Business 1040 Term Project
Business 1040 Term Project
Business 1040 Term Project
RESEARCH
Clinical Trials
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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
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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.
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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/