Chapter 6: Research on People who Lack Capacity

Chapter 6 is in two sections:

  1. The problems encountered in New Zealand when health and disability research is intended to be carried out on people who lack capacity to consent (non-consensual studies) and the gap in the legal framework.

  2. International standards for research on people who lack capacity and the essential features of the statutory protections in ss 30 – 34 of the Mental Capacity Act.
  1. This chapter considers the statutory safeguards provided in the Mental Capacity Act (MCA) for adults who lack capacity to consent to research.720 While the discussion here aims to inform the proposed consultation by the Health and Disability Commissioner on Right 7(4) of the HDC Code (Right 7(4),721 the recommendation is for legislative authority to be established rather than simply making changes to the HDC Code, to address “the clearly unsatisfactory but remediable situation” 722 that currently exists in New Zealand. The MCA provisions provide a useful legal framework which New Zealand could use to establish its own statutory protections where none currently exist.

  2. Sections 30 – 34 of the MCA provide lawful authority to carry out research on participants who lack capacity, where approved by a research ethics committee, as long as various safeguards are complied with.723 These safeguards relate both to the characteristics of the research and to the participation of individuals in it. Among the numerous patient protections, the MCA provides that the research must have the potential to benefit the patient without imposing a burden that is disproportionate to that potential benefit, or the research must be of wider benefit for persons affected by the same or similar condition, and impose no more than negligible risk to the patient.

  3. In New Zealand, it has been reported that since 2006 there have been 40 medical studies approved by ethics committees, in which some or all participants may not have had capacity to provide informed consent.724 Right 7(4) of the HDC Code,725 based on the common law doctrine of necessity, and the outdated provisions in the PPPR Act, substantially restrict the ability of researchers (investigators) to provide treatment without consent in the context of research (for non-consensual studies).726 Deciding the legality of enrolling adults who lack capacity to consent in research that cannot reasonably be expected to provide benefit to them has been problematic and the current state of the law is a “legal near-vacuum”.727

720 Sections 30-34 of the MCA are set out in Appendix C. “Research” is intended to refer to health and disability research which falls under the current ethical review framework in New Zealand.

721 In March 2015, Commissioner Hill announced that he would consult on whether Right 7(4) of the HDC Code should be amended in respect of research where participants lack capacity to consent. See A Hill (Commissioner) “20 Years Strong – The Commissioner, the Code and Informed Consumers” (A presentation at the Conference: “Improving the Consumer Experience”, Wellington, March 2015).

722 J Manning “Non-consensual Clinical Research in New Zealand: Law Reform Urgently Needed” (2016) 23 JLM 516.

723 Mental Capacity Act 2005, s 31.

724 B Heather “Drugs Tested on Mentally Disabled” Sunday Star Times (13 July 2014) Manning, above n 722 cites a number of examples at footnote 15.

725 Right 7(4) of the HDC Code is colloquially referred to as “right seven-four”. See discussion of Right 7(4) in Chapter 5A Best Interests in New Zealand Law.

726 The National Ethics Advisory Committee has issued guidelines for researchers on the ethical review of both intervention studies (clinical trials and medical experimentation which may or may not have therapeutic benefit to individuals participating), as well as “observational studies” (observational research which is not a “clinical trial”). National Ethics Advisory Committee (NEAC) Ethical Guidelines for Intervention Studies: Revised edition (Ministry of Health, Wellington, 2012).

727 As described by the Scottish Law Commission who were reporting on the same problem over 20 years ago, prior to the enactment of the Adults with Incapacity (Scotland) Act 2000: Scottish Law Commission Report, 1995 [5.65], cited in Ward, above n 128.

  1. Any changes made to the law in this sphere will need to be considered in conjunction with the governance arrangements for ethics committees and the standards they adhere to. In New Zealand, there is no overarching legal framework that expressly recognises the role and function of ethics committees to protect human participants in research and innovative practice.728 Ethics committees have a dual function in this respect: not only to protect the interests of research participants, but also to allow ethically sound research that will secure benefits.

  2. The problems that exist for non-consensual studies are, in part, indicative of the changes made to ethics committees in 2012 and the undermining of the ethics review system.729 Although the government inquiry aimed to make New Zealand a more attractive place for innovative clinical trials,730 the downgrading of protection for research participants and restructuring of ethics committees is not in line with international standards,731 and the current ethics review system is “ad hoc, and fragmented and difficult to navigate”.732

728 Health and Disability Ethics Committees are established under s 11 of the New Zealand Public Health and Disability Act 2000. The Act empowers the Minister of Health to create ministerial committees with functions as determined by the Minister of Health. Section 16 of the Act mandates the appointment of a national ethics advisory committee for health and disability services, including health research. Ironically, New Zealand has had specific legislation for the protection of animals in research since 1983 but not humans: Animals Protection Act (NZ), subsequently repealed and replaced with the Animal Welfare Act 1999. G Gillett, A Douglass “Ethics Committees in New Zealand” (2012) 20 JLM 266.

729 The impact of the changes and gradual undermining of the independence of ethics review In New Zealand since the Cartwright Report in 1988 is discussed in: M Tolich and B Smith The Politicisation of Ethics Review in New Zealand (Dunmore Publishing Ltd, Auckland, 2015).

730 New Zealand Health Committee Inquiry into improving New Zealand’s environment to support innovation through clinical trials (House of Representatives 49th Parliament, Wellington, June 2011).

731 The WHO Standards and Operational Guidance for Ethics Review of Health-related Research on Human Participants (2011) include: establishing a research ethics review system with an “adequate legal framework”, presumptive oversight of all research by ethics committees to avoid gaps, and scientific design and the conduct of the study as part of ethical review.

732 NEAC “Cross-sectorial ethics arrangements for health and disability research: Submission summary“ (14 July 2015); see also New Zealand Law Society submission (26 February 2015)

  © 2020 Alison Douglass