Introduction

Many doctors, nurses, medical technicians, and other health care
workers are involved in medical research. The field of medicine is not
limited to the direct treatment of patients but also involves the
continued expansion of medical research. A large part of such research
is clinical research, which puts patients into the role of experimental
subjects. This raises a number of challenging questions for health care
ethics, many of which follow from the fact that physicians, nurses, and
others involved in clinical research have a dual role. As researchers,
they are committed to generating new knowledge about diseases,
developing new treatments and drug therapies, and, in general, helping
to improve the welfare of human beings by eliminating or controlling
diseases and increasing longevity. However, researchers involved in
clinical research must also be committed to the highest quality care for
individual patients taking part in research studies. This assessment
explores some of the ethical issues that clinical research raises and
some of the safeguards in place to protect the interests of patients
involved in research.

Demonstration of Proficiency

By successfully completing this assessment, you will demonstrate your
proficiency in the following course competencies and assessment
criteria:

• Competency 1: Articulate ethical issues in health care. 
  • Explain how the principle of informed consent is relevant to these issues.
  • Explain the costs and benefits of offering unapproved experimental drugs to patients.
• Competency 2: Apply sound ethical thinking related to a health care issue. 
  • Identify relevant ethical theories and moral principles.
  • Articulate arguments using examples for and against offering pre-approved drugs to wider pools of patients.
• Competency 5: Communicate in a manner that is scholarly,
  professional, and respectful of the diversity, dignity, and integrity of
  others and is consistent with health care professionals. 
  • Exhibit proficiency in clear and effective academic writing skills.

Preparation

When a new drug is undergoing clinical trials to be approved for
treatment, it must pass through a number of distinct phases of testing.
These phases require rigorous study and evidence to demonstrate the
safety and efficacy of new treatments. Passing through these phases and
achieving approval takes many years for some trials. Before approval,
patients not part of a clinical trial have limited or no access to
experimental drugs, even though these drugs could be helpful and
potentially save their lives. There are various groups pushing for
greater patient access to drugs still in the experimental stage. In
recent years, the FDA has made it somewhat easier to receive treatment
with experimental drugs, but according to advocacy groups there are
still too many restrictions (Munson, 2014).

This leads to a potential quandary when early stages of research on a
drug sometimes suggest that the drug could be effective in treating a
certain disease. On one hand, offering easier access to early stage
trial drugs could help individuals suffering with a medical condition.
However, on the other hand, making early access to experimental drugs
easier could limit the pool of patients available to participate in
clinical trials that establish whether or not the drug is truly
effective and safe. This is an important consideration, as the vast
majority of experimental drugs turn out to be completely ineffective or
could have very dangerous side effects that will only show up over time
and across a wider test population.

When completing this assessment, it is important to keep in mind the
ethical arguments that are relevant to both views regarding the right to
experimental drugs. It may be useful to review the suggested resources
and conduct additional independent research while you are planning your
assessment submission.

Instructions

Do patients with no other treatment options have a moral right to
unproven drugs? Write a paper that explains and defends your view on
this issue. In addition to reviewing the suggested resources, you are
encouraged to locate additional resources in the Capella library, your
public library, or authoritative online sites to provide additional
support for your viewpoint. Be sure to weave and cite the resources
throughout your work. In your paper, address the following points:

• Identify relevant ethical theories and moral principles.
• Explain how the principle of informed consent is relevant to the issue.
• Explain the costs and benefits of making unproven, unapproved
  experimental drugs widely available to patients. Consider the costs and
  benefits not only to the individual patients who take these drugs but
  also potential costs and benefits to other patients.
• Explain arguments using examples for and against offering pre-approved drugs to wider pools of patients.
• Support your view using ethical theories or moral principles (or both) that you find most relevant to the issue.

Additional Requirements

• Written communication: Written communication is free of errors that detract from the overall message.
• APA formatting: Resources and citations are formatted according to current APA style and formatting guidelines.
• Length: 2–3 typed, double-spaced pages.
• Font and font size: Times New Roman, 12 point.

Reference

Munson, R. (2014). Intervention and reflection: Basic issues in bioethics (concise ed.). Boston, MA: Wadsworth.

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As noted in the textbook, “Of the leading causes of death listed in Table 1-1, four are directly related to nutrition, and another – motor vehicle and other accidents – is related to drinking alcohol” (Sizer and Whitney, 2013).  Expanding on the information from the quote above, please provide a comprehensive response to the following statements:

Explain why nutrition is important and how it impacts physical and mental health.
Differentiate the six classes of nutrients and explain how they individually and collectively help us to maintain our health status.
Describe the five characteristics of a healthy diet and provide a dietary example for each.
Explain how nutrition is a science and how the scientific method is used in this field.
Summarize the four different types of studies (case, epidemiological, intervention, and laboratory studies) and explain the use of research in the development of dietary guidelines.
Briefly define and provide a diet-related example for each of the stages of behavior change.
Explain the role of competence, confidence, and motivation in behavior change.

This assignment must be a minimum of three pages in length (excluding title and references pages) in APA format as outlined in the Ashford Writing Center. Use subheadings to help organize your paper. Include a minimum of two scholarly resources, cited according to APA style. At least one of your resources must be from the Ashford University Library.
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