Instructions:
1. Write your name and ID on the heading of the answer sheet
2. Maximum pages for answer sheet is 3 pages
3. Font size for the write-up of answer sheet is 12; Spacing 1.5; Font type Times New Roman.
4. Due date to return the assignment is on Friday, Sep 30, 2022, to the department by email using
email subject of “Assignment 1: Name: Ethics”.
Case #1
Dr Abbott, an oncologist at a major teaching hospital, has been asked to put forward a number of her patients for participation in a clinical trial of a new cancer treatment.
Mr Day is a terminally ill patient with a type of cancer suitable for participation in this trial. Mr Day is incredibly keen to participate and volunteers at the first opportunity. When asked to explain his eagerness during the recruitment process, he says that God has sent him this opportunity, that the treatment (which he’s “read all about on the internet”) is a “wonder drug”, that it will save his life, and that (if entered into the trial) he expects to be “completely cured” in time for Christmas (less than 6 months away).
Mr Day’s health carers all think that his views of the trial are extremely over-optimistic. What’s more, his
views persist in spite of the fact that he’s been told on a number of occasions that:
a) the experimental treatment isn’t expected to prolong his life by more than a few months (although it may have quality of life benefits too);
b) this expected benefit can’t be predicted with any certainty;
c) the chances of his being “completely cured” by it, or anything else, are close to zero.
When confronted with this information, Mr Day just says things like “you’re just being cautious and covering
your backs” or “you lack faith”.
Dr Abbott thinks that participation in the trial might benefit Mr Day psychologically, alongside any direct clinical benefits, by sustaining his hopes and expectations, and (conversely) that not permitting him to take part would be psychologically damaging. She also thinks that the fact that he’s very keen to take part should be taken seriously and that not to do so would be a failure to respect his autonomy. But, on the other hand, Dr Abbott is not sure whether Mr Day is capable of supplying valid consent, since he appears unable or unwilling to grasp the true nature of his situation and of the trial.
Questions based on case #1:
1. What are the main ethical issues that this research raises?
2. Is Mr Day in a position to give valid consent to take part in the trial?
3. Would denying Mr Day a chance to participate in the trial be a failure to respect his autonomy? What is the relationship between irrational beliefs and autonomous decision-making?
4. Should the fact that Mr Day’s seemingly irrational beliefs have a religious basis be a matter for special
attention in assessing his vulnerability?
5. Would entering Mr Day into the trial be exploiting his vulnerability?
6. Are there any alternatives to Mr Day offering consent or any additional safeguards that should be in place to protect his welfare?
Case #2
The manufacturer of a new hormonal contraceptive commissions a research team to design a clinical trial to compare the effectiveness and tolerability of the new preparation using three different methods of delivery – oral tablets, transdermal patches, and injections. The manufacturer also wants the researchers to focus on the use of this new contraceptive in women of two different socioeconomic groups. The working hypothesis is that the delivery of hormonal contraceptives by transdermal patches or as an injectable depot is as effective and safe as the use of tablets, irrespective of whether or not the users have received secondary education.
The manufacturer draws up a contract with the regional health authorities, which stipulates that the manufacturer will pay the salary of each researcher employed by the regional authorities for the study. The manufacturer further provides each researcher with a personal computer to aid in data collection and storage and pays the researchers an agreed sum of money (about US$ 1000) for each volunteer who completes the trial. The researchers then begin to identify an equal number of suitable participants for the study from each of the two socioeconomic groups. Once the two participant groups are formed, they are randomized to the three modes of delivery of the new contraceptive. The participants are told to discontinue their current contraceptive regimen for the duration of the trial.
Each research participant has the benefit of individual attention during the trial and is provided with the new contraceptive free of charge. The manufacturer pays each volunteer a small amount (about US$ 20) as compensation for possible failure or undesirable side-effects of the new preparation.
Questions based on case #2:
1. All stakeholders in this study receive some benefits. Comment on the appropriateness of each and discuss other types of compensations that could be provided. Are there any conflicts of interest?
2. Are these benefits commensurate with the possible risks?
3. Should partners be involved in the consent process?
4. If the contraceptive technique used before the trial was the condom, what should be done if the woman contracts a sexually transmitted infection, which might include HIV, during the trial?
5. What obligation does the sponsor have towards the research participants if the preparation either fails or has undesirable effects?
Case #3
You are the pharmacist in a palliative care centre. Patient BM is in the last stages of breast cancer. She is in terrible pain and has asked the doctor to increase her dose of pain-killer medicine. BM is already taking the maximum safe dose recommended for this medication, and the doctor is hesitant to increase the dose any further since it would likely hasten her death. BM has expressed to both you and the doctor that she understands this risk, but she would like to be comfortable for the short remainder of her life. BM is clear and rational while expressing this. The doctor has asked you for your advice.
Questions based on case #3:
1. What are the ethical dilemmas in your decision?
2. If this is an ethical dilemma, what are the key ethical principles involved?
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