Keynote-024 Case Study

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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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

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

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

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

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 researchethics 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

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

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 ofethics. 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 ...
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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.,

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
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

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.

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,

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
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

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

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

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

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

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 theDeclaration 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

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.

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,

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

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 ...
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

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

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

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
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)."

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.
1.2Helsinki 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
(BДѓdДѓrДѓu, 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).
3Importance 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,

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

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

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...
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

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

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,

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

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

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,

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...
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

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...
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

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
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.

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

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

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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