Schedule

Date Topic/Readings Assignments
1/15 (Tue) Introduction  
1/17 (Thu)

Prologue: Between Scandal & Protectionism
Reading questions.
Lemonick &Goldstein with Park, “At Your Own Risk”.
Seligman, “Infectious Disease” and “Ethics and Institutional Review Boards”.
1/22 (Tue) The History of Research Involving Human Subjects (Unit #1)
Reading questions.
Weindling, “The Nazi Medical Experiments”, pp. 18–30.
Annas & Grodin, “The Nuremberg Code”, pp. 136–140.		 Topic for analytic summary #1 handed out (rubric) (guidelines) (template).
1/24 (Thu)

The History of Research Involving Human Subjects
Reading questions.
Arras, “Jewish Chronic Disease Hospital Case”, pp. 73–79.
Robinson & Unruh, “The Hepatitis Experiments at the Willowbrook State School”, pp. 80–85.
1/28 (Mon)   Analytic summary #1 due by 12:00pm (noon) via TurnItIn.
1/29 (Tue)

The History of Research Involving Human Subjects
Reading questions.
Jones, “The Tuskegee Syphilis Experiment”, pp. 86–96.
Rothman, “Were Tuskegee and Willowbrook ‘Studies in Nature’?”

  
1/31 (Thu) The History of Research Involving Human Subjects
Reading questions.
Beauchamp, “The Belmont Report”, pp. 149–155.
Porter & Koski, “Regulations for the Protection of Humans in Research in the United States”, pp. 156–167.		  
2/5 (Tue) The History of Research Involving Human Subjects
Reading questions.
Emanuel & Grady, “Four Paradigms of Clinical Research and Research Oversight”, pp. 222–230.
Emanuel, Wendler & Grady, “An Ethical Framework for Biomedical Research”, pp. 123–135.		 Topic for analytic summary #2 handed out (rubric) (guidelines) (template).
2/7 (Thu)

Ethical Issues in Clinical Trial Design (Unit #2)
Reading questions.
Levine, “The Nature, Scope, and Justification of Clinical Research”, pp. 211–221.
Freedman, Fuks & Weijer, “Demarcating Research and Treatment”.

  
2/11 (Mon)   Analytic summary #2 due by 12:00pm (noon) via TurnItIn.
2/12 (Tue)
 Ethical Issues in Clinical Trial Design
Reading questions.
Miller & Weijer, “Fiduciary Obligation in Clinical Research”.		  
2/14 (Thu) Ethical Issues in Clinical Trial Design
Reading questions.
Morreim, “Litigation in Clinical Research”.		  
2/19 (Tue)

 Ethical Issues in Clinical Trial Design
Reading questions.
Joffe & Truog, “Equipoise and Randomization”, pp. 245–260.		 Topic for position paper handed out (rubric) (guidelines) (template).
2/21 (Thu) Ethical Issues in Clinical Trial Design
Reading questions.
Miller, “The Ethics of Placebo-Controlled Trials”, pp. 261–272.		  
2/25 (Mon)   Position paper due by 12:00pm (noon) via TurnItIn.
2/26 (Tue) Class Cancelled  
2/28 (Thu) Class Cancelled  
3/5 (Tue) Respecting Autonomy in Clinical Research (Unit #3)
Reading questions.
Brock, “Philosophical Justifications of Informed Consent in Research”, pp. 606–612.
Appelbaum & Lidz, “The Therapeutic Misconception”, pp. 633–644.		  
3/7 (Thu) Respecting Autonomy in Clinical Research
Reading questions.
Dickert & Grady, “Incentives for Research Participants”, pp. 386–396.
Miller, “Recruiting Research Participants”, pp. 397–403.		  
3/12, 14 Spring Break
3/19 (Tue) Respecting Autonomy in Clinical Research
Reading questions.
Levine, “Research Involving Economically Disadvantaged Participants”, pp. 431–436.
Bonham & Moreno, “Research With Captive Populations: Prisoners, Students, and Soldiers”, pp. 461–474.		 Topic for analytic essay #1 handed out (rubric) (guidelines) (template).
3/21 (Thu) Respecting Autonomy in Clinical Research
Reading questions.
Levine & Skedsvold, “Behavioral and Social Science Research”, pp. 336–355.
3/26 (Tue) Respecting Autonomy in Clinical Research
Reading questions.
Milgram, “Some Conditions of Obedience and Disobedience to Authority”.
Wendler & Miller, “Deception in Clinical Research”, pp. 315–324.		  
3/28 (Thu)

Respecting Autonomy in Clinical Research
Reading questions.
Humphreys, “The Sociologist as Voyeur”.
Elms, “Keeping Deception Honest”.
4/2 (Tue) Respecting Autonomy in Clinical Research
Reading questions.
Etzioni, “Medical Records: Enhancing Privacy, Preserving the Common Good”.		  
4/4 (Thu)

Justice in Clinical Research (Unit #4)
Reading questions.
Meltzer & Childress, “What Is Fair Participant Selection?”, pp. 377–385.

  
4/8 (Mon)   Analytic essay #1 due by 12:00pm (noon) via TurnItIn.
4/9 (Tue) Justice in Clinical Research
Reading questions.
Wertheimer, “Exploitation in Clinical Research”, pp. 201–211.		  
4/11 (Thu) Justice in Clinical Research
Reading questions.
Fleischman & Collogan, “Research With Children”, pp. 446–460.		  
4/15 (Mon)    
4/16 (Tue) Justice in Clinical Research
Reading questions.
Spriggs, “Canaries in the Mines: Children, Risk, Non-Therapeutic Research and Justice”.
Buchanan & Miller, “Justice and Fairness in the Kennedy Krieger Institute Lead Paint Study”.		 Topic for analytic essay #2 handed out (rubric) (guidelines) (template).
4/18 (Thu) Carnival  
4/23 (Tue) Justice in Clinical Research
Reading questions.
Idänpään-Heikkilä & Fluss, “International Ethical Guidance From the Council for International Organizations of Medical Sciences”, pp. 168–173.
Macklin, “Appropriate Ethical Standards”, pp. 711–718.
4/25 (Thu) Justice in Clinical Research
Reading questions.
Crouch & Arras, “AZT Trials and Tribulations”.
Holm & Harris, “The Standard of Care in Multinational Research”, pp. 729–736.
4/30 (Tue) Justice in Clinical Research
Reading questions.
Participants in the 2001 Conference on Ethical Aspects of Research in Developing Countries, “Fair Benefits for Research in Developing Countries”.
Emanuel, “Benefits to Host Countries”, pp. 719–728.
5/2 (Thu) Justice in Clinical Research
Reading questions.
London, “Responsiveness to Host Community Health Needs”, pp. 737–744.
5/10 (Friday)   Analytic essay #2 due by 12:00pm (noon) via TurnItIn.