• Describe the historical background of ethics in health research
• Explain how a concept of human rights is integral in understanding human research protection
  

• Lecture and discussion
• Self-Reading

Powerpoint Slides
Articles
Internet Resources
VideoCasts

• Demonstrate a familiarity of the various international research ethics codes (Helsinki, Belmont, CIOMS, IOMS, etc)
• Indentify the important issues involved with international research
• Analyze and evaluate problems regarding the performance of international research

• Lecture and discussion
• Self-Reading
• Group Work Exercise

• Distinguish between the ethics in medical practice and research ethics

• Lecture and discussion
• Self-Reading
• Exercise

Powerpoint Slides
Articles
Exercise

• Explain a regulatory definition of 'human subjects' and 'research'
• Distinguish between the different types of clinical trials
• Describe the ethical dimensions of different types of research, including clinical trials and qualitative and quantitative studies

• Lecture and discussion
• Self-Reading

Powepoint Slides
Articles

• Identify researches that qualify for exempt from ongoing REC review

• Lecture and discussion
• Self-Reading

Powepoint Slides
Articles

• Describe the basic ethical requirements for health research
• Apply the basic ethical requirements in the review of a research

• Lecture and discussion
• Self-Reading
• Exercise: Use of a checklist in the review of a protocol

Research Ethics Committees I: Roles and Functions

• Explain the reasons for independent review
• Describe the functions and roles of an REC

• Lecture and discussion
• Self-Reading

Powerpoint Slides
Articles
Decision Charts
Exercise: Group Work

Research Ethics Committees II

• Define typical committee structure
• Describe the characteristics of effective ethics committee meetings
• Describe the educational needs of ethics committee members
• Describe the skills required of ethics committee members

• Lecture
• Self-reading
• Group work: list potential REC members and the role for each member.

Powerpoint Slides
Articles
Decision Charts
Exercise: Group Work
VideoCast

Informed Consent I

• Identify the elements of informed consent
• Assess the appropriateness of an informed consent process
• Evaluate an informed consent form by the use of a checklist

• Lecture and discussion
• Self-Reading

Informed Consent II: Exercises

• Demonstrate how to write an informed consent document.
• Demonstrate how to obtain informed consent.

• Video – 'Wit'
• Role play of informed consent form process
• Group Work: write a consent form from a previously reviewed protocol

Articles
Exercises
Checklist
Template Consent Forms

Waiver of Informed Consent

• Identify when it is appropriate to waive informed consent
• Analyze cases involving consent waiver

• Lecture and discussion
• Case Discussions
• Self- Reading

Vulnerability

• Identify vulnerable groups
• Explain what it means to be vulnerable
• Analyze issues involved with vulnerability

• Lecture and discussion
• Self-Reading
• Group Work Exercise

Evaluating Risks and Benefits

• Identify what counts as the benefits and risks of research
• Assess the risks and benefits of a protocol

• Lecture and discussion
• Group Work on a case assessing risks and benefits
• Self-Reading

Research Involving the Mentally Ill

• Describe how the mentally ill can be vulnerable
• Identify the safeguards for the mentally ill when they participate in research
• Assess a research protocol involving the mentally ill

• Lecture and discussion
• Group Discussion on a case assessing risks and benefits
• Self-Reading

Good Clinical Practice

• Describe what constitutes good clinical practice in research

• Lecture and discussion
• Self-Reading

Data Safety Monitoring

• Identify the ways in which data safety monitoring can occur during the conduct of research

• Lecture and discussion
• Self-Reading

Protocol Review

• Evaluate the scientific and ethical aspects of a research protocol
• Demonstrate an ability to discuss one opinions and listen with respect the views of others

• Mock Review of a Protocol

Protocol Review
VideoCast
Protocol Review Checklist