Opt out is a cop-out

ONE of the most important tenets of biomedical research on humans is informed consent: volunteers must understand what the research is about and what the risks are before agreeing to take part. If they are unable to do so,  a family member must consent  on their behalf. Sometimes, however, obtaining informed consent is impossible. That often happens in trauma medicine where eligible patients arrive at hospital unconscious and close to death. Under these circumstances the authorities  can waive the requirement for informed consent. Under US  law, for example, trauma victims can be enrolled in certain medical trials without their knowledge. The latest trial to employ this waiver is poised to begin at a hospital in Pittsburgh, Pennsylvania. Ten victims of stabbings or gunshots will be put into a form of suspended animation to buy extra time to repair their wounds (see page 8). In this case, waiving informed consent is clearly the right thing to do: if the procedure works it promises to save countless lives. But the issue must still be handled with care. US law requires that potential volunteers – that is, local people – are consulted and informed. They must also have been offered the chance to opt out. But there are concerns that such measures don’t always leave a community well informed. In 2008, a similar experiment collapsed in acrimony after it turned out that the procedure – infusing saline into trauma victims’ bloodstreams – did not appear to improve survival rates. It did not damage patients’ chances of survival either, but when local people found out,  they reacted angrily and the researchers were overwhelmed by requests for opt-out wristbands. Mandatory consultation was clearly not enough – perhaps because the law doesn’t set a minimum acceptable level of public awareness. The law needs to change. You could even argue that these studies should demand that people opt  in rather than opt out. That might seem onerous. But it is surely better to secure genuine prior consent than to risk jeopardising a medical breakthrough that could save many lives.  ■