Grading Rubric Must be Followed

Instructions

Do patients with no other treatment options have a moral right to unproven drugs? Write a 3 page text paper that explains and defends your view on the issue of whether or not patients with no other treatment options have a moral right to unproven drugs.. In addition to reviewing the suggested resources, you are encouraged to locate additional resources 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.

Resources:

Ethics and Informed Consent

As we have seen, when it comes to the ethics of medical research using human test subjects, there are a number of moral concerns raised. Researchers must be careful to not only avoid harming patients, but 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 from the bookstore.
  • Chapter 2, "Research Ethics and Informed Consent," pages 59–118.
    • As you read the chapter, consider the following questions (especially as you consider pages 88–90):
      • 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?
• 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 and compassionate use programs and the percentage of drugs from said programs that ultimately cleared through the full FDA trials process.
• Raus, K. (2016). An analysis of common ethical justifications for compassionate use programs for experimental drugs. BMC Medical Ethics, 17.
  • This article analyzes the justifications used in providing and/or gaining access to compassionate use programs, as well as the author's view of the ethics and logic of said justifications.