The data presented shows that, in a very real sense, people are taking part in genomic research without being fully informed. Furthermore, there is clear evidence of misunderstanding, suggesting that consent could not have been informed and is therefore invalid.

Dominant, and predominantly Western, thinking on informed consent would suggest that the consenting in the COTASS-II process was therefore flawed and unethical. People were very likely recruited into the biobank study when they did not have a full understanding of the research, its risks, and benefits, or how the results would be used.

This is not inconsistent with what we already know. Previous studies have shown that, post-involvement, research participants will often have a poor recall, and demonstrate a relatively poor understanding of the research (Bukini et al. 2020; Robinson et al. 2013). This does not, of course, necessarily indicate a sub-par informed consent process, but may merely represent waning recall. What matters for valid consent is what participants understand at the time, and not what they remember 6–12 months afterwards.

What differs here is that some participants seem to describe providing consent in the knowledge that they did not have a full understanding of the research, whilst others describe going in with clear (though not, of course, to them) misapprehensions about how they will benefit. This seems not only to fall below the standard for informed consent but also for understood consent (Isles 2013; Vasquez 2017).

Trust, however, appears to act as a mediator, allowing consent to be given in the absence of full understanding. The idea that trust is an important factor is consistent with the findings of Ahram et al (2022), who associated lack of trust with a low willingness to participate in biobanking. This is also consistent with the characterisation of informed consent articulated by Manson and O’Neill (2007), which holds that due to the imperfection of communication, the notion of fully informed consent is unattainable. In the absence of full understanding, informed consent becomes a question of understanding enough to be able to decide to waive the usual social rules that govern behaviour and allow somebody to act upon you.

This, of course, requires trust, and our study participants recognised this, describing a consenting process where they focussed more on making an informed decision about trusting the researcher (and the research) rather than understanding the research. This still seems like an informed decision, albeit with a focus on the human rather than the science. This does not mean that efforts should not be made to provide information to potential participants. It does mean that we can consider ‘informed consent’ to allow for different understandings of what it means to be informed. So long as the decision to trust is itself informed, and that researchers are worthy of that trust, we see no reason to view consent informed by trust as any less valid than consent informed by understanding. This does place the onus on researchers to ensure that they are demonstrably trustworthy, and on institutions and regulators to act against practices they might exploit trusting behaviour.

Whilst an informed decision to trust can, in our view, mean that consent is valid notwithstanding incomplete understanding, there is a difference between entering into research with missing information and with erroneous understanding. We view the therapeutic misconception as an example of the latter, and it is important that participants do not enter into research falsely believing they will personally benefit, as this is both an insult to autonomy and will erode trust in the long term.

It is not clear to what extent our empirical findings can be transferred to similar settings outside of, or even within, Sri Lanka. The question matters because it is important to consider whether these findings, particularly about the use of trust as a mechanism for consent, can be assumed to be true of other settings, or if they are likely to be unique to the participating group. This has implications for whether we might want to propose using informed trust as a basis for consent only in the study setting, for Sri Lankans in general, or across other settings that are sufficiently similar. We have no reason to think there is anything specific or unique about our small group of participants, or about Sri Lankan culture in general, that is likely to make them focus on trust in a way that other groups will not; and it seems to us likely that trust may serve this bridging function in other contexts where there is similar goodwill towards research but a lack of understanding. Care must always be taken, however, not to unreflectively generalise. Our data, and our empirical hypothesis about trust being used to bridge the gap in understanding, might be usefully used as a lens to explore and understand other contexts, but it cannot be simplistically assumed to apply.

We have, however (and in keeping with a reflexive balancing approach), used the data to inform a hypothesis about the ethical acceptability of informed trust as a basis for consent. This hypothesis, though informed by our empirical analysis, is not tied to it. As such, that hypothesis might be taken and explored in various different contexts, tested, and either rejected or accepted in further work, which will determine its ethical acceptability in specific contexts. As such, this paper has reported the first two stages of Ives’ (2014) reflexive balancing methodology, with the third yet to be reported.

Our takeaway message from this study, then, is that informed trust may be an acceptable basis for consent, particularly in settings where scientific literacy might be low. However, researchers must work to be worthy of that trust and work to ensure that misconceptions are actively addressed.

Our aim in this paper has not been to provide a knock-down argument to establish that informed trust is a sufficient basis for consent, such that it can and should replace informed consent. Rather, we have demonstrated how an in-depth exploration of the experience of a group Sri Lankan people has cast doubt on the appropriateness of importing a Western ideal of informed consent into a context where scientific literacy is low; and proffered a possible solution – informed trust—that (prima facie) allows us to reconcile the importance of consent in itself with a context in which it seems unlikely to be achievable (at least, as things currently stand).

Further work will need to be done – reflecting the third stage of reflexive balancing—to explore more fully the normative implications of this suggestion, and as such we have only presented part of the work here. Future work will need to consider (inter alia): how researchers can earn and demonstrate trustworthiness (in a way that does not simply exploit existing trust heuristics); where the balance lies between accepting informed trust and attempting to educate and scientifically inform; and, indeed, whether that latter question itself is premised on a problematic and colonial assumption that scientifically informed consent is the ideal we ought to be striving towards. There may, in fact, be room to explore arguments that informed trust is a superior – and perhaps in some cases more honest – basis for consent, given that being fully informed may never really be achieved – which is certainly in keeping with Manson and O’Neill’s (2007) contention that consent transactions can rarely (if ever) involve full understanding (even in the best of circumstances). Going further, it might also be considered whether informed trust is a more inclusive basis for consent, given that the requirement for a certain level of understanding in order to participate in research could serve to exclude groups of people who cannot demonstrate the required level. This kind of argument would then require consideration of how to ensure trustworthiness in the researcher, and could be explored from various theoretical perspectives – one being to develop a concept of ‘researcher virtue/integrity’ as proposed, for example, by Banks (2018) and Daku (2018).

We do not have space to consider these arguments here but we hope, in this paper, to have contributed to the large and multifaceted debate on consent for research by proposing ‘informed trust’ as a model that may be appropriate in some contexts.