Stephen Leeder: Complicating consent

AS a young intern at Sydney’s Royal North Shore Hospital in the late 1960s one of my duties included admitting patients on the weekend for elective surgery and “getting consent”.

A grey printed sheet was attached to the front of each patient’s chart. I would explain the proposed surgery to the patient — many knew all about it from their surgeon, but not all — and ask them to consent to it and to any necessary additional procedures or interventions that might be required, such as blood transfusions. They would then sign the form and I would witness it.

I learned years later that these consent forms had no legal value and that if the operation went wrong or the surgeon did more than agreed with the patient no matter how much apparent surgical freedom the consent form gave — such as removing the ovaries as well as the uterus during a hysterectomy — he or she could be sued.

But at least the forms served to stimulate an interaction and information exchange between a doctor and the patient about the procedure, albeit a young doctor who may not have had many answers.

The need to gain informed consent from patients having standard care has been considered increasingly in the 40 or so years since I was an intern. Patients are given pamphlets, apps and websites to peruse preoperatively before they sign up.

There has been a parallel increase in concern about informed consent for patients participating in clinical trials and other research. This is now a legal essential for conducting and publishing research.

As chair of a human research ethics committee at Westmead Hospital for the past two decades, I have seen many a change in the way informed consent is obtained for research.

It has grown from being a simple matter of personal communication between the researcher and the patient to a highly formalised, legalistic, paper-based exercise designed to protect the sponsoring company, usually pharmaceutical in a clinical trial, from accusations that the participant had not been clearly informed of known side effects of an experimental intervention.

Consent forms — or their close cousin, participant information — can now run to 10 or more pages.

Just how effective is this process?

This is hard to judge because while tight rules are set about how disclosure and information transfer are to be done, there is no monitoring of the extent or effectiveness of this exercise in Australia.

Researchers may not check with research participants in clinical trials about what they actually know is happening or is likely to occur after consent is obtained. As with so much in medicine, we know lots about the process and next to nothing about the outcome.

Almost 20 years ago, surgeon and ethicist Miles Little (and I, to a minor extent) wrote a paper about the limitations of the idea of informed consent. In it, we said: “The legal and moral issues [of informed consent] have become confused. This is unfortunate, because the legal concern often centres on avoidance of actions in law rather than on the more fundamental issue of benefit to the patient. There is a need to teach doctors … that fully informed consent is seldom — if ever — possible, and that skill in understanding what the patient is seeking is more important than the development of rigid and legally ‘complete’ consent forms.”

The matter of informed consent has become even more complex now that clinical research is, at last, concerning itself with rigorously assessing and comparing the effectiveness of one form of clinical care with another.

Given that such experiments are grounded in the clinical care setting, and do not concern an add-on as we may think of a trial of a new drug, what does informed consent mean and how do you get it?

Does it mean that when obtaining the consent of people randomised to standard care, they should get more detailed explanations than routinely given to patients receiving such care? And do we need consent if there is no real intervention in the sense of a new surgical operation or medication, and that all is being done is rigorous observation?

A study published last week in Annals of Internal Medicine provides helpful insights into what patients think about the process.

The investigators used a cross-sectional survey of 1095 adults, finding that most participants — no matter what scenario of clinical research is occurring, whether a randomised trial or observation — appreciate knowing what is going on.

But few participants felt the need to always sign on a line to prove that they had been informed. In circumstances where obtaining signed consent may be difficult they were prepared to trust the investigators.

These important insights should allow research to flourish right in the very heart of providing care to patients.

We are all under increasing pressure to choose wisely when it comes to treatments, making certain we spend effectively and efficiently. We can’t do this by guesswork. We need data. Hence we need research.

Informing patients about what is going on makes great sense in clinical practice and in clinical research — it is an ethical responsibility. It involves, above all, person-to-person communication. Let’s never forget that is the heart of it and that it is much more than filling in consent forms.

 

Professor Stephen Leeder is emeritus professor at the Menzies Centre for Health Policy at the University of Sydney. Find him on Twitter: @stephenleeder

Jane McCredie is on leave.