Specific, broad and meta-consent

Informed consent to biobank research may be based on different models. A model of specific consent ties consent to specific research projects and purposes. It requires that consent requests to individuals ask for consent for specific research projects and purposes on the basis of specific information about these.2

A model of broad consent ties consent to broad categories of data and research. It requires that consent requests to individuals ask for consent for broad categories of research on the basis of information about these categories of data research.3–5

The defining idea in the meta-consent model is that individuals should be given the opportunity to decide how they would like to provide consent in the future.6–8 They should be given the opportunity to choose if they in the future want to provide specific or broad consent to the use of their biological material and data. In distinction to specific and broad consent, meta-consent is thus not a matter of consenting or refusing consent. It is a matter of designing future consent requests from researchers. When a participant consents to participate in biobank research, he would be asked to consider a set of meta-consent options, which would determine under what conditions he would want to be contacted if future research projects fall outside the terms of the original consent. Table 1 illustrates a possible meta-consent form, where a participant can indicate their consent preference for future research. In the figure, we have included some options for new research procedures and new research contexts. The options could be specific to each individual biobank. Moreover, depending on the scope of any actual biobank, options for disease categories may be needed, for example, if the biobank is established as a cancer biobank then it is possible that it will have wider use.

In practice, a meta consent system would be implemented as part of the biobanks’ IT system and would include the possibility to revise the initially chosen meta-consent options in the future. The user interface could easily be implemented as a smartphone app.9

The cost of a meta consent model

We share the view that the costs of implementing models of informed consent are a genuine and relevant concern. The costs may pose a burden to research to such a degree that less research is conducted, and this may ultimately result in the non-maximal generation of utility at the societal level. This is certainly both possible and ethically relevant. We are also happy to concede for the sake of argument that a meta-consent model is likely to cost more to implement than broad consent.

However, even if it is conceded that a model of meta-consent is costlier than alternatives such as broad consent, then this does not in itself provide us with much of a reason to prefer broad consent over meta-consent. First, pace Manson biobank researchers establish a long-term relationship with their participants (see more below) and therefore have some imperfect obligation to promote their welfare and autonomy. Second, what matters is not the cost in itself, but whether that cost matters. If the increased cost of implementing meta-consent is only marginal in relation to the total cost of running the biobank, it is implausible that it will have much impact on the research that is actually conducted. Furthermore, if meta-consent is the better model, funders should be willing to fund it even if the costs are more than marginally higher. Moreover, finally, in those cases where more than broad consent is ethically required, biobanks must bear these costs or negate their ethical obligations.

Meta-consent, autonomy and biobank research

According to Manson, there is a great deal of confusion about respect for autonomy in bioethics. We do not want to contribute any further to this and shall, therefore, take as authoritative Manson’s definition:

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 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). (emphasis in original)

So, respecting a person’s autonomy in relation to biobank research requires that valid informed consent is obtained and obtaining a valid informed consent requires that a person is provided with conditions for making an adequately informed choice about the specific proposal that is being put forward.

According to Manson, a meta-consent model is simply ‘overkill’. By allowing individuals to design how to consent in the future, a meta-consent model provides individuals with options of choice that are not required in order to obtain valid informed consent. It moves beyond providing conditions for adequately informed decision-making, that is, beyond respecting autonomy. Thus, in essence, Manson denies that a right to design future consent requests is a prerequisite of making an adequately informed decision about participation in a biobank.

Manson in part builds his position on a simple analogy between biobank research and the situation of someone going on vacation and wanting to borrow a camera. He states:

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.

The analogy suggests both that it is possible to get a valid consent without the consenting party having the right to shape the consent, that is, meta-consent is not a pre-requisite of respecting autonomy, and that a model of broad consent is sufficient to obtain valid consent. The analogy between biobank research and borrowing a camera for a vacation is misleading because it suggests that what it means to be part of biobank research is just as constant and clear throughout years of participation as what it means to borrow a camera for a vacation. However, that is not true.

If I decide to lend out my camera for someone’s vacation, then it is because we have some sort of mutual understanding of what it means to lend a camera for a vacation. Suppose I have an interest in helping out a friend but also an interest in taking good care of my camera. If I am to make a sufficiently informed decision about which of these interests should dominate in this situation, it must be because my friend and I have some sort of mutual understanding—a shared meaning—of what it means to borrow a camera for a vacation. I may arrive at the decision that I know too little of how specifically the camera will be used to let him borrow the camera, but even to arrive at this decision in an informed way presupposes that my friend’s proposal ‘can I borrow your camera for my vacation’ cannot mean anything in the world. It cannot be, as Humpty Dumpty scornful states, that a word ‘means just what I choose it to mean—neither more nor less’.10 Consent—even in a very broad form—must rest on a shared meaning of what a person is consenting to in order to be informed to a degree passing a threshold of acceptability.

Being part of long-term biobank research is not comparable to borrowing a camera for a vacation. What participants give to many biobanks is not just their biological samples, and the data that can be derived from those samples, they often also give the biobank permission to access and link to their health information in perpetuity. It is this ongoing, prospective linkage that is perhaps the most valuable thing that participants give to the biobank. Biobank participation is therefore often not a single event, but a long-term relationship. But, biobank research is highly dynamic. The research questions change radically over time as do the methods used to answer them. Doing healthcare research into heritable diseases has changed completely with the introduction of whole genome/exome sequencing with a host of implications for research participants, many of which could not be clear to anyone when participants initially gave their consent to the proposal that researchers could use their samples and data to do ‘research into heritable diseases’. The data used in biobank studies and linked to the biological information generated from the samples also change over time. Suppose that a participant has agreed to linkage to ‘health data’ when recruited 20 years ago, and the researchers are now considering linking to IQ data from military conscription tests, or environmental exposure data derived from the home address. Is such data ‘health data’ or not? People might reasonably disagree, but under a broad consent model, a decision will have to be made either way. But, who should make the decision and on what basis? The participant consented to the proposal of linkage to health data 20 years ago, based on his or her understanding of what health data were at that time; and different participants may have consented based on somewhat different understandings.

On Manson’s conception of valid consent, that is, consent to ‘that proposal’ which is being put forward, it is the participants’ understandings of all the terms in the information and consent materials that should continue to govern the research, because if it is not, it is no longer the proposal to which they consented. But this creates an enormous problem for broad consent over time, as it will often be very unclear whether what researchers want to do now is inside or outside the terms of the original consent. Moreover, if the new research is outside the original understanding of just one of the participants who validly provided broad consent, their consent has been invalidated and the researchers are infringing on their rights.

The dynamic nature of biobank research thus implies that a one-off broad consent for such research will sooner or later become invalid, that is, it will no longer respect the person’s autonomy and rights. And, consequently, it raises the question of how we respect a person’s autonomy in relation to such changes? It seems that if an individual is to make an adequately informed decision about participation in biobank research, then it must involve a decision as to what should happen in case the research radically changes in nature. But if we ask participants to agree in advance to radical changes deemed by the researchers to be within the original consent, we are no longer asking them for broad consent to research within specific boundaries, we are asking them for something much closer to completely unspecified blanket permission. If we think that is unreasonable or perhaps even ethically problematic, we need already at the start to add the possibility of future consent events when interpretive uncertainty arises to the initial broad consent. But then we have what is essentially a version of meta-consent.

We have argued that Manson’s claim regarding the costs of a meta-consent model are incomplete, that a model of broad consent in relation to biobank research does not respect autonomy in the long run and that a model of meta-consent is nothing but a simple extension of a right to demand or waive future consent requests. On this basis, we confidently conclude that meta-consent is still the solution.