blog

This is a guest post by Tom Woodcock, Southampton General Hospital, UK, a Faculty Member in Critical Care & Emergency Medicine. This post is taken from his evaluation of a Menon et al. article, “Factors affecting consent in pediatric critical care research.”

---

In the modern idiom, autonomy is a principle that protects the expression of the free will of the individual, so is it ethical to analyse the factors affecting the giving or withholding of consent to research in order to manipulate the decision-maker’s response? Isn’t that the exercise of paternalism by covert means? This thought-provoking article addresses the controversial issue of consent in pediatric critical care research.

English law sees consent as the flak jacket that protects the doctor from an accusation of assault or the key that opens the door to lawful interaction with the patient. In the therapeutic context, what we are really dealing with is a request from the patient to receive diagnosis and treatment and the physician’s agreement to provide it. In the context of research and organ donation, it is the doctor making the request and the patient or his lawful surrogate who must decide. Experienced clinicians know that patient choices can often be influenced by the way information is imparted, sometimes being even more influential than the weight of the information itself.

The UK Transplant Authority became convinced that the falling consent rate could be reversed by using trained consent-obtainers, but a randomised trial found that they were no more persuasive than the clinicians {1}. This Canadian study of consent to research also found that involvement of the caring physicians was associated with a higher consent rate. We can expect more research efforts to be proposed in these fields, but should research ethics committees approve them? There are no bright lines along the spectrum of free choice, persuaded choice, coerced decisions and forced decisions, and the law gives us no clear guidance as to when consent is invalidated by coercion.

In the eighteenth century, Immanuel Kant agonised over which citizens were capable of autonomous decision making. Not women, obviously, nor men of lowly position in society. Rational autonomous agents must apply the Categorical Imperative and act as they would wish a universal law to require them to act; in other words, always to consent to organ donation or research regardless of their own interests. Will it be an ideal world in which trained consent-obtainers can achieve informed consent rates for research or organ donation close to 100%?

References:
{1} ACRE Trial Collaborators, BMJ 2009, 339:b3911 [PMID:19815583].