Ethical Dilemmas In Clinical Research

Ethical Dilemmas In Clinical Research
In this chapter, we primarily discuss about clinical trials and a few sources of publicly available
clinical trial datasets that have been utilized for our experiments.
2.1 Clinical trials
Clinical trials are conducted to add medical knowledge related to treatment diagnosis, preventing
certain diseases or testing new drugs on human volunteers before releasing to the market. In clinical
trials, participants receive specific interventions in the form of drugs, medical products, procedures
or change in the behavior such as diet. Several phases involved in clinical trials tend to generate a
lot of data [2].
ClinicalTrials.gov is designed to benefit community of clinical researchers by expanding access to
clinical trial data. Clinical trial registry launched by clinicaltrials.gov, has data for more than
100,000 clinical studies and has promoted the state of clinical research. As per the instructions of
ClinicalTrials.gov, data providers have to specify outcome measures and timeframe of the clinical
trials. This has helped a growing number of clinical researchers to conduct a several primary and
secondary analyses. The contribution of publicly available clinical trial data will continue to make
significant impact on clinical research enterprise [1]. ... Show more content on Helpwriting.net ...
OAI clinical trial has about 5000 participants with clinically significant knee OA or having risk of
developing one. OAI has made the trial data available on website and it can be accessed by
accepting data use agreement. OAI aims at multiplying scientific research contributions by
providing study data to OA research community. The primary aim of OAI is to prevent knee OA
patients from pain and disability of knee. Dataset provides number of data files with information
about biomarkers, subject characteristics, joint symptoms, medical history, medications etc.
... Get more on HelpWriting.net ...

Clinical Research Past and Present
Clinical Research Past and Present Tina Ross–Cruz Abstract Research disasters have been noted for
years. In the early years, the reasons for these disasters was that there were no regulations governing
the protection of human beings; and there were no guidelines for safety and efficacy of a new
medication or treatment prior to the use in humans. Now regulations and guidelines are in effect for
the protection of human subjects. These guidelines and regulations also protect the researchers.
These regulations have enabled the researchers to further scientific knowledge of diseases and the
etiology, along with the bioavailability, toxicology, and pharmacology of the new medication or
treatment. Even with all of these regulations and ... Show more content on Helpwriting.net ...
307, P 719–724). Therapies were not based on observational studies but on the authority of tradition.
For instance, take the great cough medicine; people were sold the recipe of whiskey, honey, and
lemon to quiet the cough. Recipes similar to these were sold to the public without any evidence of
safety and efficacy. The products that were non–effective; most of them were 99% water. In the
words of Oliver Wendell Holmes, M.D., "If all of these patent medications were thrown into the
ocean it would be good for the population, but bad for the fish in the ocean" (Parasandola, 1999).
"The history of medicine is abundantly endowed with therapies that were widely used and then were
shown ineffective or deadly" (Passamani, 1991). For instance, radiation therapy was used on
patients between 1940 and 1968 for the treatment of acne. The radiation treatment was found later to
lead to a high incidence of thyroid cancer in the treated patients. The thalidomide disaster was
another treatment found to be toxic. Thalidomide was used in pregnant women for morning sickness
in the early 1950 's. This led to birth defects in hundreds of babies. Because of the birth defects in
infants, the drug was banned from use in the United States. In 1906 a law was passed to set
standards for drug purity and quality through the United States Pharmacopoeia and the National
Formulary; however, there still was not a law regulating the safety profile

Clinical Depression : Research And Treatment Methods
Clinical Depression: Research and Treatment Methods One of the most common psychiatric
disorders is known as clinical depression and affects anywhere between 3% and 13% of the
population with some form of depressive symptoms affecting as much as 20% of the adult
population at some point in their lives (Amenson & Lewinson, 1981; Kessler et al., 1994; Oliver &
Simmons, 1985, as cited in Antonuccio, Danton, & DeNelsky, p. 574). The concept of 'harmful
dysfunction' advanced by Horwitz and Wakefield (2007) describes two key components of clinical
depression: a dysfunctional mechanism and the dysfunction being harmful to the individual (as cited
in, Parker & Paterson, p.405). This paper explores the following questions: what does research
indicate about clinical depression and what are the implications for treatment? Reviews are
presented in regards to the emergence of depression and psychotherapy versus medication to treat
clinical depression. Considerations are briefly discussed and the research paper will conclude with
an interpretation of the critical points.
Emergence of Depression According to Castrén (2005), geneticists are searching for particular genes
that may be associated with mood disorders as they often occur in the family lineage. For example,
the chemical hypothesis of depression states that extended periods of changes in either the
productivity or action of molecules in the brain are said to cause mood disorders. In this case,
individuals can make use of

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.

Essay on Research In Clinical Practise
Research In Clinical Practise
Introduction to Portfolio
The research articles to be critiqued relate to the author's area of practice; community nursing and in
particular; the cost–effectiveness of community leg ulcer clinics. The author currently manages a leg
ulcer clinic and an insight into the research underpinning their cost–effectiveness would be of
benefit in her quest to deliver evidence–based practice in line with the principles underpinning
clinical governance.
Management of venous leg ulcers had advanced considerably over the last decade. This is due to
various factors from greater knowledge of the aetiology of leg ulceration to more recent
developments, such as dedicated leg ... Show more content on Helpwriting.net ...
Nursing has been striving to become a research based profession since the Briggs Report (1972) and
the lack of apparent integration of research findings into nursing practice has been lamented
consistently ever since (Walsh and Ford, 1989). As long ago as 1989 the Department of Health
(DoH), in their Strategy for Nursing stated; 'All clinical practice should be founded on up–to–date
information and research findings.
Practitioners should be encouraged to identify the needs and opportunities for research presented by
their work. Research is fundamental to achieving evidence–based practice in nursing. Evidence–
based health care aims to promote clinical and cost–effective care/treatment through the explicit,
conscientious, and judicious use of the currently available best evidence from research to guide
decisions (Sackett et al, 1996).
Recently, there has been an increasing emphasis on evidence–based practice. The NHS information
strategy, the development of the NHS net and the National Electronic Library for Health all testify
to the NHS commitment of bringing research evidence closer to clinical decision makers
(Thompson et al 2001). Journal based initiatives are also available such as Evidence Based Nursing
(Cullum et al. 1997) and Clinical Effectiveness in Nursing (Newell 1997). Furthermore, guidance
can be found in publications such as NICE (National Institute

Ethics Of Prisoners
One of the important undertakings in clinical research is the use of prisoners as human subjects
since the prison population is characterized by more problems than among non–prisoners. As such,
researchers tend to associate some of such problems with criminal behavior. Research thus serves to
provide valuable outcome and interventions on the well–being of incarcerated individuals. However,
studies involving prisoners are laden with troubling ethical issues, such as coercion of prisoners to
participate in such studies without their informed consent. Incarceration thus constraints prisoners
from exercising their rights to voluntary and un–coerced decisions on participating in research as
human subjects.
The US government has erected stringent protections for the prison populations to be left out of
medical research entirely. However, such routine exclusion may harm the public good as well as the
prisoners. Ethical principles for research with human subjects should be applied to avoid
unconscionable violations of human rights. Further, performing medical experiments without the
consent of the prisoners constitutes crimes against humanity. This ... Show more content on
Helpwriting.net ...
The report identifies principles of respect for persons, beneficence, and justice that researchers
should use to categorize and analyze issues related to studies on human subjects. The respect for
persons involves providing informed consent to the research participants. As such, the researchers
should treat the individuals as autonomous agents should protect people with diminished autonomy.
Therefore, the subjects should enter the research voluntarily and with adequate information
Prisoners should not be deprived of the opportunity to volunteer for research, however, they should
not be coerced or unduly influenced to take part in the research on anthrax vaccine for which they
do not wish to

Antibiotics For Acute Respiratory Infections
Antibiotics are over–prescribed, and this has contributed to community bacterial resistance to
antibiotics. The use of antibiotics for acute respiratory infections (ARIs) is controversial. The
delayed antibiotic strategy has been advocated as a safety net for uncomplicated ARIs, in an effort to
reduce antibiotic use. The authors conducted the study to evaluate the antibiotic usage, clinical
outcomes, and patient satisfactions for acute respiratory infections (ARIs) of the delayed strategy
compared to immediate and no antibiotic strategies.
1. Are the results of the review valid?
a. Are the studies contained in the review RCTs?
Yes, this review included ten studies, involving randomized controlled trials (RCTs) with a total of
3157 participants. These RCTs met quality inclusion criteria. The delayed antibiotic strategy was
compared to antibiotic used immediately or no antibiotics in the participants of all ages with ARIs.
The authors evaluated clinical outcomes antibiotic use, patient satisfaction, and re–consultation rates
in the three methods.
b. Does the review include a detailed description of the search strategy to find all relevant studies?
Yes, a detailed description of search strategy is included in the review. A large number of database
were searched, such as Cochrane Central Register of Controlled Trials and Ovid MEDLINE,
EMBASE, Science Citation Index – Web of Science, and BSCO CINAHL. The month/year ranges
they conducted the search were provided.

Career Definition : Clinical Research
Clinical Research Associates
Career Definition:
Clinical research associates work in a research facility setting and are included in a wide assortment
of lab investigations and undertakings. Their run of the mill obligations incorporate running or
helping with the running of examinations and clinical trials, making vivd observations ,objective
facts, translating and breaking down information, and framing results and conclusions. Clinical
exploration partners may likewise be in charge of defining and composing research conventions,
outlining information accumulation shapes, and overseeing administrative printed material and
applications.
Education requirements: While the certifications expected to wind up a clinical research associate,
change by spot of occupation and with the requests of particular positions, you 'll likely need no less
than a four year certification in a biomedical–related field like restorative innovation or life science.
Average courses in an important 4–year, four year certification program incorporate science, natural
science, organic chemistry, assessment techniques, clinical data frameworks, research in
biomedicine, and life structures. Clinical examination partners ought to likewise have an exhaustive
comprehension of good clinical practice models as laid out by the Worldwide Meeting on
Harmonization (ICH) and appropriate neighborhood regulations, www.ich.org. Capabilities. To end
up a clinical examination partner (CRA) you need either a degree

Using Simulators For Advance Clinical Research
Using Simulators to Advance Clinical Research
Sheila E. Brooks
Stanbridge College
ABSTRACT Throughout history numerous reports of abuse in clinical trials have surfaced. These
reports shed light not only of emotional abuse but the physical abuse as well. As we will see, some
of the abuse continues today. This abuse has led to public mistrust and scrutiny even to this day.
Clinical research participants are hesitant to enroll in clinical research trails for fear of being misled
or mistreated. Clinical researcher nurses are in the unique position to ensure not only patient safety
but to elicit public trust. However, clinical research nurses do not have formal educational tools to
develop important skills such as critical thinking, communication, or clinical skills which are
necessary to ensure patient safety, to reduce clinical mistakes, and to increase patient trust. One way
to develop such skills is through the use of simulation. Throughout history simulators have been
used in a variety of fields such as the military and aviation. Medical schools have used simulation to
practice skills as well. To date, little research has been done in the use of simulators in clinical
research programs for nurses. The purpose of this paper is address how simulators can improve
critical thinking in research nurses through the use of nursing theory, health promotion, and
community resources. We will

College Experiences Of First-Generation Armenian-American...
Risk and Benefit The research study will inquire the perspectives and experiences that the
participants (first generation Armenian–American students of different socioeconomic statuses)
have had throughout the college process. Personal questions regarding these experiences, such as
the presence, or lack thereof, financial hardships, may result in changes in emotions. Thus, this
research does pose a minimal risk. These risks are primarily psychological, as during the discussion
of past and current financial, familial, and academic situations, participants may experience changes
in their mental and emotional states, such as feeling anxious, overwhelmed and stressed. However,
there are no physical risks, as this study will not subject the participants ... Show more content on
Helpwriting.net ...
I will keep the data confidential by changing identifiable information, such as names and addresses.
To ensure that the information a participant gives is not connected to him or her, I will have aliases
for the participants. Thus, if the individual divulges in information regarding their academic and
cultural stances, financial status, familial relationships, or other sensitive information, they may do
so without having that linked back to them. So, while I will know who my participants are, the
documentation of the information will not reveal their identities; they will remain anonymous. Any
documentation for the study will be secured and disposed of properly, destroying any documents
that contain identifiable

Prospective Clinical Research Requires Informed Consent Essay
8. Prospective clinical research requires informed consent. Please explain the process and what
information is required by the Office of Human Research Protection to be included in the consent
form (10 points).
The informed consent is a process can be summarized within three main elements which include
information, voluntarily and understanding/comprehension. First, the researcher has to disclosure of
information in informed consent to make sure the participants have sufficient information about the
study. The content of informed consent must be clear, simple, avoiding technical jargon and
providing all important information to allow the subject to understand the content and ask for any
further question. After understanding of study purposes and process of the study; the subjects can
decide to participate voluntarily in the research or not.
According to the Office of Human Research Protection, there is certain information required to be
included in the informed consent. The consent has to include a statement indicates the nature of the
research project including study goals, study procedures, participation period and description of
treatment that will be used. It needs to provide a description of risks and potential benefits of the
study and if there is any alternative to participating in the research. Moreover, the researchers should
explain how subject's confidentiality will be adequately maintained. There must be a statement
offering subject opportunity to ask

The Effects Of Authority On The Society Today
ABUSIVE AUTHORITY
America consists of many authorized positions of authority. Such titles consist of Politicians,
Lawyers, Doctors, Law Officials etc.–––– including our former and past candidates of presidency.
These Political figures are expected to guardianship the well–being of the citizens in our country.
Their "means of interest" in the people of our country is now being exposed for liberation, freedom
and truth in which it is properly due to all men and women that are created equally. This essay will
explore how abuse of authority impacts upon individual freedom in our society today. If we examine
the first impact of abusive authority, we will find that moral standards are today, at its lowest
percentile. It is fair to say that America has lost its morality. No longer are we conservative or
discreet. Yet, we are outspoken and boastfully filled with pride and our very own alto ego; living for
self. No longer are we caring or outreaching. Yet and still, we build a wall. For example, there are
many obscurities that can be easily witnessed while watching American television. Whereas, many
actors are now shown at their least of clothing or somewhat nudity in the midst of primetime
broadcasting. What happened to broadcasting services only allowing such nature of television that is
shown at a specific time during the night? Has the media authority taken advantage of our
innocence, our kids innocence? Maybe! Another example, there have been many shootings and

Clinical Companionship Research Paper
The age of renaissance is gone and the Renaissance man is dead. This is the age of the man with
specialties and subspecialties. A few centuries ago, the ideal man of science was the one who knew
a little bit of each and every field. He would know medicine, arts, physics, mathematics, biology,
chemistry, etc. That man cannot survive now because the depth of knowledge has grown
exponentially over the past few decades. Any one, perhaps, now knows more than the leading
scientists of that time. But sometimes I find myself thinking I am a little like that man from
centuries ago because I still find myself drawn to internal medicine, emergency medicine,
neurology, anesthesiology and radiology whereas most of my other class fellows already decided ...
Show more content on Helpwriting.net ...
I think I am easy going and try as much as I can to help others. I feel a friendly working
environment is essential to a good clinical practice. In my opinion, team work and coordination are
an integral part of a health care setting. I came to realize this when I was working as a clinical
research assistant at University of Maryland. I also think that the ability to perform a detailed
physical examination is very important to be a good physician. Several diseases can be picked up on
a good exam. I realized this when I was rotating in Mayo hospital because back home we have only
limited access to latest imaging techniques like CT scans and MRIs. I am still undecided as to what
specialty should I choose and I don't know other fields enough to be able to decide what I like the
most. But now I think I am ready to let the Renaissance man inside me transform into the modern
man by finding out my true calling. I hope your program will help me in the transformation. I want
to work in an institution that teaches me not only how to treat patients well but how to be a better
healer and I think your residency program will be a good place for me to become a good

The Assistant Director : The Real Estate Agent, The Owner...
The Assistant Director, the Real Estate Agent, the Owner and the Clinical Research Scientist. Four
very different paths that all began in the same place. They started off as young, ambitious college
students ready to take on the world. This is a glimpse into my family's career tree. The Assistant
Director graduated from college with a Bachelor of Science degree in Human Development and
now oversees staffing of the classrooms and facilitates sets up appointments and meetings, manages
on sight records and finances and ensures that all procedures and lesson plans are being
implemented. My mother's social and conventional interest led her to a field where she could
express both and at the same time "have her children close to her and see them throughout the day."
It wasn't something she intended on doing, however, over the years her skills developed and she
found it beneficial to be in this field. She loves that she "isn't confined to a desk and that she is able
to meet and interact with all kinds of people." She believes that jobs that allow flexibility, help you
grow, and give you the ability to make a positive change in people's lives are the best kinds.
However, jobs that offer a generous income and qualified, well–rounded coworkers are also
important to her. Based on this, her work values line up with altruism, economic return, associates,
variety and intellectual stimulation. Although, she wishes "the field of early childhood education
was valued as important as

Healthcare Regulation Of The Pharmaceutical Industry
Healthcare Regulation The pharmaceutical industry is one of the most heavily regulated of all
industries and Pfizer is a global US based pharmaceutical company and in the pharmaceutical
industry companies are regulated by the Food and Drug Administration (FDA), World Health
Organization (WHO), and Medicines and Healthcare Products Regulatory Agency (MHRA). Each
of these regulatory bodies focus on the manufacturer, drug sellers, and prescribing to physicians
process. (World Health Organization). In accordance to the Internal Revenue Service, the US firms
must meet government regulatory requirements. The drug company must get market approval and
show it safe for human consumption through animal and human testing and prove it is effective for
the illness and its intentions to alleviate. The scientific community established a four–phase method
to establish effectiveness. First phase is animal and toxicity studies, second phase is the
investigational new drug application filed to test small numbers of human and allow transportation
of unapproved drugs. Thirdly, a large scale trials conducted with thousands of patients proves the
product is effective against a specific disease. Human trial subjects must provide consent for the
experimental group. Lastly, a post approval marketing testing which are conducted to generate
marketing data for the competitive market (involves competitor products) (Internal Revenue
Service, 2015) These measures must be in compliance with the FDA in

Essay On Doing What's Rights
Doing What's Right Albert Campus once said," A man without ethics is a wild beast loosed upon
this world." Ethics is a huge component in any aspect of life, but it becomes extremely crucial when
the well–being of a patient becomes involved. Medical ethics during clinical research should be
made more regulated because organ/tissue harvesting without consent and exposing patients to
invasive procedures that are not necessary are all ethical concerns that researchers say are necessary
to get good research results. Ordinarily, it is common to teach children not to take what isn't theirs,
but this concept is often overlooked in the medical field. Human cells are needed to further the
research of the human body, but sometimes ... Show more content on Helpwriting.net ...
The unnecessary invasive procedures can sometimes benefit the trial/research which leads to a bias
that could harm the patient greatly. Invasive procedures are done to patients to get specific research
results, but often the desire to get results is more than the desire to keep the patient safe. A doctor by
the name Mohammad Motamedi stated that the exposure of patients of invasive procedures is one
of," The 10 most common issues which are frequently neglected when dealing with study proposals,
which I would consider to be a breach of medical ethics in one way or another." This idea is a scary
one. It happens more than people think possible. The benefits of the research may be great, but it is
not more important than the safety of a patient. Conversely, some may argue that unethical
procedures must be performed to get accurate and desired research results, but this is not the case.
The results are a huge part in a research study, but the possibility of harming a patient to get these
results is a situation that researchers unnecessarily puts themselves in. Accurate results can be
achieved through ethical procedures, even though it may take a while longer. In the Hippocratic
Oath, which is an old pledge of ethics made by Hippocrates, it is thought that doctors should always
pledge to," keep them from harm and injustice." Exposing

Research Critique of New Graduates' Perceptions of...
Research Critique of New Graduates' Perceptions of Clinical Practice
The article involved in this research critique focuses on the "stresses and challenges experienced by
graduate nurses in clinical practice during their initial orientation period and examines the
relationship of social support to these stresses" (Oermann, 1997). The critiquing of this article will
address the purpose of the article, the design of the research, the presentation of the findings in the
study and the significance of this research to the nursing profession. Also, the researcher's approach
to the study and the potential benefits of this study to nursing will be focused on as well. The
purpose of this article is clearly articulated in first two ... Show more content on Helpwriting.net ...
Since the focus is on the volunteers' experiences in the new clinical setting, it is essential to have
significant information on them. The researcher was very thorough in reporting the types of
instruments used in the study, which include a demographic data sheet, a social support instrument,
and a modified Pagana Clinical Stress Questionnaire. Each of the three instruments are well defined
and described. It is evident that the researcher has tested each instrument and is familiar with it.
Also the researcher describes how the instruments were distributed to the volunteers via a contact
person at each hospital, which gives the reader a better picture of how the study was carried out. The
results presented are readily understood and are applied to the research question. The data is applied
and interpreted in accordance with the scales and instruments used. Types of stresses are listed
according to ranking order of severity and other stresses are listed as well. This allows readers to get
an idea of what stresses are affecting the subjects and also to what degree they are affected by these
stresses. A chart is included that depicts the positive and negative emotions the subjects experienced
in orientation along with the mean score and standard deviation. This chart clearly outlines the data
for readers and is very simple to understand. The best aspect of the researcher's presentation of the
findings is the fact that each

Ethical Issues Facing The Clinical Research
Introduction
There are many ethical concerns that arise when a company, or individual, stand to make a monetary
gain by making a medical decision. In the clinical research, there have been concerns ranging from
faking the number of patients enrolled in a study to fabricating study data and insider trading. These
issues are what arise when money drives an industry that is supposed to be concerned with patient
safety and scientific investigation. The conflicting interests of financial gain and the need for
accurate and complete medical research are the overarching issues facing the clinical research
industry.
History of Clinical Research
Clinical research trials can be traced as far back as biblical times, though in those days the
researchers used legumes and lemons1. As medicine advanced, so did clinical research techniques.
The first double blind controlled trial which occurred in 1943, was for a drug to treat the common
cold. By 1946, the first randomized trial began for Streptomycin. It didn't take long for leading
researchers to discover the need for regulatory framework1. The ethical framework that formed our
healthcare delivery system is rooted in the Hippocratic Oath, which states that the prime duty of a
physician is to avoid harming the patient. However, this oath has not been shown the same respect
in the clinical research world1. The FDA, founded in 1862, was designed to be a scientific
regulation institution that quickly became a law enforcement organization in

Role Of Clinical Nurses With Research
Discussion
In general we found that clinical nurses with research–active characteristics become research–active
in response to a clinical trigger and they were successful because they were in an environment that
was supportive of clinical nursing research. Unlike the findings reported by Woodward et al. (2007),
our nurses did not think research was a hard or daunting undertaking. However, our sample differed
significantly as nurses in our study were not conducting research as an educational exercise to meet
a course or degree requirement. It may be that the nurses in the Woodward et al. study lacked
research–active nurse characteristics and/or were attempting to complete their research in an
environment that was not supportive of research by nurses. Their only motivation was that the
project was required, and since this was a school project, lack of organizational support might not be
surprising.
Similar to the findings by Tanner and Hale (2002) the nurses in this study became research–active in
response to a need or desire to solve a clinical problem (trigger). In addition, like Tanner and Hale
our nurses did not identify barriers to the conduct of research; rather they talked about things that
supported their research. Similarities between this study and the study by Tanner and Hale may be
related to sampling. Neither of these two studies included nurses who completed a study as part of a
degree or course requirement.
Our model may explain findings of Syme and Stiles

Animal Experimentation Successes And Clinical Research...
An examination of the conditions endured by research animals beforehand can also be attributed to
a source of conclusion inaccuracy between animal experimentation successes and clinical research
failures. Stress, commonly experienced by animal subjects in a lab setting, is a major factor known
for contaminating the accuracy and reliability of biomedical research results. Stress causes a chain
reaction of heightened readings, such as increased heart rates, pulses, muscular actions, and
hormonal balances. Executing experiments on a subject with misrepresentative vital signs can
greatly skew the results and interpretations drawn from a study. Stress can be experienced in a
variety of manners. Mice, for example, experience a reactive condition known as "sympathy pains"
when in a laboratory setting. In addition to the individual response taken at the foreign sights,
sounds, and smells, mice are affected by the stress level and anxiety experienced by other mice
surrounding them. Like humans, mice can feel sympathy towards one another and react accordingly.
Performing experiments on animals that suffer from an abnormal amount of stress will skew
evidence collected, and make it difficult for scientists to reach conclusions about predicted similar
human responses. In reference to the aforesaid example of animal research being done to advance
cancer exploration, alternative options are becoming more available. The benefits of using non–
animal testing are immense: lack of suffering,

Drug Discovery And Clinical Research
ntroduction
Drug research is connected to a range of academic studies such as biology, pharmacology, medicinal
chemistry and toxicology. Pharmaceutical researchers can design novel therapeutic drugs based on
these studies above. The invention of new drug can be divided by function into two stages: drug
discovery and drug development. Drug discovery is the process by which a new drug candidate is
found and identified. Distinctively, bringing a new drug candidate to the market through clinical
trials is called drug development. The first part of this essay provides an overview of drug discovery
and pre–clinical research and development
An Overview of Drug Discovery and Pre–clinical Research and Development
At pre–discovery stage, it will ... Show more content on Helpwriting.net ...
The various lead compounds can be initially tested and virtual screened by high–throughput
screenings (HTS) to evaluate their properties in biochemical reactions, and then the lead compounds
will be optimized through altering their molecular structure. Several physicochemical properties and
pharmacokinetics properties of the lead compounds will be established, such as lipophilicity,
solubility, ionization, molecular size and H–bonding. The process of lead optimization can not only
improves lead compounds' physicochemical properties, but also makes them more effective and
safer. Simultaneously, medicinal chemists begin to consider about chemical manufacture and control
(CMC), such as synthesis, formulation, delivery mechanism and large–scale manufacturing. The
optimized lead compound could ultimately evolve into a new drug candidate. The function of pre–
clinical research is to assess all of the physicochemical and pharmacokinetics parameters prior to
clinical trials. Or, to put it another way, whether the lead compound is safe enough to move on to
clinical trials depends on pre–clinical research. For example, pharmaceutical researchers carry out
pharmacokinetics (PK) testing which involves absorption, distribution, metabolism, excretion
(ADME), and toxicology to estimate the safety starting dose through in vitro and in vivo testing.
After these complicated and rigorous pre–clinical trials, scientists have

Clinical And Clinical Research Project
Finlay (2001) investigated how schizophrenic symptoms are paralleled by complex structural and
functional abnormalities in brain regions such as the thalamus, the prefrontal cortex and the
temporal lobe. As a result of the delayed onset of symptoms in early adulthood, abnormal
development occurs in the nervous system which may contribute greatly to the neurobiology of the
disorder. Weinberger's (1988) longstanding hypothesis focused on the dysfunction of the prefrontal
cortex and the association with schizophrenic cognitive deficits. Furthermore, Finlay's (2001)
research focused on the concept of a dysfunction of the mesoprefrontal DA neurons that may relate
to the cognitive deficits associated with schizophrenia. As the clinical symptoms of this disorder
emerge during early adulthood, abnormal developmental processes are thought to contribute to the
pathos–physiology of the disorder. It was discovered the the DA intervention of the prefrontal cortex
undergoes significant change up until adulthood which leads to Finlay's hypothesis that the
abnormal development of this system may be related to the emergence of schizophrenia.
Experimental and clinical research portrayed the relationship between this system, and
abnormalities in cognitive performance. Another interesting finding by Finlay (2001), was that
impaired function of mesoprefrontal DA may be the causation of decreased density of DA– which
contains nerve endings within the prefrontal cortex of afflicted individuals.

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,

Case Study On Psoriasis Vulgaris
Background: Psoriasis Vulgaris is the commonest encountered type of psoriasis and it accounts for
approximately 90% of cases. It occurs worldwide and has been on an increased trend in last decade.
According to the World Health Organization report 2016 the prevalence of psoriasis in countries
range between 0.09% and 11.43%. This shows that the disease is a global threat and approximately
120 millions of people suffer from psoriasis. The disease has been shown to have a complex genetic
predisposition with an inheritance pattern. Besides genetics, multiple environmental risk factors
have been implicated in the psoriasis disease process. Trauma, stress, seasonal variations, infections,
drugs, alcohol, smoking and sunlight are the environmental ... Show more content on
Helpwriting.net ...
In Dalian, there were 26 patients who were retired and there was significant association (MD: 24, CI
95%, X²= 7.21, p= 0.0015)
Association of onset of psoriasis according to marital status: In Mauritius out of the 50 patients,
there were significance between these factors (CI 95% X²=2.32, p=0.001). In Dalian, there were 26
patients who were retired and there was significant association (CI 95%, X²= 5.21, p= 0.0013) d)
Duration of skin complaints according to gender and marital status:
In Mauritius, out of the 50 patients, 30 were males and skin duration was on average 11 years (MD:
11.2, SD: 10.4). The 5 year duration 27% were male and 10 year duration 23% were male and there
was association between skin duration and gender( CI 95%, X²= 0.64,p=0.0002). In Dalian, the skin
duration was on average 10 years (MD: 10.1, SD: 10). The 5 year duration 33% were male and 10
year duration 53% were female and there was association between skin duration and gender( CI
95%, X²= 2.54,p=0.00015).
e) Progression of psoriasis vulgaris according to exacerbation and

Clinical Governance Research Paper
Governance for Safety and Quality in Health Service Organisations
Dwyer, A.J., Becker, G., Hawkins, C., McKenzie, L., Wells, M., 2012. Engaging medical staff in
clinical governance: introducing new technologies and clinical practice into public hospitals. Aust.
Health Rev. 36, 43–48.
The authors evaluate effective and successful clinical governance process for introducing new
technologies and clinical practice into Melbourne Health (MH), a major tertiary teaching hospital.
The researchers use data collected through feedback from committee members, surveys of medical
staff and head of units. The findings, while limited, demonstrate an effective and successful clinical
governance process for introducing new technologies and clinical practice ... Show more content on
Helpwriting.net ...
Safety and quality of nurse independent prescribing: a national study of experiences of education,
continuing professional development clinical governance. J Adv Nurs 70, 2506–2517, doi:
10.1111/jan.12392
In this article Smith et al. reviewed the legislation in England passed in 2006 that enabled nurses
with independent prescribing qualifications to prescribe across a list of available medicines with the
exception of some controlled drugs in the UK. It is claimed to be the first and largest study
implementation of the important safety quality mechanism for non–medical prescribers in the wake
of 2006 legislation changes. The authors use data gained through cross–sectional national survey
questionnaires to determine if the educational preparations for nurse independent prescribers are
sufficient and to find out current professional development, clinical governance and professional
regulation approaches in place in NHS Trust in England. The respondents are nurse independent
prescribers (NIP) and non–medical prescribing (NMP) leaders in England. Their research focuses on
assessing the core competency of safe and effective role of nurse independent prescribers. The
article is highly readable. There is a logical progression in explaining the rationale of the data
collection and study design. The results are supported statistically and important findings were
presented in a simple tabular form. This source is recent and includes many

Clinical Research Coordinators And Pis
clinical research coordinators and PIs are typically involved in this process. As the protocol is
further developed, so are the CRFs. They are utilized to collect proper content of a protocol,
presentation of insuring questions are asked properly to collect the proper data and the methodology
of what design alternatives should be used and or avoided to minimize any problems associated with
the study and the collection of data. Although there are standards to develop CRFs and collect data
across all trials, there may be some situations that will require changes and therefore deviate from
the norm. Demographics, vital signs, physical exams and lab data can all be removed from standard
CRF data collection I order to meet protocol requirements. CRFs should always follow the
Sponsor's protocol in order to collect data as effectively and efficiently as possible.
2.3 Data capture, which is an accumulation of clinical data in a clinical trial, although may vary
across different organizations, does have similar objectives when capturing the effectiveness and
accuracy of data.
Data that is captured in a clinical trial should represent all of the Investigator's observations that
have occurred with any given subject over the course of the study. Data entry in a study is usually
single or double captured. When data is double captured, it increases accuracy due to two different
entries but two operators. Data entry screens are an effective way of capturing double data. Once
data is

A Research Study On Clinical Research
1. Describe the type(s) of internship(s) you are seeking this summer.
This summer, I have been seeking clinical research internships. These include any research that is
conducted in a hospital setting and correlates to patients. I would be developing my research skills
in a laboratory setting while also developing intrapersonal skills working with patients. The research
that I have conducted at the University of Richmond has been invaluable; however, I plan on
applying to an MD/PhD program and I feel that clinical research would be a more valuable
experience for this upcoming summer.
I have applied to a clinical research internship at Stanford University that focuses on training
undergraduate students who are perusing a MD/PhD. The ... Show more content on Helpwriting.net
...
The internship will provide me with a challenging opportunity to develop skills pertaining to clinical
research that will further benefit me on my career path.
I have also looked into clinical research at the Hospital of the University of Pennsylvania through an
inquiry form outlining my interests. This has the ability to match me to various laboratories. This
was not an official application, but my information has been passed along to faculty mentors at the
Hospital.
2. Why do you want to intern this summer?
I believe the summer is the perfect opportunity to jump into something new and challenging in order
to develop one's intellect and character. My ultimate career goal is to become a physician scientist
and I feel using the summer to gain clinical skills earlier on will positively impact my career
trajectory. During my undergraduate experience, I have not had many opportunities to conduct
clinical research, but I am eager to learn new skills immerse myself in learning opportunities.
Furthermore, an internship can provide me with unique networking opportunities to learn not only
from my internship mentor, but other physician–scientists and interns as well. Currently, I do not
have the place to gain such connections but I am eager to form them.
My experience at Richmond has allowed me to hone basic research skills, volunteer in a clinical
setting, and

The Ethics of Clinical Research in the Third World by...
Third world countries and underdeveloped nations have become the new proverbial Petri dish of
experimentation and offer particular conditions which researchers would never be able to find in
their home countries. This only serves to highlight the problem that inherently faces all research
studies, the ethical debate in regards to the protection and rights of their subjects. Is it feasible to
expect the same standards to apply in certain countries where an economical imbalance between
what is possible and what is not can be the largest hurdle to overcome? These are key issues
examined in the New England Journal of Medicine by author Marcia Angell, M.D., and co–authors
Harold Varmus, M.D. and David Satcher, M.D. in their respective articles ... Show more content on
Helpwriting.net ...
in her article "The Ethics of Clinical Research in the Third World", stating that it is only ethical to
use placebo–controlled studies "when there is no known effective treatment" (Angell, 847). The
current protocol consists of a lengthy treatment with costly drugs, but Angell argues that despite the
logistics, beneficence still applies, and the available treatment should be the standard to which all
others is measured against. There is also the guiding of issue of not only ensuring that subjects are
not treated as just a minimal part of the ultimate goal, but ensuring that the subjects' well–beings be
the primary concern for researchers as well. Yet, the available treatment is being withheld, leaving
the placebo–controlled group without any treatment at all. The justification is weak at best, Angell
says, with researchers claiming that the placebo–group would not be receiving the necessary
treatment anyway, so they are simply observing the natural manifestation of the infection in the
mother and infant that would occur regardless of the study. Yet, if there is a shift in ethical reasoning
from what is "best" to what is "local", vulnerable populations will be open to further exploitation by
researchers and the practice is ultimately a direct violation of the guidelines set forth by the various
public and global health organizations which all require equal protection to that received in the
sponsoring nation (848). The context of the study,

Compulsory Assessments
The four accepted articles were analyzed and summarized. Article validity, reliability, and bias are
included in the discussion. An overview of the articles are included in Table 2, indicating evidence
level, design, population characteristics, intervention specifics, outcome measures, and PICO
question relevance.
Article One: Jung–Hyun, C. & Nyeon–Jun, K. (2015). The Effects of Balance Training and Ankle
Training on the Gait of Elderly People who have Fallen. Journal of Physical Therapy Science, 27(1),
139–142. Selection of the randomized controlled trial (RCT) by Jung–Hyun and Nyeon–Jun (2015)
was based on inclusion criteria, objective of the study, and outcome measurements. Jung–Hyun and
Nyeon–Jun compared the effects of balance exercises ... Show more content on Helpwriting.net ...
(2009) recruited 28 women from three nursing homes who met inclusion criteria, one woman
dropped out prior to randomization. The 27 women were randomly assigned to two groups. In the
first session, 14 women received a 10–minute friction plantar massage and 10 minutes of
mobilization to feet and ankle joints, while 13 women received a 20–minute placebo intervention
(Vaillant et al., 2009). In the second session, the treatments were reversed, with at least 1 week
between sessions (Vaillant et al., 2010). Statistical significance was established by p ≤ 0.05 and CI
of 95%, which decreased the risk of a Type I error and improved precision, respectively (Jewell,
2015). Between–group comparison analyses indicated a single session of massage and mobilization
resulted in significant improvements in OLB and TUG tests, but not in the LR test (Vaillant et al.,
2009). Vaillant et al. concluded that balance responses in elderly women could improve after a
single session of foot and ankle manual

research on clinical psych
80
Why Love Matters: How Affection Shapes a Baby's Brain
81
Why Love Matters: How Affection Shapes a Baby's Brain by Sue Gerhardt
Psychoanalytic Psychotherapist and Author of 'Why Love Matters' and 'The Selfish Society'
SUMMARY
Why babyhood rather than childhood?
The case that I want to make is that babyhood is much more important to our lives than many
people realise. A lot of the behaviour that worries us in later childhood, such as aggression,
hyperactivity, obesity, depression and poor school performance, has already been shaped by
children's experiences in babyhood. For those of you who have not studied the scientific literature,
this might seem a bit ... Show more content on Helpwriting.net ...
But first let me make the case for the importance of infancy.
"Research now shows that many challenges in adult society – mental health
problems,obesity/stunting, heart disease, criminality, competence in literacy and numeracy – have
their roots in early childhood." (World Health Organisation)
The over–riding importance of early conditions
The strange fact is that very often the early conditions of our lives have a profound impact on the
whole of our development. Let me start by describing how this works with regard to the body and
physical health, which might seem more obvious, because we can see that nutrition affects the body.
The body grows or it does not. It develops healthy organs or it
83
does not. And actually, the early development of the body's organs and other systems are affected by
the nutrition available at

Placebo Effect Essay
Placebos in Medicine – Placebo Effect in Surgery for Ménière's Disease
1. What was the rationale for doing the study?
Torok, an author to another study regarding Ménière's Disease, reviewed 834 articles pertaining to
Ménière's Disease between 1951 and 1975. He found that advocates of either medical or surgical
treatments claimed success in 60% to 80% of patients. Because there are so many different therapies
deemed successful, Torok believed that the placebo effect might be a common factor to all of those
treatments.
The goal of any treatment of Ménière's Disease is alleviation of vertiginous attacks as well as
removing the fear of getting these attacks. Because the basic cause of this disease is basically
unknown, there is no proof that medical, physical, or surgical treatment has the most symptomatic
effect over the other. The authors of this study are attempting to prove that the placebo effect is a
common factor in treatments for Ménière's Disease, specifically surgery.
2. Briefly, explain the design of the study. ... Show more content on Helpwriting.net ...
One group was to receive the active surgery which was an endolymphatic sac shunt operation
(Silastic sheet mastoid shunt), while the other group receives the placebo surgery which was a
regular mastoidectomy, but neither group was to know which operation they are receiving. All
patients were asked to score their dizziness, nausea; vomiting, vertigo, tinnitus, hearing impairment,
and pressure in the ears on a scale 3 months preoperational and 12 months post operational. After
the 12 months, post op was finished the patients were asked to rate the value of their
operation/surgery on a scale of good, reasonable or

Pharmaceutical Industry and The Manipulation of Clinical...
For as long as civilization has existed, humans have been looking for ways to advance in the field of
medicine in order to cure illness and elongate the human lifespan. This has led to many positives
such as ground–breaking new discoveries, inventions, and vaccines. One aspect of medicine that has
grown dramatically in the past decade is the pharmaceutical industry. The pharmaceuticals are
responsible for the manufacturing and the distributing of medicine in the form of drugs. While the
drugs main purpose is to help the sick, you cannot say the same for the pharmaceutical industry.
Unfortunately, the pharmaceuticals discovered that the more we advance in the field of medicine,
the more money there is for the taking. The World Health ... Show more content on Helpwriting.net
...
When pharmaceutical companies manipulate data, it means that they change the results from the
research to their favor just in order to get their new drug approved by the FDA. There are several
ways pharmaceutical companies manipulate data in order to yield favorable results. The company's
drug maybe compared with another drug administered at a dose so low that the company's drug
looks more powerful. Or a drug that's likely to be used by older people will be tested in young
people, so that side effects are less likely to emerge. The standard practice of comparing a new drug
with a placebo, when the relevant question is how it compares with an existing drug, is also
misleading. (Espejo) Sometimes, pharmaceuticals will straight up lie in their research results,
because there is no way for the FDA to check thoroughly. Many pharmaceutical companies have
sponsors that have significant influence over government personnel within the FDA, and many
times they use their influence to get FDA members to "look the other way" (Rodwin). The main
reason that these pharmaceutical companies manipulate data is to increase their profit. Company
managers have strong financial incentives, in the form of stock options and bonuses, to get drugs
approved and widely marketed (Brown). This is all with disregard to the quality of the drug in
question. This means that pharmaceutical companies will rush to manipulate

Clinical Research Coordinator Essay
I am writing to apply for your position of Clinical Research Coordinator. I strongly believe that this
position is a great fit for me, as it would provide me with the opportunity to continue to utilize my
research skills with a new team. Moreover, it would provide me with a range of opportunities to
engage in career exploration.
My varied coursework in biology, psychology, and statistics has provided me with the analytical and
organizational skills to successfully perform research tasks in your lab. Ranging from recording and
analyzing data to designing and conducting studies as the principal investigator, I would be well
suited in this position. Additionally, through my experiences at Swarthmore College and the John A.
Burns School of Medicine at the University of Hawaii, I have developed excellent interpersonal,
communication, and time–management skills. ... Show more content on Helpwriting.net ...
As a research assistant, I was assigned many projects that linked different aspects of the lab, so I
was able to learn details about performing Diffusion Tensor Imaging, programming in MATLAB,
conducting phone screens, recruiting subjects, and administering neuropsychological tests. I
primarily worked on a project for my principal investigator to study the impact of marijuana
exposure on adolescent brain maturation through using various image processing and statistical
packages.
Furthermore, I learned how to meet deadlines under pressure while building and maintaining an
interpersonal relationship within the team. My work at the lab taught me how to be flexible and
solve problems in order to achieve the best solutions to a variety of different tasks. Although I have
conducted my preliminary research on the impact of marijuana exposure on brain maturation, I am
interested in further expanding my knowledge into clinical research as I plan on applying to medical
school in the

Finally, the principle of justice is also applicable here....
Finally, the principle of justice is also applicable here. The Belmont Report addresses the principle
of justice in terms of who ought to receive the benefits of research and bear its burdens. (Belmont
Report, 1979). The benefit to society is always the focus of justice in medical research, not the
benefit to the subject. It represents both aspects of utilitarianism, the benefit to society as a whole, as
well as egalitarianism, the notion that equals ought to be treated equally. An injustice occurs when
some burden is imposed unduly. It is important to insure that those who are already burdened are not
overburdened and the group participating in medical research should receive the benefit of it. The
selection of research subjects must be ... Show more content on Helpwriting.net ...
Justice is further illustrated in Grimes. Researchers used economically vulnerable children as their
subjects. The court concluded that the research was inappropriate and unethical and emphasized the
importance of ensuring the ethical treatment of humans enrolled in research, especially members of
vulnerable populations. So too, Cincinnati represents a further discussion of vulnerable groups being
taken advantage of. In Cincinnati, cancer patients, who were primarily indigent, poorly educated
African–Americans, were exposed to large doses of radiation. It is further unjust because the
purpose of the research was to benefit the military, not the subjects. The tests were not conducted to
determine the effect of radiation on persons with cancer, but rather just the effect of radiation on
humans in the event that members of the military were exposed in a nuclear attack. The use of this
already burdened group without any rational relationship to the research being conducted was
entirely unjust especially when the population used was not the population intended to receive the
benefit. Finally, the notion of justice is also present in the Tuskegee study. The research used
disadvantaged, uneducated, rural men to study the untreated course of a disease that is and was by
no means confined to that population. The subjects were

The Politics and Economics of FDA Drug Approval Essay
The Politics and Economics of FDA Drug Approval
The United Sates Food and Drug Administration has been protecting American consumers for
around 70 years. The FDA assures the safety drugs, medical devices, chemicals, cosmetics, foods
and additives by evaluating products for approval. Controversy has recently been surrounding the
FDA's drug approval process, due to a general trend to get pharmaceuticals on the market more
quickly. The FDA has been under pressure from congress and the public to speed approval, but
pharmaceutical companies, who benefit more than anyone form accelerated drug approval, have
also been applying pressure to the FDA through congress. The speeding of the approval process
helps patients with incurable illnesses ... Show more content on Helpwriting.net ...
The Radiation Control for Health and Safety Act guarantees consumers protection from excess
radiation in certain devices. Lastly, The Public Health Service Act expanded the FDA's authority to
cover serums and vaccines and also justified the inspections of restaurants (Food and Drug
Administration [Britannica]). The FDA is adjusting to a switch in leader ship since Jane Heney,
previously the FDA's deputy commissioner of operations, was nominated in June 1998. Heney, the
first woman to head the FDA, has a packed resume that includes a vice presidency of the University
of New Mexico and a specialization in cancer research. Her strategy for the future of the FDA
includes the enforcement of new federal laws to modernize the FDA and addressing concerns about
drug safety and approval speed, as well as controlling food contamination (Davis 5D). The FDA
requires pharmaceutical companies to conduct years of research on their drugs before they begin the
actual process approval. Drug companies submit test results to the FDA to be reviewed by their
scientists; the FDA actually does no preliminary research on the drugs. In order to be approved, the
companies must prove to the FDA that each drug is safe and effective and that the benefits of the
drug must outweigh its side effects. The FDA has 800 to 900 employees involved in reviewing
drugs before they get to the market. After a drug is approved, the FDA researches by collecting and
analyzing thousands of reports each

Fda Approval Process Of Drugs Essay
Joston Toney Nicole Thompson English 2010 Online 03 December 2016 The FDAApproval
Process of Drugs When I was a kid, I always wondered why it took so long for an ill person to
become well again. I always thought that if the ill person went to the doctor they would be back to
normal the next day, but that's not the case. For some people it took several days, weeks, months,
and even years to conquer an illness but as a child I never could understand that. I don't know how
many times I've asked my mom or dad how come the doctors don't get together and make a
"miracle" drug that could heal anything and everything. It wasn't until the age of 15 when my
grandmother was diagnosed with breast cancer that I understood why it took so long for others to
heal and the process that they had to endure in order to be healthy again. Shortly after my
grandmother's diagnosis, I started looking into what it would take to get a drug that would cure
cancer through the approval process on the shelf to save some many others just like my
grandmother. But I kept running into a dead end. Everything seemed to keep pointing towards
chemotherapy and radiation. Although I wanted something to heal my grandmother fast,
chemotherapy and radiation was the only solution if I had wish to see her watch me graduate high
school. I went to almost every appointment with her to watch how it helped strengthen but also
watch as it drained her energy. A month of chemotherapy and a few weeks of radiation and my

Theoretical Model Of Mjb
MJFF Workshop
Bridging the Gap: Developing Computational Models of PD Subtypes and Progression Models for
Clinical Research
Rationale and Impact:
Developing data science code for use in clinical research is limited. Computational researchers
either develop black box methods for general use or specific models to answer a particular scientific
question. Development of models into a useable clinical research tool is unusual. Many codes are, at
best, uploaded to a software repository online, like GitHub. At this point, the computational
researchers would usually move on to the next project and the model would not have any clinical
impact. While it is likely that clinical researchers could benefit from these codes the development of
the code ... Show more content on Helpwriting.net ...
A workshop that brings together computational scientists with expertise in progression modeling
and clinical researchers could lay the foundation to address some of these problems to bridge the
gap between clinical and computational expectations to arrive at progression models that can be
used in clinical research and biomarker identification.
Workshop Goals:
Overall Goal: Determine challenges in developing a clinically meaningful model of PD
heterogeneity, subtypes, a progression model and the high–level method for a roadmap around these
challenges
Goals:
Review Model Examples: Computational researchers will review examples of how subtyping and
progression modeling can be used in clinical research by demonstrating current models at a high
level. These short overviews will help to frame the discussion around the design of a roadmap for
how progression model is done and can be integrated into clinical research.
Review Desired Outcomes: Clinical researchers will review how an understanding of PD subtyping
and progression will improve clinical research and how computational progression models could be
constructed to ensure that the clinical knowledge is efficiently represented as model inputs and
clinical

The Ethics Of Clinical Research
A 35–year–old man named Paul, who has a supportive wife and two adventurous kids, has been
diagnosed with a very severe case of bone cancer for 1 year now. Since this type of cancer is so
severe, chemotherapy is starting to not work as well. Paul's oncologist unfortunately had to suggest
a final option for Paul to try which was a clinical research trial. Clinical research trials are
experimental studies that deem whether or not a medical drug, treatment, surgery, or device is safe
and beneficial for humans to use ("National Heart, Lung, and Blood Institute"). As explained in
Marcia Angell's Article, "The Ethics of Clinical Research in the Third World", the Declaration of
Helsinki of the World Health Organization (WHO) provides a guideline ... Show more content on
Helpwriting.net ...
This temptation happens when the research question, such as a cure for cancer, is extremely
important and the answer could save lives. If the investigators cared more about the scientific or
medical advancement than the well–being of their participants, they would cross a line that prohibits
treating human subjects as a means to an end. When this line is crossed, there is little left to protect
patients from a callous disregard of their welfare for the sake of research goals. Informed consent
would not matter because of the unbalanced relationship between the knowledge and authority
among the researcher and the subject. Approval by an institutional board, although it is important,
can be subject to change in its responsiveness to patients' interests when they conflict with the
welfares of the researchers. Going back to Paul's case, he agrees to enter a clinical trial which was
suggested by his oncologist. The study, that Paul has agreed to enter, has claimed that this research
team has created a new drug that may be on its way to cure cancer. Obviously to a father and
husband, this trial looks very appealing. However, the researchers knowingly form two groups that
will compare two treatments. What Paul doesn't know, is that one of the treatments is better than the
other. One group will receive this new drug and the other group will receive a placebo. Comparing
this new treatment

Kava-Kava: A Possible Solution for Stress and Anxiety Essay
Throughout life, we each experience the anxiety of the unknown and the inevitable stress of our
responsibilities combined with our limited supply of time. New technology, a strong economy, and
increased competitiveness for jobs in the work force seem to usher in increased stress and anxiety.
Although many dismiss this as a natural part of life, the health arena asserts the detrimental side
effects of continual stress upon one's body. In fact, "experts attribute almost 60 percent of doctor
visits to stress–related ailments, including high blood pressure, arthritis, and cancer
(http://www.doctorcass.com/html/kava_book.html)." In the past, the only mainstream options for
treating excessively harmful stress and anxiety were prescription drugs, ... Show more content on
Helpwriting.net ...
In addition, substantiated clinical studies and reviews from peer–reviewed journals must be
summoned to validate the value of Kava–Kava as a candidate to fill the role of an alternative to
anti–anxiety psychiatric treatments.
WHAT IS KAVA–KAVA?
Originating from the South Pacific as a favorite drink of the Pacific Islanders, the plant known as
Kava–Kava (Pipper Methysticum Forster) is a member of the pepper family. The brownish root of
the plant, known as Waka, is sun–dried, ground into powder, and mixed with water to create the
therapeutic drink known by the name of the plant, Kava–Kava
(http://www.kavakure.com/WHATISKA.htm). Although only recently advertised in the United
States, Kava–Kava, also known as awa and yaquona, has been used for thousands of years by
Pacific Islanders as a ceremonial drink, social beverage, and therapeutic elixir for relaxation and
anti–anxiety. In these cultures, the drink is often drunk by elite chiefs and elders and commonly
used for both official and social events, sacred rituals, and for welcoming special guests
(http://lavakava.com/aboutkava.htm). However, white man did not discover the drink until Captain
Cook's voyage in 1768–1771 lead to an encounter with Kava at sacred ceremonies
(http://lavakava.com/aboutkava.htm). Many years later, in 1995, Killham of Lincoln, Massachusetts
finally convinced an American herbal company, Pure World, Inc. to begin

Ethical Dilemmas In Clinical Research

Recommended

Recommended

More Related Content

Similar to Ethical Dilemmas In Clinical Research

Similar to Ethical Dilemmas In Clinical Research (13)

More from Carmen Martinez

More from Carmen Martinez (14)

Recently uploaded

Recently uploaded (20)

Ethical Dilemmas In Clinical Research