The 11-course syllabus below is designed to develop expertise in research ethics. Each course is taught as a seminar, encouraging discussion and interaction.
In addition to the formal courses, each on-site module includes presentations on controversial topics by faculty and trainees in the program. These additions are aimed at encouraging thoughtful discussion and critical engagement with the material.
History of Research Ethics and Critical Assessment of Codes
This course reviews the defining history that shapes contemporary research ethics and critically reviews the various international codes and declarations that have formed contemporary understanding of the ethical conduct of human subject research.
- Historical Development of Science
- Historical Development of Human Subject Research
- Historical Abuses of Human Subjects (pre- regulations)
- Historical Abuses of Human Subjects (post-regulations)
- Evolution of Clinical Trial Oversight (review and critical appraisal of international codes: Nuremberg Code, Declaration of Helsinki (revisions), Belmont Report, Common Rule, Council for International Organizations of Medical Sciences (CIOMS), and International Conference on Harmonisation (ICH)
Methods of Research
This course provides trainees with a background in research methodology that will allow them to competently review proposals submitted to an IRB. It presents a survey of clinical research methods, starting with definitions of variables and study designs and progressing to practical matters such as prospective versus retrospective study designs, selection of subjects, outcomes and analysis methods, as well as economic analyses and outcomes research.
- Overview and administrative issues
- Variables and their Measurement
- Choosing Research Questions and Study Subjects
- Decision Analysis and Cost Effectiveness Analysis
- Research Design
- Randomized Trials
- Causal Inference and Observational Studies
- Diagnostic Tests
- Human Subject Research
- Sample Size and Power
- Community-Based Research
- Secondary Data Analysis
- Qualitative Research
Responsible Conduct of Research: The Ethics of Science
This course provides training in research integrity and professionalism.
- Science as a Profession: Ethics and the Scientist
- Scientific Misconduct: Misrepresentation of Data, Plagiarism, Misappropriation
- Collaboration in Research: Authorship, Peer Review, and Mentoring
- Ownership of Data and Intellectual Property
- Eliminating Bias and Promoting Objectivity: Managing Competing Interest
Introduction to the Ethics of Medicine
This course provides a perspective on the ethics of medicine and an account of the basic principles of medical ethics. This background is important for enabling students to comprehend clinical responsibilities, to distinguish them from the responsibilities of a researcher, and to sort out what needs to be done when an individual has both responsibilities at once.
- The Distinctiveness of Medical Ethics
- The Virtues of a Clinician
- The Fiduciary Responsibility of Clinicians: Acting for the Patient's Good
- Truth-telling and Informed Consent
- Clinical Justice
Three Distance Learning Courses (8 weeks each) - This series of courses cover the key issues in research ethics. Readings, written assignments, and online threaded discussions are incorporated into each course. In addition, each student will select a subject from this sequence as the topic for a presentation at the Practicum the following July.
Basic Concepts in Research Ethics
This course focuses on clarifying the basic concepts governing the ethical conduct of human subject research ethics.
- Justification of Human Subject Research
- Who Should Be a Research Subject?
- Research Design: Equipoise and Clinical Equipoise
- Research Design: Placebo-Controlled Trials
- Risks, Benefits, and Insurance
- Informed Consent
- The Therapeutic Misconception
- Confidentiality and Privacy in Clinical Research
- Inducements for Researchers: Conflict of Interest and Payments
- Subject Inducements
Populations and Regulations in Research Ethics
This course addresses special populations such as children, the mentally ill, prisoners, animals, and the factors that should be considered when these cohorts are used as research subjects.
- The Use of Animals in Research
- Research with Children
- Research with Children: Consent & Assent
- Research with the Mentally Ill
- Research with Prisoners
- Research with Other Vulnerable Subjects
- Brain and Behavior Research
- Stem Cell and Embryo Research: The Status of the Embryo
- Contemporary Dilemma: Gene Transfer Research
- Contemporary Dilemma: Surgical Research
The Ethics of International and Public Health Research
In an era of global business and global health concerns, issues of international research ethics, public health, and health services research come to the fore. Similarly, advances in genetics have brought us to the threshold of population genetics and personalized medicine which require the ethical use of gene and tissue banks. The Ethics of International and Public Health Research takes up these issues as advanced topics in research ethics.
- Research without Consent: Community Consultation and Notification
- Population Studies and Public Health Research
- Vaccine Development and Research
- Justice in Project Selection: Health Problems of the Poor
- International Research: Conducting Studies in the Developing World
- International Research: The Double Standard
- International Research: Allocation of Benefits Among Individuals and Communities
- International Research: The Effect on Local Health Care Capacity
- Gene and Tissue Banking: Risks and Harms
- Public Health Surveillance and Health Services Research: Studying Disasters &Tracking Infectious Diseases
Practicum (one week at UBMS) - Students reassemble for another intensive week and complete two skill-based courses.
Teaching Research Ethics
This course draws on theories of adult learning to develop skills in planning and delivering effective presentations on research ethics. During the week, each student presents a paper or case related to a specific subject addressed in one of the distance learning courses and leads a discussion of the topic. These presentations serve as a review of the distance learning material and also provide trainees with the practical experience of presenting on research ethics. During these sessions the faculty and other trainees offer constructive criticism on the presentation delivery and also guidance on constructive feedback. Students will later practice their skills by giving one another effective feedback.
- Delivering Effective Presentations
- Constructive Feedback
- Teaching within Limited Time
- Setting Goals for Learners
- Using Questions as a Teaching Tool
The Organization and Conduct of an IRB
An Institutional Review Board (IRB) is a committee charged with ensuring the rights and welfare of research participants. This course is designed to provide learners with the tools and skills to establish an IRB, to effectively conduct initial and continuing protocol review for human subjects research, and to conduct IRB meetings in their own regions and countries.
During this one-week practicum, the ethical principles promulgated by the Council for International Organizations of Medical Sciences (CIOMS) and the International Conference on Harmonization (ICH) are discussed in detail and compared and contrasted to current US Federal Regulations. Application of these principles to research review is demonstrated through carefully selected examples. Video clips of IRB meetings allow students to critique the communication that they observe and a series of simulated IRB meetings involving all course participants provide opportunities to practice skills.
- The IRB Impetus and Infrastructure
- IRB: Initial Protocol Review Process
- Informed Consent
- Issues Based on Study Population
- Issues Based of Type of Research
- IRB: The Meeting, and Immediate Aftermath
- IRB: Continuing Review and Study Monitoring
- Executive Level and Administrative Support for IRB functions (including tracking tools)
Independent Mentored Project in Research Ethics
In addition to this sequence of formal course work, all students complete an independent project. This work may be either a practical project (e.g., the development of a course, a proposal for the creation or revision of regulations, the development of institutional policy or an institutional program) or an extended paper. Work on this project enables trainees to integrate the knowledge and skills they have acquired with the guidance and support of someone who has experience in such an undertaking. Each student works on the project under the direction of a faculty member from our program who is well suited for advising in that area. For those students who are chosen to pursue a Master's degree, the project will be counted toward the satisfaction of their degree requirements.
Reunion Retreat (three days at UBMS) - The Reunion Retreat is built around a third practicum. It also is also an occasion for reinforcing the experience of the group as a community of scholars and reinvigorating the personal relationships they have formed over their years in the program. This social experience sets the stage for future collaborations among trainees. For this reason, trainees from the cohorts that have already received their practicum training during a previous Retreat, are invited to participate in later Retreats as well. During the Retreat, students present their independent projects. These presentations, again, provide a review of critical material and also be an opportunity for trainees to gain experience in presenting research ethics material. In addition, the presentations allow them to give and receive feedback and to promote interest in and support for each other's work.
Writing Grants and Papers for Publication
This practicum will provide trainees with skills training to help them advance their careers in research ethics by developing a framework for organizing their efforts in applying for grants and submitting papers for publication.