A Right to Experimental Drugs?

A Right to Experimental Drugs? 

Write a 2–3 page paper that explains and defends your view on the issue of whether patients with no other treatment options have a moral right to unproven drugs. 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 and involves the continued expansion of medical research. A large part of such research is clinical research, which puts patients in the role of experimental subjects. This raises challenging ethical questions, many of which stem 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 improving the welfare of human beings in general by eliminating or controlling diseases and increasing longevity. However, clinical researchers must also be committed to providing the highest quality care for research study participants. This assessment explores ethical issues that clinical research raises and safeguards to protect the interests of patients involved in research. SHOW LESS 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 trial 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. Ethics and Informed Consent As we have seen, there are numerous moral concerns regarding the ethics of medical research using human test subjects. As researchers take care to avoid harming patients, they must also ensure that study participants have given truly informed consent. Determining precisely what that involves and whether it has been given in a specific case can be challenging. Munson, R. (2014). Intervention and reflection: Basic issues in bioethics (Concise ed.). Boston, MA: Wadsworth. Available in the courseroom via the VitalSource Bookshelf link. Chapter 2, “Research Ethics and Informed Consent,” pages 59–118. As you read the chapter—particularly pages 88–90—consider the following: Should Mrs. Wilkins’s consent to participate in a Phase 1 trial be regarded as informed, in your view? Why or why not? Is Mrs. Wilkins an appropriate candidate for participating in a Phase 1 clinical trial? How should investigators go about getting people to consent legitimately to Phase 1 trials? McIntyre, A. (2018). Doctrine of double effect. In The Stanford Encyclopedia of Philosophy. Retrieved from https://plato.stanford.edu/entries/double-effect/ In a double effect, a harmful action may be a good ethical choice if there are positive outcomes. Miller, J. E., Ross, J. S., Moch, K. I., & Caplan, A. L. (2017). Characterizing expanded access and compassionate use programs for experimental drugs. BMC Research Notes, 10. This article presents findings related to the characteristics of expanded access, compassionate use programs, and the percentage of drugs from these programs that ultimately cleared the FDA trials process. Raus, K. (2016). An analysis of common ethical justifications for compassionate use programs for experimental drugs. BMC Medical Ethics, 17. The author’s view of the ethics and logic of the ethical justifications for use of experimental drugs is included in this analysis. General Education Information Skills Library Guide. SHOW LESS Key Events in Ethical Research Complete the following to explore the positive and negative effects of key events related to research using human subjects. As you work through this activity, think about how these events shaped the current guidelines for access to experimental drugs and how you could incorporate your considerations into your assessment. This is for your own self-assessment. Preparation Clinical trials for drug approval involve several distinct testing phases requiring rigorous study and evidence to demonstrate the safety and efficacy of new treatments. Approval takes many years for some trials. Before approval, patients outside the clinical trial have limited or no access to experimental drugs, even though these drugs could be lifesaving. There are various groups pushing for greater patient access to experimental drugs. In recent years, the FDA has made it somewhat easier to prescribe experimental drugs, but advocacy groups say there are still too many restrictions (Munson, 2014). This may lead to a quandary when early stages of research suggest that a drug could be effective in treating a certain disease. On one hand, offering easier access to early-stage trial drugs could help patients suffering with a medical condition. But easing access to experimental drugs could decrease available participants for clinical trials that establish whether 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 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 planning your assessment submission.