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Research with adults unable to provide informed consent

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 on the HDC website.


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