Medical Ethics Program

Second Year

Ethics of Clinical Research

Abuse of Trainees

Impairment in Trainees and Physicians

Learning Objectives:

At the end of the phase, students will have an enhanced ability to:

• Recognize ethical aspects of enrolling patients as participants in clinical research
• Describe the basic requirements of ethical research with human subjects
• Recognize examples of abuse of trainees
• Recognize examples of and resources for impaired trainees and physicians
  

Faculty:
Please Note: You must log into the system to view pictures.

Richard L. Elliott, MD, PhD, FAPA, Professor and Director, Medical Ethics

Martin H. Greenberg, MD, Professor, Pediatrics, Savannah

R. Stephen Williams, MD, MHSA, Assistant Professor

-- Attention Students:  If you have problems viewing any of the PDF's, please contact Michelle Bliss at bliss_m@mercer.edu.

Your preparation:

There are three lectures in this phase:

Week One lecture - Ethics and Clinical Research

Week Two lectures

          1.  Medicine and the pharmaceutical industry

          2.  Abuse of trainees and the impaired physician

During the first week there will be a one hour group.  The three   cases  will be discussed and students should have read and analyzed these beforehand.  A potentially useful tool for analyzing the cases is a modified form of the case analysis tool used in First Year Medical Ethics ( Download Research Case Analysis Form) ). The readings (Declaration of Helsinki and Institute of Medicine - IOM) should be seen as resources – you might find them a great help as you analyze the cases, but you are not otherwise responsible for the information they contain.  The readings are: World Medical Association (WMA), “Ethical Principles for medical research involving human subjects” (Declaration of Helsinki) and Institute of Medicine (IOM), pp. 146-193 of “Understanding and Agreeing to Children’s Participation in Clinical Research,” Ethical Conduct of Clinical Research Involving Children (2004). The selection from the IOM report contains information useful for all three cases (and not only as it might seem Case 2). 

• Download Cases

Phases of Clinical Research

If you are not familiar with the four phases of clinical research, you may wish to begin by reading the following excerpt from the WHO’s Medical Ethics Manual.

• Phase one research, usually conducted on a relatively small number of healthy volunteers, who are often paid for their participation, is intended to determine what dosage of the drug is required to produce a response in the human body, how the body processes the drug, and whether the drug produces toxic or harmful effects. 
  
• Phase two research is conducted on a group of patients who have the disease that the drug is intended to treat. Its goals are to determine whether the drug has any beneficial effect on the disease and has any harmful side effects.  These are sometimes referred to as "proof of concept" trials, i.e., trials showing possible efficacy in the clinical condition under study.
  
• Phase three research is the clinical trial, in which the drug is administered to a large number of patients and compared to another drug, if there is one for the condition in question, and/or to a placebo. Where possible, such trials are ‘double-blinded’, i.e., neither research subjects nor their physicians know who is receiving which drug or placebo.  The FDA requires two such "pivotal study" phase III trials showing efficacy.
  
• Phase four research takes place after the drug is licenses and marketed. For the first few years, a new drug is monitored for side effects that did not show up in the earlier phases. Additionally, the pharmaceutical company is usually interested in how well the drug is being received by physicians who prescribe it and patients who take it.
 

Attendance Policy
Group discussion is a one-hour module. Failure to attend will result in an “Unsatisfactory” grade.

Evaluation
Evaluation will be based on satisfactory participation in the group discussion and passing 70% of 10 multiple choice questions included as part of the end-of-phase Community Medicine examination.

Questions on the written examination are in MDE format and will cover such areas as:

1.  What were the key aspects of the Tuskegee Syphilis Study that would be considered unethical today?  Why?

2.  Was it unethical for the investigators in the Tuskegee Syphilis Study to withhold treatment shortly after the start of the study?  Why or why not?

3.  What is the minimal composition of an Institutional Review Board (IRB)?

4.  Who are considered vulnerable populations from the perspective of the IRB?

5.  Approximately how much of postgraduate healthcare education is industry sponsored?

6.  What are the key ethical issues for each of the three cases discussed in group?

Back to Biomedical Ethics Program Homepage