![COURSE OUTLINES
Class Topics Student activities
8
Animal research 5th
round of class
presentation
Midterm paper (and 2-week break for midterm examination)
9
Human research – principles to consider when performing studies with human
subjects
6th class
presentation
10
Human research– Clinical trials for drugs, vaccines and medical devices 7th class
presentation
11
IRB and informed consent. [Reference to be announced] • Guest lecturer:
Huan Vuong, M.D.
12
Modern technology & Bioethics: Genome, genetic testing and GMO
Debate: Genetic editing
2nd
class debate
13
Modern technology & Bioethics: Human enhancement and immortality
Debate: Human enhancement
Discussion of Final Exam preparation
3rd class debate
14
Bioethics related to Artificial Intelligence
Debate: Artificial Intelligence
4th class debate
15 Lecture: Technology and society: (Technology Friend and Foe or the Impact of
science and tech on society, Societal responses to global issues created by science
and technology, Poverty and issues of concern in developing countries, Low tech
technologies)
Career Orientation (Msc. Bui Thi Nhu Ngoc)
Review of Bioethics course
8th class presentation](https://image.slidesharecdn.com/courseintroduction-241209064403-d02a7b5d/85/Course-Introduction-pptxXXXXXXXXXXXXXXXX-12-320.jpg)
![Plagiarism: According to the Merriam-Webster Online Dictionary, to plagiarize means to
steal and pass off the ideas or words of another as one’s own; to use another’s production
without crediting the source; to commit literary theft; to present as new and original an idea
or product derived from an existing source.
Corruption:“Corruption can be defined as the abuse of power, office, or resources by
government officials or employees of organizations for personal gain, e.g., by extortion,
soliciting or offering bribes”
Misconduct: The Office of Research Integrity (ORI) in the USA defines misconduct as:
[F]abrication, falsification, or plagiarism in proposing, performing, or reviewing research, or
in reporting research results.
Other issues related to ethical behaviors](https://image.slidesharecdn.com/courseintroduction-241209064403-d02a7b5d/85/Course-Introduction-pptxXXXXXXXXXXXXXXXX-36-320.jpg)
![Intellectual Property (IP): is defined by the Canadian Intellectual Property Office (CIPO):
“very broadly, means the legal rights that result from intellectual activity in the industrial,
scientific, literary and artistic fields. IP rights, whether in the form of patent, trade-mark,
copyrights, industrial designs, integrated circuit topographies, or plant breeders’ rights
reward this intellectual activity” [CIPO, 2011].
Privacy: refers to the freedom from intrusion or public attention; to be removed from public
view or knowledge. There is an interesting article, Bioinformatics and Privacy that adds
much information on this topic [Robison,W., 2010].
Confidentiality: refers to being entrusted with information that must not be divulged. This
applies frequently in medicine and in research or testing with human subjects. It is usual that
in the ethics application, a guarantee is made that the data will be kept confidential.
Conflict of interest: “occurs when an individual or organization is involved in multiple
interests, one of which could possibly corrupt the motivation for an act in the other”
[Wikipedia, 2011b].
Other issues related to ethical behaviors](https://image.slidesharecdn.com/courseintroduction-241209064403-d02a7b5d/85/Course-Introduction-pptxXXXXXXXXXXXXXXXX-37-320.jpg)
Course Introduction.pptxXXXXXXXXXXXXXXXX
- 2. INSTRUCTOR ▪Huong Ha ▪Ph.D. in Neuroscience ▪Chair – Biomaterial and Regenerative Department, BME School ▪Vice Chair of Ethic committee, BME School. ▪Certified in Good Clinical Practice ▪Researches in human and animals. ▪Email: htthuong@hcmiu.edu.vn
- 3. TAs Bao Nhien, BME K21 aunhien2903@gmail.com Thanh Nhan, BME K22 nhandothanh91gmail.com
- 4. LET’S GET TO KNOW EACH OTHER Your name Your fun fact Your dream career
- 5. THIS IS WHY YOU HAVE TO BE HERE: OUR PROGRAM’S EDUCATIONAL OBJECTIVES ▪Graduates of the program will: 1. Be successful in solving problems in a quantitative and systematic fashion, based on biomedical engineering knowledge and multidisciplinary perspectives; 2. Continuously expand their knowledge, be creative and innovative in their contributions to the field of biomedical engineering; 3. Perform in an ethical and professional manner; carry this out at the highest levels in public and private sectors. 5
- 6. THIS IS WHYYOU SHOULD BE HERE ▪To minimize the risk that you can introduce to other human beings, the society or even animals when performing your job ▪To guide your decision in complex and difficult moral dilemmas So that you will not make an unethical decision and avoid getting fined, losing your license, or even…being imprisoned. 6
- 7. WHERE IS BIOETHICS INYOUR EDUCATION ROADMAP?
- 8. COURSE DESCRIPTION Many difficult ethical questions have arisen from the explosive growth of biomedical research and the health-care industry since World War II. For example: ▪ When does life begin to matter morally? ▪ When and how should doctors be allowed to help patients end their lives? ▪ Should embryos be cloned for research and/or reproduction? ▪ What sort of living things is appropriate to use as research subject? ▪ How should we distribute scarce and expensive medical resources? This course will show students how problems in bioethics can be approached from a variety of perspectives,with the aim of understanding how we have got, where we are,and how we should decide where to go next.
- 9. COURSE OUTCOMES 1. Develop and sustain a logical argument/comments - and defend that argument/comments in a reasonable manner (PI 3C) 2. Evaluate the professional and ethical dimensions of engineering cases (PI 4A)
- 10. TEXTBOOKS – YOUR CLOSE FRIENDS 1. John Harris.The value of life. An introduction to medical ethics.Taylor & Francis e-Library, 2001. 2. Monique Frize. Ethics for Bioengineers. Morgan & Claypond. 2012 3. Biomedical Ethics Opposing Viewpoints. Greenhaven Press.1998 4. Daniel A.Vallero. Biomedical Ethics for Engineers: Ethics and Decision Making in Biomedical and Biosystem Engineering. Elsevier. 2007
- 11. COURSE OUTLINES Class Topics Student activities 1 Course introduction ∙ Review Syllabus ∙ Class Discussion: goals and rules Introduction to Bioethics 2 Beings, human beings and persons Introduction to logic 1. Basic Logic: Argument, Structure Validity and Soundness 2. Informal fallacies 3 Engineering Ethics How to prepare and deliver a debate 1st round of class presentation 4 Bioethics at the beginning of life – Abortion, IVF, other reproductive technologies and the selection of “best embryo” Guest speaker: (potentially) Thao Nguyen M.D. (Tan Tao University) Debate: Abortion 1st Class debate 5 Bioethics at the beginning of life – Human cloning 2nd class presentation 6 Bioethics at the end of life – Killing: A caring thing to do? Assisted suicide & Euthanasia. 3rd class presentation 7 Organ donations and the engineering solutions Discussion of midterm paper outlines 4th round of class presentation
- 12. COURSE OUTLINES Class Topics Student activities 8 Animal research 5th round of class presentation Midterm paper (and 2-week break for midterm examination) 9 Human research – principles to consider when performing studies with human subjects 6th class presentation 10 Human research– Clinical trials for drugs, vaccines and medical devices 7th class presentation 11 IRB and informed consent. [Reference to be announced] • Guest lecturer: Huan Vuong, M.D. 12 Modern technology & Bioethics: Genome, genetic testing and GMO Debate: Genetic editing 2nd class debate 13 Modern technology & Bioethics: Human enhancement and immortality Debate: Human enhancement Discussion of Final Exam preparation 3rd class debate 14 Bioethics related to Artificial Intelligence Debate: Artificial Intelligence 4th class debate 15 Lecture: Technology and society: (Technology Friend and Foe or the Impact of science and tech on society, Societal responses to global issues created by science and technology, Poverty and issues of concern in developing countries, Low tech technologies) Career Orientation (Msc. Bui Thi Nhu Ngoc) Review of Bioethics course 8th class presentation
- 13. PRESENTATION AND DEBATE SELECTION Group Members Presentation topic Debate topic 1 2 3 4 5 6 ▪4-5 members for 1 group
- 14. GRADING Participation: 10% • Weekly journal: 5 % • In-class response: 5% 1 Class activities: 30% • Presentation: 15% • Debate: 15 % 2 Midterm paper: 30 % 3 Final exam: 30 % 4
- 15. HOW TO DO WELL IN THIS COURSE? ▪Among your group, discuss what you should do to maximize your learning experience from this course? (5 min) Hint:Think about your own responsibility, your teamwork, help from instructor and TA, course material, etc.
- 16. HOW TO DO WELL IN THIS COURSE & STUDENT RESPONSIBILITY Attendance and participation: Be on time, focus and actively participate during class time No late submission of any class assignment is allowed. Pay close attention to and strictly follow all announcements and instructions of the teaching team. If you have questions or feedback, please do tell the teaching team. No plagiarism is allowed. Students are expected to spend at least 1-2 hours per week for self – studying. Missed tests: Students are not allowed to miss the final exam.
- 17. ENOUGH LOGISTICS, LET’S GET TO THE MEAT!
- 19. Ethics is a standards of conduct that deals with questions of right and wrong, good or bad. Ethics seeks to determine what a person should do as the best course of action for himself as well as for the society and environment, and provides reasons why. 1.What is Ethics?
- 20. Morality vs. Ethics Both are standards of conduct (chu n m c ng x ): ẩ ự ứ ử • Morality is the general standards of conduct in a society. These standards apply to all people in society regardless of their professional or institutional roles. Moral standards include those rules that most people learn in childhood, e.g.“don’t lie, cheat, steal, harm other people, etc.” • Ethics is the standards of conduct in a particular professional or institutional branches such as: – Bioethics (Ethics in Biosciences) – Other professional ethics
- 21. How many hours per day do you read newspaper?
- 22. Bioethics = Bioscience AND Ethics • Science – COULD it be done? • Ethics – SHOULD it be done? It is important that both are being considered What is Bioethics ?
- 23. WHAT IS BIOETHICS ? ▪ Bioethics is the study of ethical issues and decision-making associated with the use of living organisms in bioscience ▪ Bioethics is the study of how to balance different benefits and risks to living organisms, such as: ▪ Medical/Clinical Ethics ▪ Human/Animal Research Ethics ▪ Food ethics ▪ Agricultural and Environmental Ethics
- 24. ▪ Steroids for sports performance ▪ Genetic test ▪ Vaccinations ▪ Organs Examples of Bioethical Controversial Topics
- 25. Group Discussion Lockdown for Covid-19 pandemic ▪ What are the ethical implications of COVID-19 lockdowns? ▪ Do you agree with this decision? Why?
- 26. the relevance of three widely recognized considerations whenever we confront an ethical choice 1. respect for persons 2. minimizing harms while maximizing benefits 3. fairness Many other ethical considerations exist, such as authenticity, responsibility, and intrinsic value.We will use these considerations to come to decisions about the best course of action in a given case. Core Bioethical Considerations
- 27. ▪ not treating someone as a means to an end or goal. ✔ For example: even if one person’s organs could help five people live, it would be an ethical violation of respect for persons to kill that one person and distribute the organs to save the five who need them. (Kidnapping) ▪ also often a matter of not interfering with a person’s ability to make and carry out decisions. In some cases, it is also a matter of enabling a person to make choices or supporting them in the choices they make. ✔ Voluntary to use new products: contact lenses or artificial bone, artificial skin 1. Respect for Persons Core Bioethical Considerations
- 28. 2. Minimizing Harms While Maximizing Benefits Core Bioethical Considerations
- 30. 3. Fairness Core Bioethical Considerations
- 31. Fairness: Weighing Ethical Considerations We will discover that sometimes these ethical considerations clearly point out how best to act, while at other times they conflict and cannot all be satisfied. Sometimes it is not easy or even possible to act in accordance with all the relevant considerations at the same time.
- 32. Example: Should you allow your grandma with Alzheimer’s disease to drive? Which core ethical considerations should count more: respect for persons or minimizing harms?
- 34. Group Discussion In your opinion, what principle is the most important when considering an ethical issue? Why?
- 35. 1. The use and clinical trials of Drugs and Vaccines 2. The use and clinical testing of Medical Devices 3. Abortion 4. Death right 5. Human cloning 6. Stem cells 7. Genetic engineering 8. In Vitro Fertilization (IVF) Common Issues in BioEthics to be addressed in this course
- 36. Plagiarism: According to the Merriam-Webster Online Dictionary, to plagiarize means to steal and pass off the ideas or words of another as one’s own; to use another’s production without crediting the source; to commit literary theft; to present as new and original an idea or product derived from an existing source. Corruption:“Corruption can be defined as the abuse of power, office, or resources by government officials or employees of organizations for personal gain, e.g., by extortion, soliciting or offering bribes” Misconduct: The Office of Research Integrity (ORI) in the USA defines misconduct as: [F]abrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Other issues related to ethical behaviors
- 37. Intellectual Property (IP): is defined by the Canadian Intellectual Property Office (CIPO): “very broadly, means the legal rights that result from intellectual activity in the industrial, scientific, literary and artistic fields. IP rights, whether in the form of patent, trade-mark, copyrights, industrial designs, integrated circuit topographies, or plant breeders’ rights reward this intellectual activity” [CIPO, 2011]. Privacy: refers to the freedom from intrusion or public attention; to be removed from public view or knowledge. There is an interesting article, Bioinformatics and Privacy that adds much information on this topic [Robison,W., 2010]. Confidentiality: refers to being entrusted with information that must not be divulged. This applies frequently in medicine and in research or testing with human subjects. It is usual that in the ethics application, a guarantee is made that the data will be kept confidential. Conflict of interest: “occurs when an individual or organization is involved in multiple interests, one of which could possibly corrupt the motivation for an act in the other” [Wikipedia, 2011b]. Other issues related to ethical behaviors
- 38. GROUP DISCUSSION
- 39. Case 1: HENRIETTA LACKS ▪ What were the intentions/motivations of the doctors/scientists who took Henrietta Lacks’ tissue? ▪ Who have benefited from those tissues? https://www.hopkinsmedicine.org/henriettalacks/
- 40. Case 2: Brain Death https://edition.cnn.com/2018/06/29/health/jahi-mcmath-brain-dead-teen-death/index.html
- 41. QUIZ ▪ Should we keep the ventilation on a brain-dead patient? ▪ What are the pro and cons of keeping a brain-dead patient on ICU for a long time? ▪ If someone close to you is declared brain-dead, what would you do?
- 42. Any questions?
Editor's Notes
- #6: In North America, each professional engineering association and technical society provides its own ethical code and guideline to help engineers avoid misconduct, negligence, incompetence, or corruption. A complaint against an engineer can lead to discipline, which can include a fine, and/or losing the license to practice. Knowledge of the ethical decision-making process can guide engineers facing complex and difficult moral dilemmas. Principles of ethics and ethical codes are at the core of the duties and responsibilities of engineers. Although there are small differences between the ethical codes of various jurisdictions, many of the core values are the same. Engineers should review regularly the code of ethics of the jurisdiction in which they practice to ensure that they remain ethical in all their professional activities and keep up with changes in the codes when this occurs. Ethics is a dynamic concept which must be adapted to emerging issues as they arise.
- #16: 3. How to do well in this class? Attendance and participation: Be on time, focus and actively participate during class time. Regular on-time attendance in this course is expected. It is compulsory that students attend at least 80 % of the course to be eligible for the final presentation. If you show up more than 5 minutes late, your attendance of that class is not counted. You will get full score for your participation only if you contribute to discussions during class. No late submission of any class assignment is allowed. If you submit your assignment late, it will not be graded and will be considered as “no submission”, which is equal to zero grade for that assignment. Why? Because you need to develop a good task managing skill and a respect for deadline. If you have emergency situation, you can inform the lecturers about it and negotiate for a new deadline, but you will need to be really convincing and sincere. Pay close attention to and strictly follow all announcements and instructions of the teaching team. They can come via blackboard, email and facebook group, as well as directly from your lecturers and TAs. If you have questions or feedback, please do tell the teaching team. Maximize your learning efficiency by going to TA office hours. No plagiarism is allowed. If you copy information (more than a whole phrase in a sentence) from your classmates, from online source, from other papers without citing them, that is considered plagiarism. This is an unacceptable practice in our class and for your future career. Please use your own writing. Students are expected to spend at least 8 hours per week for self – studying. This time should be made up of reading, working on exercises and problem and group assignment. Missed tests: Students are not allowed to miss the final presentation. There are very few exceptions. (Only with extremely reasonable excuses, e.g. certified paper from doctors, may students re-take the tests.)
- #24: All citizens — and certainly students as they reach maturity in the next decades — will confront questions such as these: People face all these questions today. As you familiarize yourself with this curriculum supplement, you will be equipped with concepts, cases, fact sheets, and teaching strategies that will help you and your students examine these questions and others like them. The modules’ activities invite your students to grapple with new questions that no one can predict now but that society is most assuredly going to have to contend with over the coming decades, as biomedical science continues to advance.
- #26: The supplement encourages students to answer all four key questions fully and comprehensively and then, in light of their responses, to come to a decision or recommendation about the ethical question raised in the cases they explore. The purpose is not to encourage group consensus, but rather to encourage each student to develop his or her own point of view based on careful reasoning. Students should refer to these questions and considerations in the justifications they provide about why their decision is the best one.
- #27: Respect for persons means not treating someone as a means to an end or goal
- #28: In doing so, one must consider which actions would do the least harm
- #30: Students bring an inherent understanding of the concept of fairness to the classroom. Even very young children can be heard voicing their opinions on whether an action is fair or not.
- #31: In addition to the three common and very important core ethical considerations discussed in this supplement, many other considerations can be equally important depending on the nature of the ethical choice
- #32: In a case like that, When an ethical problem arises, each individual may prioritize and choose which considerations shoube favored in a different way. Often, there is no one right answer. In addition, people can emphasize different ethical considerations in the process of ethical analysis but arrive at the same decision about what should be done.