Case Study: Medical Research

1. Case Study: Medical Research Jillian Cudmore Mallory Anne Andrea Currie Amy DeBaie

2. Helping Patients Decide Whether to Participate in Clinical Trials "I've been feeling miserable lately, and I haven't been able to eat much at all," Mr. Brooks said, wincing as he shifted on the exam table. "Well, end-stage colon cancer is a pretty nasty disease," Dr. Winston, his primary care physician of 15 years, replied softly. "And I understand from your chart that the masses in your liver and lungs haven't gotten any smaller since your last round of chemo." "That's right. And the last drug we tried was the only standard option left, which might be a good thing, since I'm getting pretty tired of all of the awful side effects. My oncologist, Dr. Lin, really wants me to try one more drug, and I think I'm going to do it. I guess he's in charge of this study. He told me it's called a phase 1 trial. He said this drug has worked really well in mice and that it might work well for me too." "Hmmm, well I don't know much about experimental cancer treatments, but phase 1 studies are very new and often have more benefit for future patients than for study participants," Dr. Winston cautioned.

3. Ethical Question "Honestly doc, I hate to sound selfish, but at this point I'm not really thinking about helping other people. I just want to feel better, and Dr. Lin said that this is my best shot. Joining the study sounds like a good idea, right?"

4. Hastings Center Model for analysis 1. Identify the ethical questions raised in the case. 2. What is the primary ethical dilemma? 3. Are there certain rights, responsibilities or duties to be considered? 4. Gather and assess all the relevant facts. 5. Are there legal issues to address? 6. Are there social consequences to consider? 7. Are there facts that you do not have? Any way to get them? 8. Identify the stakeholders. a. Who will be most affected by the decision taken? b. Who else will be affected? individuals? groups? population? 9. Identify the values that play a role in the decision (autonomy, beneficence and non-maleficence, justice, truth telling, disclosure, confidentiality, caring) 10. Identify possible solutions: What are possible courses of action? Choose the better solution(s) and justify it (them); Eliminate unacceptable or unjustified options; Identify the solution or decision that you would choose; Explain why you think it is a good choice. 11. What actions need to now be taken?

5. a. plays a role in the decision by ensuring that Dr. Winston informs Mr. Brooks about all the. To support his patient in being autonomous the doctor must ensure that Mr. Brooks is well education before making a decision to participate in the trail or not, “To make an autonomous choice one must have sufficient information; we cannot judge the likely consequences of our choices, or be expected to take responsibility for them, if we are lacking information relevant to that choice” (Collier & Haliburton, 2011, p.76). Dr. Winston should consult with his patient’s oncologist, Dr. Lin, to understand his motives and to obtain all the information about the study, to ensure that he has all the information necessary to make an informed decision. “In health care, autonomy supports informed consent” (Collier & Haliburton, 2011, p.303). Dr. Winston should also ensure that his patient has a comprehensive understanding of his condition, end stage colon cancer, and any other available treatments not just the standard pharmaceutical treatment. “When considering the role that autonomy should play within the patient doctor relationship, we need to consider both the abilities of the patient and the obligations of the doctor to fully inform that patient of her diagnosis or prognosis” (Collier & Haliburton, 2011, p.76).

6. Autonomy • Consult with Dr. Lin to obtain information about clinical trail. • Ensure Mr. Brooks is well informed about phase 1 clinical trials, the treatment available, and his disease and current condition. • “In health care, autonomy supports informed consent” (Collier & Haliburton, 2011, p.303).

7. Beneficence &Non-maleficence • “The principle of autonomy needs to be balanced with the principle of beneficence- the requirement that we ought to do good, and the principal of non-malfeasance-the requirement that we ought to prevent harm.” (Collier & Haliburton, 2011, p.78) • This principal is reflected in the Hippocratic Oath that every doctor must recite: First, do no harm.”(Collier & Haliburton, 2011, p.303). Dr. Winston should consult with Dr. Lin about whether the study will yield more risks or benefits for Mr. Brooks.

8. Justice • “Justice means that we should be fair in our treatment of other people and treat like cases equally” (Collier & Haliburton, 2011, p.304). • Must consider all aspects of his life and if his participation in the study would improve his quality of life.

9. Veracity & Disclosure • Principle states that we should tell the truth. “It also means that we should provide individuals with comprehensive, accurate, and objective information , for example in relation to their illness, or regarding their participation in a clinical trial” (Collier & Haliburton, 2011, p.304). • Disclosure is the act of making new or secret information known. • “informed consent, insisting on transparency and truth, and rejecting procedures and processes that could result in using research subjects solely as a means to an end”(Collier & Haliburton, 2011, p.119).

10. Confidentality • Confidentiality “holds that we should keep privet the medical information that is disclosed to us in the course of our professional duties. In addition, it can be understood to include the requirement that we keep privet the personal information that others provide to us, unless they authorize us to share it” (Collier & Haliburton, 2011, p.304).

11. Caring • Caring is “attending to and meeting the needs of particular others for whom we take responsibility” Collier & Haliburton, 2011, p.26). • “the ethics of care sees humans as interdependent with one another, and formed through relationships…. and should pay attention, in particular, to the needs of those who are dependent on you”(Collier & Haliburton, 2011, p.27). • “speak to everyone on the list, to determine what they want and need, and how they feel about the situation they find themselves in. Focuses on the needs of those who are most dependent within relationships. ”(Collier & Haliburton, 2011, p.27).

12. RESOLUTION OF THE CASE • Recommendation or come to a decision and provide reasons:

13. References • Collier, C., & Haliburton, R. F. (2011).Bioethics in Canada: a philosophical introduction. Toronto: CSPI. • Smith, M.L., & Kodish, E.D. (2007). Virtual Mentor: Helping patients decide whether to participate in clinical trials. American Medical Association Journal of Ethics,9(1), 16-20.