Health and Disability Commissioner Anthony Hill released a report about possible changes to the rules governing the circumstances when research can occur that involves adult participants who are unable to provide informed consent.

Today I released a report about possible changes to the rules governing the circumstances when research can occur that involves adult participants who are unable to provide informed consent.

If you have previously provided feedback on this topic, thank you. It is a complex subject and we received submissions representing a range of views, all of them valuable.

I have taken time to consider the issues raised and have tried to strike the balance between protecting vulnerable people, and allowing low-risk ethical research that could help improve treatment and services for such people. 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.

I have made a number of recommendations to the Minister of Health to consider. If introduced, these changes would provide more clarity about when health and disability research involving people who cannot give informed consent to participate could occur. The changes would also, with robust safeguards in place, allow some research to occur that is not currently permitted.

I have recommended that the current “best interests” test in Right 7(4) of the Code of Health and Disability Services Consumers’ Rights remain for providing treatment and services, and to introduce a new test for research, with additional safeguards. The test would be that such research could only take place if it 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.

The full report, including my recommendations, is available on the HDC website.

https://www.hdc.org.nz/media/5364/hdc181101-research-report-fa-web.pdf

Yours sincerely

Anthony Hill
Health and Disability Commissioner