The Helsinki Declaration underpins the ethics of medical research. Yet the minds behind these noble and pivotal codes of conduct could surely have not envisaged the fast pace of cutting-edge emergency care delivered both inside and outside of hospitals in our modern healthcare systems. Furthermore, it fails to address the population-level community consent sometimes required to undertake health service research and evaluations. With community consent information about the study is provided to the local community of potential subject and it is explained that everyone in the community will be considered for participation unless they opt out.
Individualised informed consent which involves a detailed discussion of the risks and benefits of study participation allows for trust and confidence to be established between researchers and subjects and acts as the ultimate legal buffer should expected adverse events occur. But what about time-critical interventions in incapacitated patients? For a while it seemed that emergency care was forever condemned to be backed up by low-quality retrospective data. Ethics committees world-wide have begun to appreciate the need to expand the scope of emergency research to not only improve the quality of care emergency and trauma patients receive, but to also open up study settings that were previously inaccessible to clinical trials such as the pre-hospital environment.
The controversy surrounding community consent is perhaps somewhat overblown, given the history of futile interventions that trauma patients have been subjected to over the years both inside and outside of hospitals. Resuscitative thoracotomy following blunt trauma is still performed despite dismal outcomes overall. How about pneumatic anti-shock trousers, junctional tourniquets or other interventions with limited evidence bases beyond a handful of swine or canine models in controlled settings? Perhaps it’s not so much about the pitfalls of trying to establish a system of community consent, but more a question of why is this such a controversial issue given our history of subjecting incapacitated people to potentially dangerous interventions in their ‘best interests’? This despite there being no guarantee that our interventions aren’t causing more harm than good.
A pragmatic approach is increasingly being taken to emergency and prehospital research. Much is covered by guidelines similar to the FDAs Exception From Informed Consent Requirements for Emergency Research (EFIC) which states qualifying conditions under which emergency research can take place, namely:
· The human subjects are in a life-threatening situation that necessitates urgent intervention.
· Available treatments are unproven or unsatisfactory.
· Collection of valid scientific evidence is necessary to determine the safety and effectiveness of the intervention.
· Obtaining informed consent is not feasible because the subjects are not able to give their informed consent as a result of their medical condition.
· The intervention must be administered before consent can be obtained from the subject’s legally authorized representative.
· There is no reasonable way to identify prospectively individuals likely to become eligible for participation.
· Participation in the research holds out the prospect of direct benefit to the subjects.
· The clinical investigation could not practicably be carried out without the waiver.
The Centre for Trauma Sciences (C4TS) at London’s Queen Mary University is well versed in recruiting trauma patients into clinical trials directly from the resus bays of the Royal London Hospital, the busiest trauma centre in Europe. Whether it be observational coagulopathy studies, or a randomised control trial for REBOA consent is simply obtained from a senior member of the ED team who has no direct involvement in the trial and functions as professional legal representative. Written consent from the patient or next of kin is sought as soon after enrolment as appropriate. Most of the interventional studies tick all of the aforementioned EFIC boxes. Following enrolment of over 1800 patients to one particular study over a 10 year period at C4TS, only 5% of patients or relatives subsequently over-ruled the consent of the independent physician. Of course, the inability to reverse the original intervention and its effects potentially opens up the door to legal challenges from the study subject, irrespective of whether their next-of-kin consented on their behalf during their period of incapacitation.
In the prehospital arena, studies such as the one looking at using whole blood on helicopters clear local ethics boards with similar ease owing to a culture of research and innovation which has been allowed to take root and flourish. Another approach from the Royal London Hospital has been to display notices in the ED waiting room to inform patients that they may be enrolled into clinical studies and therefore consent is presumed unless patients specifically request opt-outs. Furthermore, trauma systems research into the development of refined triage tools may require cluster randomisation of entire communities and neighbourhoods. Presumed community consent is surely the only way to make all this feasible.
From spring 2020 UK citizens will have to get used to a similar opt-out principle with regards to organ donation. It would therefore be unsurprising if presumed consent became the default position for a wider scope of emergency clinical trials in years to come.
Obi Nnajiuba is a British general surgical resident with a specialist interest in trauma, acute care, prehospital care, triage, mass casualty events and trauma systems. His postgraduate qualifications include an MSc in Trauma Sciences and membership of the Royal College of Surgeons of England. He is also a registered Motorsport UK physician, providing trackside advanced trauma care to competitors at world famous motor-racing circuits such as Brands Hatch, Goodwood and Silverstone.