Consenting to the unknown: what should patients know before experimental surgery?
Clinical negligence solicitor Michael Roberts discusses the issues with consenting to experimental surgery
Posted on 09 September 2016
It is well established in law and in medicine that doctors need to get consent from their patients before performing surgery on them. This consent must be informed, meaning that the patient has not simply given permission for the surgeon to carry out the operation, but has done so with a comprehensive understanding of the intended benefits as well as the possible risks should things not go to plan. The patient should also be advised of any alternative treatment options that may be available.Ordinarily, this is a relatively straightforward (though still important) discussion as the risks and benefits for most operations are well known, but, sometimes, if the surgery has rarely (or never) been performed before, the potential consequences can be extremely difficult to predict.
Experimental surgery is crucial to the progress of medicine. All operations, many now taken for granted, were experimental at some point and it is vitally important that centres with the appropriate expertise do offer experimental surgery to patients when appropriate, but when is it appropriate to offer experimental surgery? Centres need to be confident that it is a viable option before it is discussed with the patient.
Given that experimental surgery is, by definition, a step into the unknown, it is rarely (if ever) appropriate for a single surgeon to decide to offer it without firstly consulting colleagues. Most centres which undertake experimental surgery will have processes in place to ensure that the basis behind the proposed surgery is rigorously considered before it can even be brought up with the patient. At Great Ormond Street Hospital, for example, there is an Ethics Committee which has to approve surgery that is considered to be experimental. They will often spend hours considering the ethical, medical, and (perhaps) legal ramifications of the surgery that is proposed.
If the experimental operation is deemed appropriate, the surgeon then has licence to offer the surgery, but the patient still has to give informed consent before the surgery can be carried out. The surgeons will of course use their skill and experience to present their best educated guess about the possible benefits and risks, but often it really is just that: a guess. A lot of experimental surgery concerns infants and children, because congenital conditions often present highly unique challenges. This is a particularly difficult situation, as it then falls to the parents to make difficult decisions on behalf of their children, serving to increase the importance of ensuring that any consent provided is fully informed.
What, then, should the surgeon bear in mind when taking consent to ensure the patient is properly informed? The NHS has produced some guidance1 to help with this, which says that the surgeon should take care to explain to the patient what, if any, evidence exists to support the effectiveness of the treatment – either in the UK or around the world. It is also important that the surgeon explains what personal experience s/he has with the surgery that is being proposed.
Although the surgeon should try to provide the best advice possible regarding the risks and benefits, sometimes they are simply not known. In this case, importance of full and frank discussion is amplified. The patient needs to, in effect, become part of the team. They should be in the consulting room with the doctors, fully aware of the research the doctors have done and why they think it is right to offer the surgery as an option.
If the patient is not able to understand, at least, the reasoning behind the surgery when signing the consent form (i.e. why, in theory, the surgery should work), it is arguable that informed consent has not been obtained.
It should go without saying, but it is also of vital importance to both the doctors and the patient that detailed notes of this whole process are taken.
The importance of full and frank consent was highlighted in recent case of Montgomery vs Lanarkshire Health Board, in which the Supreme Court said that it is not simply for the doctor to decide what information a patient should be told about proposed surgery; the patient has a right to know of all material risks before deciding whether or not to consent to an operation.
Progress is made through trial-and-error and some patients will find themselves on the receiving end of a failed experiment, with often catastrophic consequences. Surgeons should continue to experiment and innovate to advance medical science, but it is important that their patients are treated as participants, not guinea pigs.