, ultimately allowed the study to be undergone with less regulation, whereby human rights to justice ... Show more content on Helpwriting.net ... Ultimately, the investigators are responsible for the well–being of the patients and that only when there is no effective treatment know, it is ethical to compare a potential new treatment with a placebo, however, when effective treatment is known, the the control group must be given the best treatment. In this case, an effective treatment was in fact known (penicillin), however, as it was not standard procedure to treat in prisons and was not given to the control group. Meanwhile, those who were seen to have the illness outside of this study in both Guatemala and the U.S. were treated with penicillin. Clearly, violating the investigator's state of equipoise and the human rights of the subjects. All of this can be summed up with a point made saying: "a problem inherent in research that must be balance and rights of individuals and the group benefit is not social good but global good," (EHC, ... Get more on HelpWriting.net ...
  • 14.
  • 15. Xenotransplantation Essay Moral, Environmental and Cultural Issues From the beginning, xenotransplantations have been an ethically controversial procedure and for many diverse reasons. Diverse groups are fervently opposed to it: animal rights groups, for instance, are undoubtedly against butchering animals to collect their organs for some human's sake. Although, most major religions aren't resistant to the use of genetically modified xenografts to save human lives, the proscription of pig consumption poses some dilemmas for the Jewish and Islamic communities. "When divine providence is not being used to justify the genetic engineering of animals, then some evolutionary ethic of 'the strongest calls the tune' or 'might is right' seems to obtain" (Sherlock & Morrey, 2002, ... Show more content on Helpwriting.net ... Patients, in that case, must be entirely aware of what the procedure implies, without any outside influence affecting their choice, and must, themselves, understand the risks and benefits of this type of transplantation. Also, some have suggested that family and close friends of the patient should also give consent because of the magnitude of repercussions xenografts imply; the great possibility of diseases and viruses crossing over to humans make the patients' closest contacts at risk as well. Therefore, it is important that those contacts be monitored to assure that a xenozoonosis is not happening. This proposal arise another ethical question: the consent of the patient can turn out to be narrowed down if the family and friends don't agree with putting themselves at risk and the confidentiality principles would also be broken. Evidently, the public's safety remains a significant element to be measured. Procedures must be in place to protect the public from any risk due to possible outbreaks. Ergo society must understand the risks and benefits of xenograft and consent to its application. This societal response is a very important ethical issue according to the Ethics Committee of the International Xenotransplantation Association and it will be hard to overcome until researches proves the achievement of a low risk graft, resulting from genetically modified ... Get more on HelpWriting.net ...
  • 16.
  • 17. Nuremburg Code Of Ethics Essay The rights of research participants became a topic of concern as a result of the Nuremberg Trials in 1945. After World War II and the Holocaust it was discovered that Nazi soldiers conducted experiments on prisoners of war. Informed consent from the prisoners was not granted and they became participants against their wishes. These prisoners of war were not given a choice whether or not to participate. People all over the world were outraged and the Nuremburg Code of Ethical Human Subjects Research Conduct came into being. This code of ethics is the first of its kind in our society to highlight the necessity of voluntary participant consent when conducting research and investigations. Declaration of Helsinki In 1964 the World Medical Association ... Show more content on Helpwriting.net ... This study again demonstrates the need for informed participant consent. In this study participants were not provided with proper information regarding the study. Although the subjects consented to being part of the study they were not told of the true intent or purpose of the research. Participants did not receive the implied treatment they needed to survive the illness. The men involved in the study were in fact misled and were not presented with factual information to make an educated decision regarding their participation. Subsequently, the news media broke the story forty years later. Public uproar demanded an investigation. As a result the study ended immediately and a higher need for informed consent came to light once more (Centers for Disease Control and Prevention, 2017). The need for satisfactory moral and ethical laws was now at stake. The result of the Nuremburg Trials and the Tuskegee Study resulted in the National Research Act (Pub. L. 93–348). This act was signed into law on July 12, 1974. The passing of this law produced the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (Department of Health, Education, and Welfare, 1979). The job of this commission was to pinpoint principles which involved human participants and to provide the rules and procedures necessary to insure the safety of research participants. As a ... Get more on HelpWriting.net ...
  • 18.
  • 19. Biostatistics Student Journal Club Biostatistics Student Journal Club Questions and Answers 10/17/2016 Group #12: Jenna Nixon, Vu Le, Sarah Jacob, Kajri Shah, Andres Brito, Isis Sanders Question #1: What was the null hypothesis of the study and was it accepted or rejected? Answer: The null hypothesis was that there is no association between lower blood sugar and taking the oral glucagon receptor antagonist LY2409021 in healthy and diabetic individuals. The study found that taking the glucagon receptor antagonist does indeed help lower blood sugar in healthy and diabetic individuals with very limited hypoglycemia; therefore, the null hypothesis was rejected Question #2: What ethical guidelines, if any, were used during this research study? Answer: The study used the Declaration ... Show more content on Helpwriting.net ... Answer: The primary objective was to test if the glucagon receptor antagonist use is safe and if study participants will be able to tolerate the drug. Also, they wanted to test the therapeutics effect of the LY2409021 drug on the study participants and how the participants' body will affect the drug. Question #4: What measurements were conducted during the study to ensure that the participants were safe? Answer: The subjects in the study were regularly tested on their vital signs, echocardiogram and clinical laboratory tests. Question #5: Was this journal peer reviewed and what was its impact factor? Answer: The journal (Diabetes, Obesity, and Metabolism) had a journal impact factor of 6.198 in 2015, according to InCites. The journal, however, is not peer–reviewed per Ulrich's Periodicals Directory. Question #6: How were the participants selected for the studies? Answer: The study participants for the studies were selected based on the following criteria: For Type 2 Diabetes Study Participants: Hemoglobin A1C level that 11.1/1, following an oral glucose tolerance test For Healthy Study Participants: BMI 18.5–29.9 kg/m2, Fasting blood glucose level of ... Get more on HelpWriting.net ...
  • 20.
  • 21. The Pros And Cons Of The Declaration Of Kosovo A unilateral declaration of independence by Kosovo's February 17, 2008 has caused mixed reactions in the international community. To date, Kosovo's independence from Serbia was recognized by 110 states out of 193 (56.9%), the United Nations Member States (the United Nations). At the same time, other states – members of the United Nations (more than 1/3), including two permanent UN Security Council members (China and Russia), refused to recognize the independence of Kosovo or declared neutrality. In order to take a seat at the UN, country must have the support of 2/3 of the states – members of the UN (129 out of 193) and the approval of the UN Security Council, in particular, the absence of a veto of any permanent member of the Security Council ... Show more content on Helpwriting.net ... Of course, the UN Security Council resolutions can be changed, but as long as it remains applicable legal act, and its non–compliance is a violation of international law. Referred to in resolution 1244 in 1999, but we should not forget that the current document does not contain a single word about independence (the more independence from Serbia Serbian same territory) can argue about the legal identity is now a legal entity. On the contrary, the text of resolution 1244, and its applications on several occasions expressed the commitment of all Member States to the sovereignty and territorial integrity of the Federal Republic of Yugoslavia (Muharremi, 2014). Kosovo precedent would undermine the role of the UN and enhancing the role of the EU and NATO. The role of the observer, which is assigned before the UN Mission in Kosovo (1999 to 2008) is now transmitted to the representation of the EU International Steering Group for Kosovo, composed of 15 European countries to recognize Kosovo's sovereignty. Creating Group is contrary to UN Security Council resolution 1244 and internationally agreed principles of settlement of the Kosovo (Peters, ... Get more on HelpWriting.net ...
  • 22.
  • 23. Code of ethics serves as the moral compass that directs... Code of ethics serves as the moral compass that directs and guides the integrity, values, and beliefs of an organization. A code of ethics clarifies to employees what the company stands for and its expectations for employee conduct (Daft, 2013). A well–written code is a true commitment to responsible business practices in that it outlines specific procedures to handle ethical failures. Within the research enterprise, the code of ethics ensures that research projects involving human subjects are carried out without causing harm to the subjects involved. Research ethics also ensure researchers conduct research in an ethical manner. This paper will focus on the regulations and guidelines that govern ethics in research, a study where ... Show more content on Helpwriting.net ... Within the research enterprise, ethics serve as the moral compass in to ensure that research projects involving human subjects are carried out without causing harm to the subjects involved. In addition, it provides a governing structure which ensures that human participants in research are not exploited either physically or psychologically. In addition, research ethics educates and monitors scientists conducting research to ensure that they are adhering to the guidelines and regulations associated with research. Ethics also ensures that researchers can use the knowledge obtained to oversee clinical research and insure its conduct in a safe, scientifically sound and ethical manner (Tremaine, Carlson, Isaacs, Motil, Robuck, & Wurzelmann, 2005). This research paper will provide a brief history of ethical guidelines associated with research, one research tragedies where research ethics were violated, and recommendations to ethics are maintained with the research enterprise. Brief History on Research Ethics There are several regulations and guidelines that govern the research enterprise. They provide the foundation for research ethics. These regulations and guidelines were formulated to ensure researchers conduct research in an ethical manner and to ensure that no human subject is harmed or violated. There are three key guidelines that have been implemented to ensure that ... Get more on HelpWriting.net ...
  • 24.
  • 25. Nazi Medical Experiments Research Paper Nazi medical experiment: 1933 to 1945, the program of the Nazi regime included sterilization, euthanasia, and medical experimentation for the purpose of producing a population of "racially pure" Germans who were destined to rule the world. The medical experiments were conducted on prisoner of war and those that were considered racially valueless such as Jews. They were confined to concentration camps, exposed to high altitudes, freezing temps, malaria, poison spotted fever, and untested drugs and surgical procedures without anesthesia. Nuremberg code: involved in the Nazi experiments. Mistreating of human subjects in these studies led to the development of the Nuremberg code in 1949. The code included guidelines that should help with consent ... Get more on HelpWriting.net ...
  • 26.
  • 27. Tuskegee Case Study Introduction The Tuskegee Syphilis experiment was an unethical scientific study funded by the US Public Health Service that was performed on African American men in Macon County, Alabama that took place from 1932– 1972. The purpose of this experiment was to study the progress of untreated syphilis in African American men; a total of "600 black men – 399 with syphilis, 201 who did not have the disease." (U.S. Public Health Service Syphilis Study at Tuskegee, 2013) The study was conducted under false pretenses, in that the scientist lied to the patients saying they were being treated for "Bad Blood" while being provided a placebo. In 1945 penicillin was discovered to be an adequate treatment for syphilis, and everyone who could get ... Show more content on Helpwriting.net ... This provides a guideline that ensures that researchers minimize the amount of risk a study may impose to a participant. When planning a study, it is also important that each of the participants are provided with a sense of security and not placed at a disadvantage. When participants enter into a study, a level of trust is established, and their identities and the information they provide must be protected and never be used against them or exploited for any reason. Respect for human dignity includes two rights; the right to self–determination and the right to full disclosure. When conducting a research study these two rights must be maintained to ensure that the participants are not coerced into participation and that they are making the choice of their own free will. Patients must be provided with all the information necessary to make an informed decision and voluntarily participate. No deception or concealed data collection can be done because it will violate the patients' rights. Justice represents two rights; the right to fair treatment and the right to privacy. The right to fair treatment consists of being treated in a nonjudgmental, nonprejudiced manner and with respect. Those that do not complete the experiment cannot be denied treatment that may be established from the information gathered, nor can they be denied treatment if they seek outside treatment. The right to privacy provides limits that "their research is not more intrusive than it needs to be, that ... Get more on HelpWriting.net ...
  • 28.
  • 29. Keynote-024 Case Study The KEYNOTE–024 trial was designed by Merck representatives and academic advisors. According to European legislation, Merck, as the Sponsor, designated, per country, a national principal coordinator, responsible for coordinating the work of the principal investigators at the different trial sites in each member state of the multicentre trial, according to national regulations. Each coordinator agreed to allow: 1) the respect of local laws, rules and regulations relating to the conduct of the clinical trial; 2) a regulatory authority inspection of trial–related documents and procedures and 3) the access to all trial–related source data and documents. The Code of Conduct, a collection of goals and considerations that govern the ethical and scientific ... Get more on HelpWriting.net ...
  • 30.
  • 31. Guatemalan Pharmaceuticals In the case of the Public Health Service (PHS) experimenting on inmates at the Terre Haute Federal Penitentiary for prophylaxis in gonorrhea, the study was abandoned at a critical stage in its development where a line would have been crossed, exposing moral and ethical boundaries set about in countries such as the U.S. as far as research on human subjects is concerned. The study was undergone with less regulation as a result of the decision to extend the research beyond borders to study syphilis, use subjects from a Guatemalan National Penitentiary with the mere consent of their supervisors (not from the subjects themselves), along with the differences in human rights policy in this nation, whereby human rights to justice and moral obligation issues were jeopardized. The questions would therefore be: can it be well argued that the actions of the PHS and the OverNow study were morally justifiable under the given circumstances while conducting their research abroad? ... Show more content on Helpwriting.net ... All actions taken by the researchers and their constituents (the pharmaceutical co–sponsoring the study, Healthy People Pharmaceutical) should evaluated according to the principles set about by Rawlsian justice and from a deontological perspective that is concerned with the moral obligations one has to the betterment of society as a whole and the morality of individual action. Through this essay, I seek to prove that the conducted research was unethical and a clear violation of human rights. Thus, further examination has revealed clear violations of the principles of Rawlsian Justice from a deontological perspective, and a multitude of internationally recognized legal principles that directly address cases of human research subject injustice that were observed in the past were also ... Get more on HelpWriting.net ...
  • 32.
  • 33. Research Ethics : Animal And Clinical Research Research Ethics: Animal and Clinical Research When it comes to clinical research, many people think of clinical trials, but that's only merely a small portion of a process towards a medical development involving a process call bench to the bedside. Clinical research outline scientific investigation involving animal or human subjects helping translate basic research into new treatments that would be valuable to patients. Clinical trials can contain a variety of research under the departments of physiology and pathophysiology, health services, and mental health. Furthermore, the process of developing new treatments from the bench to the bedside come in three stages: basic research, transitional research, and clinical research. First ... Show more content on Helpwriting.net ... Phase III Trials usually randomize compared trials, test efficacy compared to standard of care, once again test for further safety, and conclude to an effective dosage. Animal studies would be necessary based on the animals and the trials scientist are trying to conduct. Every animal is different, especially when compared to humans, but there are some in different animals that can help test based on the compound for the trials. Over time there has been numerous ethical violations in clinical research; some more significant than others. In 1906, when the Pure Food and Drug Act was passed, there were no regulations regarding the ethical use of human participants in research. There were no consumer regulations such as the Food and Drug Administration, Common Rule and Institutional Review Boards. One of the most significant events in research history involved human participants was the Nuremberg Code on December 9, 1946. American military opened criminal proceedings against several leading German physicians for their willing participation in crimes against humanity. German Physicians were charged for conducting medical experiments on thousands of concentration camp prisoners without their consent; in most of which the participants as a result either died or were permanently damaged physically. In conclusion of the trial, in 1948 the Nuremberg Code was established, making it known that participants should give consent. ... Get more on HelpWriting.net ...
  • 34.
  • 35. Therapeutic Disorders: A Case Study Case 9F In this case study we are introduced to a discovery from the 1980s. In the 1950s and 1960s patients from a state–operated mental health facility from Illinois underwent "therapeutic surgery." Therapeutic surgery is a treatment used to treat existing diseases. These surgical procedures were done without the consent of the patients undergoing these procedures. The purpose of this surgery was to improve the symptoms of schizophrenic patients. This surgical procedure consisted of the removal of the adrenal glands. The background behind this surgical procedure was that by removing the adrenal glands this could help correct a hormone imbalance that could help cure schizophrenia. The problem in this case study is that these surgeries were ... Show more content on Helpwriting.net ... This research project main focus was to find a way to reduce the disappearance of specific brain tissue that most people with Parkinson's disease had been suffering from. The people performing these research studies thought that the central nervous system could reduce the disappearances of the brain tissue if they regrowth the specific brain tissue. One of the methods that they would use was to place fetal tissue to desired locations within the brain. They would do this by drilling wholes in the skull and placing the tissue inside specific areas of the brain. The problem in this case study is to determine whether it was ethical for this study to use a control group that would not receive the treatment of the fetal tissue, but they will still have holes drill in their skull. When it comes to clinical trial there must always be a control group to show the progression of the study. However, the fact that these people with severe Parkinson disease were not going to have the opportunity to have the fetal tissue inject, but will still have holes drill in their skulls is unethical. By drilling holes in the control group skull their human rights would be violated and many of the laws that now protect individuals right when undergoing a research study would be broken. According to the RIB, " ....we have posited in conjunction with the goal of human flourishing, namely, never to allow scientific inquiry to trump the interest and inherent value of the irreplaceable human being enrolled in such research." Throughout history we have seen many human right violated when it comes to using human for experimental research. For example, the cruel way that the Nazi concentration camps used Jews as part of unethical experiments, or other research projects that use humans as an experimental tool without thinking about that persons feelings. This why law as like the Nuremberg Code, Belmont ... Get more on HelpWriting.net ...
  • 36.
  • 37. Carl Gustaf Emil Mannerheim Analysis When the topic of significant historical figures from the mid–17th century to present arises, people's minds typically gravitate towards a handful of usual suspects. Some examples might include George Washington, Abraham Lincoln, Winston Churchill, Franklin Delano Roosevelt, to include villainous figures such as Benito Mussolini, Joseph Stalin, and of course, Adolph Hitler. While these impactful historical characters are indeed intriguing, as there are countless books, articles, documentaries, and other literary pieces telling their respective stories, it is also important to learn and become further educated on other, less known historical figures. We all are pieces that eventually fit into our world's grand historical puzzle. And without historical education and learning about the people that paved the path for the world today, we can never truly understand today's world. Carl Gustaf Emil Mannerheim is a sizable piece of our historical puzzle, and his story is one that deserves recognition. Born on June 4, 1867, Carl Gustaf Emil Mannerheim was born into a wealthy family. He was son to a Swedish nobleman who was highly regarded in his society. Carl Gustaf spoke better in Swedish and Russian tongue than he could in Finnish, but this would prove obsolete in his ability to accel in Finland later in life.1 Mannerheim started his military education at the Hamina Cadet School, though he was eventually expelled from the institution due to disciplinary reasons.2 Following ... Get more on HelpWriting.net ...
  • 38.
  • 39. Examination Of Past And Present Ethical Guidelines On... Eilidh Cowan Ethics of Biomedical Science Research Ioan Alexandru Beldean Examination of past and present ethical guidelines on biomedical research Ethics can be defined as a set of moral values informing one's decisions. But this set of moral values can be influenced by many different things, such as various cultures, religions, and even technological advancements. This is called moral relativism, the idea that there are no real truths in ethics and what is right or wrong varies person by person. That is why before there was any codes or set of rules regarding what was ethical put in place, people were able to get away with doing all sorts of scientific research, that would now be deemed unethical. Biomedical research is to be done to eventually better the health of humans. Biomedical research has been going on for many years, it is how we have knowledge of many deadly diseases as well as the discovery of vaccines and antibiotics! These things seem so common today, but infact went through lots of stages of research to get to the technologies we have today. However, before 1947, there were no codes of ethics or regulations to ensure that research being done was ethical. The smallpox vaccination, although the first successful vaccine to ever be developed, would be considered highly unethical today. Edward Jenner experimented on a healthy young 8 year old boy without consent. In today's society, this study would never have been allowed to continue. There are many other ... Get more on HelpWriting.net ...
  • 40.
  • 41. Unethical And Criminal Behavior During The Prussian... The experiment with human subject was brought to an attention to the Prussian Parliament, when several unethical and criminal behaviors were traced in the field of research in Germany in the nineteenth century. The research was mainly conducted unethically in the hospitals, mainly without any informed consent. The turning point for the establishment of universal rule regarding human experiment was done after the case of Neisser, where in 1898, Albert Neisser, who discovered the gonococcus and professor of dermatology at university of Breslau, conducted "clinical trials on serum therapy in patients with syphilis. In order to find a method of syphilis prevention, he injected cell free serum from patients with syphilis into patients who were admitted for other medical conditions. Most of these patients were prostitutes, who were neither informed about the procedure, nor asked for consent." After several discussions in the Prussian parliament about the case, attention was given to the need of participant's autonomy and beneficence. The criticism of unethical human experiments in the media and in the parliament, the Reich government issued detailed 'Guidelines for new therapy and human experimentation' in 1931 (Vollmann, & Rolf, 1996). Nuremberg Code (1946) Since, the post–World War I gave a way for Nazis to rise to power in Germany and that had led to an era, where all basic human rights of the citizens were ceased, the research sector was also greatly affected as 'the Nazi ... Get more on HelpWriting.net ...
  • 42.
  • 43. The Pros And Cons Of Bioethics In healthcare, bioethics is studied to improve patient outcomes and treatment. Research is conducted by bioethicists on ethical, social, and legal issues that have come about in biomedicine (National Institute of Health). Since the beginning of time, much knowledge has been gained through experimentation. Healthcare is an everchanging field in which experimentation is a key aspect. Some research can be done without using humans as test subjects, however, others must be tested on humans. The primary purpose of medical research involving human subjects is to understand the causes, development and effects or diseases and improve preventive, diagnostic and therapeutic interventions (World Medical Association). Accordingly, there are fundamental boundaries that should be respected, relating to the principles of beneficence, nonmaleficence, autonomy, and justice. The World Medical Association (WMA) originally adopted the Declaration of Helsinki in 1964, which protects the ethical principles involving human subjects. It serves as a statement of ethical principles for medical research involving human subjects, as well as research on discernable human substance and data. The document provides guidelines to ensure that the life, well–being, dignity, integrity, privacy, autonomy, and confidentiality of subjects are protected (WMA). Though the declaration is not a legal document, it has been integrated into laws governing medical research across the world. Before a research ... Get more on HelpWriting.net ...
  • 44.
  • 45. Application Of Individual Voluntary Consent Despite many ethical guidelines, various issues stay debatable, including the relevance, prioritization, and application of individual voluntary informed consent in developing countries. The practical problems of informed consent in developing countries are huge due to several factors, including relatively low levels of formal education, lack of access to good quality health care services, and in some circumstances, diverse values, knowledges of health and illness. HIV research in developing countries has caused in amplified arguments of ethical concerns, mainly the subject of the quality of informed consent. The ethical dilemmas in the standards of informed consent applied by research institutions and pharmaceutical companies of HIV clinical trials in developing countries will be discussed. 2. Vulnerability and Informed Consent in Research and Health Care a) Vulnerability and Vulnerable Populations "Vulnerability" term is a fairly new one in the discourse of bioethics; it was used in the Belmont Report in 1979 for the first time. The meaning of the concept has gradually evolved over time. At first, vulnerability was reflected as a special deliberation in the application of the bioethical principles of respect for persons, beneficence, and justice, mostly applicable in the framework of research with human beings. In the 1993 CIOMS guidelines, the notion of "vulnerability" developed to include a distinctive application of the principle of justice and the principle of respect ... Get more on HelpWriting.net ...
  • 46.
  • 47. There Should Be Guidelines To Human Experimentation The modern understanding of medicine was created by the many people who were subjected to medical testing without their consent. There should be guidelines to human experimentation. Human experimentation should only be performed on consenting adults that understand what is going to happen. In other words, the doctors should get informed consent from their patients. There have been many unethical human experimental trials performed on people that had no idea what was happening to them. This is unethical and very dangerous for the people. There also have been different guidelines and codes for human experimentation, such as the Nuremberg Code and the Declaration of Helsinki. An example of such unethical human experimentation is The Tuskegee Syphilis Experiment. This happened in Alabama and was performed by the U.S government in 1932. The men that were in the trial were given free health care, meals and burial insurance. 399 men had syphilis beforehand and 201 did not. Funding was cut for the experiments but they still continued to study these men even though the antibiotic penicillin had come out in 1947. They told the men that they had something called "bad blood" and they refused to tell the men that they had syphilis. This trial was continued until 1972 when the ... Show more content on Helpwriting.net ... The nazis performed experiments involving torture, disabling injury, and death.The Nuremberg code is a set of guidelines in which doctors must follow. The Nuremberg code was published in 1947. The Nuremberg Code was created after the Nuremberg trials where high ranking Nazi members and doctors were put on trials for their heinous acts during the World War II. The Nuremberg Code was not the first guideline for human experimentation. The Nuremberg Code was based on the Guidelines for Human Experimentation of 1931. The Nuremberg code is not regularly reviewed or ... Get more on HelpWriting.net ...
  • 48.
  • 49. Ethical Research: Should Research Be Informed Consent? Before any research is conducted, as stated by the NHS Health Research Authority (2015) it is essential that the researcher ensures all relevant permissions are sought. Long & Johnson (2006) argue, any research can be harmful to both its participants and or researchers, therefore as per the guidance issued by the Royal College of Nursing (RCN) (2011), the researcher should ensure research governance is adhered to and permission is sought from the local and university ethics committee. Additionally, it is expected researchers should comply with the Declaration of Helsinki (American Medical Association, 2013). Interestingly, Hammersley & Traianou (2012) question whether the Declaration is fit for its purpose as it is not compulsary for researchers to adhere to this. However, as stated by Gerrish & Lathlean (2015) it is considered the Declaration of Helskini is the foundation on which all ethical research is built upon. Thus to comply with the declaration, as stipulated by the RCN (2011) the researcher should address six key ethical points ... Show more content on Helpwriting.net ... Therefore in order to address this key issue, the author proposes to breif students of the intended research aims at the beginning of a lecture and provide the benefits and potential harms of taking part in the study. Additionally, participants will also be informed of the right to withdraw from the study at anytime without prejudice or impact on their studies. As Dyson & Norrie (2013) recommends the explanation should be carried out in a simplistic way, so that participants can understand and ask questions, in order to provide informed consent. It is important to note as per the RCN (2011) guidelines, at no point will the researcher make the individuals feel pressured or coerced into taking part in this study. The next paragraph will now consider how this carrying out this research is relevent to ... Get more on HelpWriting.net ...
  • 50.
  • 51. 10 Principles Regaarding Ethical Clinic and Set of... Nuremberg Code is a set of 10 sophisticate principles regarding ethical clinical research on human being (Grodin, 1994). It is mainly for protection of subjects' human right (Shuster, 1997), such as compulsory of informed consent and the equal authority of subjects as the physician–researcher to end the experiment. 1.2 Helsinki Declaration (1964) Helsinki Declaration is a set of guidelines on clinical research for physician as their responsibility toward protection of their research subjects (Williams, 2008). World Medical Association (WMA) also encourage it is used as reference by other parties in conduction of clinical research (Bădărău, 2013). Compared with the Nuremberg Code, which mainly focuses on safeguard of the subjects, its ... Show more content on Helpwriting.net ... The vile medical crimes during the WW II had raise the awareness on the need of a world body which able to define and promulgate medical ethnics around the world (Tyebkhan, 2003). Thus, the World Medical Association (WMA) was set up in 1947 with 1st Annual Meeting of General Assembly in September 1947, Paris (Human and Fluss, 2001). WMA is an international confederation composed of national medical associations that seek to promote medical ethics and professional standards (Human and Fluss, 2001). Helsinki Declaration was first developed and promulgated in June 1964 by World Medical Association General Assembly in Helsinki after more than a decade of debate and discussion among the members of WMA (Williams, 2008). Since the first adoption, revision and amendment were done several times on the Helsinki Declaration for refinement. The Helsinki Declaration had been revised 8 times at meeting of WMA: Tokyo 1957, Italy 1983, Hong Kong 1989, South Africa 1996, Edinburg 2000, Washington 2002, Tokyo 2004, Seoul 2008 and Brazil 2013 (Association, 2013). 3 Importance of Nuremberg Code and Helsinki Declaration In my opinion, Nuremberg Code and Helsinki Declaration play an important role as guideline in clinical research involving human being. Both Nuremberg Code and Helsinki Declaration protect the clinical subjects in term of their right and safety. By referring to them before performing of the protocol, ... Get more on HelpWriting.net ...
  • 52.
  • 53. Obtaining Ic in Er Situations Obtaining Informed Consent in Emergency Situations Introduction As research advances in finding answers and treatment for diseases, the process of obtaining a patient's informed consent becomes more detailed required. The informed consent is known as the cornerstone of Good Clinical Practice for ensuring patient safety. In a normal clinical paced environment, time is given to ensure patients are provided all the required information and the time to make a rational and voluntary decision to participate in a study. At times this process is not feasible do to emergency situations, such as when a patient arrives in the emergency room in a compromised mental and physical state that does not permit ample time for this process. Such cases ... Show more content on Helpwriting.net ... The Belmont is based on three basic principles: 1) Respect for persons. Autonomous subjects, subjects have the right not to participate and withdraw their participation at any time. 2) Beneficence. To prevent and do no harm; the risks should not outweigh the benefits. 3) Justice. All subjects should be treated equally regardless of their race, age or economic status7. Exception to Emergency Informed Consent Form In 21 CFR 50.24, federal regulations allow for emergency research to be conducted without an informed consent. The Consent is designed to exempt the subject's normally required signature due to the following reasons below: (1) The patient is in a life threating condition, requiring treatment outside of the standard of care. The study treatment may be unproven and require data on safety and effectiveness. (2) The patient's mental and/or physical state does not permit them to give their consent. (3) The treatment in question will need to be administered before a family member or a Legally Authorized Representative (LAR) is able to provide consent. (4) There is no way to determine prospectively if patients would be eligible and provide their consent to participate in the trial. (5) The benefits associated with the investigational product ... Get more on HelpWriting.net ...
  • 54.
  • 55. The Need To Safeguard The Practice Of Research Ethics Research Ethics This essay is aimed at my fellow students and tries to explain using some different case studies firstly what research ethics are and what happens when you don't stick to these same ethics. Research ethics involves concepts and principles of right conduct within the research being carried out. Oxford dictionary defined ethics as 'Moral principles that govern a person's behaviour or the conducting of an activity' (Oxford). This is especially true within research ethics as this research is a public trust that must be ethically conducted, trustworthy, and socially responsible if the results are to be valuable and be believed. The need to safeguard the practice of research ethics within all fields of sciences and engineering is ... Show more content on Helpwriting.net ... Research should be carried out only by medically/scientifically qualified individuals and in appropriate laboratories. 5. Risks should not exceed benefits that will potentially result from the experiment. (Research & Economic Development) During the World Summit on Sustainable Development (WSSD) in Johannesburg in 2002, held on the, the then UN Secretary–General Kofi Annan (2002) stated that "And more and more we are realizing that it is only by mobilizing the corporate sector that we can make significant progress. The corporate sector has the finances, the technology and the management to make this happen" (Annan, 2002, para. 5–6). This shows that assessing the compatibility of business ethics and sustainable development is important and is encouraged at the highest level. A basic ethical dilemma that commonly takes place with many engineers has to be the duty to report a to the proper responsible authorities if a client or employer is failing to follow the engineer's directions and/or designs causing possible harm. This duty should annul all or any duty to a client or the employer as it may put people in harms way. As an engineer they may face some penalties, or have their license taken away, if something unethical has occurred (Engineers, ... Get more on HelpWriting.net ...
  • 56.
  • 57. Ethics of the Nuremberg Code Essay From 1946 to 1947, the Nuremberg War Crime Trials took place, withfifteen of twenty–three German physicians and research scientist–physicians found guilty of criminal human experimentation projects. The trial court attempted to establish a set of principles of human experimentation that could serve as a code of research ethics. The result was the Nuremberg Code, which attempted to provide a natural law–based set of universal ethical principles. Looking beyond the Nuremberg Code and applying it to modern medical research ethics, there are many challenges that it poses. Many have argued that the Code tries to provide for all unforeseen events, which restricts the researcher by requiring him to anticipate every situation, demanding the ... Show more content on Helpwriting.net ... Hence, a proxy was given to those who did not have legal capacity allowing researchers to expand their population for experimentation. The term informed has also been criticized because sometimes even the researcher is not aware of the risks associated with the experiment or they are too technical for the subject to understand. Thus scientists have argued that only adequate information should be released to the patient and a full understanding is not necessary. In this clause, responsibilities are placed on the individual who is initiating, directing, or engaging the experiment but there is no place for the researcher to be reviewed for his actions. The scientist is in full control of making any necessary ethical deliberations. The Declaration of Helsinki added a clause stating experimental protocols should be transmitted to a specially appointed independent committee for consideration and comments. The third principle of the Code addresses the justification of the performance of the experiment based on previous studies done on animals. This may be challenged because the researcher cannot always guarantee success of the experiment even though it has been successful on animals or in previous studies. Uncertainties in the experiment will always be present. The Declaration of Helsinki does not ... Get more on HelpWriting.net ...
  • 58.
  • 59. Ethics of Offshoring: Novo Nordisk and Clinical Trials in... Ethics of Offshoring: Novo Nordisk and Clinical Trials In Emerging Economies Offshoring is a highly debatable topic throughout the country and the world. Many people base their opinions on different aspects of offshoring. Some people are against offshoring because they feel as if the working conditions in other countries aren't up to par and are unethical. Some people are against offshoring because they feel it is taking jobs away from people within their own country. Some people are for offshoring because they feel there is greater profit involved or that they can get harder workers in other countries. No matter what side of the debate, everyone can agree on a few things like there needs to be better standards for working conditions, ... Show more content on Helpwriting.net ... Another question that needs to be addressed is if trials are conducted in an emerging economy, how should they be managed and which standards should apply? I think medical ethics is a big issue when it comes to trials being conducted in an emerging economy. One famous incident of this was the Tuskegee syphilis study. This study left 400 African Americans untreated in order to research how they obtained the disease. The cure for syphilis, penicillin, had already been found in the 1940s. To prevent this from happening again, professional medical organizations developed guidelines and principles of ethics to guide their research, notably the Helsinki Declaration. I believe Novo Nordisk does a great job of adhering to these guidelines by putting safety measures in place. Emerging economies like India and China are attractive places to have clinical trials because of how much cheaper it is, the willingness to try new things as an emerging economy, and because a possible lack of standards. Novo Nordisk only conduct trials in countries where they have affiliates with necessary competence to arrange and monitor the trials. Also, they conduct clinical trials globally to test the safety and efficacy of new drug candidates in order to obtain global marketing authorization. These trials always have the same standards at all trial sites. The standards in ... Get more on HelpWriting.net ...
  • 60.
  • 61. Informed Consent In Medical Research Informed consent is the current guiding principle for the ethical conduct in medical research and originated after the 1947 Nuremberg Code and the 1964 Declaration of Helsinki (Nguyen et al., 2015). The purpose of the informed consent process is to provide potential research subjects information about the nature of the clinical trial, the risks, benefits, underlying procedures, and alternative treatments (Bloswick & Skowron, 2015). The research team must provide the patient with sufficient information so the participant can fully make an informed, uncoerced choice about whether to begin or continue participation in a clinical trial. This process is an ongoing exchange between the subject and the research team throughout the research study. ... Get more on HelpWriting.net ...
  • 62.
  • 63. Ethical Research In Australia Australia's policy on research ethics is very similar to most developed nations' policies, in that it aims to ensure that the people on whom studies are conducted are treated fairly and are afforded basic rights and their freedoms are protected. Australia also sets forth guidelines for researchers with the goal of managing the ways that researchers use and share data, attribute other authors and conduct effective peer reviews. A relevant document is the Australian Code for the Responsible Conduct of Research which is a "guide [to] institutions and researchers in responsible research practices". This document provides a basic reference for the development of policies that ensure ethical practices. This document and many others in Australia define ... Show more content on Helpwriting.net ... Additionally, the government is responsible for providing grants to researchers and institution, and thus must have stringent policies on making sure that research is ethical before providing grants as well as having an ethical review committee for assessment of the ethicality of potential research. Moreover, in the case that research is being conducted abroad, domestic ethics review committees may need to work in conjunction with the ethics committees in the host nation, or in some circumstances even help in creating such a committee. Ethical ramifications of research done outside one's nation will be extensively discussed further in this paper. The next level of research is the research institution, specifically dealing with private institutions, as public ones are generally covered under the governmental level, institutions' are responsible for disseminating governmental decrees as well as educating their staff on all tenets of ethical research and make sure that researchers have a conducive environment for researching, so that they may advance human knowledge and health. The final level is the researcher, for whom these standards are addressed to and whose responsibilities include being aware of laws in ... Get more on HelpWriting.net ...
  • 64.
  • 65. Project Case Obtaining Informed Consent in Emergency Situations Introduction As research advances in finding answers and treatment for diseases, the process of obtaining a patient's informed consent becomes more detailed required. The informed consent is known as the cornerstone of Good Clinical Practice for ensuring patient safety. In a normal clinical paced environment, time is given to ensure patients are provided all the required information and the time to make a rational and voluntary decision to participate in a study. At times this process is not feasible do to emergency situations, such as when a patient arrives in the emergency room in a compromised mental and physical state that does not permit ample time for this process. Such cases ... Show more content on Helpwriting.net ... The Belmont is based on three basic principles: 1) Respect for persons. Autonomous subjects, subjects have the right not to participate and withdraw their participation at any time. 2) Beneficence. To prevent and do no harm; the risks should not outweigh the benefits. 3) Justice. All subjects should be treated equally regardless of their race, age or economic status7. Exception to Emergency Informed Consent Form In 21 CFR 50.24, federal regulations allow for emergency research to be conducted without an informed consent. The Consent is designed to exempt the subject's normally required signature due to the following reasons below: (1) The patient is in a life threating condition, requiring treatment outside of the standard of care. The study treatment may be unproven and require data on safety and effectiveness. (2) The patient's mental and/or physical state does not permit them to give their consent. (3) The treatment in question will need to be administered before a family member or a Legally Authorized Representative (LAR) is able to provide consent. (4) There is no way to determine prospectively if patients would be eligible and provide their consent to participate in the trial. (5) The benefits associated with the investigational product ... Get more on HelpWriting.net ...
  • 66.
  • 67. Grimes Vs Kennedy Krieger Institute Case Summary What comes to your mind when you hear the word ethics? Do you think of morals, right or wrong, Ten Commandments, Hippocratic Oath, The Golden Rule, or a little bit of everything? Ethics can be described as a philosophy dealing with the actions, beliefs and decision–making of an individual or groups of individuals and what may be seen as good or bad. Ethics and ethical decision–making can be found in all aspects of society, professions, culture, human development, institutions, law and religion. This paper will examine the case of Grimes v. Kennedy Krieger Institute and the Lead Abatement Study and how ethics, legal theory and law plays a vital role in the institution of human research, specifically on children. What follows will evaluate how this case violated or conformed to the assigned ethics documents: The Nuremberg Code, Helsinki Accord, Belmont ... Show more content on Helpwriting.net ... The Belmont Report is a summary and outline of ethically guided principles of justice, respect for the individual and beneficence. Consent, assessment of risks and benefits, and selection process of individuals are also mandatory. The Belmont Report had already been in place prior to the John Hopkins study. All aspects of the report were violated as a result of the research. A complete and informed consent was not absent, children were harmed and not treated as other children, perhaps being used individually for the good of children as a whole. All of the possible risks were not disclosed, the benefits of the research for the children if any, were unclear and the selection process may have been unjust. Kennedy Krieger's Chief Executive argued however, that most children benefited from the study. He stated that if they had not moved into the homes of the study, things could have been ... Get more on HelpWriting.net ...
  • 68.
  • 69. The European Union ( Eu ) The European Union (EU), as a supranational organization, has increased its stock of importance within the international realm through increased integration. Sector after sector has been targeted in attempts to create a more perfect union where all European member states are represented equally. That quest for deeper integration ultimately brought the founders of the EU at the threshold of defense and foreign policy. No one knows for sure the collective direction of the EU, only to say that the goals of the organization tends towards creating a federal state. That would mean that the EU would be the voice over all pertinent matters including foreign and security policy. It also happens to be that those two areas are held in high regard by ... Show more content on Helpwriting.net ... By suggesting that the safety of European Community would be bolstered only in the cooperation of the European states in the rebuilding of Germany, these gentlemen put forth the theoretical beginnings to what the European Union is today. The idea was that the individual nations within the European Community would relinquish a portion of their state's sovereignty in a massive effort to avoid the chance of another tragic war on the continent. More than any other continent on earth, the European continent had experienced, what seemed like, constant war between relatively close states. Because of this, it is definitely understandable the need for some significant peace time on the continent, and the utilization of this fragile moment in European history as a time to create a new, more interconnected community. Monnet, while wanting eventually, this collection of European states under a central authority, realized the time restraints: "Jean Monnet had understood that any attempt to introduce a comprehensive institutional structure in one go would bring a huge outcry from the different countries and was doomed to failure. It was too early yet to envisage wholesale transfers of sovereignty. The war was too recent an experience in people 's minds and national feelings were still running very high (Schuman, 1950)." ... Get more on HelpWriting.net ...
  • 70.
  • 71. Ethics of Offshoring Novo Nordisk Essay To: Anders Dejgaard From: Jennifer Tsai Subject: Ethics of offshoring Date: 05/23/2011 Critical issued of the appropriateness of conducting clinical trials in emerging countries has arisen over years. Being a leading company in biopharmaceutical industry, Novo Nordisk faces the critiques of whether it is justice to offshoring their clinical trials in developing economies. With the consistency of ethical principles brought up by Novo Nordisk, the company would be able to move their trials into emerging economies with the best interest for stakeholders. I will also propose ideas to Mr, Dejgaard for possible approach to media as well as the practices that Novo Nordisk could have changed over time at the end. Conducting Clinical ... Show more content on Helpwriting.net ... Firms definitely need to incorporate their highest moral standards to build trust and reputation for themselves in order to better off in long run. Novo Nordisk always follows the regulation from Helsinki Declaration with other international ethical guidelines. They made sure that the interest and well–being of the trial subject should always transcend over the interest of science, society and commerce. Decision Principles Even though I think conducting clinical trials in emerging economies is beneficial to the firm, Novo Nordisk should still follow below guidelines for this major decision to protect its own reputation and serve the best interest for every stakeholder: Execute clinical trials when the internal organization is well established and external environment is proper regulated in emerging countries. Conduct placebo clinical trials when they are scientifically and ethically justified. Ensure the human rights of the participants in emerging countries associated with the predictable risks Responses to The Media I understand that Mr. Dejaard holds a high ethical stands, and is not interested in misleading the public or ethical dissembling in the response. It is also important to clear up the actions Novo Nordisk has taken for the past years and give public a clear picture of how the firm is operating. If a journalist is inviting for an interview, Mr. Dejaard should present himself ... Get more on HelpWriting.net ...
  • 72.
  • 73. Ethical Issues During The Nuremberg Trial Some may say it is ethical to use information from an unethical study, but I believe that it is unethical to use information that was obtained in an unethical way. However, the Nuremberg Trial shows why it is unethical to use information from studies that are unethical. The Belmont Report and Declaration of Helsinki both allow for researchers to understand what is considered ethical and unethical before starting their research. Unethical research has been characterized by the Nuremberg trials and other research that has been done in the past to cause harm to an individual that is participating in research. According to Neutens, children are considered a vulnerable population along with the elderly. Although children and elderly are both considered ... Show more content on Helpwriting.net ... Now we have the Belmont Report and the Declaration of Helsinki to guide researchers in the most ethical direction when they are conducting their research for studies. Luckily now researchers have to basically write out their entire plan throughout the study step by step. They must write out any way that the human subject may be harmed, what they will do if someone is harmed, any potential costs, and much more. Once all of this is written out researchers then have to get their study approved before they can move forward with their study (Neutens & Rubinson, 2014). The steps that have to be taken to conduct research may seem like a lot, however, it may save a lot of time and energy in court if something happens to go wrong during the trial. The Nuremberg Trials may have been awful but now researchers are aware of the difference between right and ... Get more on HelpWriting.net ...
  • 74.
  • 75. The Provision Of Fair Benefits The question 'does the provision of fair benefits counter a claim that communities have been exploited in the context of international research?' opens discussion to a complex topic on ethics in international research. The question asks whether the provision of fair benefits protects research communities, defined as communities on whom the research is conducted, from exploitation. In order to discuss this question, it is necessary to first understand what constitutes fair benefits and exploitation in the context of international research. Whilst several divergences of the definition of "exploitation" in international research exist, exploitation in the context of this discussion is defined as the unfair distribution of risks and benefits ... Show more content on Helpwriting.net ... Whilst low income nations most commonly take on the risks of research, the majority of benefits achieved through research are shared with communities in high income countries3,6. Poor healthcare, poverty, illiteracy, cultural and linguistic differences, limited scientific understanding and lack of or inefficient research regulations and independent monitoring contribute to the vulnerability of communities in low income countries to exploitation. Over the last ten years there has been an increased interest by organisations and sponsors from wealthy countries to conduct research in low income countries due to reduced costs3,7,8. Emanuel et al. claim that the prevention of exploitation of study participants and their communities demands the provision of "fair benefits" to these communities7. The fair benefits framework aims to protect communities from exploitation in international research through the fair distribution of burdens and benefits between involved parties9. The framework asserts that research participants and their communities are entitled to a "fair level" of benefits which balance the burdens and risks participants experience during the research. As the benefits attained by sponsors and researchers increase, so ... Get more on HelpWriting.net ...
  • 76.
  • 77. Informed Consent Mark A. Puno Instructor: Craig Bartholomaus English 102 27 March 2013 Informed Consent What is an informed consent? What do we know about it? Where did it come from? What purpose does it serves? These days, there is a variance in what informed consent means. Its definition depends on what specific manner it accentuates in accordance with the pertinent setting of application. The American Medical Association (AMA) has definitions on a clinical setting and on the field of research. However it is defined, informed consent was the product of a period of work and experience. Informed consent is the cornerstone of human subject research protection. (Rowbotham et al.) The principles of informed ... Show more content on Helpwriting.net ... HeLa cells are considered the first immortal human cells ever grown in culture – they divide indefinitely and that is what sets them apart from other cell lines. HeLa cells have been used in various important medical research, i.e. cancer research, culturing and growing cells, cloning, gene mapping, and development of vaccines. The most recognized vaccine created is the polio vaccine. HeLa cells also helped found or create the field of Virology – the study of viruses. However, Henrietta Lacks' and her HeLa cells story is far more about her contribution to medical research, it was about the unethical process of the collection of her tissue sample and what came after it. Rebecca Skloot had written a best–selling book about her life story and her cells. (Skloot) With human health experiments steadily exposed people to conditions beyond the boundaries of medical evidence, the United States Congress passed the National Research Act in 1974. The National Research Act then created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Among the Commission's most significant work was the formulation of the Belmont Report and the Institutional Review Report. The Belmont Report is one
  • 78. of the primary report in health care research and ethics. The report comprises of three (3) basic ethical principles; which are justice, respect for persons, ... Get more on HelpWriting.net ...