Clinical Trials Ethics and Review

Safety of Human Participants

 

In this lesson we take a look at safety for people who volunteer to participate in research experiments, also called clinical trials. Their purpose is to test an outcome, like effectiveness or safety. The development of ethical guidelines in response to past abuses is perhaps one of the most widely discussed topics pertaining to modern-day science. The Tuskegee experiment, for instance, was an attempt at withholding treatment from 400 African Americans with syphilis so that scientists could study their course; it’s quite possible this will never happen again thanks largely due to these very decisions made following such dark times for humanity!

The clinical trials ethics, ethical standards of clinical research have been guided by many Codes of Conduct and regulations, including:

  • Nuremberg Code of 1947
  • The Belmont Report 1979
  • U.S. Common Rule of 1991
  • The Declaration of Helsinki 2000
  • CIOMS Guideline 2002

 

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