Adult decision-making capacity and health research in Aotearoa New Zealand

The Health and Disability Commissioner is currently conducting a review of the Code of Health and Disability Services Consumers’ Rights (the Code)¹ and the Health and Disability Commissioner Act (the Act).² We are concerned about the role of the Code in limiting research with adults who lack the capacity to consent.

Judge Silvia Cartwright led an inquiry into allegations concerning the treatment of cervical cancer at National Women’s Hospital and released her report in 1988.³ The Act² was passed in 1994, reflecting recommendation 5b(iv)(3). The Code¹ was introduced in 1996, reflecting recommendations 6b(iv) and 5b(iv)(3). The National Ethics Advisory Committee (NEAC) was established in 2001 under the New Zealand Public Health and Disability Act 2000, now under the amended Act 2010,⁴ reflecting recommendation 5b(i)(3). The Act was groundbreaking legislation, in regulating for a code that for the first time provided normative standards for clinical care, research and teaching, quality improvement obligations and a complaints mechanism. The Code was introduced 5 years before  NEAC was established and 16 years before NEAC’s first research guidelines were released. For the period 1996–2012, the Code was an important safeguard to support ethical research. NEAC set up a comprehensive structure of ethics review committees, and in 2012 their guidance standards on ethical research came into effect. A major revision was released in 2019, and those standards are currently under review. The current standards run to 250 pages.⁵

The application of the Code to clinical care has been the subject of many complaints and findings by the Health and Disability Commissioner. This has given greater clarity to providers on the Commissioner’s interpretation of the Code in relation to clinical care—for example, in relation to when the qualifications included in section 3 are relevant. The Commissioner has noted that there have been few complaints in relation to research⁶ and so there has been no similar development of the ways in which the Code applies to research.

Research is a more complex and multidimensional practice than the provision of clinical care. The goal of clinical care is to benefit the patient. While there may be disagreement as to which course of action is in the patient’s best interests, both clinicians and patients are typically aligned in their intent. By comparison, the goal of research is to produce generalisable knowledge to benefit future patients—specifically to provide new knowledge to prevent, identify and treat illness and disease.⁵ Therefore, in research, the goals of the researchers may differ from the goals of the research participants, who are often motivated by the prospect of personal benefit, access to otherwise unavailable procedures or drugs or last-ditch attempts at potentially life-saving interventions.⁷ A decision to proceed with clinical care involves the patient and clinician balancing risks and benefits for the specific patient. A decision to proceed with research requires research teams, research ethics committees and clinical governance groups to assess and weigh the risks to the participants against the potential benefits to the population. Once approved, research then requires each individual potential participant to consider, based on the information provided, whether they wish to participate. Given that, generally, the goals of patient and doctor in clinical care are congruent and that there are often conflicting goals in research, exploitation is a greater threat in research than in clinical care.  

 The application of the concept of informed consent to research has changed over time. While informed consent is always sought, it is common that participants make decisions to participate in research based on a relationship with or trust in the researcher,⁸ and many cannot recall the details of the information provided after having signed consent.⁹ Te Ara Tika¹⁰ described ethical standards for research with Māori from the viewpoint of Māori researchers. The framework they proposed saw informed consent as a necessary but not sufficient requirement of ethical research, and they placed more emphasis on meaningful collaboration between researchers and participants at all phases of the research, from choosing the research topic, designing the study, implementing the study and reporting the results. The latest edition of the NEAC guidelines has these concepts embedded within. So, while the Health and Disability Commissioner sees informed consent at the heart of the Code,⁶ NEAC has a wider focus. In discussing research on peoples with disability the main focus is on co-design and collaboration:

Their primary aim should be co-design; that is, research that is designed in collaboration with disabled people themselves. Co-design fosters trust and builds relationships with participants, which is a fundamental part of ethical research.

5.2 Researchers should strongly consider a participatory approach when conducting disability research, whereby appropriate engagement with prospective participants and relevant stakeholders helps them frame research questions, devise methodology, interpret findings, avoid an ‘ableist’ bias, and improve the overall efficacy of the study.⁵

There is an extensive section in the NEAC guidelines on supported decision making for those with limitations to their capacity, suggesting (in the context of people with disabilities) “that almost any person, with the right support, is capable of providing informed consent.”⁵ Informed consent remains at the heart of clinical practice. For research, it is one of several safeguards aimed to protect patients. The NEAC guidelines do an effective job of providing guidance on these safeguards.

Tensions between the application of the Code to clinical care versus research are most notable in relation to Right 7(4), which requires that when the consumer (patient or research participant) is not competent to make decisions for themselves, services can be provided if it is in the best interests of the consumer.¹ The 2019 report that was instigated by the Commissioner in response to the last review of the Code describes this issue succinctly:

When someone is unable to give informed consent, in certain limited circumstances, including that the research will be in the person’s “best interests”, Right 7(4) of the Code allows the person to be enrolled as a research participant. The “best interests” test does not provide for any consideration of the potential for advances in knowledge that may benefit people other than the participant.⁶

Right 7(4) is particularly problematic for research with adults who are unable to give consent.¹¹ A person with capacity can choose to be part of a research study because they value contributing to knowledge that will benefit other patients. But for a patient lacking capacity, the “best interests” test in Right 7(4) applies and research cannot proceed unless it is deemed by the responsible doctor to be in the best interests of the patient. In a letter from NEAC to Associate Minister of Health Jenny Salesa on this topic they described a study that could be affected by these constraints:

Among patients who are hospitalised with severe traumatic brain injury, 60 percent either die or survive with severe disability. One treatment—a decompressive craniectomy—showed promise in reducing deaths caused by traumatic brain injuries. To see whether this treatment that had started to become commonplace was the best approach, a study was conducted in 2011. This study showed that what appeared to be a treatment with good outcomes, in fact ended up being worse for patients. The study’s results, by changing standard practice, also saved an estimated 20 million dollars a year for New Zealand.¹²

As a matter of justice, all classes of patients deserve good evidence to inform their clinical care; this includes patients with conditions that impair their capacity to consent either permanently or for a critical period of time (e.g., congenital intellectual disability, dementia or lack of consciousness with a critical injury). If clinical care is offered during this period, we need evidence to inform this care. Inevitably, this will entail some form of research. Conservative research ethics paradigms that restrict research with these groups may further entrench their vulnerability by denying them access to the standard of evidence-based clinical care that other, non-vulnerable groups expect. This is unjust.¹³

Balancing these competing interests and adequately protecting patients who cannot consent themselves from exploitation in research requires detail and nuance that is beyond the scope of the Code. NEAC has developed considerable expertise in setting pragmatic standards that carefully navigate the complex interests at play in research. NEAC has supported the development of a network of ethics committees at various institutional levels to provide guidance and review of specific research studies.

By comparison, the Health and Disability Commission has developed into an agency whose expertise is receiving and resolving complaints and advocating for improvements in individual-level clinical care. A search of Health and Disability Commission decisions for “research” locates just three cases of decisions relating to research. The Health and Disability Commission has limited expertise in considering the balance between patient rights and population benefits in health research.

The 2019 report from the Commissioner on this issue⁶ recommended changing the “best interests” test in Right 7(4) in relation to research to “no more than minimal foreseeable risk and no more than minimal foreseeable burden.” The report notes that there are two places where decisions are made—at the level of an ethics committee approving a study, and then at the level of potential participants agreeing to participate in the study. The report was concerned about additional safeguards and suggested involving a wider group in the decision making on participation. No changes have occurred as a result of this report.

The latest NEAC guidelines propose a two-step test in relation to patients who lack capacity:

Where the research imposes only minimal risk, it should have the prospect of providing benefits to the participants or the group to which they belong. Where the research exposes participants to greater than minimal risk, it should have the prospect of benefit for the individual participant. Benefits should be commensurate with the level of foreseeable risk. In balancing benefit to risk, the risk/benefit ratio should be ‘at least as favourable to the participants’ as alternative approaches.⁵

Our proposal is that this test be used to determine whether a research proposal can be approved by a health and disability ethics committee. This provides safeguards at the level of study design. We agree with the Commissioner’s suggestion that involving a wider group in the decision making on participation would be an appropriate safeguard at the level of individual participation.

For these changes to be implemented, legislation would need to be amended. At the least, the Act, the Code and the Protection of Personal Property Rights (PPPR) Act, to which the Code aligns, will require amendment. We note that the Law Commission is currently investigating proposals for a replacement to the PPPR Act.¹⁴

It is redundant, confusing and constraining to have two bodies in Aotearoa New Zealand setting normative standards for health research.

The Medical Council of New Zealand is also responsible, on authority from the Health Practitioners Competence Assurance Act,¹⁵ for setting standards for the ethical conduct of doctors in Aotearoa New Zealand. But the Medical Council has largely delegated the task of balancing the benefits of the research with the risks to the participant to the NEAC ethics approval process¹⁶—and we argue that the Health and Disability Commission should do the same. The Health and Disability Commission is under considerable resource pressure because of rising complaints;¹⁷ it would be sensible to focus their resources on advocacy and complaint resolution in relation to clinical care. In relation to research, the Code should be aligned with NEAC guidelines so that ethical control of research is assured through NEAC processes.