Research with adults unable to provide informed consent - media release

Health and Disability Commissioner Anthony Hill today released a report proposing changes to rules for when health and disability research can occur that involves adults who are unable to provide informed consent.

Following discussion with experts in the area and public consultation on the issue, Anthony Hill made a number of recommendations to the Minister of Health to consider. If introduced, these changes would provide more clarity about when research could occur, and with robust safeguards in place, would allow some research to occur that is not currently permitted.

Anthony Hill said the issue was a complex and nuanced one, and public views on the matter were mixed.

“Informed consent is a critically important issue which lies at the heart of the Office of the HDC and the work we do, and considering this issue has been a complex and challenging exercise. My primary concern is to do what is best for people,” Anthony Hill said.

“With these proposed changes I have tried to strike the balance between protecting vulnerable people, and allowing low-risk ethical research that could help improve treatment and services. These are difficult trade-offs, because research by its very nature requires some people to take risks and undergo burdens for the benefit of others.”

Currently health and disability research involving adults unable to consent must be in that person’s “best interests” under Right 7(4) of the Code of Health and Disability Services Consumers’ Rights. While this is an important safeguard for vulnerable people, there is a view that it creates barriers to potentially valuable low-risk research with the result that some groups of people are missing out on improvements and progress in health care and disability services.

Anthony Hill has recommended that the “best interests” test remain for providing treatment and services, and to introduce a new test for research, with additional safeguards. The test would be that research posed “no more than minimal foreseeable risk and no more than minimal foreseeable burden” to participants.

The additional safeguards include principles set out in the Code and elsewhere; enhancements to current ethics review and approval processes and governance systems; and monitoring of any changes that are implemented, with a particular focus on the outcomes for individuals.

At this stage the proposed changes are recommendations to the Minister of Health to consider and further public consultation would be required before any changes could be made to the Code.

Anthony Hill said the public must have trust and confidence in the system that governs health and disability research, and in those who undertake it.

The full report, including the Commissioner’s recommendations is available here.


Background on HDC report into research with adult participants unable to provide informed consent  

Who would be affected by these changes?

The HDC report is about health and disability research involving adult participants, aged 18 years and over, who are unable to give informed consent to participate. People who are unable to consent include those who are unconscious when the research is conducted or those with significant cognitive impairments who are unable to give informed consent even with support, such as advanced dementia.

When will these changes be introduced?

HDC has made recommendations to the Minister of Health to consider. At this stage there is no set timeframe for any changes to be introduced and further public consultation will occur before any changes are implemented.

What is the public view on this?

HDC consulted experts in the field and carried out public consultation on this issue, asking a range of ethical and legal questions relating to research with adults unable to consent, and received 154 submissions from a range of individuals, groups and organisations. The consultation document and an analysis of the submissions are here.

The submissions did not provide a clear position, with some arguing that this type of research should never be permitted and others that the current “best interests” test could result in people missing out on potential benefits of low-risk research for their conditions.

What research might be affected by these changes?

Research involving participants who are unable to give informed consent could provide information about the conditions that cause people to lack or lose capacity, and about the diagnosis, treatment, care, and needs of such people, and in some circumstances such data cannot be gained through research with people who can give informed consent.

The HDC public consultation document had a number of case studies demonstrating the issues:

Research into sepsis and antibiotics

In this example, research participants all receive one of two standard treatments. The research is to find out whether one of the treatments is better than the other. The participants are randomised into one of the groups and have additional blood samples taken.

This research would currently be contrary to the Code because the participants are not better off if they are included in the research but under the proposed changes, so long as the volume of blood drawn is small, the research is unlikely to pose more than minimal risk. However some individuals may be at risk from taking blood so the person enrolling participants would need to consider each person’s particular condition.

Neurosurgery research

A research example would be to compare the safety and effectiveness of two products used to achieve a watertight closure of patients’ brain membranes following neurosurgery. Both products are clinically approved and commonly used by surgeons. Patients undergoing neurosurgery would be randomly allocated to receive one of the two products. The researcher would then collect data about the safety and effectiveness of each product.

Currently this research would be contrary to the Code because the participants receive standard treatment and are not better off if they are included in the research. Under the proposed changes it would be lawful to enrol them in the research as there is no risk to patients from the research - because they would receive one of the products anyway.

Dementia research

This example relates to a study of the care provided to rest home residents with severe dementia. Residents would be randomly allocated into two groups, with each group receiving a different type of care. Group 1 would receive conventional care, which focuses on physical task-oriented practices and physical needs. Group 2 would receive “interactive care”, an alternative to conventional care that is intended to maintain personhood as dementia progresses. “Interactive care” includes a greater focus on the psychosocial needs of the individual. Participants would undergo additional assessments as part of the research. The additional assessments could benefit the participants if the increased contact with the researchers was beneficial to them, or changes in their condition were picked up that would not otherwise have been noticed. On the other hand, there is a risk that some participants may find the additional contact distressing.

Currently this research would be contrary to the Code. Under proposed changes this study would require assessment of each individual. It is likely to present no more than minimal risk but in some cases there could be more than minimal foreseeable burden.

Research into cardiac arrest

Another example is a clinical trial regarding use of adrenaline in the treatment of cardiac arrest. Previous studies suggest that while adrenaline may help to restart the heart initially, it may also lower overall survival rates and increase brain damage. The trial would be randomised, double-blind and placebo-controlled. Some of the participants would receive adrenaline and some would receive a placebo. During the trial, neither the participants nor the paramedics would know who was being given adrenaline and who was being given placebo.

Currently this research would be contrary to the Code because it is not possible to decide in advance whether an individual would be better off if they were enrolled in the research. Under the proposed changes this research would appear to involve more than minimal foreseeable risk for some of the participants so it still would not be allowed.

A similar research trial was conducted in the UK and the results concluded that in adults with out-of-hospital cardiac arrest, the use of epinephrine resulted in a significantly higher rate of 30-day survival than the use of placebo, but more survivors had severe neurologic impairment in the epinephrine group.

Research involving people with Down syndrome

Another example of research would be a clinical trial of a drug for people with Down syndrome. In a randomised, double-blind, placebo-controlled study some of the participants would receive the study drug and some would receive a placebo. During the trial, neither the participants nor the researchers would know who was receiving the drug. Participants would be required to undergo regular six-hour assessment visits to check their progress.

The study drug has already been tested on people without Down syndrome. That research provided some information about the possible risks and side-effects of the drug, including that, for some participants, it increased the incidence of contemplating suicide. There may be other risks or side-effects that have not yet been discovered and the effects of the drug on people without Down syndrome may be different from those on people with Down syndrome. It is not known whether the drug will have the desired effect on cognition or learning (or any other beneficial effects). However, it is likely that even if the drug did lead to an improvement in cognition for the research participants, the effect would be temporary.

Currently this research would be contrary to the Code. Under the proposed changes it would still not be allowed because it would present more than minimal foreseeable risk and more than minimal foreseeable burden to participants.