HDC Consultation on research involving adult participants who are unable to give informed consent.
By The Nathaniel Centre
We note and endorse the idea that “The right to make an informed choice and give informed consent before receiving health or disability services, including participating in research, is the cornerstone of New Zealand’s Code of Health and Disability Services Consumers’ Rights (the Code)”, (HDC Consultation Document, p. 1). In a similar vein, we have previously written about the critical importance of informed consent, advocating that all people have a right not to be experimented on without their knowledge or consent, whatever the nature of the research.i
It is broadly accepted that the history of ‘informed consent’ in human research goes back to the Nuremberg Code of 1947. This Code was developed after the Nuremberg trials at the end of the Second World War which exposed the unethical nature of research carried out by many Nazi researchers. The lesson learnt from this and other well-known instances of unethical research, such as Tuskegee and Willowbrook, is that justifying research on the basis of its potential benefits or outcomes alone, and without reference to the inalienable rights and dignity of human participants, all too easily leads to human exploitation and harm. Upholding informed consent is one of the key ways in which the rights and dignity of research participants can be protected.
In New Zealand, current thinking and practices around ethical review and the centrality of informed consent have been informed by our own instances of unethical research, including the removal and retention of organs from deceased babies without parental consent and the ‘unfortunate experiment’ on patients with cervical cancer carried out at National Women’s Hospital.
The current Code of Health and Disability Services Consumers’ Rights allows research on a person who is unable to give consent totake place only if participation in the research is in the person’s best interests. It thus reflects a strong commitment to the principle of informed consent. It also reflects a commitment to ensuring that the interests of the person must not be subsumed to those of society. In other words, it embodies a rejection of the main premise underpinning utilitarianism, the idea that ‘the greatest good for the greatest number’ is a sufficient measure of what is ethically acceptable.
If there are to be changes to the parameters which currently proscribe non-consensual research on adults, it is critical that our society’s commitment to the notion that the best interests of the person must ultimately always outweigh those of society (Consultation Document, p. 44, n.3) be upheld and not eroded in any way.
We have previously argued that there can be legitimate exceptions to the requirement that informed consent be obtained from research participants in certain exceptional circumstances. Thus, in 2015 we wrote that the “only exceptions to this are in circumstances where (i) the research is strictly observational or (ii) participants are, for various reasons, unable to give consent, in which case consent must be sought from someone legally entitled to provide consent for them.” In the same article we alsostated: “In exceptional circumstances, limited disclosure may be justified or consent might be obtained retrospectively, for example because of the need to avoid a biased response. It is also possible to seek a waiver of consent where the risk is low and where there are strong reasons why it would not be practical or possible to obtain consent.” We then added: “… in these situations, the ethical rider is that such research must always be held up to close scrutiny by an appropriately accredited and independent review body.”ii
We note that current practice in New Zealand, by allowing consent to be waived in circumstances when it is deemed to be in the person’s best interests, already constitutes an exception to the principle of informed consent, albeit a very narrow one. This debate, therefore, is about the scope of such exceptions in New Zealand and, more specifically, whether they might now be broadened to include some situations where research on a person unable to give consent is justified on grounds other than being in their personal best interests.
Our overall position is that we are not in principle opposed to broadening the parameters which regulate non-consensual research on adult participants.
Our response to the two fundamental questions posed in the Consultation document (“Are New Zealand’s current laws regarding non-consensual research [involving adult participants] appropriate and, if not, how should they be amended?”(Consultation document, p.2)) reflects our belief that it is, in theory, both possible and ethical, in certain proscribed circumstances with adequate scrutiny and safeguards, to broaden the circumstances in which consent for adult participants in research might be waived.
We add the qualifier “in theory” because we believe that any moves to broaden the parameters around non-consensual research would only be acceptable within a system of robust, accredited and independent ethical overview. Given the experience of two of the writers of this submission who have previously served as members of a HDEC Ethics Committee for a combined period of 11 years, our concern is that some of the more recent restructures of New Zealand’s HDEC ethical review system have contributed to a less comprehensive and less robust system than was previously the case – fewer committees and fewer members as well as a significantly narrower set of criteria for determining when research requires HDEC review.
Any moves, therefore, to change the current law must, in our mind, first be considered against the current effectiveness of ethical review committees in New Zealand. In which case, a decision in principle to broaden the criteria for non-consensual research might be considered unworkable or unsafe in the current context of ethical review. The decision might, therefore, be made not to proceed with any changes for pragmatic reasons even while it was otherwise considered ethically acceptable in theory.
In the event it was deemed practically acceptable to broaden the parameters, it is our firm belief that, because of the inherent risks in non-consensual research, such applications should require an additional layer of scrutiny to what is already currently available by a group under the auspices of the Health and Disability Commissioner’s Office that includes representatives of, or people able to speak on behalf of or advocate for, the group of persons on whom the research will be carried out.
When reflecting on why it might be ethically acceptable to allow non-consensual research on a person when it is not in their best interests and when it will introduce an element of risk, the obvious answer is that there will be benefits for others, whether persons in similar circumstances or, perhaps, society in general. Herein lies the greatest danger in broadening the parameters of non-consensual research because any such move inevitably opens the door to the sorts of utilitarian arguments and premises that have characterised unethical trials such as Tuskegee and Willowbrook.
This danger reinforces for us the need to de-lineate three other parameters when evaluating non-consensual protocols: (i) ‘the interests of the person must always be assumed to outweigh those of society’; (ii), in situations where this is not clear for a specific person, the ‘precautionary principle’ must be automatically invoked which dictates that the person not be included and (iii), any expression of dissent (“whether by showing signs of resistance or otherwise” – Mental Capacity Act 2005 (England and Wales) as quoted in Consultation Document, p. 43) from a potential participant incapable of giving consent should be regarded as sufficient reason for them not to be included (see also Declaration of Helsinki, as quoted in Consultation Document, p. 58).
In addition, as we highlighted in our submission to the National Ethics Advisory Committee (NEAC) on “Cross-sectoral Ethics Arrangements for Health and Disability Research” (February 2015), we see that it is a significant weakness of the current system of ethical review in New Zealand that there is no mechanism for checking that a particular study is carried out according to the agreed protocol. We believe that such follow up should be mandatory for all non-consensual research projects, something that will require a specific mechanism to be created and funded. This requirement, we note, is stipulated in Paragraph 24 of the Declaration of Helsinki under the heading of Research Ethics Committees: “The committee must have the right to monitor ongoing studies.”
Whereas some might see such requirements as creating unnecessary barriers for researchers, we see that they will ensure that non-consensual research proceeds only when it is absolutely required, and that non-consensual research is undertaken with a strong focus on ethical practice.
An Adjusted Framework for Non-consensual Research on Adult Participants:
Our suggestion is that an adjusted New Zealand Code follow and reflect the relevant sections of the Declaration of Helsinki which address the question of non-consensual research:iii
28. For a potential research subject who is incapable of giving informed consent, the physician must seek informed consent from the legally authorised representative. These individuals must not be included in a research study that has no likelihood of benefit for them unless it is intended to promote the health of the group represented by the potential subject, the research cannot instead be performed with persons capable of providing informed consent, and the research entails only minimal risk and minimal burden.
29. When a potential research subject who is deemed incapable of giving informed consent is able to give assent to decisions about participation in research, the physician must seek that assent in addition to the consent of the legally authorised representative. The potential subject’s dissent should be respected.
30. Research involving subjects who are physically or mentally incapable of giving consent, for example, unconscious patients, may be done only if the physical or mental condition that prevents giving informed consent is a necessary characteristic of the research group. In such circumstances the physician must seek informed consent from the legally authorised representative. If no such representative is available and if the research cannot be delayed, the study may proceed without informed consent provided that the specific reasons for involving subjects with a condition that renders them unable to give informed consent have been stated in the research protocol and the study has been approved by a research ethics committee. Consent to remain in the research must be obtained as soon as possible from the subject or a legally authorised representative. (Our emphasis added).
In summary, we argue that the key points of an adjusted Code which would broaden the parameters within which non-consensual research could be carried out in New Zealand are:
The research cannot otherwise be carried out using participants capable of providing informed consent and …
The research will directly promote the health of the group represented by the potential subject and …
The research entails only minimal risk and minimal burden and …
The potential subjects’ dissent, however it is expressed is respected absolutely and …
The research may be done only if the physical or mental condition that prevents giving informed consent is a necessary characteristic of the research group and …
Informed consent is sought from a legally authorised representative and …
The research is given a full review by the appropriate accredited HDEC Committee and …
The research is subject to an additional layer of scrutiny by a group that is overseen by the Office of the Health and Disability Commissioner, a group which includes representatives of, or people able to speak on behalf of or advocate for, the group of persons on whom the research will be carried out and …
There is ongoing, independent, effective and active monitoring of the research project while it is being carried out and …
The participants’ confidentiality is absolutely respected and …
In cases where a participant regains consciousness after having been included in a trial, they are given the option of having their data withdrawn where that is possible and …
Any data that is retained after a study is only able to be used for further research in an aggregated or totally anonymous form unless separate independent ethical consent is sought.
We are in principle open to the parameters of non-consensual research being broadened within New Zealand in line with the World Medical Association Declaration of Helsinki that we have outlined above. What we are proposing would involve moving from the “best interests framework” that characterises current practice in New Zealand to one that takes account of and permits a degree of minimal risk and minimal burden to participants.
The key questions in moving to an approach that tolerates a degree of risk are ‘Who decides?’ and ‘How will assessments about “minimal risk” and “minimal burden” be made?’ For this reason, we have argued that there must first be a degree of confidence in the current system of ethical review in New Zealand. That is, a determination must be made that the HDEC review committees are adequately resourced and adequately trained to foresee and prevent the sort of excesses that have characterised research on vulnerable persons throughout the 20th Century in numerous places around the world including New Zealand.
While broadening the parameters of non-consensual research carries inherent attitudinal risks because it can dispose society to the dangerous excesses of utilitarian thinking and make certain actions which undermine the inherent dignity of persons seem morally acceptable, we think this risk can be safely managed by the introduction of an additional layer of ethical scrutiny that is carried out under the auspices of the Office of the Health and Disability Commissioner.
Sue Buckley (PhD) has been involved in social and health research over the last 16 years in both government and university contexts.
Associate Professor John France (PhD, DSc, FAACB) is a reproductive scientist (now retired). He is a former member of the Auckland Health and Disability Ethics Committee and former member and Deputy Chair of the Northern Regional Health and Disability Ethics Committee.
John Kleinsman (PhD) is director of The Nathaniel Centre and a former member and Deputy Chair of the Central Region Health and Disability Ethics Committee. He is a current member of two Institutional Research Ethics Committees.
i Kleinsman, J, and S. Buckley. "Facebook Study: A Little Bit Unethical but Worth It?" Bioethical Inquiry 12, no. 2 (2015): 179 - 82.
iii Declaration of Helsinki. 64th WMA General Assembly, Fortaleza, Brazil, October 2013. https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/