Learning Objective #1: Identify the historical development of the informed consent

Learning Objective #2: Describe the ethical consenting issues of past and current research

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The informed consent has a fascinating history that has been formed by hidden, significant ethical issues that have been brought to the public's attention. Although the concept of informed consent was formed many years before the Nuremberg Code of 1947, it was these murders and incredible crimes that were professed to be done in the name of research at Nuremberg that first brought the unethical practice of using unwilling and uninformed people for research to the world's attention. The Nuremberg Code was the first official document that provided guidelines for human experimentation. The major landmark guidelines that have directed the practice of clinical research will be explored. This includes the Helsinki Declaration, the National Commission for the Protection of Human Subjects for Biomedical and Behavioral Research, and the Belmont Report. The ethical principles of respect for persons, beneficence, and justice that are exemplified in the Belmont Report will be discussed.

Although the National Institutes of Health has provided regulatory guidance on the protection of human subjects in research, there have been past and recent reports of unethical research practice done here in the United States. Multinational research that may be funded by a country where few, if any, human subjects participate provides extraordinary examples of questionable research practices. Through this presentation, participants will learn both sides of thought regarding research in countries that do not have the same health care as the sponsoring country.