Improving informed consent

The importance of providing information which is as comprehensive as possible and which is well understood by any person about to receive healthcare cannot be over emphasised.

But these are issues some service providers continue to struggle with, even though the Code of Health and Disability Services Consumers’ Rights has been in place in New Zealand since mid-1996.

The introduction of the code, with its 10 rights, including the right to give informed consent, followed the introduction of the Health and Disability Commissioner Act which will turn 30 this year.

Anyone inclined to play down the importance of informed consent may need to be reminded the Act and code followed Judge Silvia Cartwright’s inquiry into the scandal known as the "unfortunate experiment" at Auckland’s National Women’s Hospital. In the experiment, which went on for more than 20 years, women presenting with carcinoma in situ of the cervix, without their consent, were not properly treated. Many went on to develop cancer and some died.

Last July, Health and Disability Commissioner Morag McDowell said about 18% of complaints to her office involved informed consent processes, and communication issues featured in more than half of complaints (60%).

Informed consent and inadequate communication featured in Ms McDowell’s report released this week into the tragic case of Dunedin man Rory Nairn (26), who died from myocarditis 12 days after receiving the Comirnaty (Pfizer/BioNTEch) Covid-19 vaccine in 2021.

The coroner had earlier found his death was directly caused by the vaccine.

Mr Nairn had experienced chest discomfort and heart flutters following the vaccination at a pharmacy. He had these symptoms for 12 days before deciding to go to hospital but collapsed and died before he got there.

He had been apparently unaware myocarditis (inflammation of the heart) was a potentially serious side effect of the vaccine and that his symptoms required urgent medical attention.

He had been informed of the common side effects, but not of the rare and more serious myocarditis.

Photo: Getty Images
Photo: Getty Images
Ms McDowell was satisfied official agencies intended the risk of myocarditis to be communicated to consumers as part of the consent process and they were also to be given what she called "safety-netting" advice about myocarditis symptoms following their vaccination.

However, she found that none of the sources of official information explicitly required vaccinators to disclose the risk of myocarditis as part of the informed consent process before vaccination.

Ms McDowell said Manatū Hauora Ministry of Health needed to provide clear and unambiguous guidance to vaccinating providers about what and when they needed to tell consumers about myocarditis.

This was particularly relevant following the first death in New Zealand from myocarditis following Covid-19 vaccination, which occurred several months before Mr Nairn’s vaccination.

It appeared, however, that while the national immunisation programme sent providers information about myocarditis after that death, it was in the midst of a significant amount of material.

Ms McDowell made the point the broader public context was also relevant for Mr Nairn’s case, which had taken place during the unprecedented international and national response prompted by the pandemic.

The Comirnaty vaccine was, at the time, relatively new and new information about its use, risk and side effects was still forthcoming. As new information came to light about new and emerging risks associated with a vaccine, and as official guidance changed, the ministry must also make clear to vaccinators what the new information entails and the significance of it, Ms McDowell said.

She also considered it might have been helpful to have one centralised portal to disseminate information to providers across the country.

She acknowledged this would be complex but would ask the New Zealand Royal Commission Covid-19 Lessons Learned to consider its feasibility.

Regardless of its complexity, this seems essential to reduce the opportunity for poor communication, improve the informed consent process and lessen the risk of harm.