Volunteers are often asked to take part in medical research in order to improve the health and well being of other people, now and in the future. However noble the aim, this raises many ethical questions.
How can we ensure that participants give their genuinely informed consent? What should be provided to control groups during clinical trials? How can we weigh the risks and benefits of various studies? How can we ensure scientific integrity in research? When should we conduct research with vulnerable populations, such as children and people in low- and middle-income countries? How should we interpret the Tuskegee syphilis study from a historical perspective?
There’s never a shortage of questions; it’s the answers that are harder to determine. For example, what type of consent is appropriate for biobanking research? When are the risks and benefits of research appropriately balanced? What special protection mechanisms are needed to include “vulnerable” study populations? How can we ensure scientific integrity in research? During this course, you will tackle these and other issues, while learning to apply theoretical insights to recent cases.
By the end of the course, you should be able to:
• Discern the morally salient dimensions of a research project, and come to a well-considered judgment about the acceptability of such a project
• Reflect on moral dilemmas for researchers and Research Ethics Committees, and be able to systematically analyze such dilemmas
• Weigh the various arguments involved, and work towards a well-reasoned position or decision
• Introduction to research ethics
You will learn about which historical scandals and controversial cases have led to the practice of ethical reflection on human subjects research. The questions addressed here include: How can history shed new light on ethically controversial cases? What are basic ethical requirements for human subjects research? Which main ethical codes, guidelines and declarations apply to human subjects research? What is the importance and necessity of medical research? What do we owe to research subjects? Is there a duty to participate in medical research? You will also analyze “Helsinki 6”: must the well being of individuals always take precedence over all other interests?
• Informed consent and the ethics of randomized clinical trials
After this introduction, you will tackle other demanding questions. What is genuine informed consent? What do participants need to understand in order to participate in medical research? When do we speak of undue inducements? What is the therapeutic misconception? What is an RCT? What are ethically challenging aspects of RCTs, not only at the moment of inclusion, but also during and after the trial? Is clinical equipoise a necessary and sufficient requirement for RCTs?
• Risk-benefit assessment and the role of ethics committees
You will look into the essential principles of research ethics – such as risks and benefits – and examine the role of research ethics committees. Hence you will think about how to balance the risks and burdens of research with the benefit to science and society. You will also discover the importance of ethics committees in this process and reflect upon the usefulness of the distinction between therapeutic and non-therapeutic research.
• Scientific integrity
As there is a growing amount of attention being paid to scientific integrity, you will not only learn about research ethics but also about the ethics of research, and of researchers themselves. You will read about the philosophy of science and think about what the rights and duties of clinical investigators are. You will also reflect upon important codes of conduct and think about how you should manage conflicts of interest in clinical research.
• Vulnerable groups: children and participants in developing countries
You will learn to reflect on the use of vulnerable populations in human subject research. Here the focus will lie on the moral problems involved in research with children, and in biomedical research in developing countries. The key questions are: What should you regard as vulnerable research populations? Should children be included in, or excluded from, research? What are the ethical issues involved in international research in developing countries? What do researchers from high-income countries owe to participants in low-income countries when conducting a trial in that country?
• Biobanks, stem cells and genetic research ethics
Lastly, you will discover the ethical issues involved in biobanking, stem cell research and genetic research. Here you will be confronted with questions such as: What type of consent is appropriate for biobanking research? What are the ethical issues of using stored human tissue and patient records for biomedical research? Is there a moral duty to disclose genomic incidental findings? How should you translate stem cell research from the lab into clinical studies in a morally sound way?
To successfully complete this course, you need to actively participate in the discussion forums and complete the learning unit assignments, including:
• Individual and group assignments
• A final assignment: this involves writing a paper (1000-1500 words). You are allowed to redo the final assignment once.
It might be that, due to a force majeure situation, you cannot be present during the first exam moment.
• MSc Epidemiology Postgraduate students must then, preferably prior to the first exam option, ask the academic counsellor for permission to be absent. Please note that the academic counsellor can ask for some form of proof of your absence (e.g. in case of illness) to establish if you are applicable for authorized absence. Jaco de Fockert-Koefoed, MSc is the academic counsellor you need to turn to through email@example.com.
• All other participants should contact the MSc Epidemiology Office instead, through MSc-Epidemiology@umcutrecht.nl.
In short, as of now, it is no longer possible to skip the first deadline option and -automatically- submit the assignment at the second (re-sit) deadline. Unauthorized missing the first deadline results in no longer being able to finish the course that college year.
To enroll in this course, you need:
• A Bachelor’s degree
• Sufficient proficiency in English reading and writing
Please note that you do not need to have a background in Philosophy or Ethics to follow this course.