It has become clear over the past few months that patients cannot rely on the Code of Consumers’ Rights to protect them from being enrolled in clinical trials or other research studies without their consent having been obtained first. It is proving difficult to find out exactly when patients lost that right, and even more problematic to know how to rectify the current unsatisfactory situation.
What hasn’t changed is the fact that many patients/consumers are willing to consider the offer of becoming a research participant – provided they are first given the opportunity to read the patient information sheet about the research trial and to have their questions answered.
The AWHC was established in 1988 and held its first meeting in July that year, a month before the release of the Cartwright report of the Inquiry into the treatment of cervical cancer at National Women’s Hospital. In the wake of the report’s publication ethics committees were completely trans-formed into committees with both lay people and health professionals whose primary role was to protect the rights of patients and ensure that no-one was enrolled in any kind of research without giving their informed consent to be involved.
The office of the Health & Disability Commissioner was set up in late 1994 and consultation on a proposed Code of Consumers’ Rights began the following year. On 1 July 1996 a legislated Code of Consumers’ Rights came into effect.
Right 6, the right to be fully informed, states that every consumer has the right to the information that a reasonable consumer, in that consumer’s circumstances, would expect to receive, including -
1(d) Notification of any proposed participation in teaching or research, including whether the research requires and has received ethical approval; and
1(e) Any other information required by legal, professional, ethical, and other relevant standards.
Right 7, the right to make an informed choice and the right to give informed consent, states that:
4(c) Where a consumer is not competent to make an informed choice and give informed consent, and no person entitled to consent on behalf of the consumer is available, the provider may provide services where –
(a) It is in the best interests of the consumer.
For some unknown reason the debate about ethics committees approving research involving participants who lack the capacity to consent to participate has focused almost solely on Right 7(4) of the Code, not Right 6(1) d and e. Even the Health & Disability Commissioner’s response to the letter the AWHC wrote about the practice of enrolling people in research trials without their informed consent, focused on Right 7(4). Anthony Hill stated in his letter “as you know there are two passionately held and opposing schools of thought on Right 7(4).”
Actually, the AWHC did not know that. Having been involved in the two consultation processes during the development of the Code of Consumers’ Rights, the Council believed that the mere thought of enrolling people in research trials without their consent was illegal, utterly abhorrent and against the Declaration of Helsinki, and the NZ Code of Rights, being enshrined in legislation, protected patients from such practices. After all, this issue was at the very heart of the Cartwright Inquiry. Once the recommendations in the Cartwright Report were implemented patients would never have to worry about being enrolled in research trials without their consent ever again. Right? Apparently not.
Anthony Hill stated in his letter that “this is not a matter about which HDC has received complaints, nor is it one that prompted many submissions in the recent Act and Code review, soon to be completed.”
The AWHC did not include the issue in our submission because we did not know that in New Zealand thousands of unconscious patients in intensive care units around the country are being enrolled in clinical trials without their consent. The Council was also blissfully unaware that there was any debate going on about whether this practice was legal or not.
The Ministry of Health’s chief legal advisor, in a letter to the Ministry’s ethics committee chairs and members, dated 7 April 2014 but not posted on the ethics committee website until months later stated:
“Research involving participants who do not have the capacity to consent (and where no-one legally authorised to give consent on behalf of the participant does so) is not lawful unless it satisfies Right 7(4) of the Code of Health and Disability Services Consumers’ Rights (the Code). Committees do not have the authority to give consent on behalf of participants.”1
It also says: “Investigators must satisfy the committee that proposed research is lawful before the committee approves an application. Committees are not required or able to give legal advice to investigators; it is the responsibility of the investigator to ensure that the research is lawful.”
This is not at all reassuring. There is big money involved in clinical trials and both the investigators and the DHBs have a huge conflict of interest in deciding what research is lawful and what is not.
The letter from the MOH’s chief legal advisor has not been enough to stop ethics committees’ approving research involving participants who lack the capacity to consent.
The HDC, the consumer watchdog, is sitting on his hands, has refused to undertake an investigation, and is waiting to receive a complaint from someone other than the AWHC, although the Council hasn’t given up and has written to him again.
The AWHC has also written to Minister of Health Tony Ryall. As he was the Minister who pushed through the changes that ensured the focus of ethics committees would now be on approving research proposals – not protecting the rights of research participants – it is extremely unlikely that Mr Ryall is going to come to the rescue of the unconscious patients in the country’s ICUs any time soon.