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Learning Objectives
At the end of the phase students will be able to:
· Describe ethical problems associated with the Tuskegee Syphilis Study
· Discuss the nature and responsibilities of Institutional Review Boards
· Analyze three cases involving ethical issues and experimental treatments
· Demonstrate professional behavior and patient respect when working with patients (or colleagues) with substance abuse disorders.
· Describe issues associated with substance abuse and addictive disorders among health professionals.
· Explain the ethical responsibility for reporting impaired physicians.
· Discuss the interactions of the pharmaceutical industry with the medical community.
· Discuss ethical responses to offers from pharmaceutical company representatives.
· Discuss the basic requirements of ethical research and human subjects.
· Discuss the legal aspects of medical care including the duty to report, medical malpractice, interactions with the medical board and legal testimony.
Methods
Information will be provided during three large group didactic sessions to allow for an overview of topics related to ethics. The students along with faculty facilitators will meet in groups (10-15 students in Macon, 30 students in Savannah) for case studies.
Topics to be covered include:
· Pharmaceutical Industry and Physician Interactions
· Ethics and Clinical Research
· Abuse of Medical Students and Residents
· Recognizing and Responding to the Impaired Student or Physician
Assessment
· Written examination to include multiple choice and short answer questions
Presentations 2010
Ethics in clinical research 2010
Click Here To Download
Medicine and the pharmaceutical industry Click Here To Download
Abuse of trainees Click Here To Download
The impaired physician 
Click Here To Download
Medical malpractice Click Here To Download
Your preparation:
During the phase 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).
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 65% of 10-15 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?
- Ethics of Clinical Research. 1 hr. Ethical responsibilities of clinical
investigators and of physicians who enroll patients in clinical trials.
Oct. of the second year.
- Medical Student Ethics. 1 hr. Ethics of using patients as "learning tools"
and issues arising from hierarchies in medical practice and education. End
of the second year.
