Michael Sanders and Vanessa Hirneis
This blog post is based on the Evidence & Policy article, ‘Consent, assent and randomised evaluations’.
The last decade or so have seen an explosion in the number of randomised controlled trials conducted in schools in the UK, and a similar, if less stratospheric, rise elsewhere in the world. The rise in the UK can be attributed in large part not to methodological interest by education academics, but the creation of the Education Endowment Foundation. Forming part of the UK Government’s “What Works” network aimed at improving evidence-informed decision-making in policy and overseeing a budget of more than £100 million, the EEF has funded hundreds of randomised trials of different interventions to boost children’s and young people’s attainment.
Enthusiasts of randomised trials argue that they provide the best and simplest (or least statistically burdensome) way of findings out which interventions work. However, opponents, often those responsible for designing and delivering interventions, consider them unethical because they necessitate withholding a potentially beneficial intervention from young people. In our paper, we consider another aspect of the ethics of randomised trials with young people – consent.
Informed consent is the cornerstone of postwar research, and aims to ensure that people are not experimented on against their will. As a principle, it is hard to argue with and should be at the centre of our thinking about how to run these kinds of trials.
However, as we outline in our recently published Evidence & Policy debate paper, ethical considerations in the context of school-based trials are rarely straightforward. Children are unable to provide informed consent, thus requiring their parents to do so. Many interventions in schools must be delivered at the level of a class, a year group, or even a whole school. Where this is the case, parental consent typically pertains to data collection and analysis, rather than participation in the intervention itself. This is different from the principle of consent in most medical trials, where, for example, you are not given a new vaccine simply because you live in a particular neighbourhood. But it is in line with how schools work where teachers enjoy considerable freedom to teach what and how they like.
Reflecting this, many trials in education, including those funded by the EEF, rely on parental assent, rather than consent. This means that parents are informed about the study, and about the intervention, and given plenty of opportunities, to opt their child out at multiple time points. If they do so, an alternative activity is arranged for their child during data collection.
How problematic is this? Strict adherence to consent would deem this unacceptable, as parents may incidentally allow their children to remain opted in despite potential objections. But for many researchers, this is a feature, not a bug. As has been found elsewhere, opt-out procedures increase the study’s robustness and value by including a larger number of participants compared to opt-in methods. Ethically, conducting studies that are too small is deemed unacceptable as they can yield misleading or useless results.
We also consider an additional, less considered angle on assent vs consent. A number of studies have revealed disparities not only in participation rates but also in the demographics of those involved. Opt-in studies tend to underrepresent disadvantaged groups, such as individuals from low-income backgrounds and ethnic minorities This is problematic because it means that research is less representative of the overall population than it could be, and because it excludes the voices of people who are already disadvantaged. Consequently, we may conclude an intervention is effective based on a sample that is mostly white and mostly middle class, while in fact, it may be ineffective or harmful for disadvantaged groups. In such cases, a wider rollout would lead to an increasing attainment gap as evident in a study examining the impact on care experienced by young people. Similar consequences could well arise for other groups – if only someone would do the analysis.
Consent remains an important principle for research and should not be bent or altered lightly. However, as we argue in our paper, the ethical answer cannot be to adopt a binary understanding of right and wrong. Instead, we should consider the balance of benefits and harms when deciding on study design.
Image credit: Photo by Patrick Fore on Unsplash
Michael Sanders is a Professor of Public Policy at King’s College London and Director of Experimental Government.
Vanessa Hirneis is a Research Assistant within the Experimental Government Team at King’s College London.
Read the original research in Evidence & Policy:
Sanders, M. Summers, J. Hirneis, V. Hume, S. and McGannon, G. (2023). Consent, assent and randomised evaluations. Evidence & Policy, DOI: 10.1332/174426421X16842419724551.
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