Bioethical issues: Immunisation and minimally informed consent

Recently published in the Journal of Law and Medicine at (2013) 20 JLM 723.

There is a fairly well formed doctrine of informed consent in Australasia that includes the kind of information that a reasonable doctor would impart, the information that a reasonable patient should expect to be given and any details of treatment that a particular patient would need to make a reasoned decision. Whereas this standard seems generally applicable in clinical practice, the situation is otherwise in public health. The ethical balance to be struck in public health-related choices is a little different due to several factors. These include the public interest in effective herd immunity, the practicalities of mass immunisation programs, the likelihood of subjective bias distorting an objectively reasonable choice, and the unreliability of anecdotal evidence regarding risks and benefits in this area. Four factors of ethical importance arise: a proper system of health governance and the trust it warrants; the likelihood that subjective assessments of risk and benefit may be misleading; the need for individual compliance in the service of a shared or public good; and the nature of adequate information for the relevant decision in relation to the objective best interests of members of a community. These combine to justify a less stringent standard for consent in certain public health settings.

Current laws, codes and guidelines require health care professionals to inform patients of the nature, purpose, benefits, side-effects and risks of a treatment or procedure before administering it. The level of information given should be determined in response to the particular needs and concerns of the individual patient, a standard – often referred to as the “subjective patient standard” – confirmed through the decision of Rogers v Whitaker (1992) 175 CLR 479.¹ This standard reflects a certain understanding of the ideal professional-patient relationship as a “partnership”, established on a platform of respect, collaboration and trust.

Immunisation is one aspect of health care practice where this model appears to be less applicable. Typically, immunisation procedures are carried out with an emphasis on efficiency, and little time and discussion are given to discerning whether the individual patient has particular questions or concerns about particular risks. This is not to say that the procedure is undertaken without concern for the patient, simply that the development of the relationship and ascertainment of her or his particular concern is not, in this context, considered a priority, and in some contexts seems practically unrealistic. This at least seems to be the case in mass vaccination programs, such as are annually offered by large institutions (including hospitals) to protect staff from seasonal influenza. In such programs an abbreviated or truncated clinical relationship appears to be required by the basic purpose, which is to safely vaccinate as many people as possible in as short a time as possible, and in a manner that causes minimal distress or disruption. Insisting on “full” verbal disclosure of the risks and benefits of immunisation for every patient would undermine this goal.

Nevertheless, these widespread and generally uncontroversial practices sit uneasily alongside public and governmental statements on immunisation,² which, in New Zealand, set the following demanding requirements for “vaccinators”:

Standard 2: The vaccinator obtains informed consent to immunise
Required characteristics of the vaccinator
2.1 Evidence-based information about the disease and vaccines must be given to individuals/parents/ guardians to enable them to make an informed choice and give informed consent.
2.2 The vaccinator communicates in a form, language and manner that enables the individual/parent/ guardian to understand the information provided. Communication should be supported by evidence-based health education material.
2.3 The vaccinator allows time to answer questions and obtains feedback indicating that the individual/parent/guardian understands which vaccine is being recommended and why.
2.4 The vaccinator informs the individual/parent/guardian about the NIR [National Immunisation Register] including information on the use and disclosure of the information held on the NIR, how the information is stored and that all vaccinations given will be recorded on the National NIR (if applicable) unless the individual/parent/guardian chooses to opt off the NIR …

The statements in which these requirements are set out explicitly invoke certain of the rights included in the Code of Health and Disability Consumers’ Rights, which functions as a legal standard for clinical encounters in the New Zealand setting, namely:

• Right 5: Right to effective communication;
• Right 6: Right to be fully informed; and
• Right 7: Right to make an informed choice and give informed consent.

Though these requirements are in close agreement with the general standards for clinical informed consent, they suggest a more extensive discussion than that standardly possible in the brief encounters of mass immunisation programs. One might take this as indicating that the standard requirements of informed consent are unrealistic or out of step with actual practice. Another response is to argue that our procedures to try and achieve immunisation outcomes are necessarily contrary to current ethical standards and that even though the practice could be regarded as a breach of patients’ rights, it should be permitted under the broad rubric of “practicality” and therefore as not a major concern in this setting. That stance smacks of a kind of “ad-hocery” that seems like an ethical compromise. An alternative response becomes available through a more analytical discussion of the desiderata for a range of clinical encounters in the context of a contemporary health system. In the case of immunisation, that would include a consideration of the balance between societal or institutional concerns such as access and justice for all, and the more individual requirements for consent to interventions as part of clinical care. We therefore need to explore the issues a little further to find a reason why this apparent attenuation of hard-won patient rights can properly be part of an ethically responsible health system.

We could opt for the view that notions of public or shared good legitimise tacit consent which marginalises the full requirements of individual informed participation in health practice, but that road is treacherous, for various reasons to do with transparency of government and dangers in health care attendant on the existence of major influential interest groups. The unhealthy relationship that many have noted between health industry players and policy-makers in certain contexts cautions those of us in a quasi-watchdog role as ethicists or advocates of consumers not to relax our guard.³

A different argument is available on the basis of the legitimate decision-making power of a “proper system of health care”.⁴ In such a context, “the underlying framework of shared goods and participation in the shared enterprise that is ‘a proper system’ of health care requiring individuals not to be moral free-riders has a certain ethical bite”. The upshot is that:

• “Respect for relevant values is secured by suitable safeguards in a proper system”;
• “There is no good reason for opting out of a proper system”; and
• “A proper system can presume consent except where explicitly consent cannot be obtained.”⁵

It then becomes important to spell out just what constitutes “a proper system” and what role it has in justifying lesser types of consent for immunisation than those required in general clinical practice. That case turns on several factors:

• the trustworthiness of health systems in relation to their guardianship/kaitiaki function vis-à-vis the health of the public;
• the nature of adequate information for the relevant decision in relation to the objective best interests of members of a community;
• the likelihood that subjective assessments of risk and benefit may be misleading; and
• the need for individual compliance in the service of a shared or public good.

A PROPER SYSTEM AND TRUSTWORTHINESS

A proper system of health care governance is one in which the concerns of individuals are not overridden or neglected but where the fairness of the system or its role in making good decisions for all is properly discharged. Such a system rationally weighs the factors of relevance to health care decisions, such as magnitude of distributed risk and fair use of resources to obtain maximum benefit to all those entitled to them (or, by reason of societal structure, dependent on collective decisions for their basic human rights to be respected). Such human rights in regard to health care could include adequate provision for individual wellbeing insofar as it is practicable within the collective commitments of the community and relevant to the health care system. They may not, for instance, include an unconstrained right to health care services no matter what the likely outcome nor may they include an unlimited right to life-saving interventions not generally considered within the bounds of reasonable medical health care practice.⁶ When such a system strikes the right balance between shared or public good and individual entitlement or responsibility, it can be considered trustworthy in terms of the shared values of the community supporting it and its required duties can be discharged with good conscience by the professionals involved. What is more, individual patients, as well as the public in general, ought to trust that the best will be done for them. A system violates this trust when those making health care decisions are also part of clandestine arrangements and unbalanced policies, eg at the behest of industry players or an insensitive professional elite. Such decisions often would not stand the scrutiny of a concerned public.⁷

ADEQUATE INFORMATION ABOUT OBJECTIVE BEST INTERESTS

It is part of the responsibility of a properly functioning system to foster a climate of open debate and policy-making that carefully weighs the evidence relating to any policies it adopts and makes balanced decisions about what, in general, will serve the best interests of those who depend on it for their health care. In the face of such decisions, special pleading on behalf of individuals or groups is not to be accorded unreasonable influence on what is done. For instance, were we to ask of the health system that it provide, for a small minority of those supporting it, treatments which would severely compromise its ability to care for the rest, then a decision not to do that might be the only one it could justly make. That stance leaves it open for the shortfall in available interventions to be made up outside the shared framework even though within it the stewardship of resources in the shared interest might be justly required. That policy may lead to high-profile tragedies and these might command public sympathy, but as a responsible guardian of community trust, those charged with the relevant decisions must, with due sensibility, be resolute. We often would like to do the most we can for all but there is sometimes a need to make the appropriate response rather than the response of desperate extravagance as a realistic ethical stance in a tragic situation. We are also committed to maximally valuing the life of every member of the community even though we routinely make what can seem like cynical choices that result in harm to the few.⁸ This occurs when, for instance, we set a speed limit knowing that at that speed, whatever it is, there is a certain speed-related effect on road traffic accident statistics. Parallel reasoning applies to immunisation: we adopt a community-wide health-related measure that is likely, on a statistical basis, to result in or allow certain harms to occur because of the net value to us all (even to the one adversely affected, given that he or she was part of a population for which a probabilistic net benefit was secured). To come out on the wrong side of a statistic is tragic when that wrong is severe morbidity or mortality but we live in a world of uncertainties and we have to pursue a policy of choice optimisation rather than absolute safeguards and guarantees.

THE LIKELIHOOD OF SUBJECTIVE DISTORTIONS

Immunisation is a long pay-off strategy for a society in that it is aimed at preventing future disease outbreaks which have only a statistical likelihood of adversely affecting any individual. The gains for a community from such initiatives are largely invisible in the short term and definitely not newsworthy even though they make a great deal of sense for health planners concerned with the health of populations. However, it only takes one case of a child suffering a highly visible or tragic complication from an immunisation to make a massive media impact and raise a spectre of fear in the mind of any parent. Thus, immunisation is a health intervention that is vulnerable to subjective distortion in the minds of members of the target population as individual decision-makers. Such interventions should not be subject to the irrationality of subjective bias because to allow that is to act, potentially or probablistically, to the detriment of all. Therefore, decisions in this area must be made on a more principled basis rather than each of us being allowed to make (or, worse, being set up to make) mistakes in judgment that are going to affect us all. Immunisation is a strategy in which this danger is very real: a series of badly made individual decisions could put all of us at risk on the basis of our shared herd immunity: a bad outcome that should be avoided rather than us being diverted from good policy by an undue quasi-ethical emphasis on (unrealistic) individual autonomy.

THE NEED FOR INDIVIDUAL COMPLIANCE

To safeguard the shared guardianship role of health system decision-makers, individual compliance must be the statistical (and indeed prescriptive) norm that most of us follow to do what is best for all (or to avoid putting all at risk). In such a situation, “the whole nine yards” of informed consent, as it does and should apply to an individual clinical decision, must be attenuated because of the combination of our inevitable interdependence in relation to the specific issue involved and its vulnerability to subjective mistakes of judgment. It is fine for you to refuse any clinical treatment whatsoever for yourself when it is only you (and yours) who will bear the burden of that decision (assuming you have negotiated appropriately among those of you deeply concerned in the decision). It is not fine for you to have the same sovereignty over yourself when your decision has implications for us all.

We can therefore conclude that, in relation to immunisation, both the community as a whole and the individual have not only rights but also responsibilities. The community has a right to protect itself against bad decisions by its members but it also has a responsibility to operate a properly functioning health system in which the voices of those who are dependent on it are properly considered and good decisions made which serve the objective best interests of those concerned. These decisions would need to be made properly with a critical eye to the best evidence available and a freedom from community bias, for instance by a powerful lobby with a commercial bio-medical agenda. Given that that kind of vigilance and critical thinking is in place, it is in everybody’s best interests to be part of a group in which there is herd immunity (to a health threat) rather than one in which there is not. However, if you have such an interest, you have also an obligation to ensure that you do your part to allow it to be accommodated (the same goes for sharing the benefits of health-related research). Thus it is in your (objective) best interest to be immunised and you should (for reasons of the risk to all) not be encouraged or facilitated in reneging on that responsibility. For that reason, the sometimes perfunctory consent processes on behalf of children are ethically adequate in that it is (objectively) in every child’s best interest to be a member of a community sharing herd immunity, and the child is not yet capable of an autonomous decision otherwise. In fact, we could go further and say that we have a duty to immunise children just as we have a duty to protect them from the subjectively distorted judgments of adults leading to abuse or neglect in other areas of parenting. The fact that parents only have a moral right to decide for their children insofar as they are making decisions in their child’s best interests strengthens that obligation. This argument undercuts an individual’s right to insist on a standard of information that would seriously compromise the immunisation program. A similar relaxed view of minimally informed consent could be applied to large-scale, institutionally funded, immunisation programs (such as those described earlier), especially in health care institutions like hospitals. Here the argument for a presumption of consent and therefore less rigorous consent procedures is strengthened not only by duties to the immunisee but also by the consequences of members of the workforce carrying an illness and passing it onto patients.

This understanding of our “objective best interests” as served through the effective operation of a “proper system” does not overturn the standard ethical arguments related to doctor-patient relationships and informed choice. They are rather re-framed in relation to our wider societal interdependence, in ways that are already familiar in other areas of health care ethics, eg in the use of human tissue in research, the rule of rescue, and entitlements to extraordinary health care measures at any age.

Grant Gillett
DPhil (Oxon), FRACS (Neurosurgery); Professor of Medical Ethics, Dunedin Hospital and Otago Bioethics Centre, University of Otago Medical School, NZ
and
Simon Walker
PhD, MA; Lecturer in Bioethics, Otago Bioethics Centre.

¹ Gillett G and Walker S, “The Evolution of Informed Consent” in “Bioethical Issues” (2012) 19 JLM 673.
² See New Zealand Ministry of Health, Immunisation Handbook 2011, http://www.health.govt.nz/publication/immunisation-handbook-2011 viewed 28 February 2013.
³ Spielmans G and Parry P, “From Evidence-based Medicine to Marketing-based Medicine: Evidence from Internal Industry Documents” (2010) 7(1) Journal of Bioethical Inquiry 13.
⁴ Gillett G, “The Use of Human Tissue” (2007) 4(2) Journal of Bioethical Inquiry 119.
⁵ Gillett, n 4 at 124.
⁶ Honeybul S, Gillett GR, Ho KM and Lind CRP, “Neurotrauma and the Rule of Rescue” (2011) 37 Journal of Medical Ethics 707.
⁷ Healy D, “The Latest Mania: Selling Bipolar Disorder” (2006) 3(4) PLoS Med e185.
⁸ See Honeybul et al, n 6.