In the context of medicine, we typically speak of informed consent as having both an ethical and a legal basis. The ethics are related to patient autonomy and human rights. The legal perspective relates to the definition of what occurs if consent is not obtained, and a physical intervention occurs (assault or battery at a minimum and it would appear, gross negligence if things go wrong). The literature is replete with opinions, examples, justifications and explanations set out in academic texts, papers and commentaries together with a slew of well informed and misinformed items and articles on social networking sights and populist media. The mischaracterisation of informed consent was a major feature in the trial of Dr Mak. The mischaracterisation of informed consent was a contributory factor as the prosecution pursued its dishonest and unethical case against Dr Vanessa Kwan.
As I have already indicated, the prosecution medical expert Dr Chan JY committed perjury when he claimed to be trained in cosmetic surgery during his specialist training in plastic surgery in Hong Kong. This probably explains why he could make the statement that there is “lack of major and important information that is expected to be included in a normal consent form” and yet he provided no example or justification to support his opinion.
Now a bit more background to this fascinating case, some context, if you will. The operating theatre in this private clinic had two CCTV cameras which were oriented to cover the work environment around the operating table. The operating table itself was not covered by the CCTV cameras for privacy reasons. I do not know if any of the staff or the patient were aware of the cameras at the time of this case which was in 2014. Nevertheless, the cameras showed the staff preparing the operation room and then bringing in the patient. The time stamps from the two cameras were not synchronous as they were running at different frame rates also the audio was muffled, and the transcription was muddled. What was not in dispute is that the consent would be regarded as “Montgomery” compliant and, as confirmed by the other prosecution expert, Dr Phoebe Mainland, the defendant had disclosed the risks of operation including death to the deceased. Dr Mainland even detailed the time this information was imparted: 11:24:17. However, what was obvious to me was that the CCTV “evidence” showed an almost ritualistic signing of a consent form, a procedure, and not the process of obtaining an informed consent. Because of the time stamps it could be stated that the signing of the form took a matter of just a few minutes. This relates to the title of a previous blog series I have written, “Perceptions and Deceptions”. The consent form was complex and detailed, and it would have taken longer to read it than the recorded time it took to sign it. The perception given to the Jury was that this was just another example of a slap dash doctor going through the motions. For me, it was another example of a prosecutorial deception. Informed consent is a process. This is even more crucial to understand when the matter at hand is not a curative clinical procedure, not an experimental intervention as part of a clinical trial, but a cosmetic procedure.
In addition to the consent form, there were notes for the patient to read which amplified certain areas of the consent process. Thus, the inherent risk of sedation was disclosed to patient under paragraph 15 of the consent form “I understand that intravenous sedative injection and anaesthetic have their inherent danger and traumatic effects…”
The patient also understood the relevant risks and had weighed them against the benefits as it states in paragraph 13 of the consent form: “I also understand that this is not an indispensable operation. It is my wish to undergo the operation”, and in the notices to the patient #6: “the operation is not an indispensable one. The doctor has already explained to patient risk and complications that may arise from the operation and has provided other solutions for consideration. The Patient firmly undergoes this operation after thorough deliberations. It is purely a personal request from the patient upon personal dissatisfaction against the current status”. (NB this was a translation of the Chinese documents).
My interest is pragmatic ethics. As such when does the “process” of informed consent begin? It must be context dependent and vary with each patient. Should we consider the reality that a doctor and a patient who know each other socially may have had discussions about the merits and risk of certain procedures over time? Should we consider the significance of the patient having undergone a similar procedure, performed by the same doctor, just weeks before? Until and unless we find a way to assess the true nature of the information imparted and the understanding derived, we cannot really assess whether a truly informed consent has been achieved. To my mind, a signature is not enough, neither is a video of the signing procedure. Perhaps we need a radical reset in medico-legal thinking and professional ethics. In clinical practice and in clinical research, informed consent is essential to ensure patient autonomy and basic human rights are protected. In cosmetic practice an additional reason for informed consent is to protect the basic human rights of the provider.