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Last week there was discussion in the New Zealand press about clinical trials in the setting of ICU (see here, here and here), particularly focussing on the ethics and legality of the informed consent process in comatose patients.

As with any such discussion via the media, there has been plenty of attached emotion and no shortage of uninformed broadcasting.  This has included a comparison with the well known medical scandal in New Zealand known as the Cartwright inquiry involving the unconsented experimentation on women with abnormal screening smears by withholding of treatment.  That enquiry in the late 1980s cast a burning light on the issue of medical ethics and the process of informed consent.  In particular, it led to the development of the Health and Disability Comissioner position, a patient Code of Rights and nationwide independent health ethics committees .  This discussion is not in the same ballpark but the public still need to be convinced that what we do is both ethical and legal.

There has also been some useful coverage of the issue with informed commentary from the research and ethics community.  This may serve as an excellent opportunity to engage with the public on the issue as critical care research appears to be ramping up in intensity with the formation of strong multi-centre research collaboratives and intensive care seeks to strengthen its evidence base by studying our patients more avidly.

So how does ICU research work? I wondered this prior to working in an academic ICU and the issue of performing research on unconscious, highly vulnerable patients concerned me. On the one hand, medicine has an obligation to test our treatments and advance the scientific basis from which we make our decisions. On the other hand, we serve as our patient’s health advocates in the intensive care setting and the thought of performing research seems counter to that at first glance.

It turns out that we can do both! The medical ethics behind medical research on the incompetent patient is well established now. It works on the basis that research may only proceed if it appears to be in the best interests on the patient in question, and attempts have been made to ascertain the patients likely view. In addition, delayed consent is obtained preserving the right for patients to withdraw from research once competent.

For most of the trials in intensive care, this is relatively straightforward.  We still know so little about the relative efficacy of many of our standard treatments that much of the current research centres around comparing established treatments with one another to see which is better.  

Comparison of treatments in a scientific and standardised manner for the advancement of critical care knowledge clearly seems to be better than random allocation of different treatments depending on clinician preference based on uncertain science.  Despite the fact that there is little argument that this kind of research is unethical, the public still struggle with the concept and need clear information.  As it is still medical research, the same standards of ethical committee supervision and delayed consent processes apply.

The study that brought the issue to light last week involves researching a new drug compared to standard treatment.  This is more contentious and certainly does require closer scrutiny.  It is difficult to argue with any certainty that the treatment itself is in the best interests of the patient so how can such treatment proceed?  The argument put forward in this particular case is that the improvements in processes of care and increased resources allocated to researched patients for monitoring advantage the patient more than small potential risks faced from the possible inferiority of the study treatment.  However, it is a more difficult argument and requires closer monitoring.  This is provided by ethics committee supervision and, when they are in doubt, such as in this case, the legal profession provides advice to add another layer of protection in patient advocacy.

Overall, I initially struggled with research ethics in intensive care but through regular exposure in an active academic unit have become very comfortable that there are excellent processes in place.  The trick appears to be convincing the media and public of this from time to time.

What is the environment like elsewhere? I’m sure the principles are the same but how easy or difficult is the translation into practice and are the public on board? What about our obligation to research? Should we all be involved in better informing our opinions via scientific research or is it ok to delegate that task to the highly motivated few who do it at present? Let me know your thoughts below.