Obtaining Informed Consent in Emergency Situations
Introduction
As research advances in finding answers and treatment for diseases, the process of obtaining a patient’s informed consent becomes more detailed required. The informed consent is known as the cornerstone of Good Clinical Practice for ensuring patient safety. In a normal clinical paced environment, time is given to ensure patients are provided all the required information and the time to make a rational and voluntary decision to participate in a study. At times this process is not feasible do to emergency situations, such as when a patient arrives in the emergency room in a compromised mental and physical state that does not permit ample time for this process. Such cases may also be further aggravated when a family member or a Legal Authorized Representative (LAR) is not available to decide if the patient should participate in a clinical trial that offers a treatment may increase the of survival more than the current standard of treatment. We must than think of the patient’s best interest at this point.
History of Informed Consent
Following World War II, the Nazis who performed medical experiments on prisoners of war without obtaining their consent were convicted of murder, but not for their actions of conducting unethical research. Their actions helped bring to life the Nuremberg Code of 1948; the first legal document to enforce the idea that subjects’ participation in clinical research must be voluntary. Many of the elements that help make up the Nuremberg Code are included in the code of federal regulations (CFR) parts 50 and 312 and the International Conference on Harmonisation (ICH) E6 good clinical practice guidelines2. Some key guidelines included are 1) Subjects should be of sound mind and able to understand the procedures and risks of a study and make a decision to participate