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Research with adults unable to provide informed consent
Research with adults unable to provide informed consent
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The Health and Disability Commissioner has proposed changes to the rules governing the circumstances when health and disability research can occur that involves adult participants who are unable to provide informed consent.
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.
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.
Following this, in November 2019 the Commissioner 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.
The recommendations include that the current “best interests” test in Right 7(4) of the Code remain for treatment and services, and to introduce a new test, with additional safeguards, for research involving adult participants unable to provide informed consent.
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.