21 Dec 2020

Issues remain with informed consent around hospital procedures

9:54 am on 21 December 2020

Controversy continues to dog how hospitals get permission to operate on patients.

All but one of the country's DHBs operated at a loss this financial year.

A year on from a complaint North Shore Hospital was breaching women's rights, an investigation into it by the Health and Disability Commissioner is still going on (file image). Photo: 123rf

The rules have now been strengthened a little, but too weakly for some women's health advocates and in a way that raises further questions.

The risk now was of a "piecemeal" approach, according to the Cartwright Collective - named after the 1989 Cartwright inquiry into unconsented gynaecological examinations at National Women's Hospital, that were dubbed 'The Unfortunate Experiment'.

Three decades on, the controversy flared again in December 2019 over a complaint that North Shore Hospital was breaching women's rights.

A year on from the complaint, laid by the Nurses Organisation, an investigation into it by the Health and Disability Commissioner is still going on.

The Auckland Women's Health Council said there was a lot to look into, that extended beyond Waitematā District Health Board.

The council's co-ordinator Sue Claridge said she suspected it was "an issue in all teaching hospitals and across a number of DHBs, if not all of the DHBs".

Auckland Women's Health Council co-ordinator Sue Claridge.

Sue Claridge. Photo: Supplied

Claridge recounted hearing from a woman who had a gynaecological procedure at North Shore Hospital under general anaesthetic last year.

"She was lying on the operating table, naked from the waist down, legs spread, and looked up to find an operating theatre filled with medical, midwifery and nursing students, none of whom she had been told would be there.

"She told me that she just couldn't wait for the gas to take effect."

Anecdotes indicated the problem was widespread, and not just with women - and especially for vulnerable people like migrants, lower socioeconomic groups and the very young or very old.

Research published in 2018 revealed that some Auckland med-school students were expected to perform sensitive examinations without the patients' knowledge that they were not qualified doctors.

Waitemata DHB's position had been that if a trainee - often an RMO, or resident doctor - was supervised, then they did not need specific informed consent.

The North Shore complaint spurred the Waitemata DHB to ask for urgent national guidance from the Ministry of Health (MOH).

Documents show a high-level meeting in January agreed DHBs were inconsistent nationwide.

"It was also recognised that a large component of the consent process is undocumented, which contributes to difficulties in regulating and enforcing processes both across and within DHBs," minutes of the meeting between the ministry, HDC, Waitematā DHB and Medical Council said.

It was not just an issue with juniors or students, but even specialists who were undertaking advanced training.

The meeting agreed all patients had a right to be told who was operating on them and who was in the room getting training.

The upshot of that meeting has come now, in a proposed one-line clarification issued by the Medical Council to RNZ.

"If a doctor in training or medical student will be performing or assisting in any part of a surgical procedure, then this should be discussed with the patient as part of the informed consent process," it said.

Claridge and the Cartwright Collective said that was OK but did not go far enough.

Cartwright Collective law professor Jo Manning said: "There have been questions about doctors in training and medical students who are involved in normal clinical care of patients, and that's a very tricky area".

It was "not covered at all by this clarification".

"And that's something which I think the Medical Council will have to consider. And it's something there must be full public consultation about," Manning said.

At least the new clarification strengthened informed consent a little, but it resulted from a process that had surprised the collective, she said.

When they heard in August this year what the Medical Council was doing, they questioned what was going on.

"At that point we said, 'Actually, woah, back up the bus here - the thing to do is to wait until the Health and Disability Commissioner has completed handling of the Waitematā complaint'.

"The very advisable thing to do would be to wait until she comes out with her decision because that is actually 'higher law', if you like, then anything that the Medical Council comes out with."

The collective wrote to the Ministry of Health about the need for consultation with consumers.

They corresponded with the Medical Council, but the council went ahead anyway - though the Cartwright Collective only learned about that from RNZ this week.

"It seems that MCNZ did proceed with its review, and did so without providing consumers the opportunity for consumer input as we requested. That is disappointing on both counts," Manning said.

"The collective remains of the view that it would have been much the preferable way to proceed for the MCNZ to stay its hand and postpone a fuller, more inclusive review until after the commissioner had completed her investigation of the NZNO's complaint against Waitemata DHB, rather than to proceed with what may turn out to have been a piecemeal amendment."

The council provided its one-line, proposed clarification to the HDC this week only after RNZ's inquiries.

The council said it talked recently with the HDC about it.

Disruption due to the pandemic explained why issuing the draft clarification took months, the council said.

Manning said it was unclear the extent of abuse of informed consent at hospitals, but indications were that "each generation" of health professionals was having to relearn the lessons of the Cartwright inquiry.

Claridge was angry about that - and questioned why the Medical Council's new clarification used the word "should" instead of "must" about informed consent.

"It is atrocious that 32 years on, we are still having to revisit what informed consent means.

"We are still having to tell health practitioners and DHBs what their obligations are to consumers, to patients ... whether teaching is involved or not. It's a basic human right, that people make an informed decision about their health care."

The law and Code of Rights were already clear, before the "clarification", and Waitematā had just chosen to interpret it "loosely", Claridge said.

The HDC told the meeting in January the Code was clear, and reiterated now that informed consent was "at the heart" of it.

Health and Disability Commissioner Morag McDowell said: "HDC's view is that the Code is clear on consent in relation to the involvement of trainees in the provision of services."

Under the Code, Right 6 is the right to be fully informed and Right 7 is the right to make an informed choice and give informed consent.

"It should be made clear to patients that they have the right to refuse the involvement of trainees and can express a preference as to who will provide services and have that preference met where practicable, but patients cannot require that a particular clinician treat them," McDowell said.

The Waitematā DHB had asked the MOH in December to "urgently ... provide national guidance".

The MOH, asked by RNZ what it had done since, said in a statement it took the issue of informed consent seriously.

"It is encouraging to see the Medical Council has recently reviewed its Statement on Informed Consent, with a view to strengthening and clarifying it in this context," the MOH said.

The Waitematā DHB welcomed the Medical Council move.

It had improved its own consent form this year, and the council had confirmed the form was in line with the clarification, the DHB said.

Manning noted that informed consent for medical students was being reviewed, in a "very robust" process.

"The new version will be consulted on widely, publicly. The new National Consensus Statement would be an important document for MCNZ to take into account, I would have thought."