6B: INTERNATIONAL STANDARDS AND THE MENTAL CAPACITY ACT

International ethical standards for non-consensual studies

36. International ethical standards recognise that medical research involving subjects incapable of giving informed consent may be justified, such as research with unconscious patients, if the condition that prevents them from giving informed consent is a “necessary characteristic” of the research population. The World Medical Association’s Declaration of Helsinki⁷⁷⁵ sets recognised ethical standards for the conduct of research. Its basic principles in relation to the involvement of an incapacitated adult include:

• Incompetent adults should not be included in research that is unlikely to benefit them personally, unless the research is necessary to promote the health of the population represented by the potential research subjects; this research cannot instead be performed on legally competent persons; and it involves only minimal risk and minimal burden to participants.
  
  
• Where an adult is incapable of giving consent, the responsible researcher must obtain informed consent from any legally authorised representative.
  
  
• Where an incompetent adult is capable of assenting to decisions about participation in research, this assent must be obtained, in addition to the consent of a legally authorised representative. Any dissent by the person should be respected.
  
  
• The research must be intended to provide knowledge relating to the condition or conditions that have contributed to the impairment of the individual’s incapacity.

37. The World Health Organisation (WHO), in collaboration with the Council for International Organizations of Medical Sciences (CIOMS), has issued international guidelines for ethical clinical research with human subjects.⁷⁷⁶ Guideline 9 sets a “low-risk standard” for research involving individuals incapable of giving informed consent. This states:⁷⁷⁷

    The risk from research interventions that do not hold out the prospect of direct benefit for the individual subject should be no more likely and not greater than the risk attached to routine medical or psychological examination of such persons. Slight or minor increases above such risk may be permitted when there is an overriding scientific or medical rationale for such increases and when an ethical review committee has approved them.

38. Both the Declaration of Helsinki and the CIOMS guidelines affirm the need to have a legally authorised person, other than the investigator of the research, to give legally effective consent where a person lacks capacity to consent to research. If a participant with diminished capacity is capable of “assent” and there is no “dissent”, such assent is not legally effective on its own. The level of acceptable risk must be negligible or minimal even if there may be societal benefit over and above individual benefit, and an ethics committee must approve all research. None of these criteria in international standards are expressly articulated in New Zealand law.

39. In 1995, the English Law Commission found a “striking degree of consensus over the factors which make non-therapeutic research ethical” and these are largely reflected in the MCA’s scheme.⁷⁷⁸
    
    
40. The initial draft Mental Incapacity Bill presented to the UK Parliament in June 2003 did not contain any provisions on research. The Joint Committee on the Bill concluded that there should be provision in the Bill to enable strictly controlled medical research to explore the causes and consequences of mental incapacity and to develop effective treatment for such conditions. It further recommended that these clauses should set out the key principles governing such research and the protections against exploitation or harm enshrined in the Helsinki Declaration of the World Medical Association of 1964.⁷⁷⁹ Consideration was also given to the framework for research set out in s 51 of the Adults with Incapacity Act (Scotland) 2000.
    
    
41. The report acknowledged that if legal mechanisms prevented or deterred research for such people, then the development of treatments and the undertaking of treatment trials for disorders such as Alzheimer’s disease would be very problematic. The Joint Committee said:⁷⁸⁰

    The range of medical research involving people with possible mental incapacity was considerable. Other examples include investigating why people with Down Syndrome are at such high risk for Alzheimer’s Disease, how best to treat the effects of acute brain injury, how to understand and manage problems such as self-injurious behaviour affecting people with autism, the causes of potentially very debilitating mental illness such as schizophrenia, or the best treatment of severe brain disorders such as in variant CJD. Research goes beyond the medical field and includes investigating factors influencing the quality of life of people with incapacitating disorders, or how they can be best helped to make decisions for themselves. In all of these examples, some of people involved will have the capacity to consent to research but others may not.

⁷⁷⁵ World Medical Association (1964) Declaration of Helsinki, Ethical Principles for Medical Research Involving Human Subjects, as subsequently amended most recently in 2008: see www.wma.net.

⁷⁷⁶ CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS, Geneva, 2002).

⁷⁷⁷ CIOMS, above n 776 at 49.

⁷⁷⁸ Hale, above n 194 at 220, citing Law Commission, above n 124 at [6.3(1)].

⁷⁷⁹ Joint Committee on the draft Mental Incapacity Bill First Report, Chapter 15 www.publications.parliament.uk/pa/jt200203/jtselect/jtdmi/189/18918.htm.

⁷⁸⁰ Mental Incapacity Bill, above n 779 at [279].

42. Medical research in England and Wales is governed by two distinct governance regimes. Clinical trials of investigational medicinal products are regulated under an EU Directive,⁷⁸¹ implemented by the Medicines for Human Use (Clinical Trials) Regulations 2004 (CT Regulations), with further amendments to come into effect in 2016.⁷⁸² All other medical research involving people who lack capacity (“intrusive research”), including clinical trials that do not relate to investigational medicinal products, falls under the MCA.
    
    
43. The Health Research Authority (like its predecessors prior to 2011) provides research and ethics committee governance in England and Wales, including an independent advisory panel available to assist ethics committees.⁷⁸³

44. Sections 30 – 34 of the MCA⁷⁸⁴ provide lawful authority for “intrusive research” involving people without capacity where the research has been approved by an appropriate body.⁷⁸⁵ Research is “intrusive” if it would legally require consent if it involved people with capacity.⁷⁸⁶
    
    
45. A broad approach has been taken to what constitutes “intrusive research” under the MCA. This concept is not limited to medical or biomedical research that is physically invasive. As a result, it can be difficult to decide whether some social science research, such as qualitative and observational studies, comes under the MCA, for example observational studies in care homes.⁷⁸⁷

⁷⁸¹ European Union “Regulation of 16 April 2014” No. 536/2014 (2014) Official Eur Union. The Clinical Trials Regulations 2004 were updated in 2015. After almost two years of discussions, the EU Parliament in April 2014 adopted a new regulation on clinical trials, which would replace the currently applicable 2001 Clinical Trials Directive in 2016.

⁷⁸² C Gennet, R Andorno and B Elgar “Does the New EU Regulation on Clinical Trials Protect Vulnerable Participants?” (2015) Health Policy http://dx.doi.org/10.1016/j.healthpol.2015.04.007.

⁷⁸³ The Health Research Authority is an “arms- length” Non-Departmental Public Body (NDPB) that provides research governance for the National Health Service as well as social care research under the Care Act 2014. (Interview with Clive Collett, HRA Ethics Guidance and Strategy Manager, 5 June 2015, London) www.hra.nhs.uk.

⁷⁸⁴ Mental Capacity Act 2005, ss 30 – 34 are set out in full in Appendix C.

⁷⁸⁵ Section 34 is a transitional provision relating to the loss of capacity in research that started before 1 October 2007 but has limited application under regulations: Mental Capacity Act 2005 (Loss of Capacity During Research Project) (England) Regulations 2007. The Regulations only apply to tissue and data collected before the loss of capacity from a person who gave consent and do not cover research involving direct intervention, for example, taking a further blood pressure reading or the taking of further tissue after loss of capacity. Where the Regulations do apply, research can only continue if the project has procedures to deal with people who lose capacity during the project and that has been approved by an ethics committee.

⁷⁸⁶ Research may be unlawful for several different reasons, not only because it involves what would otherwise be an assault: for example, where use of the data or samples collected would breach confidentiality or data protection laws or the Human Tissue Act 2004. See MCA Code of Practice, above n 285 at Chapter 11.

⁷⁸⁷ Interview with Martin Stevens, Chair of the Social Care Research Ethics (SCREC) (London, 10 June 2015).

46. Some people who consent to long-term research studies may lose capacity before the study ends or experience diminishing and fluctuating capacity. The MCA follows the common law position that consent to participate in research does not survive the loss of capacity. This means that if a person has already consented to participate in research then loses capacity in the course of research, their continued participation would be unlawful unless the procedures applying to incapacitated participants were then followed.
    
    
47. A key difference under the CT Regulations is that consent survives the loss of capacity. If th person loses capacity during the research then a legal representative (who may be a professional) can consent on the person’s behalf.⁷⁸⁸

48. Under the MCA, an ethics committee, established as the “appropriate body”, must approve any medical research project,⁷⁸⁹ and can only approve a project that involves a person who lacks the capacity to consent to involvement if the following requirements are met:⁷⁹⁰

1. The research must be connected to an impairing condition affecting the person or his treatment
   
2. There must be reasonable grounds for believing that research of comparable effectiveness cannot be carried out if the project has to be confined to, or only relate to, people who have capacity to consent to take part.
   
   
3. The research must:
   
   
   1. have the potential to benefit the person without imposing a burden that is disproportionate to the benefit, or

      
      
   2. be intended to provide knowledge about the causes of the impairing condition, its treatment or about the care of people affected by the same or a similar condition, provided the research involves negligible risk.

      
      
4. Arrangements must be in place to comply with s 32 (consultees) and s 33 (additional safeguards).

⁷⁸⁸ The legal representative under the CT Regulations has legal authority to give consent or refusal. The differences between the two regimes regarding consultees can be confusing to researchers. In 2010 the NRES released an on-line toolkit offering practical advice on the confusing legal requirements and is explained in a video: https://connect.le.ac.uk/alctoolkit/

⁷⁸⁹ Mental Capacity Act 2005, s 30(4).

⁷⁹⁰ Mental Capacity Act 2005, ss 31(2)–(5).

49. An ethics committee may not approve a project unless it is connected with an “impairing condition” or its treatment.⁷⁹¹ Ensuring the research is related to the person’s condition is described by Lewis as the “subject condition” requirement.⁷⁹²
    
    
50. It is important that impairing conditions are linked to the condition that is being researched. For example, research that considers the increased incidence of falls in the elderly may justify enrolling people with dementia. However, enrolling people with dementia in genetic research to examine the genomes of a rare cancer unrelated to dementia should not, and did not, gain ethical approval.⁷⁹³

51. Section 31(4) of the MCA requires reasonable grounds for believing that if research were to be confined only to people who lacked capacity to consent, it would not be as effective. This condition is described by Lewis as the “necessity” requirement, because research of equal effectiveness could not be carried out if confined to participants with capacity.⁷⁹⁴

52. The Social Care Research Ethics Committee declined to approve a proposed study of acute psychiatric care in respect of people who lacked capacity. The researcher wanted to observe the mental health assessment process, including both the mental health practitioner and the service user.⁷⁹⁵ The study raised the issue of the consent mechanism at a time when people lack capacity to consent because of a critical illness, but may regain capacity. The necessity condition was not met because research could have been carried out equally well by only including assessments of psychiatric patients who had the capacity to consent to taking part. The ethics committee noted that the research was of no personal benefit to the individuals and there were “non-negligible” risks involved given the intrusive nature of the assessment process. In addition, having a personal consultee,⁷⁹⁶ such as a family member, give consent could potentially cause a conflict of interest and would place more stress on the participants.

⁷⁹¹ Mental Capacity Act 2005, ss 31(2) and 31(3). An impairing condition is one which is, or may be, either the cause or the effect of an impairment or disturbance in the functioning of the mind or brain or which contributes to it.

⁷⁹² Interview with Professor Penney Lewis, King’s College London, London, 7 May 2015. See also P Lewis “Procedures that are Against the Medical Interests of Incompetent Adults” (2002) OJLS 575 at 602. This was also originally contemplated by the Law Commission, above n 125 at 98-100.

⁷⁹³ As was the case in a large longitudinal study, the “100,000 Genomes” project. Interview with Nigel Wellman, Chair of the Oxford C Ethics Committee,( Oxford, 2 June 2015). The project will sequence 100,000 genomes from around 70,000 people. Participants are NHS patients with a rare disease, plus their families, and patients with cancer www.genomicsengland.co.uk/the-100000-genomes-project.

⁷⁹⁴ Lewis (2002), above n 792.

⁷⁹⁵ “Exploring AMHP decision-making during mental health assessments”, Extracts of anonymised minutes released by the National Social Care Research Ethics Committee, 12 June 2015.

⁷⁹⁶ Personal consultees are discussed below.

53. A similar study was approved which aimed to include participants who had sufficient capacity to agree to the researcher being present at the assessment (assent and no dissent). Consent for the data collected at the time of the assessment to be included in the research was sought if and when the person regained capacity. If the person did not regain capacity, or refused to allow their data to be used in the research, it would be discarded.⁷⁹⁷

54. Where the research meets the requirement of being connected to the person’s impairing condition but does not have the potential to benefit the person without imposing a burden that is disproportionate to that benefit,⁷⁹⁸ the MCA imposes a number of additional requirements. There must be reasonable grounds for believing that:⁷⁹⁹

• The risk to the research subject is likely to be negligible [minimal];⁸⁰⁰
  
  
• Anything done to, or in relation to, the research subject will not interfere with the person’s privacy or freedom of action in a significant way;
  
  
• Anything done, to or in relation to, the research subject will not be unduly invasive or restrictive.

55. The research should have the potential to benefit the person without imposing a burden that is disproportionate to that benefit. Therefore, if participants stand to benefit personally from the research, a greater level of risk or inconvenience may be acceptable.⁸⁰¹
    
    
56. The Scottish and English legal frameworks adopt similar approaches to the benefit and risk thresholds, but with nuanced differences. The Scottish legislation says that where the research entails “no foreseeable risk, or only a minimal foreseeable risk”,⁸⁰² the research must be “likely to produce real and direct benefit” to the adult.⁸⁰³

⁷⁹⁷ Stevens, above n 787

⁷⁹⁸ Mental Capacity Act 2005, s 31(4). Examples of possible benefits to participants include developing more effective ways of treating them or managing their condition, improving the quality of their care, discovering the cause of this would be helpful to them, and reducing the risk of harm or disadvantage. MCA Code of Practice, above n 285 at [11.14]. Examples of useful general knowledge might be to see whether a particular way of helping people with congenital learning disabilities might also help people with disabilities caused by head injuries MCA Code of Practice at [11.17].

⁷⁹⁹ Mental Capacity Act 2005, s 31(6).

⁸⁰⁰ The Government committee considering the MCA Bill considered that ”negligible” was synonymous with “minimal”. Joint Committee On Human Rights Fourth Report (on HL Bill 13) (24 January 2005) http://www.parliament.the-stationery-office.co.uk/pa/jt200405/jtselect/jtrights/26/2607.htm, at [4.67].

⁸⁰¹ This kind of research is sometimes referred to as “therapeutic” research. However the distinction between therapeutic and non-therapeutic research can be difficult. Under the NEAC guidelines, “intervention studies” refers to research that includes therapeutic interventions as well as preventative and diagnostic interventions, above n 726.

⁸⁰² Adults with Incapacity (Scotland) Act 2000, s 51(3)(d).

⁸⁰³ Adults with Incapacity (Scotland) Act 2000, s 51(3)(a). If it is not of real and direct benefit, it must be likely to benefit others with the same incapacity through ‘significant improvement in the scientific understanding of the adult’s incapacity to the attainment of real and direct benefit to the adult or to other persons having the same incapacity”, s 51(4). Therefore, the necessity and condition requirements of both laws are similar.

57. Manning argues that the Scottish model is clearer and more protective of subjects because it only allows minimal risk, regardless of the potential to benefit the adult, whereas the MCA does not define what an acceptable risk might be.⁸⁰⁴ At the time the MCA Bill was before the UK Parliament there was a misapprehension that the Scottish wording “real and direct benefit” was too restrictive and that it meant that there would definitely have to be benefit to the individual research participant.⁸⁰⁵ The approach taken in the MCA was also justified asovering the broad range of research possible under the Bill (“intrusive research”), rather than only direct medical interventions.⁸⁰⁶
    
    
58. The Scottish model does not address the principle of proportionality when taking into account the relative risks and benefits of participating in research.⁸⁰⁷ By comparison, the MCA recognises a greater risk (burden) is justified where there is potential to benefit the individual concerned.⁸⁰⁸

⁸⁰⁴ Manning, above n 722 at 527.

⁸⁰⁵ Joint Committee On Human Rights Fourth Report, above n 779 at [4.63].

⁸⁰⁶ Joint Committee On Human Rights Fourth Report, above n 779 at [4.55].

⁸⁰⁷ Mental Capacity Act 2005, s 31(5)(a).

⁸⁰⁸ The omission of the principle of proportionality in the Scottish legislation in respect of research was noted by the Joint Committee on Human Rights, above n 779. The general principles in Part I of the Scottish legislation include the ”least restrictive” principle and that there should be “ no intervention in the affairs of an adult unless the person responsible for authorising or effecting the intervention is satisfied that the intervention will benefit the adult and that such benefit cannot reasonably be achieved without intervention,” s 1(2).

59. Section 32 of the MCA requires researchers to have adequate arrangements in place for consulting designated persons (“consultees”) about whether a person lacking capacity should take part in the research. Reasonable steps must be taken to identify a “personal consultee”. This should be someone who knows the individual who lacks capacity in a personal capacity and is able to advise the researcher about the person’s wishes and feelings in relation to the research.⁸⁰⁹ This will ordinarily be a family member or someone close to the person, or it could be someone acting under a lasting power of attorney (LPA) or appointed by the court.
    
    
60. If no appropriate person can be identified who is willing to act as a personal consultee, the researcher may consult a “nominated consultee”, that is, someone appointed by the researcher who has some connection with the participant (often a paid care worker or professional) and is independent of the research. Researchers have sometimes shown a reluctance to have a nominated consultee where a personal consultee is not available, or more rarely, where there is a conflict of interest.⁸¹⁰
    
    
61. The consultee gives advice rather than consent.⁸¹¹ They must be given information about the project and advise on what the participant’s wishes and feelings would be about taking part, similar to the approach taken when assessing a person’s best interests under s 4 of the MCA. A key difference in the CT Regulations is that it gives the legal authority to enrol a person in research to someone else (other than the researcher),⁸¹² whereas, under the MCA, it is the researcher who makes the decision about participation, provided the process has been approved by an ethics committee.
    
    
62. The consultee provisions in the MCA are stronger than the steps required under Right 7(4) in New Zealand and are tantamount to a power of veto over participation in the research. The researcher must take heed of any advice from the consultee that enrolment or continued involvement in the study would be contrary to the wishes of the person who lacks capacity.⁸¹³ Even if a person with capacity had originally consented to join the research project, if they later lose their capacity they must be withdrawn if this approval process has not been completed, unless withdrawal of the treatment would involve significant risk to their health.⁸¹⁴

⁸⁰⁹ Mental Capacity Act 2005, s 32(2).

⁸¹⁰ Stevens, above n 786. For example, Independent Mental Capacity Advocates (IMCAs) appointed under the MCA could be a nominated consultee, but are not currently appointed for this purpose (Interview with Dr Michael Dunn, Ethox Centre, Oxford University and member of the Social Care Research Ethics Committee, Oxford, June 2015).

⁸¹¹ Mental Capacity Act 2005, s 32(4). Guidance on nominating a consultee for research involving adults who lack capacity to consent issued under s 32(3) of the MCA, Department of Health, 2008.

⁸¹² The legal representative can either be personal or professional and the latter can include the patient’s own doctor unless connected to the research study: Clinical Trials regulations, above n 772 at Part 5.

⁸¹³ Mental Capacity Act 2005, ss 32(4) and 32(5).

⁸¹⁴ The consultee provisions are similar in some respects to human tissue legislation in England (Human Tissue Act 2004) and New Zealand (Human Tissue Act 2008) but there is no hierarchy of persons who can consent or object. See an explanation of the informed consent and objection provisions in the Human Tissue Act: A Douglass “The New Human Tissue Act” (2008) NZLJ 377.

63. The consultee provisions in s 32 also need to be read in light of additional safeguards in s 33 which include “dissent” during the course of the research.⁸¹⁵ These provisions mean that the research cannot proceed if the person appears to object, unless it would protect them from harm or reduce their pain or discomfort.⁸¹⁶ Nor can anything be done which is contrary to an advance decision, or any other form of statement by the participant, of which the researcher is aware.⁸¹⁷

64. Where treatment is to be provided urgently, the MCA allows by exception for a person lacking capacity to be entered into research prior to a consultee being consulted, subject to strict conditions. The researcher must either have the agreement of a doctor who is not involved in the research, or, if this is not practicable, comply with some other procedure laid down by the ethics committee when the research was approved.⁸¹⁸ Once the urgency has passed, the research must not continue on this basis.⁸¹⁹
    
    
65. The CT Regulations were amended in 2006 to allow unconscious patients in emergency situations to be enrolled in clinical trials without prior consent, provided an appropriate research ethics committee has approved the research.⁸²⁰

⁸¹⁵ There is also a curious and slightly contradictory provision in s 33(3) of the MCA which states: “In conducting the research, the interests of the participant must always be assumed to outweigh those of science and society.” This principle is in compliance with international standards (Declaration of Helsinki, General Principle 8).

⁸¹⁶ Mental Capacity Act 2005, s 33(2)(a).

⁸¹⁷ Mental Capacity Act 2005, s 33(2)(b).

⁸¹⁸ Mental Capacity Act 2005, ss 32(8) and (9).

⁸¹⁹ Mental Capacity Act 2005, s 32(10).

⁸²⁰ Medicines for Human Use (Clinical Trials) Amendment (No 2) Regulations 2006.

66. The PARAMEDIC-2 study is a large clinical trial that will involve 8000 patients and is looking at whether the use of adrenaline is safe and effective in the treatment of cardiac arrest.⁸²¹ The ethics committee approved the study under the CT emergency regulations. As all patients undergoing treatment for cardiac arrest will lack capacity to consent to their participation, there was an agreed procedure for the investigators to recruit participants to the study.
    
    
67. Adrenaline is routinely used to treat a cardiac arrest. Analysis of international evidence available has shown that while use of adrenaline may improve the return of spontaneous circulation and short-term survival, there is insufficient evidence to suggest that it improves long-term survival and neurological outcome.⁸²² International consensus demonstrated the need for a randomised, placebo-controlled trial of adrenaline. Therefore there is genuine clinical equipoise concerning the two treatment approaches involved in this study.
    
    
68. The ethics committee had to consider two main ethical issues; firstly, whether to deny patients adrenaline, which has been standard care for 50 years despite the growing evidence against its use; and, secondly, whether relatives of participants who die should be told that their family member was in the study, in view of the low (1 in 10) survival rates in out-of-hospital cardiac arrests.⁸²³
    
    
69. Following a public information campaign and consultation about the study, the ethics committee agreed to an “opt out” process for consent. Members of the public who do not wish to take part, in the event that they have a cardiac event, can request a steel “no study” bracelet. In respect of whether to inform families, it was decided the burden of actively informing the family outweighed the potential benefit, unless families initiated contact; then they can meet with the ambulance team. Although there was some public opposition,⁸²⁴ the ethics review process allowed this large and important study to proceed.

⁸²¹ The PARAMEDIC-2 trial was reviewed and approved by the South Central Oxford C Research Ethics Committee [14/SC/0137]. This clinical trial is a double blind, randomised placebo controlled trial of the use of adrenaline in cardiac arrest in hospital, commenced in December 2014 and runs to 2018. As at 11 February 2016, 2000 paramedics are now trained in the trial procedures and 1500 patients were recruited. http://www2.warwick.ac.uk/fac/med/research/hscience/ctu/trials/critical/paramedic2/

⁸²² The International Liaison Committee for Resuscitation synthesised available evidence in 2010 with a re-assessment in 2012 (see the Adrenaline Trial Protocol, 3 March 2014, Oxford C REC: 14/SC/0157). The circumstances are similar to those of the CRASH trial (corticosteroid randomisation after significant head injury): steroids that had for years been given in head injury were actually doing harm. P Edwards, M Arango, L Balica and others “Final results of MRC CRASH, a randomised placebo controlled trial of intravenous corticosteroid in adults with head injury—outcomes at 6 months” (2005) 365 Lancet 1957.

⁸²³ Interview with Nigel Wellman, Chair of the Oxford C Ethics Committee (Oxford, 2 June 2014).

⁸²⁴ M McCartney “Adrenaline in cardiac arrest: it’s unethical for patients not to know” (2014) 349 BMJ g5258 (22 August 2014). In the news media it was reported that, for people to be able to opt out, “there needs to be an information storm so that all potential participants will see some information about the trial. [Only] then is it legitimate to say that anyone who has not opted out has consented to participate.” The author of the BMJ article then asked, “But where is the consent from the thousands of other people who have cardiac arrests but do not know that the adrenaline that they receive may harm them?”

70. Although the MCA covers the involvement of incapacitated adults in research, it does not make specific mention of innovative treatment, which is sometimes difficult to distinguish from research. Innovative treatment is often an extension of usual treatment but may expose the patient to a greater degree of risk than established procedures.
    
    
71. In Simms v Simms,⁸²⁵ use of an experimental treatment, not provided during research, was authorised by the Family Division of the High Court when it had not been tested on human beings. Its use was approved for two young patients (16-and18-years-old) who were thought to be suffering from variant Creutzfeldt Jakob disease (vCJD).⁸²⁶ Dame Elizabeth Butler-Sloss accepted that, although the patients would not recover, the treatment offered the only hope for them in slowing down the decline in their condition. The concept of “benefit” in this context would encompass:⁸²⁷ An improvement from the present state of illness, or a continuation of the existing state of illness without deterioration for a longer period than might otherwise have occurred, or for the prolongation of life for a longer period that might otherwise have occurred.
    
    
72. The current standards in New Zealand⁸²⁸ have reduced the scope of ethical review, which no longer covers “innovative practice”, or what was referred to as “innovative treatment” in earlier standards,⁸²⁹ and as “new or unorthodox treatment” in the Cartwright Report.⁸³⁰ People receiving such treatments who are unable to consent through their incapacity are just as vulnerable, however, as patients involved in research. They may be just as unaware that they may be exposed to unnecessary or unacceptable risks. This was the case with the patients whose treatment was investigated in the Cartwright inquiry. Any review of the regulatory framework for ethics review should therefore put innovative treatment back into the scope of ethical review, as originally recommended by the Cartwright Report.⁸³¹

⁸²⁵ Simms v Simms, PA v JA [2003] 1 All ER 669, [2002] EWHC 2734 (FAM).

⁸²⁶ There are no reported cases regarding research in the Court of Protection under the MCA. Although this decision was made before the MCA came into force, it is likely that the Court of Protection would reach a similar decision, given that the innovative treatment was deemed to have been in the best interests of the person lacking capacity to consent: Letts, above n 282 at 149.

⁸²⁷ Simms v Simms, above n 825 at [57].

⁸²⁸ Ministry of Health Standard Operating Procedures for Health and Disability Ethics Committees (MOH, Wellington, 2014) www.ethics.health.govt.nz.

⁸²⁹ Ministry of Health Operation Standards for Ethics Committees (Updated ed, MOH, Wellington, 2006).

⁸³⁰ The “unfortunate experiment” was concerned with a situation where withholding of standard treatment of the time from women with pre-invasive cervical cancer was not thought by the researcher to expose them to harm. The women concerned did not give informed consent to participation in research and were unaware they were participating in medical experimentation. Cartwright report, above n 740.

⁸³¹ New Zealand Law Society submission to NEAC (16 February 2012).

73. There is a wide range of circumstances in which people who lack capacity to consent to research could, and should, share in the benefits and burdens of research. The key question is how to protect vulnerable research participants from harm and exploitation without excluding the populations to which they belong from the benefits of research.
    
    
74. Right 7(4) of the HDC Code is an inadequate legal basis for allowing participation in research by adults incapable of giving informed consent. In addition, the outdated provisions of the PPPR Act do not allow their participation in a sufficient range of research, or support people with diminished capacity to participate in worthwhile research that may benefit them.
    
    
75. Within a cohesive regulatory framework, where the risks are minimal, the law should permit research on people who lack capacity that has potential to benefit either them or other people with a similar condition, provided there are clear statutory safeguards to protect the interests of such vulnerable research participants.