Research and people unable to give informed consent to participate. Should the NZ Code of Rights be changed?

Dr Cordelia Thomas1

1Health And Disability Commissioner, Wellington, New Zealand

In 2017 the Office of the Health and Disability Commissioner undertook a public consultation about  health and disability research involving adult consumers who are unable to consent to their participation in that research. Those consumers might, for example, be unconscious, or have significant cognitive impairments that prevent them from understanding the implications of the decision to participate. The existing law in New Zealand as set out in Right 7(4) of the Code of Health and Disability Services Consumers’ Rights (the Code) allows such studies to proceed if participation in the research is in the “best interests” of the individual.

The nature of research is that the purpose is not generally focused on individual benefit and in addition, outcomes are uncertain, so it is difficult to assess the potential risks and benefits for the proposed participants.

New Zealand law has a strong focus on the rights of consumers. The Code gives legally enforceable rights to all consumers of health and disability services, and places corresponding obligations on providers of those services.

It is difficult to decide where to draw the line regarding what research is appropriate if the participants are unable to give consent. Such people are particularly vulnerable to abuses of their rights and interests. However, research with such participants could lead to significant advances in the services and/or treatment provided to them or to other similar consumers in the future.

This presentation will discuss what was heard from the public and the matters considered by the Commissioner during the process of deciding whether change is required or appropriate.


Biography:

Dr Thomas has a PhD in law. She was a senior lecturer in law at Massey University then the senior legal advisor for the Bioethics Council. At HDC she has held a number of roles including Specialist Senior Legal Advisor, Acting Chief Legal Advisor, Investigations Manager and Associate Commissioner. She continues to teach Public Health Law and and is a member of the Central Health and Disability Ethics Committee. She is the author of textbooks and other publications.