September 27, 2007 - Heart experts have released new recommendations designed to increase the number of studies of critically-ill or injured patients who are likely to die without treatment.
U.S. law requires that patients be fully informed of a study's risk and agree to participate before they're enrolled in medical studies. But informed consent can be impossible to obtain from unconscious patients in emergency situations.
The law does allow enrollment of patients who are unable to give informed consent if certain requirements are met, but many researchers say these requirements are hard to understand and implement, according to background information in the report.
The new recommendations, from an American Heart Association committee of cardiovascular care experts, are aimed at research scientists who conduct clinical trials of patients who aren't able to give informed consent due to the seriousness of their condition.
The effort may help reverse a major decline in studies on cardiac arrest, stroke and trauma, the report said.
This new report outlines different levels of additional risk associated with a clinical study and a clear set of rules and steps associated with the informed consent process.
"Separating the risk of the underlying critical condition of the patient from the additional risk of being in the study can be problematic. What often is missed is the additional risk of not doing an intervention -- for instance, not using a better compression device and instead providing subpar chest compressions to a patient in cardiac arrest," co-author Vinay Nadkarni, M.D., director of the center for resuscitation science at Children's Hospital of Philadelphia, said in a prepared statement.
SOURCE: American Heart Association
For more information: www.americanheart.org