Ethics of Medical Research

This week, you learned about the rigorous process of clinical trials that test new drugs before being approved for treatment. The process, which involves three distinct phases of testing, takes a great deal of time, with some trials lasting many years. 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. Early stages of research on a drug sometimes suggest that the drug could be effective in treating a certain disease. But without going through the full clinical trial process, doctors do not know if the drug is effective at all. The vast majority of experimental drugs turn out to be completely ineffective, and the drug might have very dangerous side effects. Therefore, do patients with no other treatment options, particularly those who are not able to participate in a clinical drug trial, have a moral right to unproven drugs? In other words, do these patients have a moral right to the same drugs available to patients who are participating in a clinical trial? Create an argument that explains and defends your view on this issue. In addition to reviewing your textbook, 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. Address the following points: Identify moral theories (from Week 1) and ethical principles (from Week 2) that help shed light on the ethical problems raised by expanded access and that best support your own position. Explain how the principle of informed consent is relevant to the issue. Explain the costs and benefits of making unproven, unapproved experimental drugs available to patients not participating in clinical drug trials. Consider the costs and benefits not only to the individual patients who take these drugs but also potential costs and benefits to other patients. Articulate 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. Exhibit proficiency in clear and effective academic writing skills. Assignment Requirements Your paper should meet the following 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: 3–5 typed, double-spaced pages. Font and font size: Times New Roman, 12 point. Competencies Measured By successfully completing this assignment, you will demonstrate your proficiency in the following course competencies and assignment criteria: Competency 1: Articulate ethical issues in health care. Explain how the principle of informed consent is relevant to the 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 experimental drugs to wider pools of patients. Competency 5: Apply in text the standard writing conventions for the discipline, including structure, voice, person, tone, and citation formatting.​ Exhibit proficiency in clear and effective academic writing skills. Chapter 2, “Research Ethics and Informed Consent,” pages 59–118. Use the Capella University Library to read the following articles on controversial proposals to make experimental medications (not yet approved by the FDA) available to more patients. These will be helpful in writing your assignment due at the end of this week: Raghavan, D. (2018). Right-to-try legislation: Primum non nocere just went out the window [Editorial]. HEM/ONC Today, 19(12), 8. False hope with the Right to Try act [Editorial]. (2018, June 9). The Lancet, 391, 2296.