The front page of the Herald this morning questions the participation of unconscious patients in clinical trials.
While I understand Auckland Women’s Health Council co-ordinator Lynda Williams unease, I also detected a failure to understand the process of how progress in medicine is made.
First, all research in such cases is approved by ethics committees which include lay people and patient advocates. That is clear in the article. In my experience they are very very thorough at ensuring the best interests of patients are highest priority. Family or whanau consent is almost always required (especially if the research involves an intervention*). These are the same family or whanau who are talking with medical staff and, at times, providing consent for medical interventions. When a person is vulnerable it is up to all around them to treat them with respect and care. Offering them, through their family, the opportunity to participate in research is showing respect for them as a valued member of society who is prepared to give in the interests of others. Indeed, it is a right of the patient, through their family, to be offered such research.
Second, without such research there can be no progress in medical treatment of unconscious critically ill patients. In order to save lives interventions must be made at critical junctures during the progress of a disease, normally at the earliest possible time. It is in the best interests of us all that such research take place. The alternative is to give up hope and allow current mortality rates to remain as they are. I research a disease (Acute Kidney Injury) which affects 1 in 3 people in the Intensive Care Unit and increases their chances of dying about 4 times. There is no treatment and it is devilishly difficult to detect in the early stages. An estimated 2 million a year die because of Acute Kidney Disease. Without the generosity of family and friends allowing trialling of an intervention (always based on years of prior research and judged to be possibly efficacious) there will be no progress and the death toll will remain high. I salute family and patients around the world who have participated in such studies in the past, and will do so in the future.
Disclaimers: 1. I have no knowledge or understanding of the antiobiotic trial under discussion. 2. I have been involved in an intervention study where participants were unconscious at the time consent was obtained.
*Note, there are some circumstances where when minutes count an intervention is required. Research in these areas is ethically more difficult, but no less necessary. I welcome public debate in this area. While ethics committees can deal with ensuring minimisation of harm in such circumstances, we do need to decide as a society what sacrifices of individual rights we should make for the greater good.