THIS Institute
The Health Foundation

Ethical framework for asymptomatic
COVID-19 testing

Students in higher education institutions

This framework is based on a consultation, ethical & legal analysis, and expert discussion.
Over 200 university students and staff took part in the consultation exercise.

University of Cambridge
Wellcome

Design and operation of the programme

Assess if a testing programme is the right choice and whether you can deliver all aspects of it. Make sure public and legal duties will be met

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Recommendations

Start by making an assessment of whether a programme is the right choice for the HEI, taking account of the available evidence, current pandemic conditions, and available resources and capabilities.Ensure that all other infection control measures are in place both prior to making a decision about introducing a testing programme and subsequent to the decision (whether or not it is to proceed). A testing programme should be seen as one element in a multi-modal strategy.Recognise that a testing programme requires a whole-system approach that is designed end-to-end. Testing on its own is not enough; there must also be confidence that the key control measure (isolation of confirmed cases and their close contacts) can be achieved. A HEI should therefore sign up in full to delivering on all of the components necessary for the programme.Set up a governance structure capable of dealing with all aspects of the programme, including clear decision-making, operational oversight, quality assurance, communication, and facilities for consultation and ethical advice.Plan for a range of scenarios and ensure that contingencies are in place.

How might these recommendations be put into practice?

Some hypothetical examples:

  • One HEI identifies all the components that need to be in place for an asymptomatic testing programme for its students. Having satisfied itself that it can deliver on all of these, it decides to proceed. It establishes a governance structure for the programme, identifying key responsibilities and accountabilities in the programme team and a clear decision-making structure. It decides that major decisions should be made by its COVID-19 ‘gold’ committee, alongside other important decisions for managing the impact of the pandemic. Recognising that running an asymptomatic testing programme is very different from the University’s usual operations, it sets up a committee with broad membership which liaises closely with an operational management team.

  • A different HEI, having reviewed the resources required to deliver all elements of a testing programme effectively, determines that it lacks the financial and logistical capabilities to run a sufficiently quality-assured, effective programme. It therefore decides not to proceed.

  • A HEI running a testing programme models a number of scenarios, including situations where testing is conducted routinely during a period of stability, and situations where there is a current outbreak that needs to be managed. It puts plans in place to cope with these, including, for example, scenarios where large-scale staff absences may mean that it is difficult to support isolation, including appropriate meal provision.

Goals of the testing programme

Identify the programme goals, explain why they were chosen, tell students about them, and keep them under review.

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Recommendations

Ensure that the goals of the programme are well-defined and have a clear rationale based on disrupting viral transmission through early control measures. The goals should be clearly explained to the student population and other stakeholders. If there are multiple programme goals, they should be acknowledged explicitly.Goals should be realistically attainable, based on current understanding of the epidemiology of COVID-19, the properties of the selected testing regime, and the available resources and measures for managing risk.Specify criteria to judge the effectiveness of the programme in reaching its goals.Keep the programme goals under active review, mindful that they may evolve over time. Goal drift (uses of the programme for purposes not specified) should be avoided.

How might these recommendations be put into practice?

Some hypothetical examples:

  • A HEI identifies the goals of its testing programme. It distinguishes between primary goals (reducing viral transmission through identification and isolation of cases and their contacts) and secondary goals (providing reassurance for students and staff). It explains the rationale and goals of the programme to its stakeholders, emphasising potential benefits it hopes to achieve for students (e.g. reduced risk of contracting the virus, more normality of educational experience, and psychological reassurance), and for those in the wider community (reduced general transmission of the virus). It also acknowledges the current scientific and uncertainties associated with demonstrating whether the programme can deliver on these.

  • A HEI specifies that it will judge the effectiveness of the programme in achieving its goals, using criteria relating to: participation rates, positivity rates (percentage of people tested who are positive), outbreaks, cost-effectiveness, and student satisfaction (measured by surveys). It acknowledges influences outside its own scope of control, such as community prevalence. It monitors effectiveness over time.

  • A HEI keeps the goals of the programme under active review as conditions, technology, policy, guidance, and scientific understanding evolve. The HEI clearly signals any changes to all stakeholders.

Properties of the test(s) selected for the programme

Assess the available testing options, considering current evidence and guidance. Acknowledge uncertainty and take action to address risks associated with the chosen test.

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Recommendations

Be alert to the properties of test selected for the programme and the implications of these. Test properties, such as sensitivity and specificity, may vary considerably depending on the test used and the setting (including whether or not swabbing is self-administered).Ensure that the methods of obtaining the sample (e.g. swabbing) satisfy criteria of tolerability and acceptability (e.g. should not induce excessive discomfort, pain, or anxiety).Consider the probabilities of false negative and false positive test results associated with the chosen testing regime, and identify and mitigate the possible associated risks and harms. Acknowledge the implications of false negatives and false positives in communications about the programme.Emphasise prominently and consistently the importance of continuing to observe guidance on masking, social distancing, hygiene and ventilation in the event of negative tests.Clearly communicate what should happen in response to a positive test, including any opportunity for confirmatory testing.Be alert and responsive to changes in evidence surrounding testing technologies, and be aware of current government guidance.Be mindful of relevant legal and regulatory requirements relevant to testing. Amongst other things, HEIs should consider the current authorisation and certification of the devices being used for testing, and any requirements for laboratories being used (whether in-house or under contract) to be certified.

How might these recommendations be put into practice?

Some hypothetical examples:

  • A HEI makes a full assessment of the available testing options. It considers validity and reliability, convenience and speed of administration and test result, tolerability of the test for students, costs, logistical burden and test certification.

  • One HEI, having reviewed the latest government advice and other sources, selects lateral flow testing (LFT) as its testing approach. However, it recognises the limitations of the currently available form of the technology, including the risk that its poor sensitivity could generate high false negative rates. Accordingly, the HEI emphasises in all communications that, for the present, the main goal of the programme is to detect positive cases in asymptomatic individuals. It stresses that the programme cannot provide evidence of non-infection, and that negative results should not be used to support relaxation of compliance with social distancing, face coverings, or hygiene rules.

  • A different HEI also conducts a full assessment of the available testing options. It decides to use PCR testing because of its superior sensitivity, but it also recognises some of the downsides (e.g. longer time to test results). It repurposes some of its own lab capacity to provide the testing facility but takes care to ensure compliance with any regulatory or certification requirements that may apply.

  • A HEI discovers that an unintended consequence of the programme is that those who test negative may engage in more risk-taking behaviour because they believe themselves to be free of infection. In response, it explicitly communicates that a negative test result means a student “has tested negative, but could still be infected with the virus”. It informs students that the asymptomatic testing programme is “one tool in a multi-component risk reduction strategy” and re-emphasises the importance of complying with other measures designed to minimise transmission.

  • A HEI notes that in the event of a false positive, the student would be erroneously required to isolate, as would their close and household contacts (who may not be part of the programme). To mitigate this risk, it decides to offer swift confirmatory testing to anyone who tests positive.

Enabling isolation

Provide suitable support -practical, psychological, social and educational - for students who test positive.

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Recommendations

Ensure that adequate support is in place for isolation after a positive test, both at individual and household level. Programme effectiveness in breaking chains of transmission depends on individuals (and their households) isolating after a positive test. Students in HEI accommodation are likely to require the support of their institutions to isolate for practical purposes (e.g. food, laundry etc), general health (e.g. fresh air and basic exercise) and for reasons of mental health (e.g. anxiety, loneliness).Be clear in communication about both about the requirement for isolation and the available support. A dialogue should take place to ensure that those isolating feel heard, and the experiences should be used to guide the refinement of support systems.

How might these recommendations be put into practice?

Some hypothetical examples:

  • A HEI identifies, by listening to students, the challenges associated with asking people to isolate for the specified period and takes them seriously. It identifies and organises the support – practical, psychological, social and educational – required to isolate effectively. It considers cohorting strategies to enable students to move safely outside their own bedroom in a controlled way.

  • A HEI publishes a clear statement outlining polices regarding students who may be educationally disadvantaged as a result of isolating. For example, students who are unable to carry out experimental work are reassured that reasonable adjustments will be made, so that as far as is possible isolating will not result in academic detriment.

  • A HEI communicates clearly with its students about what to do if they receive a positive result, or are a close contact of someone with a positive result, what support is available if they must isolate and how they can access it. Its communication acknowledges concerns and anxiety around having to isolate.

Choices regarding participation in testing programmes

Generally, favour the least intrusive approach to individual choice about participation.

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Recommendations

Make a reasoned decision about individual choice regarding participation. Generally favour the least intrusive approach possible proportionate to achieving the goals of the programme and bearing in mind risks, benefits, current levels of scientific certainty and pandemic conditions. Any decision to seek to increase the degree of compulsion should be considered very carefully and should be accompanied by consultation with stakeholders, with the justification openly communicated.Consider the use of any incentives carefully. If used, they should be small and presented as tokens of appreciation rather than stimulation to take part.In general, avoid penalties (or measures that have the appearance of penalties), because they have the potential to impact on trust, undermine solidarity, cause resentment, or lead to a burden of complaints to be managed.Policies on choices about programme participation should be broadly consistent within a HEI and ideally across the HEI sector, though local differences or adaptations may sometimes be necessary.

How might these recommendations be put into practice?

Some hypothetical examples:

  • A HEI offers individual students the choice whether to participate in the testing programme or not, supported by clear communication surrounding the potential benefits of the programme (including the shared benefits of health protection and community solidarity). Entire accommodation blocks as a whole are not permitted to opt out.

  • A HEI, following consultation, concludes that offering small incentives (such as a free coffee for taking part) to encourage participation would be acceptable, because students appreciate their efforts being recognised. It monitors for any unintended consequences, such as the perception that offering either excessively trivial or unduly large rewards could undermine a programme built on community spirit.

  • A HEI considers whether it would be acceptable to restrict access to face-to-face teaching for students who decline to participate in the programme, following complaints from some students about having to share space with untested colleagues. Following consultation, it concludes that it could be seen as punitive and could damage support for the programme overall. It decides to reiterate the principle that participation in testing is voluntary at an individual level, but makes it clear that it strongly encourages students who attend face-to-face teaching to participate (unless medically exempt) for the safety of others. It commits to keeping the policy under review, particularly if evidence emerges that untested students are associated with higher rates of infection.

  • An advocacy group lobbies the HEI to make asymptomatic testing programme mandatory for students residing in HEI accommodation because of the cross-infection risks for local townspeople. The HEI explains that it will consider carefully the concerns, alongside other practical and ethical considerations. As uptake in the programme is high even with voluntary participation, it decides that it cannot justify making participation mandatory, since it concludes that the potential additional benefit of changing the policy is not proportionate to the risk at the time.

Benefits, harms, and opportunity costs

Assess possible benefits, costs, risks and harms and be prepared to explain decisions.

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Recommendations

Consider the possible benefits, risks and harms of the programme, and put in place appropriate mitigations.Be attentive to issues of equality, diversity and inclusion. Identify any student groups who may be disproportionately affected by having to isolate and seek to mitigate the effects.Consider the trade-offs and opportunity costs of running the programme, the range and nature of uncertainties, and how to balance values and interests that may be difficult to reconcile.Be able to give an account of the reasonableness of the decision-making process and decisions made for the programme. Reasonable people may disagree about how a HEI should weigh up possible benefits, risks and harms, so be prepared to explain how the decisions have been made.

How might these recommendations be put into practice?

Some hypothetical examples:

  • A HEI considers the possible benefits, risks and harms of the programme and explicitly considers equity, diversity and inclusion in relation to these. It gives specific consideration to people for whom isolating is likely to be disproportionately more challenging: for example, those with lower incomes who need to work part-time to support their studies, those with pre-existing mental health problems, and those whose studies require physical presence in particular settings (e.g. labs), who may be disadvantaged by being unable to attend in person. It puts appropriate measures in place to address these challenges.

  • A HEI decides that it lacks sufficient resources to test its all students individually, but it can provide a limited testing programme for students residing in its own halls of residence. It has a communications plan for addressing concerns raised by students in other accommodation and is sensitive to issues of inclusion and diversity in this communication.

  • A HEI considers alternative uses to which the resources needed for the programme might be put. Given current evidence, it decides that the programme is a justified expenditure to reduce transmission of COVID-19 for students, staff and the local area, while enabling a better student experience. The HEI reviews this assessment at key points, for example when affordability becomes a problem or when benefits decrease (e.g. during a period when students are generally advised not to attend campus in person during a national lockdown, or when wide uptake of vaccines has reduced transmission). It explains that it is making decisions using careful assessment of the evidence, current government guidance, consultation, and assessment of its own resources and capabilities, but it acknowledges that not everyone will agree with those decisions.

Responsibilities between students and institutions

Clarify that both institutions and students have responsibilities if shared goals are to be achieved.

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Recommendations

Be clear about the responsibilities for both institutions and students in achieving programme goals, recognising the special context of higher education, where staff and students are part of a community and where cooperation will be key to achieving shared aims.Consider whether or not there might be a duty of care to students to operate a testing programme under specific conditions and what that might entail in terms of responsibilities for both students and institutions.

How might these recommendations be put into practice?

Some hypothetical examples:

  • A HEI believes, based on its assessment, that a testing programme could reduce risk for all members of its community and improve the educational experience of students. It conceptualises its testing programme as a benefit to the community. It presents the programme to its stakeholders in this way. In making clear the expectations of students in relation to the programme, it seeks to promote cooperation, trust and solidarity. The HEI identifies any factors that might undermine trust (e.g. treating some groups unfairly, appearing to be irrational, communication failures, and poor logistics) and takes steps to address these issues.

  • A HEI that has required its students to return to campus makes a full assessment of the likely benefits of the programme in reducing risk. Based on current evidence, it concludes that, while it is not a full solution, it has a duty of care to offer the programme in order to make the living and educational environment as safe as is reasonably possible. This duty derives from its responsibilities for the welfare of students, for optimising their educational experience, and for controlling risks for staff. It has further responsibilities as a landlord for students in its accommodation. It recognises that its choice to run the programme means it has responsibilities and accountabilities for the programme, including its ability to resource it appropriately.

Privacy, confidentiality and data-sharing

Ensure information governance systems meet data protection and confidentiality requirements. Be clear who is informed about test results and why.

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Recommendations

Design and operate sound systems for information governance, recognising that information about test participation and test results should be handled with full respect for principles of data protection and confidentiality. Data should be processed fairly, lawfully, transparently and securely and in accordance with data protection principles specified in General Data Protection Regulation (GDPR). Confidential health information can only be used with the individual’s consent, or where it is necessary and proportionate to protect public safety and the health and safety of other people.Consider whether a data protection impact assessment is needed for the programme.Ensure that individuals processing programme data are properly trained.Communicate clearly with students about who will be informed in the event of a positive test result, with clear justification for any sharing of health data. For example it should be clear that public health authorities may be notified of positive test results, to activate contact tracing mechanisms.Be aware that a HEI that conducts contact tracing on-site (e.g. until public health authorities are able to take over) has a duty to inform contacts that they have been exposed (which may result in deductive disclosure as students may guess the identity of the infected individual).Be mindful of relevant legal and ethical requirements of any use of data for research purposes.

How might these recommendations be put into practice?

Some hypothetical examples:

  • A HEI establishes clear workflows for handling data at every stage, ensuring full compliance with the principles specified in GDPR. Data is pseudonymised or anonymised where possible. The HEI establishes a secure system where test data are stored in a protected space with access limited to dedicated testing programme managers. It trains individuals handling data, ensuring that they are aware that data concerning health is confidential. It provides a privacy notice that provides information on sharing of personal data.

  • A HEI needs to share some limited information about positive test results so that it can facilitate support for students who need to isolate and identifies the minimum necessary to achieve this. It informs students that the staff needed to provide practical support (e.g. food, laundry) will be informed of the location of a positive test result, but not the name. It also informs students that positive test results will be shared with relevant other staff (for example, those with pastoral responsibilities), with the option to opt out.

  • The HEI’s policy specifies that student households will be notified in the event of a positive test so that household members can isolate as contacts. It also specifies the name of the individual student who has tested positive will not be shared. The possibility of deductive disclosure is acknowledged.

  • A HEI makes sure test results from the laboratory it has commissioned for its programme is feeding the results through to its country’s established public health channels.

  • A HEI seeks the consent of students for their test results to be used for scientific purposes, and obtains the proper approvals to enable use for research purposes. Those who decline consent are reassured that there will be no detriment to them.

  • A HEI decides to collect and make publicly available fully anonymised information about infection rates and informs students that it will be doing this.

Communication

Make clear communication with students and staff a priority, and put feedback and response mechanisms in place.

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Recommendations

Prioritise high quality communication about the programme.Provide clear and understandable information in a range of accessibility-friendly formats.Communication should be mindful of the need for programme trustworthiness and should be respectful and well-judged. It should address issues of diversity, equality and inclusion appropriately, including in choice of images and language.Provide a dedicated channel for participants to provide feedback and to raise concerns about the programme, for example anonymous reporting through a programme website.

How might these recommendations be put into practice?

Some hypothetical examples:

  • A HEI has a sound communications plan for the programme. It understands that students need clear information about a range of topics surrounding a testing programme. It designs concise brochures, posters, website and emails, using appropriate language and images that are accessibility-compliant, and it offers clear signposting to more detailed information. It emphasises consistently the importance of isolation in response to a positive test and the need to continue to observe guidance on face-coverings, social distancing, hygiene and ventilation in response to negative tests.

  • A HEI running a programme reassures students that there is only mild physical discomfort associated with swabbing. It posts a video showing the correct technique featuring students themselves from diverse backgrounds. The HEI acknowledges the possibility that some people might experience anxiety about the test and ensures that this is not trivialised. It provides opportunities for students to talk to people who have already had the test to answer any questions.

  • A HEI identifies that communication via email is efficient and acceptable, but also that there is a need to avoid overload. It sends the minimum number of emails possible. It supplements email communication with other resources, including a dedicated and regularly updated programme website. Links are provided to brief videos and other resources.

  • A HEI regularly releases statements outlining how it has been collecting feedback from stakeholders on the programme, outlining what changes, if any, it has made in response. As part of this, it learns through feedback that contact tracing before the public health authorities take over is not being done effectively, and acts to address this problem.

  • A HEI becomes aware of the possibility of stigma linked to testing positive (for example owing to a perception that it reflects reckless or selfish behaviour). In an effort to address this, the HEI emphasises in its communication that testing positive can occur even if an individual has tried their best to follow guidelines on social distancing.

Ethical framework for asymptomatic COVID-19 testing

Students in higher education institutions

Contributors

Caitríona Cox, THIS Institute; Akbar Ansari, THIS Institute; Meredith McLaughlin, Homerton College, THIS Institute; Jan van der Scheer, THIS Institute; Kathy Liddell, Faculty of Law; Jenni Burt, THIS Institute; James McGowan, THIS Institute; Jennifer Bousfield, RAND Europe; Jenny George, RAND Europe; Brandi Leach, RAND Europe; Sarah Parkinson, RAND Europe; Mary Dixon-Woods, THIS Institute

Funding

This study is funded by Mary Dixon-Woods’ NIHR Senior Investigator award, and by The Healthcare Improvement Studies Institute (THIS Institute), University of Cambridge. THIS Institute is supported by the Health Foundation, an independent charity committed to bringing about better health and healthcare for people in the UK. Caitriona Cox, Academic Clinical Fellow, lead researcher, is funded by the National Institute for Health Research (NIHR) for this research project, which was also part-funded by Mary Dixon-Woods’ NIHR Senior Investigator award (NF-SI-0617-10026). The project is supported by the Wellcome Trust. THIS Institute is supported by the Health Foundation, an independent charity committed to bringing about better health and healthcare for people in the UK.The views expressed in this article are those of the authors and not necessarily those of the NHS, the NIHR, or the Department of Health and Social Care or the Wellcome Trust. The survey and interview consultation received approval from the University of Cambridge Psychology Research Ethics Committee.

THIS Institute
University of Cambridge
The Health Foundation
Wellcome