Autonomy and Solidarity - the struggle of the public interest

Arguably, the dominant post-enlightenment value is ‘autonomy’, grounded in a particular construction of liberalism. However, a relatively short time before this, after World War II, solidarity and welfarism held the same dominant political and philosophical way. Bioethics research (research in medicine, life sciences, and biotechnology) is an area where the movement between the two positions remains extremely difficult to negotiate. This is essentially because individuals wish to hold two contradictory positions: many wish to hold the two positions - I want to be able to receive life-saving treatment for whatever disease or illness I might present to healthcare, but simultaneously I do not want to participate in the research that will ensure the therapies I crave.

Barbara Prainsack and Alena Buyx have done much to develop a new theory of solidarity, and this is gaining traction in bioethics discussions. However, the grip of autonomy is very strong. Thomas Beauchamp and James Childress famously developed a theory of bioethics focusing on “autonomy”, “non-maleficence”, “beneficence” and “justice”. Devised in the 1970s and 1980s, and responding to predominantly interventionist medical research, autonomy is rated highly - as it is in the Nuremberg Code, and in the Helsinki Declaration. Considered against the secondary processing of already gathered data for related research purposes, the dominance of solidarity might be challenged, but in the bioethics paradigm it is almost intractable. One wonders, however, how the collectivist, welfarist citizens of the late 1940s or early 1950s might have seen this modern dominant individualism, and the seeming contradiction of the expressed desires.

When did liberalism lose its moorings in morality?

One approach to this conundrum and paradigm shift might be found in the definition of liberalism. If one looks back to the pre-enlightenment and early enlightenment expressions of liberalism of, for example, John Locke, Ashley Cooper, Third Earl of Shaftesbury, Adam Smith, Immanuel Kant, there is an undergirding commonality of solidarity. Locke’s theory of private property allows an individual to own property on the basis of his or her added value through labor, but only to the extent that there are sufficient resources left available for others. Shaftesbury’s ‘politeness’ is predicated on the interdependency of individuals and their duty to consider the needs of others in forging a polite society (one that could replace the social order removed by civil war and the overthrow of divine right monarchs). Smith, before writing An Inquiry into the Nature and Causes of the Wealth of Nations wrote The Theory of Moral Sentiments which focuses on the necessary shared moral platform created through empathy between individuals. Kant, in the Categorical imperative, whilst fully embracing the enlightenment primacy of the individual, identifies through reason the necessity to hold others as ends in themselves not merely as ends to one’s desires.

One can perhaps go further. Nikolai Kropotkin, the central figure of anarchism, writes his central work Mutual Aid around the imperative of empathy across species; to Kropotkin, anarchism is about individuals taking control of decision-making not only about their own lives, but about their life in community with others. Anarchism has duties to others, and a mutual responsibility of care. Even in his late work on ethics, Jean-Paul Sartre seems to move from the individual as the sole focus of existentialism, to the struggle for the individual to make sense of his or her life in relation to duties to others.

This balanced liberalism - this autonomy in balance with solidarity towards others - can be seen until the 1980s. The political shift to neoliberalism, found in the Monetarism of Margaret Thatcher in the UK and Ronald Reagan in the US, saw a social shift to a liberalism that rejects, rhetorically if not fully in all social policy, the welfarist solidarity of the post-war years. Solidarity is seen as nurturing dependence and a lack of the duty to provide for oneself. One wonders to what extent the excess of the market (culminating in the financial crisis of the early 2000s) was part of the Thatcherism or Reaganomics, but the policies of individualism facilitated a social shift that allowed individuals to reject notions of the collective. This, as in all society, is seen in bioethics. The question is how RECs should respond to this shift, and to the seeming contradictions in reasoning that it produces in relation to health research and healthcare. Is it the role of RECs simply to reflect the dominant culture of the day, or, as a matter of ethics, to challenge it? One of the key areas for this is the appeal to the ‘public interest’ as a justification for overruling the individual interests of a person.

Considering the Public Interest

The public interest is a useful legal tool. It enables judicial or bureaucratic discretion to resolve fact situations that were unforeseen at the time of the drafting of the particular rule. The problem is that because it has an element of pragmatism about it, its operation is not clearly defined. It often operates through a rather Utilitarian calculus of weighing the harm to the individual who will be deprived of a particular right ‘in the public interest’ with a notional sense that the public at large will benefit from the deprivation of that right and that is a desirable situation; the deprivation of rights of one individual or a few individuals is worth sacrificing in the interests of the many.

If one is a Utilitarian, this is perhaps acceptable, although the calculus is often, in the case of the law, applied in a rather vague way; it is almost as if the public benefit part is rather self-evident in the operation of a public interest argument (see for example, the appeal often made to ‘the public interest’ by newspapers or other news media in pursuing a story that intrudes on the privacy of an individual). In a rights-based ethical environment this is much more problematic.

Townend has made a three-stage argument to attempt to operate an appeal to the public interest in a rights-based ethical environment.[1]

Stage One. This is essentially a refinement of the Utilitarian calculation. The problem of the Utilitarian calculation is that it poses one individual’s loss against the potential gain of many; one individual could lose, for example, 100 units of happiness, whereas the ‘public’ made up of 101 individuals might only gain 1 unit of happiness each, but the effect is to tip the balance in favor of the mass. A more balanced approach would be first to weigh the potential loss of the individual against the potential loss to a notional individual member of the public: one balancing with one. If one took the foreseeably worst affected member of the public this might produce the fairest consideration of the public interest argument.

Stage Two. This moves the argument from Utilitarianism to a rights-based consideration. Taking Kant’s Categorical Imperative, an individual must, in making choices, treat others as ends in themselves not merely as means to one’s ends; one should not instrumentalize others. Having made the Stage One calculation, the individual is presented must respond to the question, will you insist on your rights? That rights-claiming is, of itself, an action that is subject to the Categorical Imperative. Confronted with the information that another individual will suffer more as a result of my defending my privacy that I would lose by not defending it, I would have to ask myself if I was merely using the other person as a means to my ends, rather than treating him or her as an end.

Stage Three. Of course, Stage Two produces an individual’s moral response to the dilemma of the appeal to the public interest. Stage Three attempts to universalize that response as a law. Law-making is itself a human action that is subject, in Kant, to the Categorical Imperative. When considering whether to make a law, the law-maker can only place a burden upon an individual that s/he would be bound to accept under the Categorical Imperative. Therefore, if the law-maker sees the need to make a law in a particular area, then s/he can only require of the individual that which morality would also require - as under Stage Two. And the appeal to the public interest is the example of such a requirement; the individual’s rights must be challenged because of the supervening needs of another.

Mark Taylor takes a Rawlsian approach to the construction of the public interest. Rawls relies on the reasonableness of rational actors. Thus, the public interest is constructed by an appeal to what the reasonable person cannot disagree with, even when it is against his or her particular interest. The reasonable person, when confronted with a request in the public interest, might not like the request, as it may conflict with his or her personal desires, but he or she cannot deny that the request is reasonable and should be followed.

The Golden Standard of Participant Protection - Anonymization and Informed Consent

(Research participant) Autonomy is seen as a central premise of bioethics and of human dignity. One's right to choose to participate in medical research in an informed way, and to be protected from identification within research as far as is possible, is almost unquestioned. It is at the heart of the Belmont Report [2] and the work of Beauchamp and Childress;[3] it is one of the immediate concerns for

RECs in their assessments of research protocols.

Arguably, anonymization and informed consent are seen as default safeguards of participant autonomy. However, neither anonymization nor informed consent are without their conceptual and practical problems.

A. Anonymization

There are a number of problems, at different conceptual levels.

1. Meaning

"Anonymization" is used to mean different things in different jurisdictions and disciplines. In certain settings, it is taken to mean that the participant will no longer be identifiable in the research - i.e. in the raw data and in the processed data and products of the research, the participant will not be identifiable. In other settings, anonymous data might relate to a downstream use of the data - the data, in the hands of the individual in question (perhaps a second researcher using the data gathered by another) holds it without identifiers, but the participant could be re-identified by linking the data to the key held by another. To some, this would describe a form of "pseudonymization" of data; data held in a form that prevents immediate identification of participants without access to a key held separately. These terms are to a very large extent context specific, and the context will define the meaning of the terms. However, this uncertainty of language itself produces confusion.

2. Availability

When data was processed without electronic means, or at least before the linking power of the internet, the concept of removing parts of the data so that the remaining data no longer identified an individual (or perhaps a group to whom the individual belonged) might have been more possible. Of course, it was never completely possible. Data that relates to an individual is a dynamic composite of snips that links together in different ways making individuals more or less identifiable at any given time, depending on who is looking at the data. And equally, it is extremely rare that a single snip alone identifies a particular individual (perhaps in any meaningful sense); personal data is composite and context specific (as Taylor has shown).

First, even one's name, alone, means relatively nothing. The name "David Townend" printed on an otherwise blank piece of paper means nothing on its own. It only resonates and finds identifying meaning when it is linked to other information. Thus, if someone 'googles' his or her own name, in the vast majority of cases, one finds a number of entries for that name. First, that person will know that (almost invariably) not all the references relate to him or her; most often, the name relates to a number of individuals. However, in that realization, there is a second element: each reference gives a context within which the name becomes identified. So, an individual labelled "David Townend" might be a Professor in Maastricht (and because of the long memory of the internet, a Senior Lecturer in Sheffield), a person giving a number of conference papers in relation to Law, a singer in a jazz band, or a bass soloist in a number of choral concerts. Only some people will know that these elements different contexts relate to a particular holder of the name "David Townend", and that they should be distinguished from a host of other "David Townend"s for whom there are results.

The second major observation is that the same information has different value in different contexts. Add the name "David Townend" to a list of students and identify him as the tutor of the group, and the value is increased, but perhaps of little worth; add the tutorial times and the addresses of the people on the paper, and in the hands of a door-to-door sales person, it has a particular value (at those times, no-one is in) whereas in the hands of a house-breaker, the list has another value (at those times, no-one is in!). And arguably, there is no intrinsic value in any particular type of data (e.g. medical or genetic data); even 'sensitive personal data' has different values in different combinations and in different contexts.

This means that in some situations, we over-compensate for the presumed value of data; in other situations, we might under-estimate the value of data.

In terms of the possibility of anonymization of data, the composite, dynamic, context specific nature of data, and the vast amount of data available on-line and on demand, anonymization is perhaps a promise that can no longer be made. It is based on an idea that data sets are fully independent – fully free of external connections. If that were possible, a data-bubble might have sufficient 'snips' removed to render the remaining data without identifiers. However, such bubbles burst. Data sets are not held in perfect isolation of other data, and snips can be linked to identify individuals from other means.

3. Desirability

Anonymization has been (some would argue still is) a great safeguard for identity. However, is it a great safeguard for dignity?

Imagine that one finds that one's tissue and medical data, given for research on the strict understanding that it would be anonymized, has been used for chemical weapons research. To many, such a finding would offend his or her dignity.

Likewise, imagine that one finds that the tumor that has just been found by one's doctors and is inoperable at its stage of growth was seen (as an incidental finding) in a scan that one had as part of a research project one year earlier in a much smaller and operable state. But for the safeguard of anonymity, the researchers would have sent such data to one's personal physician. Again, a safeguard of one's dignity?

Of course, these two examples are not uncontested in themselves, but they are contested, and make the claim to the supervening value of anonymization as a natural safeguard to (medical) research participants itself debatable.

B. Informed Consent

Informed consent is difficult. It is at the heart of the modern consumer (transactional) society. Individuals have freedoms of choice and are accountable for the actions; they have the duty to inform themselves to their own satisfaction before entering a transaction as there will be no appeal to 'I didn't know' in the 'caveat emptor' market. However, there are exceptions to this hard world. Sellers have legal duties, to greater or lesser degrees depending on the jurisdiction, to tell the truth or not to conceal or cloak relevant information. More than that, although increasingly lost as the commercial model roles out under the guise of individual freedom and self-determination, 'professionalism' demands a different relationship between people.

Caveat-emptor-contracting thrives where there is, or is presumed to be, 'equality of bargaining power'. Where there is inequality of bargaining power, some duty of protection is often required of the stronger party at law - a 'fiduciary duty'. In situations where the bargain is forged with, or perhaps because of, an imbalance of power (for example, between doctor and patient, lawyer and client, banker and client, teacher and pupil, guardian and minor or incompetent adult), the stronger party is (most often) required to act in (or to protect) the interests of the weaker party.

Research with human participants arguably (strongly arguably) falls into this fiduciary duty. Researchers have in the vast majority of cases much greater knowledge of the area, it's risks and potential benefits, than the participants in their research. That imbalance, that vulnerability, must be protected. And one major element of this safeguard is to require the researchers to inform the participants about what they are proposing to do and what they expect the outcomes to be - arguably, to give some background about the choices they have made in developing the methodology. They must inform the potential participants to redress the knowledge imbalance and to equip the potential participant to make a real choice about whether or not to participate.

Does this mean "full information"? This is difficult. One must redress the knowledge imbalance, but there are arguably some caveats. First, by definition, in research there can be no "full knowledge"; research is testing a hypothesis about what might be the case. Therefore, there is a gap in the knowledge that is available that is shared by the researcher and the potential participants. So, the informed consent is already not about full information. Second, there are limits on how much information is relevant. As in clinical medicine, choices have to be made in informing potential participants about which information is relevant. Remoteness of risk and proportionality must be in play, with a strong measure of 'reasonableness' to stop the drive to information becoming a requirement to inter-connect all knowledge to the particular research. Again, the standard is not binary - information / not information - it is a spectrum.

This second problem can be seen in the area of biobanking. Biobanks operate on the basis of developing a repository of information for the purpose of 'research' (perhaps with some limits, for example, relating to disease type and the like). Access to the data set to create cohorts for particular research projects then, depending on the model, is made on the basis of the initial, broad consent of the participants to participate in the Biobank for research purposes. This causes problems to some people: informed consent requires detailed information about every research project and broad consent, by definition cannot be informed consent; to others, without broad consent biobanks become impossible to operate. Now, of course, the second argument - the practical argument - whilst important, is not of the same nature as the first. However, 'broad consent' and 'informed consent' are not opposite arguments, as the first argument implies.

When one takes the words, the opposite of 'informed' is not broad but 'uninformed'; the opposite of 'broad' is 'narrow' or 'specific'. Whilst it is conceptually difficult to imagine how one could give 'uninformed consent' as the concept of 'consent' itself seems to require a degree of information - at least to know that consent is required in a particular situation -, it is, arguably, possible to give 'informed broad consent' as well as 'informed narrow consent'. This is because, as we have already admitted, information in consent is not a binary informed / uninformed, but rather a question of being sufficiently informed to make a fair and binding decision. The question then is, 'who judges sufficiency?'

Presently, the sufficiency of information is governed in the most parts by the REC. Researchers produce information sheets and these are scrutinized and accepted by RECs as part of their validation of research. Whereas participants have the opportunity to ask questions of the researcher, and, arguably, to shape the interaction about becoming informed to make the decision to participate, in practice one wonders how far this is a real or free dialogue. Is this problematic? Yes, if it does not fit the needs of the participants.

The information sheets reflect the perceptions of those who write them (and RECs are co-authors of the sheets given their role). However, when one looks at studies of expressed sensitivities of citizens, some people will share those perceptions and concerns, whereas others will not, judging less information to be 'sufficient', and others again will require more or different information. One size does not fit all. And some will make a judgement that informed broad consent is sufficient, others will require informed specific consent.

Why is this a problem? Because increasingly, the size that is adopted does not allow for individual participants to make their choice, and that super-sizing of informed narrow consent makes many new research methodologies impossible when they would be acceptable to some participants - which is, perhaps, ironic, when the purpose of informed consent is to protect participant self-determination.

How might this be solved?

Dynamic consent. Many have written on dynamic consent, and some projects are developing models of dynamic, participant-centred consent. The idea is to develop consent interactions between (potential) participants and researchers that allow the participant to determine the level (and, perhaps, nature) of his or her participation. Such mechanisms could be on-going, perhaps making use of secure internet portals such that individual participants could develop increasingly sophisticated consent profiles as their understanding and relationship with the research (or, for example, Biobank) develops. Likewise, the portal could be used by the researchers or Biobank as an educational or information tool to share findings and discuss methods, even difficulties, with the public.

[1]Townend, D. The Politeness of Data Protection: Exploring a Legal Instrument to Regulate Medical Research Using Genetic Information and Biobanking. Maastricht: Universitaire Pers Maastricht (2012) chapter 4, especially pp. 114–116.