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The biobank consent debate: Why ‘meta-consent’ is not the solution?
  1. Neil C Manson
  1. Correspondence to Dr Neil C Manson, Department of Politics, Philosophy and Religion, Lancaster University, Lancaster LA1 4YL, UK; n.manson{at}


Over the past couple of decades, there has been an ongoing, often fierce, debate about the ethics of biobank participation. One central element of that debate has concerned the nature of informed consent, must specific reconsent be gained for each new use, or user, or is broad consent ethically adequate? Recently, Thomas Ploug and Søren Holm have developed an alternative to both specific and broad consent: what they call a meta-consent framework. On a meta-consent framework, participants can choose the type of consent framework they require, for different kinds of use, different types of user and so on. Meta-consent involves a distinctive kind of design of the consent process. Here it is argued, first, that although a meta-consent framework does not wrong participants, Ploug and Holm understate the likely costs and burdens of such a framework, so there are good practical reasons not to offer it. Second, although Ploug and Holm allude to some ethical considerations that might seem to ground an ethical argument for providing meta-consent, they do not offer any sound argument, and it does not wrong participants in any way to fail to offer them the opportunity to design their own consent process.

  • research ethics
  • informed consent

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The biobank consent debate

Over the past couple of decades, there has been an ongoing, often fierce, debate about the ethics of biobank participation. One central element of that debate has concerned the nature of informed consent. The problem arises because biobanks are repositories of biological material, stored and organised in such a way as to make them—and information derived from them—readily available for a wide variety of research purposes by a wide variety of users in an open-ended way. In order to give valid informed consent for the use of their samples and data, participants need to be told the identity of the researcher(s), the nature and purpose of the research and about the risks and burdens that the research might pose to the participant. The specific details about future users and uses are not yet known at the time of obtaining the sample. Two broad types of proposal have emerged (with a wide variety of specific variants of each broad type). One proposal is simply that specific informed consent needs to be sought (and obtained) for each separate research project.1 2 Against this ‘specific consent’ framework, it is objected that seeking specific consent every time a sample—or personal data derived from a sample—is used for a new purpose, or by a new party, poses a considerable financial and administrative burden on researchers and a ‘drag’ on research.3 Given that samples and personal data can be reused at points in time remote from the original acquisition, actually contacting the donor may be hard and become more difficult over time.

An alternative proposal is ‘broad’ consent.3–5 Broad consent theories trade on the fact that consent is directed at sets of actions (even when directed at particular individuals). Consent can be given to specified sets of researchers or research uses (with the proviso that such research and uses are monitored and sanctioned by other, semi-independent parties). Recent broad consent proposals have laid emphasis on the way that broad consent is consent to a complex normative framework that protects the data subjects’ interests, with independent monitoring (eg, via Research Ethics Committees/Institutional Review Boards) and other aspects of good governance.6 It may seem that broad consent cannot be informed consent: how can it be when the future, specific, research uses (or users) are not yet known? However, at root, informed consent requirements are obligations to disclose information that allows a consent decision to be made in a certain way (knowingly and reflectively, on the basis of adequate, relevant information). There is a contrast between informed and uninformed broad consent, and there is a contrast between informed and uninformed specific consent. Provided the donor is truthfully informed about the kinds of uses to which his or her data might be put, and the kinds of user who may have access to them, there need be nothing ‘uninformed’ about a decision to give broad consent on that basis to specified kinds of act by any of a specific kind of agent for any of a range of specified purposes.

The biobank consent debate is one with deeply held convictions on both the ‘broad’ and ‘specific’ sides. In recent years, the debate has become yet more complex with the development of ‘dynamic’ consent frameworks.7–9 A dynamic consent framework uses formation technology to enable a wide range of continuous, interactive, personalised channels of communication between researchers and data subjects. While specific consent does involve ongoing communication, such communication is grounded in, and restricted to, gaining permission for use of samples and data. Dynamic consent, by way of contrast, also aims to allow public engagement with, and involvement in, research. Dynamic consent also affords data subjects a distinctive degree of fine-tuned control over the use of their data. We shall return to this aspect of dynamic consent later. However, for now, what matters is that both dynamic consent and specific consent frameworks reject broad consent, so our debate has broad consent theorists on one side, with specific and dynamic consent theorists on the other.

Recently, Thomas Ploug and Søren Holm have developed a new proposal: what they call a meta-consent framework.10–12 Their meta-consent framework is not specifically developed for, or restricted to, biobanks, as it is meant to be applicable more broadly, including secondary research uses of already-gathered health data (including data arising from patient records). However, they do hold that the model is applicable to biobank consent. The aim here is to consider whether meta-consent does provide a ‘solution’ to the biobank consent debate (leaving aside its adequacy as a solution to questions about the regulation of medical data use in other contexts). It is argued here that contrary to Ploug and Holm, there is no moral obligation on biobanks to provide meta-consent, and there are further considerations against biobanks offering such a framework. The biobank consent debate remains active as ever.

The argument for meta-consent

What is meta-consent? Here is how Ploug and Holm put it:

‘[M]eta consent’ denotes the idea that people should be asked how and when they would like to be presented with a request for consent. That is, people should be asked to design how they in the future would like to provide consent to the use of their personal health data and biological material. By expressing a preference for how and when to provide consent, people can be said to provide consent on a meta level. This is the defining idea in the model of meta consent. (Ploug and Holm, p. 724)12

Their central idea is that biobank participants should be offered the opportunity to choose and design their own individual consent process, in line with their own preferences. One participant might choose blanket consent for national, public-funded research on non-genomic data; specific reconsent for national public-funded use of genomic data; and refusal for international use or commercial use of her sample. Other participants are likely to make different choices from the ‘menu’ of options.

Why should biobanks offer meta-consent? The central consideration that motivates meta-consent is that biobank participants vary in their preferences about how they would like to consent:

Meta consent is a truly individual consent procedure that takes into account the differences in personal interests and levels of trust in researchers among the population. (Ploug and Holm, p. 4)11

Both sides of the consent debate have focused on ‘fixed’ consent frameworks where everybody is offered the same kind of consent framework, and the question is, which type of framework—broad or narrow—should be offered to all? Meta-consent, by way of contrast, offers participants a choice and allows them to choose, in a fine-tuned way, the kind of consent process that they prefer for different users and uses of their samples and data.

Costs and burdens: why all things are not equal

Suppose we accept that a meta-consent framework would better accommodate variation in interests and preferences than a ‘fixed’ proposal.i This does not imply that biobanks are thereby under any obligation to offer that degree of flexibility? After all, a biobank participant might prefer to be given a laptop for participating. It does not follow that therefore the biobank ought to provide it.

In response, we might argue that biobanks are going to have to offer some kind of consent framework, but they do not have to offer a laptop or other payments. All that meta-consent suggests is that the biobank should offer individuals to choose their preferred version of the kind of thing that is going to be offered anyway, that is, a consent framework.

However, this line of argument is not strong. A regulatory framework—such as the consent framework for biobank participation—is, or ought to be, designed with a wide range of interests in mind, taking into account the interests, needs, costs, burdens and benefits for many different agents.ii ,12 One core line of argument for broad consent, for example, is based on two premises: that broad consent is ethically adequate and that specific consent poses considerable burdens on biobanks and those burdens, in turn, shift resources from valuable research onto administrative costs. To simply allow people to choose whichever framework they wish might seem to be an irresponsible way of ‘solving’ the biobank consent debate. By analogy, people have different preferences about taxation systems. However, it does not solve debates about the proper level of taxation for all to allow individuals to choose the tax regimen that they prefer.

Ploug and Holm do not engage with the fact that regulatory systems should not be decided by individual preferences (of one interest group) alone (especially where the balancing of interests is part of the deliberative process leading to a regulatory framework). Instead, we have a weak line of support for meta-consent:

Although different models of informed consent may lead to informed and deliberated preferences concerning participation in research passing a threshold of acceptability, it seems that we should, all other things being equal, prefer a model of informed consent that lead to more informed and deliberated preferences than alternative models of consent (emphasis added). (Ploug and Holm, p. 729)12

This line of argument is effectively saying that there is no moral reason against providing meta-consent. This seems correct, at least insofar as it does not wrong the participant. Accommodating the preferences of participants might be good for recruitment but such ‘gifts’ have costs. However, a regulatory framework that does not wrong individuals may still be the wrong one to have. For example, requiring biobanks to give a new laptop to every participant might be great for participants but bad for the research budget. Ploug and Holm do put in their qualification ‘all other things being equal’, but this raises the question whether all things are likely to be equal. For example, if we compare a broad consent framework with meta-consent, then meta-consent is clearly going to pose many additional costs and burdens. Even if many people choose broad consent, some will not. Worse, the administrative infrastructure needs to be in place to allow specific reconsent for all, even if many choose broad consent in the first instance, because participants might, at any point change their consent design. These are costs and burdens that simply do not exist on a one-off broad consent.

The meta-consent framework also faces most of the problems and burdens of specific consent: maintaining contact with participants and the problem of what to do when participants fail to reply. Modern information and communication technology may make communication very rapid, but human beings, with their distractions, other interests, emotions and attention, are an essential part of the communicative chain. Suppose 30 000 participants in a biobank have opted for specific reconsent. The technology may be there to communicate in an instant, but the authorisation for the use of each sample depends on someone being bothered to ‘click’ the appropriate ‘I consent’ response. Worse still, the costs and burdens or meta-consent are likely to be much higher than even specific reconsent. It will need to take care to avoid false positives where those who chose broad consent are contacted by mistake. The burden here is that administrative systems need to be in place to track, and accurately respond to, individual fine-tuned choices. This is a burden that simply does not exist for broad consent frameworks and is less than that needed on specific consent frameworks where all are treated in the same way.

The objection here is not that that we already have reliable, precise, costings for meta-consent. We have not shown that meta-consent has to be more expensive relative to alternatives. There are good reasons to believe that it is likely to be so, given the degree of choice offered to participants. When Ploug and Holm state that all things being equal meta-consent is preferable to fixed consent frameworks, they cannot really get away with the ‘equal’ part of that claim, as things—the costs and burdens—are very unlikely to be equal.

The ‘protecting and promoting autonomy’ argument

However, if there is a strong moral argument in favour of meta-consent, in comparison with its fixed ‘rivals’, then it ought to be introduced and any additional costs factored into the total research costs. But is there such an argument? Ploug and Holm do suggest a more substantive ethical line of argument:

A more flexible model of consent is motivated not only by endeavours to protect research. If we really want to safeguard the individuals’ interests—if we want to protect and promote individual autonomy—then we should also protect their desire to provide consent in a particular way. (Ploug and Holm, p. 45)10

The move here seems to be something like this. Liberal medical research ethics is grounded in respect for autonomy. Respect for autonomy implies a distinctive kind of positive respect for the individual as a free agent when interacting with her.

There may seem to be something intuitively plausible about this line of thought. After all, surely we have the right to shape our consent as we see fit. We have the right to choose the target of consent (the person or persons to whom we give permission); we have the right to choose the scope of consent (the set of actions are rendered permissible by our consent); and we have the right to introduce conditions on permissibility. Take a non-biobank example. If you are going on a long vacation and ask to borrow my camera, I have the discretion to insist that you may do so (but others may not) for a certain period of time (scope) but only if you contact me before using it in the rain (introducing a condition). That is, there is a kind of ‘right to design’ built into the right to consent. It would be wrong for you to reply ‘I don’t respect your right to specify how you want to consent, I will decide that’.

However, here we need to take care to distinguish two very different ways in which someone might fail to respect an individual’s ‘right to design’ her own consent. In our ‘camera’ example above, there is a distinction between the following situations: (A) you understand and accept the terms of my consent ‘design’, take the camera but fail to act within those terms; (B) you understand the terms but do not want to comply with them, so you do not take the camera, but ask somebody else instead. The former wrongs me, the latter does not. The same is true when we turn to requests. Suppose you ask me if you may borrow the camera for a long vacation, but also add the proviso ‘Look, I’m going to be out of reach most of the time, so it won’t be able to get in touch’. Here you make a proposal about the ‘shape’ of consent that you seek. Even though you do not offer me the opportunity to shape the consent process as I see fit, you do not wrong me. If I do not want to lend the camera on those terms, I do not have to, and if I do not consent on those terms, you may ask someone else.

Biobanks, in general, do not need to recruit any particular individual. What is needed is a sufficiently large number of participants of various types. It does not wrong any particular potential participant to ask her if she is willing to consent in a certain way (provided it meets the appropriate standards—and that is what the ongoing biobank consent debate is about). If this participant does not like the ‘terms’, she does not have to consent to giving a sample. If she does not consent, then others will.iii

At this point the advocate of meta-consent might argue that these non-biobank examples miss out on some important aspects of biobank recruitment. If biobanks have an obligation to protect and promote autonomy, doesn’t it then follow that they ought to respect participants’ interests in choosing how to consent? For is that not an important aspect of their autonomy? The simple answer is: no, it does not follow at all. There is a great cloud of confusion within bioethics around the notion of autonomy and the idea of respect for autonomy. A fundamental, and genuine, part of respect for autonomy is to respect the rights and powers that people have: to not force, coerce, deceive or mislead by omission. Informed consent requirements reflect a more demanding and specific sense of respect for autonomy. The underlying ethical rationale for informed consent is that if one party wants to do something that would breach the other party’s rights, then the requesting party should make sure that the rightholder is able to adequately assess that proposal, so that he or she is in a position to make an adequately informed decision whether to consent to that (and thereby knowingly undertake whatever risks and burdens have been disclosed).

However, these considerations do not get us anywhere near an ethical argument for offering meta-consent. The obligations to gain informed consent are ‘tethered’, as it were, to the fact that the researcher proposes to impinge on the participant’s liberty or to breach her rights. The reason why there are special obligations to disclose facts about the nature of research is because the research would breach rights without adequate consent. Such obligations are restricted in their scope; they extend to making sure that this particular decision about what would be a rights-breaching action can be adequately made.

There is no general obligation on researchers to ‘promote’ autonomy in an untethered, open-ended general way. Participants in medical research might have their autonomy, broadly construed, limited in a wide variety of ways. They have low income, low education or be in an abusive relationship. Their autonomy could be protected and promoted by more pay, better education and by a safe route out of the relationship. However, clearly, it is not the job of a researcher to promote autonomy in every sense, or every way.

It might be argued that even if there is no general obligation to promote participants’ autonomy, there is a narrower, ‘local’ obligation to promote their autonomy with regard to their decision to participate. However, the points made just above apply to the more specific domain too. A participant might be in a better position to make a decision were she more educated or were she not distracted by worries about her leaking roof. It does not follow that the biobank (or anyone) is under an obligation to the participant to ‘promote’ her autonomy in this way (for a broader discussion of these issues, see ref 13).

An appeal to ‘autonomy’ gives us the sense that there is an argument in play. We may think of areas of research ethics where respect for autonomy is important, we then note that offering more choice would, in a broad sense, promote more autonomy, we then flip back to the idea that respect for autonomy underpins obligations, so there must be, surely, obligations to offer choice of consent design. However, this is not an argument; this is a cluster of overlapping intuitions and slogans. If the argument for meta-consent is going to be grounded in some kind of obligation to protect and promote autonomy, it cannot be some kind of open-ended general obligation, for then researchers would be obliged to protect and promote autonomy in an open-ended way, and clearly there is no such obligation. However, if we turn to a more restricted, limited set of obligations, it is not clear that there is an additional obligation over and above the obligation to secure informed consent (whatever that amounts to for the biobank situation), whereby biobanks ought to offer the participant the opportunity to design her consent process and to then abide by that design and undertake all the obligations and burdens that may go with it.

We noted earlier that the specific consent framework has been developed into dynamic consent. Recent formulations of dynamic consent lay stress on the way that an ongoing, interactive, communicative platform makes it possible for research subjects to fine-tune their consent. Indeed, Ploug and Holm acknowledge that a dynamic consent model ‘could incorporate this “meta aspect” of the meta consent model, and thereby make their model substantially identical to the meta consent model’ (Ploug and Holm, p. 732).12 Similarly, advocates of dynamic consent have suggested something very like ‘meta-consent’ “Rather than being restricted to the opportunity only to give broad consent to the use of their samples and data, individuals could provide different types of consent depending on the kind of study’(Kaye et al, p. 142).8 The arguments offered here do not seek to show that dynamic consent (or meta-consent) cannot be justified; it is that the arguments offered by Ploug and Holm do not provide support for the idea that it would somehow be wrong, or remiss, to fail to offer such a framework.


In sum, there is no ethical reason why biobanks should be obliged to offer meta-consent rather than a ‘fixed’ option. Nobody is wronged by making a non-coercive, truthful proposal, while denying the addressee the opportunity to ‘design’ the scope of consent or to shape the nature of an ongoing consent relationship. Although there is no ethical reason why biobanks should offer meta-consent, there may be contingent, practical reasons in favour of meta-consent, both in terms of aiding recruitment and in terms of secondary effects on public trust, levels of ‘Involvement’ and social licence. However, such potential benefits of meta-consent in terms of recruitment would have to be weighed against the considerable costs and burdens that such a complex governance framework would introduce (we would also need to keep track of whom the benefits accrue to). Assessing the relative costs and benefits of meta-consent would require a great deal of empirical work by medical sociologists, research accountants and many other parties.

The aim here has been modest: to show that there is no ethical reason why biobanks should offer meta-consent; it does not wrong potential participants to fail to offer them the opportunity to design their own consent process. The biobank consent debate thus continues on, full steam ahead.


Many thanks to Edmund Henden and Peter Schaber for the invitations and to Jakob Elster and other discussants for helpful comments and responses.



  • i An (anonymous) referee wonders whether the distinction between preferences and interests might not be of relevance here. It is true that in philosophical writing, especially about the normative basis of rights and obligations, focuses on fundamental interests, rather than ‘mere’ preferences (I might prefer one cheese to another but do not have an interest here, except the higher-level interest that my preferences be satisfied, all things being equal). Such a distinction does not help Ploug and Holm (who talk of both interests and preferences). The ‘mere’ preference that one have an individually tailored consent regimen is not a candidate for grounding an obligation to provide it, and the discussion below suggests that there is no fundamental interest that grounds this positive obligation either.

  • ii While it is possible, that in some circumstances, regulatory systems might only be required to be responsive to only one set of interests, in the case of biobank participation it seems plausible (and we shall assume it to be so here) that a regulatory system for biobanks has to balance, at the very least, societal interests in securing the results (and benefits) of biobank-enabled research, against a range of individual interests, such as privacy interests and the interests that underpin rights over the body and bodily materials.

  • iii Of course, if the situation were that almost nobody would consent unless they were offered meta-consent, that would give a strong practical reason for biobanks to offer it; given that there are many well-supported biobanks across the globe, without meta-consent having been offered, this seems not to be the case.

  • Contributors I am sole author.

  • Funding The author has not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient consent Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Presented at Versions of this paper were presented at the Oslo and Akershus University College of Applied Science, and at the Center for Ethics, University of Zurich.

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