The Houston Chronicle reports that Memorial Hermann Texas Medical Center will conduct a study using an experimental gas in the treatment of unconscious people whose heart suddenly stopped. This research objective is to demonstrate that Xenon gas lessons brain injury in successfully resuscitated cardiac arrest patients—most who don’t make it or survive with poor neurological function because of the lack of oxygen and sudden reflow of blood. Those that don’t want to participate in the study can opt out by wearing a bracelet during the study informing the medical team of their non-consent.
As the Chronicle reports, until 1996 this type of study wouldn’t be possible as consent must have been obtained before testing a new therapy or procedure. During that year Health and Human Services (HHS) made an exception to the consent rule allowing pre-study “community consultation” to suffice for incapacitated patients in some situations. Examples could include “pre-study educational forums, newspaper articles and opt-out procedures.” The regulators balanced the critically need for patient informed consent with the need to ensure research improves treatment can march forward in a timely and effective manner. The regulators made an executive branch determination balancing these needs. This is an example of executive branch agency rule making which raises interesting constitutional law principles but we will spare the audience. Read the Houston Chronicle article for those interested in informed consent issues and community consultation exception.