585.635.81 - Ethics in Biomedical Engineering Research and Management

Course Structure

The course materials are divided into modules which can be accessed by clicking Course Modules on the left menu. A module will have several sections including the overview, content, readings, discussions, and assignments. You are encouraged to preview all sections of the module before starting. All modules will run for a period of seven (7) days. You should regularly check the Calendar and Announcements for assignment due dates. 

Course Topics

• Module 1
  
  • Bioethics Fundamentals - Truthfulness and Conflict of Interest
    
  • Moral Managers? Ethics at the Stakeholder Level
• Module 2
  
  • Bioethics Fundamentals - Activism
  • Leadership Traits and Behaviors
• Module 3
  
  • Bioethics Fundamentals - Treating Disease vs. Human Enhancement
  • Capitalism vs. Patient Care Leading to Human Happiness
• Module 4
  
  • Research Ethics - Cellular, Genetic, and Tissue Engineering
  • Diverse Leadership Constituencies
• Module 5
  
  • Research Ethics - Neural Engineering
  • Transformational Leadership
• Module 6
  
  • Research Ethics - Biomedical Imaging and Brain Imaging
  • Motivation and Positive Psychology
• Module 7
  
  • Professional Ethics - Human and Animal Experimentation
  • Cross Cultural Perspectives
• Module 8
  
  • Professional Ethics - Informed Consent
  • Agency and Biomedical Engineering Employment Law
• Module 9
  
  • Professional Ethics - Benefit/Risk
  • Leader/Member Exchange Theory
• Module 10
  
  • Social Ethics - Allocation of Resources
  • Leadership: Path Goal Theory vs. Management Expectancy Theory
• Module 11
  
  • Social Ethics - Manufacturing
  • Do Multinational Corporations Have Ethical Obligations?
• Module 12
  
  • Social Ethics - Data Management
  • Does Restructuring and Reissuing Rules Make Employees More Ethical?
• Module 13
  
  • 360 Assessments Report and Personal Leadership Plan Due
    
• Module 14
  
  • Course Ethical Leadership Project Presentation Due
    

Course Goals

This course is intended to introduce the biomedical engineer to the principles of bioengineering ethics and biomedical engineering ethics along with the associated leadership or managerial techniques and requirements that drive or inspire ethical behavior. Most ethics programs, especially those dealing with medicine or biosystems focus on the role of the caregiver and make little sense from an engineering perspective. The engineer of the future will continue to be asked to reduce risk while simultaneously develop new and novel therapeutics. Additionally, more so than ever before, these new therapeutics will need to be inclusive of a wide variety of members of society. 

Biomedical engineers must straddle the landscape of both the engineering profession and the medical profession. In this light, it is the goal of this course to equip the students taking it with the tools needed to approach divisive bioethical issues in both their workplace and their research and be successful in surmounting those situations and making sound scientific and ethical decisions.

Course Learning Outcomes (CLOs)

• Explain the relationships and differences between ethics and morals
• Analyze the impact of ethical and non-ethical decisions on data and data collection
• Examine the effects of ethical decision making on research outcomes
• Examine the relationship between ethical decision making and effective leadership
• Make ethical decisions in complex biomedical engineering situations
• Evaluate ethical management and leadership strategies and their relationship to the unique problems posed by biomedical engineering

Textbooks

Vallero, D.A. (2007). Biomedical Ethics for Engineers: Ethics and Decision Making in Biomedical and Biosystem Engineering. Burlington, MA. Academic Press 

ISBN-10: 0-7506-8227-2 
ISBN-13: 978-0-7506-8227-5 

Northouse, P.G. (2022). (9th ed.) Leadership: Theory and Practice. Los Angeles, CA. Sage Publications, Inc.

ISBN-10: 1071834479
ISBN-13: 978-1071834473

Textbook information for this course is available online through the appropriate bookstore website: For online courses, search the MBS website. 

Other Materials & Online Resources

Students will be required to purchase a 360 degree Leadership Assessment for $99.00 provided by AlignMark 360. The course instructors have arranged special discounted pricing and special evaluation questions designed for Engineering Management students. You will notify the professors if you are considered an engineering professional, a mid-level manager, or an executive manager at your current position. This choice will enable AlignMark to issue you a specialized assessment designed with your current subordinates, peers, and superiors in mind. A link to both register as well as pay for the assessment will be provided once class begins.

Student Coursework Requirements

It is expected that each module will take approximately 7–10 hours per week to complete. Here is an approximate breakdown: reading the assigned sections of the texts and the assigned associated readings (approximately 2–3 hours per week), listening to/watching the audio annotated slide presentations (approximately 2–3 hours per week), writing assignments (approximately 2–3 hours per week), and taking the quizzes (approximately 1 hour per week). 

This course will consist of the following basic student requirements:

Assignments (25% of Final Grade Calculation) 

Students are required to complete ALL homework assignments to earn a course grade. Homework assignments will be evaluated and graded on a scale of 0 to 100. All assignments are due according to the dates in the Calendar. The intent of these assignments is to have you practice developing your critical thinking skills. Late submissions will be reduced by one letter grade for each week late (no exceptions without prior coordination with the instructors).

Quizzes (20% of Final Grade Calculation) 

There will be short (~ 10 question) quizzes given during each Module for which there is associated textbook (or textbook excerpt) reading. You will have 15 minutes to take these quizzes. These quizzes will be open book but will be timed in such a way that if you know where to find the material and are familiar with the material they will be easy to complete but if you have not read the text you will easily run out of time hunting for the answer. You will have the entire week to start/begin the quizzes, but they will be due by 11:59PM EST (midnight on Day 7) exactly one week from their release. You will take the quizzes through the course Blackboard site. Late submissions will be reduced by one letter grade for each week late (no exceptions without prior coordination with the instructors). 

Participation in Class Discussion Boards (15% of Final Grade Calculation) 

You are responsible for carefully reading all assigned material and being prepared for discussion. Success in this component of the course will depend upon both your thoughtful consideration of the case study or ethical thought problem presented, but also especially your responses to your peers. Success in understanding and evaluating ethical or moral behavior requires one to find faults in the argument structure of premises and evaluative connections.  

You MUST post your initial response to the discussion questions by the evening of Day 4 (Saturday) for that Module Week (Wednesday – Tuesday). Posting a response to the discussion question is Part One of your grade for module discussions (i.e., Timeliness). Part Two of your grade for module discussion is your interaction (i.e., responding to classmate postings with thoughtful responses) with at least two classmates (i.e., Critical Thinking). We will be looking for a minimum of 4 “interactions” but in a course like this one, “minimum” does not meet the bar of rich insight or analysis. Just posting your response to a discussion question is not sufficient; we want you to interact with your classmates. Be detailed in your postings and in your responses to your classmates' postings. Feel free to agree or disagree with your classmates. Please ensure that your postings are civil and constructive. For this course we DO NOT want long paragraphs of text in the discussions; the forum posts should be short and to-the-point. We would much rather see a rich back and forth discussion than two really long posts with a single argument and counterargument. 

We will monitor module discussions and will respond to some of the discussions as discussions are posted if we feel like an important point has been raised or if the discussion is getting off track. The professors intend to be active participants in the discussion board of this class. 

360° Leadership Assessment and Individual Development Plan (20% of Final Grade Calculation) 

Two semester-long course projects will be assigned at the beginning of the course. For the first one, all students will complete an on-line leadership self-assessment and will identify from 8 - 12 colleagues that each student will invite to complete the online observer assessment. A link will be provided for students to access the assessment. Each student will purchase a license which enables one leader (student) and as many observers as the leader may select (not fewer than 8) to complete the survey on the leader’s behalf. Those observers (e.g., peers, direct reports, direct manager(s), supervisor(s) and/or others) must be individuals who are knowledgeable about the student’s leadership skills and abilities. In order to receive anonymous feedback, the leader must select AT LEAST two people of each category of observer. When both the self and the observer forms are completed, each student will receive around a 30-40 page summary of the combined survey results that can be used to complete the self-reflection paper. Students will need to purchase the license as soon as possible to begin the assessment process.

Each student will have the opportunity to explore, analyze and refine his or her leadership and motivation skills and understanding in order to optimize personal effectiveness as a leader and a team member.  This project will help you think and write personally and more critically about how you, as a current or soon-to-be leader, will meet these challenges as you endeavor to optimize your personal leadership effectiveness and personal ethical management style.

The leadership assessment paper is evaluated by the following grading elements: 

1. Develop and discuss an integrated set of your assumptions, values and beliefs that define your current or future role as a leader in your organization and how these assumptions were derived
2. Assess your personal leadership and team development strengths and areas of needed development, in light of the assessment feedback and other insights
   
3. Articulate an individual development plan (IDP) that will address those areas identified above, in the context of your integrated assumptions about leadership, motivation, and team effectiveness
   

The paper should be clearly organized. Please use numbered sections to organize and present your insights and to ensure you have included all that is supposed to be included in the paper. Failure to discuss each of these emphasis areas will be considered as not meeting the project requirements and will likely result in a point deduction on your project evaluation. This entire paper should be no more than 10-12 pages of double-spaced, 12-point font text organized in clear sections with headings and subheadings.  References, title page(s), and appendices (if applicable), are in addition to the 10-12 pages of text. Your paper will be due by the end of Module 13. You will have the opportunity during Module 13 to discuss the paper with the professors during both synchronous and asynchronous office hours as well as use the discussion forums to discuss the paper and your report findings with your peers in the discussion forums.

Course Ethical Leadership Project (20% of Final Grade Calculation) 

Two semester-long course projects will be assigned at the beginning of the course. For the second one you will be taking on the role of an executive leader of an organization with a mismanaged and unethical corporate structure. The course ethical leadership project will ask that you select a publicly reported and easily researchable instance of a failure in ethical leadership related to healthcare, medical device design, etc. that has occurred in the private sector no further back than January 2005. Topic selection of the midterm course project will be due by the start of Module 4. Topic selections are first come first serve. Only one student will be able to select each event. Students should pick the event and place themselves in the shoes of the CEO (or the Board Chairman or the Research Director if the CEO was the culprit, or the facility was a research lab/hospital). They will then prepare a post-mortem analysis of what went wrong and when, highlighting specifically the ethical or non-ethical decisions that were made, which lead to the event. This analysis should include the student’s recommended remediation solutions. The students will then prepare a presentation of this post-mortem analysis along with recommendations and action items for moving the company (or research institution) forward. This presentation will be given in front of a camera and posted to the course. This presentation should be addressed to the camera and given in business attire. The second companion piece to your presentation will be to post in the discussion forum a 2021 update of where that organization is now and how they have evolved (or not) since the event in question. DO NOT just recycle what the company actually did to try and solve their problems for your presentation. We want to hear what YOU would do, using the tools and topics that YOU learned in this course at your disposal. You will not be graded on your accuracy or probability of success of your ideas but rather be grading your engineering professionalism and critical knowledge of ethical behavior. The presentation will be due by 11:59pm EST Sunday night of Module 14 so your classmates have Monday and Tuesday to watch your presentation and give you feedback. You will have the opportunity during Module 14 to discuss the presentation with the professors during both synchronous and asynchronous offices hours.

Final grades will be determined by the following weighting: 

Grading Policy

Assignments are due according to the dates posted in your Blackboard course site. Assignments are due 7 days from the day they are assigned. Each Module in this course runs from Wednesday to Tuesday. All assignments will be due by 11:59PM EST (midnight on Day 7). You may check these due dates in the Course Calendar or the Assignments in the corresponding modules. We will do our best to try and post grades one week after assignment due dates. 

We generally do not directly grade spelling and grammar. However, egregious violations of the rules of the English language will be noted without comment. Consistently poor performance in either spelling or grammar is taken as an indication of poor written communication ability that may detract from your grade.

Academic Policies

Deadlines for Adding, Dropping and Withdrawing from Courses

Students may add a course up to one week after the start of the term for that particular course. Students may drop courses according to the drop deadlines outlined in the EP academic calendar (https://ep.jhu.edu/student-services/academic-calendar/). Between the 6th week of the class and prior to the final withdrawal deadline, a student may withdraw from a course with a W on their academic record. A record of the course will remain on the academic record with a W appearing in the grade column to indicate that the student registered and withdrew from the course.

Academic Misconduct Policy

All students are required to read, know, and comply with the Johns Hopkins University Krieger School of Arts and Sciences (KSAS) / Whiting School of Engineering (WSE) Procedures for Handling Allegations of Misconduct by Full-Time and Part-Time Graduate Students.

This policy prohibits academic misconduct, including but not limited to the following: cheating or facilitating cheating; plagiarism; reuse of assignments; unauthorized collaboration; alteration of graded assignments; and unfair competition. Course materials (old assignments, texts, or examinations, etc.) should not be shared unless authorized by the course instructor. Any questions related to this policy should be directed to EP’s academic integrity officer at ep-academic-integrity@jhu.edu.

Students with Disabilities - Accommodations and Accessibility

Johns Hopkins University values diversity and inclusion. We are committed to providing welcoming, equitable, and accessible educational experiences for all students. Students with disabilities (including those with psychological conditions, medical conditions and temporary disabilities) can request accommodations for this course by providing an Accommodation Letter issued by Student Disability Services (SDS). Please request accommodations for this course as early as possible to provide time for effective communication and arrangements.

For further information or to start the process of requesting accommodations, please contact Student Disability Services at Engineering for Professionals, ep-disability-svcs@jhu.edu.

Student Conduct Code

The fundamental purpose of the JHU regulation of student conduct is to promote and to protect the health, safety, welfare, property, and rights of all members of the University community as well as to promote the orderly operation of the University and to safeguard its property and facilities. As members of the University community, students accept certain responsibilities which support the educational mission and create an environment in which all students are afforded the same opportunity to succeed academically. 

For a full description of the code please visit the following website: https://studentaffairs.jhu.edu/policies-guidelines/student-code/

Classroom Climate

JHU is committed to creating a classroom environment that values the diversity of experiences and perspectives that all students bring. Everyone has the right to be treated with dignity and respect. Fostering an inclusive climate is important. Research and experience show that students who interact with peers who are different from themselves learn new things and experience tangible educational outcomes. At no time in this learning process should someone be singled out or treated unequally on the basis of any seen or unseen part of their identity. 
 
If you have concerns in this course about harassment, discrimination, or any unequal treatment, or if you seek accommodations or resources, please reach out to the course instructor directly. Reporting will never impact your course grade. You may also share concerns with your program chair, the Assistant Dean for Diversity and Inclusion, or the Office of Institutional Equity. In handling reports, people will protect your privacy as much as possible, but faculty and staff are required to officially report information for some cases (e.g. sexual harassment).

Course Auditing

When a student enrolls in an EP course with “audit” status, the student must reach an understanding with the instructor as to what is required to earn the “audit.” If the student does not meet those expectations, the instructor must notify the EP Registration Team [EP-Registration@exchange.johnshopkins.edu] in order for the student to be retroactively dropped or withdrawn from the course (depending on when the "audit" was requested and in accordance with EP registration deadlines). All lecture content will remain accessible to auditing students, but access to all other course material is left to the discretion of the instructor.