Want Real blood? Wear a Bracelet…

March 2, 2006

Medical ethicists are raising concerns about a study of blood substitute being used on trauma patients without their consent. Northfield Laboratories got federal approval for its study of the blood substitute Polyheme back in 2004 but the debate was reignited by a recent Wall Street Journal story suggesting the company tried to hide some crucial details about a previous blood substitute study.

In the current study, trauma victims get Polyheme or saline fluid in the ambulance on the way to the hospital. Those given the Polyheme treatment continue to receive it for up to 12 hours, while those on saline get blood transfusions. Ethicists say the problem is that the testing should be done separately in patients who can give consent or who have family members who can consent.

Although “informed consent” has become a standard bioethical consideration, the trauma study was approved under a federal exemption that applies to emergency research. Rather than requiring informed consent when needed, community briefings are offered in which residents can “opt out” of the research by wearing plastic hospital-style bracelets in case they are injured and unconscious.

Rather than opt out of such research, the requirement should be that people opt in by wearing a bracelet only if they are willing to participate in the study. Requiring citizens who live near urban hospitals to wear an identifying tag in order not to be experimented on is an absurd an unnecessary burden.