Emergency research without consent
Earlier this year it was reported that researchers at the Boston Medical Center and Massachusetts General Hospital are seeking to undertake research on emergency patients without first obtaining their consent. The aim of their research is to test a drug during the early stages of traumatic brain injury. They want to test whether the effectiveness of the hormone progesterone on unconscious accident victims as they arrive at the hospital, and sometimes they won’t be able to contact a family member to consent to the research.
This presents a conundrum. Rightly or wrongly, obtaining consent is often considered a sine qua non of medicine, as well as research involving humans. It sits at the very top of the Nuremberg Code https://en.wikisource.org/wiki/Nuremberg_Code and the Declaration of Helsinki http://www.wma.net/en/30publications/10policies/b3/. And while consent to research participation may sometimes be implied, or waived by participants, that doesn’t seem to be the case here. As Boston University bioethicist George Annas pointed out: “People don’t expect to be researched on when they go to an emergency department, and they don’t consent to research just by being in an accident”.
The research team in Boston has made legally mandated efforts to manage the issue. They’ve looked to garner community support for the research. And, there is an online option for anyone to fill out and pre-emptively opt out of the research in the event they find themselves in A&E.
These efforts are well-grounded. It seems that an opportunity to provide consent in advance is exactly what most people are after. Studies have shown that while the public often doesn’t express support for research without consent on other people, they are nevertheless willing to participate in emergency research if they’re given the opportunity to agree to the research in advance. This perhaps surprising finding reflects responses to a survey in Canada, where women undergoing gynaecological surgery had routinely been subjected to pelvic examinations by medical students and trainees without their knowledge. The regulations permitting this practice are now under review, but as the controversy was unfolding in 2010, it was noted that women were typically prepared to participate in medical training under sedation, provided they had been given an opportunity to consent to the procedures.
Routine research permits easily for requests made in advance. Emergency research does not. Yet it is real and it happens here in Melbourne consistent with the National Statement on Ethical Conduct in Human Research where it is approved at the discretion of human research ethics committees and subject to a series of harm minimising conditions.
What this tells us is that informed consent is not the be-all and end-all of research ethics.
In addition to the circumstances where consent is not necessary, there is ample evidence that consent is not sufficient for ethical research. Sometimes well-informed people can consent under duress; where they perceive (rightly or wrongly) fear or favour from the researchers; and where the likelihood of harm is too great for the researcher and their employer to risk.
While the principle of respect demands that we take the intentions of research participants very seriously, it is also clear that the research participant ought not to carry the entire burden of the risk associated with the research. That obligation is properly assigned to the researchers, ethics committees and institutions.
But while members of the public cannot be expected to take responsibility for risky research, they can and should benefit from it. And we do better to seek their consent by whatever means possible.
Perhaps a good comparison can be made with organ donation. In Boston journalist Chelsea Conaboy followed up on a suggestion made by her readers that members of the public might consent to emergency research on their driver’s license, in the same way we consent in advance to donating our organs (click here for the article).
Of course ‘opt-in’ methods of consenting to organ donation such as these have certainly been criticised, and some jurisdictions are moving towards ‘opt-out’ policies for this reason. The numbers for opt-in systems are devastatingly low—much lower, in fact, than the numbers suggested by the studies above. And conflict with family viewpoints may also apply. My desire to participate in socially beneficial research may not be shared by my next of kin, whose endorsement will be sought in an emergency.
Further, putting into a place a system which permits consent to emergency research to be indicated on driver’s licenses is no simple task. The cooperation of Vic Roads, the RTA and other motor vehicle licensing bodies is not something to take for granted.
But the benefits of emergency research to society are no trifling matter either. If lives and the quality of our lives can be saved it is perhaps worth trying.