Lesson 2: Ethics of Clinical Trials

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Introduction

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.

References:

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.