It has become a familiar symbol. The little red heart on a driver’s license indicates that the card’s owner agrees to become an organ donor if tragedy strikes.
What if it were possible to create a similar symbol to indicate a person’s willingness to participate in a research study should they suffer head trauma or another disabling injury that prevents them from providing their consent?
A couple of readers suggested that might be one timely solution to a long-running debate. I wrote in Saturday’s Globe about researchers from Massachusetts General Hospital and Boston Medical Center who are hoping to get clearance from research review panels to enroll patients in a study without consent.
The team wants to join a national trial evaluating whether giving patients the hormone progesterone in the hours immediately after head trauma will prevent some of the secondary injuries caused by swelling and other effects. Many of those patients arrive at the hospital unable to communicate, and it can be difficult for doctors to quickly find family members who can speak on their behalf.
Federal law and the ethics of medical research require patients or their surrogates be told about any risks of participating in a study and have the chance to refuse enrollment. But the law allows for an exemption in certain cases involving emergency care.
There was some strong debate on Boston.com over the weekend about the general idea of enrolling people in a study without consent. Reader “keithdouglas” wrote, “It is unethical. End of discussion.” Others took a less hard-line approach.
“Redsox183” wrote: “I understand people’s objection to not having consent. But brain trauma is arguably the worst injury a person can sustain. And I am also not a paranoid individual. I believe doctors and nurses have chosen the most noblest of careers. They go to work to save lives...not hurt them. For this reason, I would not object to non-consented treatment.”
The U.S. Food and Drug Administration or another entity could create a system for grading the risk of a medical study, Barry Mirrer of Newton suggested in an e-mail. A study ranked as a “1” would pose minimal risk to participants, with “4” indicating substantial risk.
“On your driver’s license, you could give consent to be included in trials of a certain level,” he said. “The default, of course, would be ‘0.’ However, given the grading criteria, someone could choose to consent, in advance, to being included in trials up to risk level ‘2,’ for example.”
Online, “JenKate1949” offered sound advice, no matter your take on the issue: “Buckle up, don’t speed, and wear your helmet to reduce your chances of becoming a research study participant without consent!”
