Lesson 2: Ethics of Clinical Trials

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Ethics of Clinical Trials

A well-designed clinical trial should answer important public health questions without impairing the welfare of participants. Ethical obigations to trial participants and to science and medicine pertain to all stages of a clinical trial:  design, conduct and reporting results. (Friedman, Furberg, DeMets, Reboussin, Granger, 2015, Chapter 2)

 Learning objectives & outcomes

Upon completion of this lesson, you should be able to:

  • State at least 3 internationally recognized conditions that are necessary to justify conducting a medical experiment in humans.
  • Define the condition that is required to justify randomizing a patient to a treatment.
  • Differentiate between ethical and unethical use of placebo control.
  • Recognize requirements for IRB approval of human research studies involving any product regulated by the U.S. FDA.
  • Recognize U.S requirements for investigators to report financial interests that may affect design, conduct or reporting of research regulated by the U.S. Public Health Service.


Annas GJ and Grodin MA. (1992) The Nazi doctors and the Nuremberg Code: Human Rights in Human Experimentation. New York: Oxford University Press.

Carter RL, Scheaffer RL, Marks RG. (1986) The role of consulting units in statistics departments. Am. Stat. 40:260-264.

Friedman, L.M., Furberg, C.D., DeMets, D., Reboussin, D.M., Granger, C.B. (2015). Chapter 2 Ethical Issues. In: Friedman, L.M.,Furberg, C.D.,DeMets, D.,Reboussin, D.M.,Granger, C.B. Fundamentals of Clinical Trials. 5th ed. Switzerland: Springer International Publishing.  (Notes will refer to Friedman et al 2015)

Piantadosi Steven. (2005) Clinical trials as research, Why clinical trials are ethical, Contexts for clinical trials. In: Piantadosi Steven. Clinical Trials: A Methodologic Perspective. 2nd ed. Hobaken, NJ: John Wiley and Sons, Inc.

Scott PE. (2004) Medical device approvals: An assessment of the level of evidence. PhD dissertation: Johns Hopkins University, Baltimore, MD.