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.
By successfully completing this assessment, you will demonstrate your proficiency in the following course competencies and assessment criteria:
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.
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:
Munson, R. (2014). Intervention and reflection: Basic issues in bioethics (concise ed.). Boston, MA: Wadsworth.