It was 1932 when the United States Public Health Service first decided to conduct clinical research in order to determine the effects of untreated syphilis. These trials resulted in the exploitation of four hundred African Americans carrying the disease who were mislead of their true diagnoses, kept from exercising their rights of obtaining proper treatment, and observed as this deadly disease slowly withered away their lives. This unethical plan, however, was soon uncovered in 1972, when the infamous Tuskegee study went public. It was at this point in time that the pursuit of truth and the desire for the evolution of science had crossed a dangerous boundary. "America's Nuremburg," equated with the Nazi criminal acts against humanity during WWII, led to not only the requirement of informed consent of research participants, but also to other established safeguards, including the creation of essential Institutional Review Boards (IRB) all across the nation. The Federal Drug Administration (FDA) regulated review boards are now responsible for making sure inhumane studies of the past never repeat themselves.

Institutional Review Boards are formally designated groups of people that review and monitor all types of research involving human participants. In accordance with FDA policies and procedures, an IRB has the authority to approve and disapprove research protocol, as well as require modifications to secure approval. Its actions are imperative in assuring human research subjects' rights and welfare are protected at all times throughout research study. The IRB can be credited with alleviating apprehension in all those involved in clinical research studies. To accomplish this purpose, IRBs use a group process to evaluate research protocols and related materials, such as informed consent documents and investigator brochures. This is conducted both in advance and periodically as studies proceed. The FDA, in turn, conducts on-site procedural reviews of all existing IRBs, ensuring that they are indeed operating in accordance with their own written procedures as well as in compliance with FDA regulations. In the absence of such groups and processes, human subjects in the United States might once again be left exposed to less than favorable research environments.

Recent interventions in research studies by the IRB include those of one of the world's top medical research institutions, John Hopkins University. The university had failed to sufficiently monitor an asthma study in which a twenty-four year-old healthy research volunteer died after inhaling Hexamethonium. This drug had been previously used to treat hypertension in the 1940's, but the FDA later withdrew its approval and banned any further usage. Moreover, the FDA had never approved this specific chemical as an inhalant, which was the form utilized in the Hopkins study to restrict patients' airways in order to observe how healthy lungs fight asthma-like conditions. The primary researcher involved not only withheld informative documents from review boards overseeing the study, but also did not submit an IND for investigational new drugs. As a result, the ramifications of this unfortunate drama included the suspension of most of Hopkins' 2,400 federally funded experiments for five days until regulators permitted them to resume one at a time.

Research must be safe with minimal risks, if any, when human participants are involved, and subjects should know exactly what they are getting involved in from start to finish. The existence of IRBs to maintain a secure research setting is crucial for the continued benefits of clinical studies to be seen now and in the future.

Angelo Lambropoulos graduated from UIC in May 2001 with a degree in Exercise Physiology. He aspires to pursue a career in medicine.