Business 1040 Term Project

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E THICS OF H UMAN

RESEARCH
Clinical Trials

Human research is defined as a systematic investigation that can either be


research or clinically oriented and involves the use of human subjects in
any capacity. Systematic investigation incorporates both the collection and
analysis of data in order to answer a specific question. Human research
subjects are used in a variety of fields from biology, clinical medicine,
nursing, psychology, sociology, political science, to anthropology.

Juliette Herrera, Nicole Dorrell, Cienna Smith


12/7/2014

Ethics of Human Research

12/07/2014

Human research is defined as a systematic investigation that can


either be research or clinically oriented and involves the use of human
subjects in any capacity. Systematic investigation incorporates both the
collection and analysis of data in order to answer a specific question. Human
research subjects are used in a variety of fields from biology, clinical
medicine, nursing, psychology, sociology, political science, to anthropology.
There has always been the question of whether human medical research is
ethical or not. We are going to explore the patient safety, the researchers
duty to intervene, and the informed consent and confidentiality aspects of
human clinical trials.
Patient safety is a crucial part of clinical trials. There is certain
criteria that a clinical study must meet before the trial can begin. One
criteria of every clinical trial in the United States is that it must be approved
and monitored by an Institutional Review Board (IRB). An IRB is an
independent committee of physicians, statisticians, community advocates,
and others. The IRB ensures that a clinical trial is ethical and the rights of
study participants are protected. This board also examines all trial activities
including recruitment, advertising, and potential risks. The IRB makes sure
that the Food and Drug Administration regulations are being followed. The
participant signing the informed consent document also protects patient
safety. The informed consent document provides details about the study, such

Ethics of Human Research

12/07/2014

as its purpose, duration, risk and benefits, required procedures, and key
contacts. By signing, the participant is acknowledging the risk and benefits of
the trial; however, the informed consent is not a contract therefore the
participant can withdraw from the study at any time.
Juliette interviewed a coworker, Trista Long, on her experience as a
study participant. Trista participated in an Intrauterine Device (IUD) study
at the University of Utah. The goal of the study was to research a new
method of IUD insertions. Before Trista agreed to the study, she was
contacted by one of the researchers and asked to schedule a meeting to go
over the study. During this meeting, Trista was informed of the risks that
were involved, as well as the benefits. She considered this a very intimate
type of procedure but was pleased that during the procedure the researchers
were explaining step-by-step what they were doing. Trista was very pleased
with all of the steps they took to insure her safety and understanding.
Overall, Trista had a great experience and has decided to participate in many
other clinical trials.
The next crucial part of a clinical trial is the researchers duty to
intervene. This obligation for the researcher allows there to be trust among
all trial participants and their researchers. From the Declaration of Geneva
of the World Medical Association (WMA) in the general principles it states
how the physician is bound with the words, The health of my patient will be
my first consideration, and the International Code of Medical Ethics declares

Ethics of Human Research

12/07/2014

that, A physician shall act in the patient's best interest when providing
medical care. Also stated in these general principles from the WMA is that
"it is the duty of the physician to promote and safeguard the health, wellbeing and rights of patients, including those who are involved in medical
research. The physician's knowledge and conscience is dedicated to the
fulfilment of this duty. This means that it is the researches duty to put the
patient before the research, and if they do not then it will be their fault.
Many times their duty to intervene can damage the data in the study. This is
why most studies require their participants to be in good health. (World
Medical Association, Inc., 2014)
Cienna interviewed the Randall family of the University of Utah
Alzheimers medication study. This family has had Nellie be part of this
study for 8 years. When Nellie was first diagnosed 10 years ago, she was only
given 6 years to live. The family was able to discover the study being held at
the University of Utah. Since being part of this study, Nellie has not only
lived 4 years past the original diagnosis but has thrived. This study has
upheld their duty to intervene thus far. Nellie is required to have her blood
tested monthly in order to double check that she is still in good health and
that her body has not had a bad reaction to the medication. There have been
many others from this study where the researches had to intervene due to the
patient's safety. Overall, Nellies experience has and continues to be amazing.

Ethics of Human Research

12/07/2014

Another crucial aspect of clinical research is the informed consent and


confidentiality agreement. Because many participants most likely have a
limited understanding of medicine and medical procedures, it is crucial to be
up front with the participant in making sure that they have all of the
information that they need regarding the purpose and risks of the trial. A
participant also needs to understand completely that clinical trials are for
research purposes and are not a substitution for clinical care. The informed
consent doctrine is the responsibility of the doctor performing the research
study to inform the participant of the risks before they decide whether they
want to participate. Informed consent doctrine evolved in response to
researchers failures to ensure that participants had the capacity to decide
and fully understand the information presented, and to make truly voluntary
decisions (Informed Consent, 2008). The main goal of the informed consent is
the importance of an individuals autonomy, meaning the participants ability
to make his or her own decisions without outside influences.
Privacy and confidentiality is a big fear that participants may also
have, essentially fearing that ones personal information is not misused. This
responsibility falls upon the researcher to prevent any sort of unauthorized
disclosure that would damage the trust relationship between themselves and
the participant. This could cause reluctance of participation towards any
future research studies. Protecting the confidentiality of individually
identifiable health information that is acquired, used, disclosed, or stored in

Ethics of Human Research

12/07/2014

the design, performance, or analysis of human subjects research is essential


to respecting the dignity and privacy of human subjects participating in
clinical research (Respect for Human Research Participants, 2008).
Nicole interviewed a friend, Bill Boggs, to see what his experience was
like participating in a clinical trial. He participated in a sleep study at
Fairchild Medical Center in Yreka, California. Bill said that the researcher
that was working with him during his participation there was very
professional and nice. The researcher was very informative and thoroughly
answered all of his questions, even though he asked several. Overall, Bill said
that his experience was fun and very interesting.
Clinical trials are very complex and many steps and procedures must
be met in order to be deemed ethical. Many opponents of the ethics of human
trials have not done their research as to the new policies and regulations put
in in place to keep these trials ethical. Clinical trials are ethical because
participant safety is the number one priority for the researcher. These trials
are also ethical because the researcher is bound to intervene no matter the
circumstance in order to keep the participant safe from harm. Clinical trials
are ethical due to the informed consent disclosure, which gives the
participant the full understanding of the trial. These trials are ethical due to
the privacy and confidentiality laws being upheld. In conclusion, the clinical
trials being held today are ethical.

Ethics of Human Research

12/07/2014

In resolution after exploring the patient safety, the researchers duty to


intervene, and the informed consent and confidentiality aspects of human
clinical trials we find that human medical research is ethical. We recommend
that anyone wanting to participate in a clinical trial really understands all of
the policies, procedures and regulations of the trial. We also recommend that
this future participant insure that their safety is the number one priority of
the researchers, explore the patient safety, the researchers duty to intervene,
and the informed consent and confidentiality aspects of human clinical trials.

Ethics of Human Research

12/07/2014

BIBLIOGRAPHY
Boggs, B. (2014, November 20). Sleep Study Trial. (N. Dorrell, Interviewer)
Family, T. R. (2014, November 15). Alzheimers Medication Trial. (C. Smith, Interviewer)
Huntsman Cancer Institute. (2014). Huntsman Cancer Institute University of Utah.
Retrieved from University of Utah Health Care:
http://healthcare.utah.edu/huntsmancancerinstitute/clinical-trials/
Informed Consent. (2008). In E. J. Emanuel, The Oxford Textbook of Clinical Research
Ethics (p. 591). Oxford University Press.
Long, T. (2014, November 27). IUD Clinical Trial. (J. Herrera, Interviewer)
National Center for Biotechnology Information. (n.d.). Journal of Clinical Pathology.
Retrieved from US National Library of Medicine National Institutes of Health:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1860367/
Respect for Human Research Participants. (2008). In E. J. Emanuel, The Oxford Textbook of
Clinical Research Ethics (p. 673). Oxford University Press.
The University of Utah Health Sciences Center. (2013). Frequently Asked Questions.
Retrieved from University of Utah Health Care:
http://healthcare.utah.edu/clinicaltrials/faq.php#irb
World Medical Association, Inc. (2014). WMA Declaration of Helsinki - Ethical Principles for
Medical Research Involving Human Subjects. Retrieved from World Medical
Association: http://www.wma.net/en/30publications/10policies/b3/

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