Issue 16 / 4 May 2015

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.

4 thoughts on “Stephen Leeder: Complicating consent

  1. Matthias Maiwald says:

    I couldn’t agree more with the opinion expressed by hpdietz. I always compare this with the hypothetical scenario of an olympic 8 rowing boat with 8 rowers and 1 cox. What is currently happening worldwide in healthcare is that rower by rower is replaced by additional coxes. This is happening on two levels, (1) the numbers of employees in administrative vs. primarily non-administrative positions, and (2) the administative taskload among people in primarily non-administative positions. Another phenomenon that is partially linked is that what used to be common sense is increasingly being replaced by formalistic rules and procedures, and the requirement for common sense and rational thinking is being phased out. A case in point is a recent question that I have seen circulating on an infection control e-mail forum. An infection control nurse had observed someone taking a blood culture, and after swabbing the rubber bottle top, the person left the alcohol swab on the bottle and injected the blood through the swab (rather than taking off the swab) into the bottle. The question then was whether anyone on the forum had a Policy and Procedure (PnP) document that they could share, indicating that this should not be done. All this is happening in an environment of a large number of PnP documents already existing in most healthcare facilities. A colleague of mine is estimating that our hospital (a big hospital) has anywhere between 20,000 and 50,000 PnP documents across its diverse departments.

  2. Oseka Onuma says:

    I thank Stephen for his commentary and I agree with Hans (Prof Dietz) that there is nothing to fault in his statements and that we are ‘committing slow suicide by paperwork.’ Having obtained a Masters in Jurisprudence on the subject of patient complaints and the practice of defensive medicine 14 years ago, I remain of the opinion that subject of consent is a significant factor in the growth of the practice of ‘defensive medicine.’ One can argue about the merits of and exactly what constitutes ‘defensive medicine,’ but it is likely not in the best interests of our patients. To examine closely the issue of consent and the problems inherent, one needs to examine the activity and reports of many so-called medico-legal ‘experts.’ Often their reports are without evidence and derogatory of the actions of their colleagues, even when it is apparent to many that they have treated patients in the same manner as they are criticising on paper for financial benefit. In the long run, it is the patient that suffers.

  3. University of Sydney says:

    Thanks for this important contribution. As a senior clinician and researcher with almost 30 years on the job I agree with just about every sentence.

    It may be worthwhile pointing out that the trend towards complicating consent is only a small aspect of the gross over- bureaucratisation of research governance in Australia, with NSW the ‘first state’. And even the dire state of research governance is only a small part of what I’m tempted to call a societal disease. Its main manifestation is the unthinking assumption that making a process more complicated will improve that process. This may have been true one or two generations ago, but not today. We need to realise that large parts of Australian society have become badly over-regulated. We have picked all the low- hanging apples in terms of regulatory benefits. Further beneficial impacts of regulation are unlikely, just as there wont be any benefit in expanding a consent form from 4 to 6 pages. We need to realise that we are increasingly at the mercy of a parasitic bureaucracy that will continue to grow like a weed unless culled. Every few years someone starts making noises about ever- decreasing productivity in particular sectors of society. It now takes us 30 years to plan and build a new suburb, and a bus shelter costs over A$ 10.000- but nothing happens. We’ll just commission another review or White or Green paper that miss the point.

    The result of over-regulation and excessive bureaucracy is a reduction in productivity. And that’s very, very serious. As Paul Krugman said: ‘Productivity isn’t everything, but in the long run it is almost everything.’

    We are committing slow suicide by paperwork. Not a pretty sight.

    HP Dietz, Sydney


  4. A/Prof levinia crooks says:

    This is very timely given I have just been reviewing informed consent in the context of HIV testing. It seems that the need for consent in the testing arena is an exact reflection of the stigma and potential discrimination experienced by a person being diagnosed HIV positive. If we are going to normalise HIV infection and identify people who are not coming forward for testing then we need a much more simple process. Including an HIV test in antenatal screening should be routine, we can now treat the expectant mum and prevent transmission to the baby. Routinely performing HIV tests on people with conditions which share a similar route of transmission, such as an STI or hepatitis C, could also identify people who could benefit from treatment. A recent study of this indicator trigger testing in the UK found a yield of 3% previously undiagnosed HIV infection in hospital admissions. Are we yet at a time where a clinician can say “we are going to perform a battery of tests one of which is HIV, are you ok with that?” or “We do a health check with all new patients this includes HIV.”

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