One government source regarding clinical trials is Clinicaltrials.gov (https://clinicaltrials.gov), which is available to health information seekers as a resource to find information about past, current, and recruiting clinical trials. Currently, if you participate in a clinical trial you are required to provide your “informed consent.” This means you have been informed of the risks, benefits, purpose of the study, and your rights. This information is provided to you so that you, as the potential participant, can make an informed decision before deciding whether or not to participate. If you work with or in research, you will become very familiar with the term IRB, which stands for “Institutional Review Board.” An IRB is a panel intended to oversee the entire scope of one or more medical research studies including protecting the rights and welfare of human research subjects. Although it may seem like common sense that these two things are necessary, there was a time when they did not exist. A new approach to bioethics and the regulation of clinical trials and medical studies using living human subjects came about from public and governmental outrage over one study, known as the Tuskegee Syphilis Study. By looking specifically at this case, which led to the rise of bioethics at the federal-government level in the 1970s, the origin of IRBs and informed consent as they relate to medical studies and human subjects will be illuminated. The issues of IRBs, informed consent, and bioethics are important in the library and information science community because we often interact with a public that is impacted by the policies and regulations related to these issues. In addition, we are the very researchers, or hold relationships with researchers, that are held to the strict standards set in place by IRBs and bioethics in general.
Tuskegee Syphilis Study of 1932–1973 and the Rise of Bioethics as Shown Through Government Documents and Actions
