ELG7114 / EACJ 5300

Topics in Systems and Control: Ethics, Research Methods and Standards for Biomedical Engineering

 

Schedule: Tuesdays (LMX 242) and Thursdays (LMX 407)  11:30-13h  

 

Instructor: Monique Frize, P. Eng.

                    CBY A612,  ext. 6065, frize@site.uottawa.ca

                    MC 7084, ext. 8229, mfrize@connect.carleton.ca

 

This course will present general concepts defining ethics, ethical theories, codes of  ethics and the ethical decision-making process. Other issues such as conflicts of interest, plagiarism, intellectual property, confidentiality, privacy will be discussed. Ethical considerations relating to human and animal experimentation, consent, and current practices of ethical review board and particular bioethics issues such as stem cell research, cloning and genetic engineering, reproductive technologies, xeno-transplantation and organ transplants will be discussed. Research methods, regulation and standards for the design of medical devices and certification procedures, data collection, management and analysis, and assessment of the impact of technology on people and society will be discussed.

 

Calendar Description: Ethical theories, ethical decision-making, codes; human and animal experimentation, consent, practices of ethical review boards; research methods and regulations for design, manufacture, certification of medical devices; data collection, management, analysis, including security, confidentiality, privacy; bioethical dilemmas, impact of technology and research (social, political, financial).

 

Pre-Requisites: Graduate student in Engineering or 4th year students in these disciplines.

 

Week by week schedule:

 

Week 1: Course outline and requirements; introduction

 

Week 2: Ethics, ethical theories, codes of ethics, ethical decision-making.

 

Week 3 & 4: Conflict of interest, intellectual  property, confidentiality, privacy, security.

             Impact of technologies on society; design and human oriented technologies                   (E. Kranakis and G. Lindgaard); assignment 1

 

Week 5 & 6: Ethical considerations relating to human and animal experimentation, consent.  Guidelines and ethics review process

 

Week 7 & 8: Regulations for design, manufacture, certification of medical devices; standards; research methods; data collection, management and analysis

 

Week 9: Experience with ethics review process: a medical point of view (R Walker);     discrimination in research and services; Clinical research: a case study (A. Seely)

 

Week 10:  Human reproductive technologies, gender selection, designer babies; other    ethical   dilemmas

 

Week 11:  Cultural impact on ethics.

 

Week 12: Emerging trend in biomedical engineering (Complementary and Alternative     Medicine); research and testing in developing countries.

 

Week 13:  Projects presentations.

 

Assignments: There will be three assignments: The first will consist of an article on ethics in biomedical engineering; the second will be a case study analysis; the third will be on an ethical dilemma. All students must be prepared to describe their findings briefly during a class discussion on the topic of the assignment (by the date on which this is scheduled) and submit the assignment in writing one week later.

 

Schedule for class presentations of assignments:

No 1: January 31

No 2: February 16

No 3: March 7

 

Note: Written assignments are expected to be approximately 4-6 pages with 1.5 or double spacing and 1 inch margins.

 

Term project: Choice of a proposal for ethical clearance on a research project.

The term project will be presented in class on March 28 and 30. The project is submitted in writing by noon on April 7th and is expected to be around 10-15 pages.

 

Scheduled Exam (by Faculty)

 

Course Assessment and Requirements

Each assignment will count for 15 percent of the final mark; verbal presentations of assignments and project will be 5 percent; the written project will count for 20 percent. The exam will count for 30 percent of the total mark.

 

Objectives of this course: Students will:

  1. Become familiar with a number of ethical theories and codes of ethics, as well as a number of ethical dilemmas; this will help students to think about ethical issues and concerns when developing a research plan.
  2. Become familiar with the process of ethical decision making.
  3. Learn how to apply for ethical clearance to an ethics review board for research projects that involve humans or animals. This involves becoming familiar with principles of ethical research.
  4. Become aware of good research practices and of main standards in the field of biomedical engineering.