Researchers looking for exclusions to consent rule in study
When a patient is brought to a hospital in Pennsylvania with a brain injury, doctors immediately begin treatment to minimize the damage to the rest of the brain and the body. After a traumatic brain injury, serious damage to the brain can begin immediately if the right treatments are not used quickly. Treatments and drugs that are used in hospitals are tested by researchers for several years before they receive the approval of the FDA, and each patient involved in one of these studies must agree to be a part of the study, with very few exceptions.
Scientists believe that administering progesterone to a patient immediately after a brain injury can help to prevent or lessen many secondary consequences of the injury. Because it is difficult to obtain informed consent from a patient with a serious brain injury or a family member, studies regarding the effectiveness of this drug are rare.
In an effort to change this fact, researchers are hoping to obtain an exclusion from the informed consent rule that would allow them to enroll patients in the study before they are conscious or a family member has been reached. It is believed that even a period as small as four hours can make a large difference in the long term.
All people have the right to determine what goes into their bodies. Without informed consent, doctors are not allowed to enroll any patient into a research study of any kind. Although there may be benefits to doctors obtaining this exclusion, informed consent may be necessary to maintain the integrity of research in the country.
Source: The Boston Globe, “Hospitals want to test drug with no consent,” Chelsea Conaboy, June 8, 2013