THIS Institute
The Health Foundation

Ethical framework for asymptomatic
COVID-19 testing

Staff in workplaces

This framework is based on a consultation, ethical & legal analysis, and expert discussion.
Over 60 staff took part in the consultation exercise.

University of Cambridge
Wellcome

Design and operation of the programme

Assess whether a testing programme is the right choice for your organisation and whether you can deliver all aspects of it. Ensure you can meet public health and legal duties.

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Recommendations

Start by making an assessment of whether a programme is the right choice for your organisation, taking account of the available evidence, current pandemic conditions, and your own 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. Testing on its own is not enough. There must also be confidence that the key control measure (isolation of confirmed cases and close contacts) can be achieved.Sign up in full to delivering on all of the components necessary for the testing programme, ensuring that adequate resources, capabilities and quality assurance mechanisms are in place.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.Consider whether there may or may not be a duty of care to operate a testing programme if current evidence points in favour of the benefits of a testing programme outweighing any downsides and the organisation is reasonably able to offer a programme.

How might these recommendations be put into practice?

Some hypothetical examples:

  • An organisation where much of the workforce is required to be in the workplace, and where many staff are in public-facing roles, makes a full assessment of whether an asymptomatic Covid-19 testing programme could reduce risk of infection and contribute to improved safety for colleagues and clients. It considers how likely it is that it can reasonably achieve these aims given current pandemic conditions, the available technologies, and its ability to deliver a programme in full.

  • An organisation identifies all the components that need to be in place for the programme to work well. It makes an assessment of the costs, opportunity costs (e.g. things it can’t do because it is doing the programme), risks and possible unwanted consequences of the programme. It considers the available evidence on testing programmes, current pandemic conditions, its own business needs, its ability to commit resources, and the willingness and ability of the workforce to participate. It is confident that isolation of cases that test positive can be achieved. It concludes that running a testing programme is a justifiable addition to its multi-modal approach to ensuring a safer workplace.

  • A different organisation, 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 and effective programme. It therefore decides not to proceed with a testing programme.

  • An organisation that has decided to proceed with a testing programme organisation creates a sound governance structure. It identifies key responsibilities and accountabilities in the programme team, a clear decision-making structure, and a resources plan. The programme team has operational strengths and sound understanding of the science and ethics of testing, and is aware of the public health and legal responsibilities associated with testing. The team designs a holistic, end-to-end programme. The organisation designs and implements appropriate quality assurance mechanisms. It is alert to public health guidance and government policy as it changes over time, and makes appropriate adjustments to its programme.

  • An organisation running a testing programme models a number of scenarios and puts plans in place to cope with them, for example to address business continuity in situations where large numbers of staff test positive.

  • An organisation that has decided to run testing programme conceptualises it as a duty of care to staff and clients and as a benefit to staff and the community. It presents the programme to its stakeholders in this way, with the aim of engendering trust, solidarity and a sense of mutual responsibility. The organisation also identifies any factors which might undermine trust (e.g. treating some groups unfairly, communication failures, poor logistics, lack of support for isolation) and takes steps to address these issues.

Goals of the testing programme

Identify the programme goals, explain why they were chosen, tell staff 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, especially isolation of positive cases and their contacts. If there are multiple programme goals, they should be acknowledged explicitly.The goals should be clearly explained to staff.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:

  • An organisation defines the goals of its asymptomatic testing programme as improved workplace safety for all colleagues and fulfilling duties of care to client groups. Secondary goals include delivering broader public health benefits and providing reassurance for staff and clients. The organisation is clear about the underlying rationale for why these goals might be achievable: detecting asymptomatic infection enables isolation of positive cases and close contacts, and therefore reduces onward transmission. It also acknowledges the current uncertainties associated with demonstrating whether the programme can deliver on its goals.

  • An organisation communicates that the wellbeing and safety of staff and clients is the primary motivation for the programme. It clarifies the scope of the programme, explaining that the programme is intended to identify positive cases who can then isolate to disrupt viral transmission. Following feedback from staff, it reaffirms that it is not using negative tests as a way of forcing people to come to the workplace when they could reasonably work from home for the present.

  • An organisation specifies that it will judge the effectiveness of the programme using criteria relating to: participation rates, positivity rates (percentage of people tested who are positive), outbreaks, cost-effectiveness, and staff satisfaction (measured by surveys). It acknowledges influences outside its own scope of control, such as community prevalence. It monitors effectiveness over time. It keeps its programme under review as conditions, technology, policy, guidance, and scientific understanding, and staff views evolve. It clearly signals any changes to all stakeholders.

  • An organisation plans regular reviews to check that the purposes being served by the programme are still valid and relevant to need, and to ensure that goal drift has not occurred (such as, for example, using data from the programme as a means of surveillance of productivity or attendance).

Properties of the test(s) selected for the programme

Assess the available testing options, considering current evidence and guidance. Acknowledge uncertainty, take action to address risks of the chosen approach, and make sure other infection control measures are maintained.

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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. do 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.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 and the support available.Acknowledge the implications of false negatives and false positives in communications about the programme.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, you 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:

  • An organisation 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 staff, costs, logistical burden and test certification.

  • An organisation takes steps to ensure that swabbing is done correctly. It reassures staff that there is only mild physical discomfort associated with a nasal swab. It posts a video showing the correct technique for self-swabbing on its website, with voiceovers led by staff themselves, and emphasises that support is available should the test outcome trigger self-isolation. The organisation acknowledges the possibility that some people might experience anxiety about taking the test, about the results of the test, or about the impacts that test results could have for people and their households. It ensures that these concerns are not trivialised. It provides opportunities for staff to talk to people who have already had the test to answer any questions.

  • One organisation, having reviewed the latest government advice and other sources, selects lateral flow testing (LFT) as its testing approach. It checks that the system has been certified for the purposes for which the organisation is planning to use it. 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 (people testing negative for Covid-19 even though they have it). Accordingly, the organisation 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 does not 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 organisation also conducts a full assessment of the available testing options. It decides to use PCR testing, and contracts with an external laboratory to provide the facilities needed. It ensures that the lab is certified appropriately for the tests, so it meets the required legal standards.

  • An organisation reminds its staff of current national guidelines regarding whether it is possible to return to work after close contact with a confirmed case of Covid-19 on the basis of a negative test.

  • An organisation considers the probability of false positives associated with its chosen testing regime. It notes that in the event of a false positive, a staff member and their close contacts will be erroneously required to isolate. To mitigate this risk, it offers swift confirmatory testing.

  • An organisation discovers that an unintended consequence of the programme is that those who test negative may engage in more risk-taking behaviour. In response, it explicitly communicates that a negative test result means an individual “has tested negative, but could still be infected with the virus”. It informs staff that the asymptomatic testing program is “one tool in a multi-component risk reduction strategy”. It increases its communication about distancing, face-covering, hygiene, and other infection control measures.

Enabling isolation

Be clear about requirements for isolation. Make sure the right support and communication is in place to support staff and their households to isolate effectively.

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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 close contacts isolating after a positive test.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:

  • An organisation emphasises to staff that they must self-isolate if they test positive or have had close contact with a positive case. It assesses what is needed to support this. It is aware of worries and concerns staff may have when self-isolating (e.g. anxiety, loneliness, limited access to food shopping and exercise, difficulties related to caring responsibilities, and impact on household members who may also have to isolate as close contacts). The organisation makes sure that isolating staff receive paid leave and practical support where needed. It makes mental health support resources available. Using a clear process, it offers additional financial assistance for staff who might otherwise struggle (e.g. because they or their household members are on zero hours contracts).

  • An organisation communicates clearly with its staff about what to do if they receive a positive result, what support is available if they must isolate, how they can access it. Communication is intended to address concerns and alleviate anxiety around the possibility of having to isolate; the organisation is attentive to feedback from staff about the experience of isolating, and demonstrates that it is acting on it to reduce the burdens of isolation.

Choices regarding participation in testing programmes

Carefully think about how far staff participation in testing should be mandatory or voluntary. Consider ethical issues, relevant laws, and the special nature of the employee/employer relationship.

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Recommendations

Make a reasoned decision about how far staff participation in the programme should be voluntary or mandatory, with explicit attention to ethical principles, relevant laws and the nature of the employee/employer relationship. Some considerations include (but are not limited to) the priority to be given to individual choice, the extent to which the effectiveness of the programme depends on full participation, and the possibility of creating unfairness (for example if choice is more easily exercised by more senior groups while increasing risk for front-line groups or by undermining the efforts of those who do participate).If the decision is taken to mandate programme participation, explain the rationale clearly. The reasons for not enabling individual choice should be clearly articulated, and any opportunities for individual exceptions to be made (and the criteria that might apply) should be explained.Where a decision is taken to mandate a testing programme, communication should be sensitive to the potential for industrial relations conflict (e.g. with trade unions or staff representatives), hostility, loss of trust, and possible poorer compliance with the programme.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.

How might these recommendations be put into practice?

Some hypothetical examples:

  • An organisation offers individual staff the choice of 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). Following complaints from some staff about having to share workspace with untested colleagues, and organisation decides to reiterate the principle that participation in testing is voluntary at an individual level, but makes it clear that it strongly encourages staff to participate for the safety of others unless they have good reasons not to participate. It commits to keeping the policy under review if new evidence emergences.

  • A different organisation makes it clear that its expectation is that all staff will participate in the programme, but it provides a formal process for individuals to apply to be exempted from participation. Its communication focuses on the need for solidarity and collegiality in reducing viral transmission, the shared benefits of reduced risk, and averting unfairness. It reiterates its commitment to equality, diversity and inclusion.

  • Following consultation with staff representatives, another organisation decides to mandate the programme for all staff who will work on its premises. It assessed that making it voluntary could lead to the programme goals being undermined (reduced ability to disrupt transmission through identification and isolation of positive cases), could potentially lead to unfairness across different staff groups, and could be a source of tension between colleagues. The organisation explains that it will consider carefully any concerns as part of its programme’s governance mechanisms. It provides a formal process through which individuals can apply to be exempted from participation (e.g. medical or religious reasons).

  • An organisation, following consultation, concludes that offering small incentives (e.g. free coffee for taking part) to encourage participation would be acceptable. 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.

Benefits, harms, and opportunity costs

Assess possible benefits and risks, harms, costs, and things that you can't do because you are doing this programme. Think about equity and whether some staff groups might bear more burdens than others.

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Recommendations

Consider the possible benefits, risks and harms of the programme, including issues of equality, diversity and inclusion. Put appropriate mitigations in place where possible.Identify any staff groups who might be disproportionately affected by the testing programme and seek to mitigate the effects.Consider the trade-offs and opportunity costs (e.g. things that could not be done because of running the programme), the range and nature of uncertainties, and the need to balance values that may be difficult to reconcile (e.g. individual liberty and collective benefit).Be able to give an account of the reasonableness of your organisation’s decision-making process and its decisions. People may reasonably disagree about how an organisation should weigh up possible benefits, risks and harms and the different views on these questions, so be prepared to explain how the decisions have been made.

How might these recommendations be put into practice?

Some hypothetical examples:

  • An organisation considers the possible benefits and harms of the programme and explicitly considers equity, diversity and inclusion in their distribution. It identifies that those on low incomes or pre-existing mental health conditions may be disproportionately disadvantaged by isolation. It also identifies that some appear to be experiencing stigma and discrimination in relation non-participation in the programme. The organisation puts appropriate measures in place to address these challenges, including reminders that some people have legitimate reasons not to participate, a hardship fund for staff facing particular difficulties, reduced productivity expectations, and paid leave.

  • An organisation examines costs and benefits of the programme. It considers alternative uses to which the resources might be put, and decides that the programme is a justified expenditure for now because of the potential reduce transmission of COVID-19 for staff, clients and the community, while also facilitating business continuity. The organisation reviews this assessment at key points, for example when costs increase or benefits appear to decrease.

  • An organisation, through its governance mechanisms, makes clear and explicit the rationale underlying its decisions and acknowledges that not everyone will agree with all of them. It uses consultation where appropriate to engage with diverse views and ensure that they have been taken into account.

Privacy, confidentiality and data-sharing

Ensure the programme meets data protection and confidentiality requirements. Be clear who will be 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 for the programme is needed.
Ensure that individuals processing programme data are properly trained.
Communicate clearly about who will be informed in the event of a positive test result, with clear justification for any sharing of health data.Communication should make clear that public health authorities may be notified of positive test results, thereby activating contact tracing mechanisms.If you conduct contact tracing on-site (e.g. before the public health authorities take over), you have a duty to inform contacts that they have been exposed (which may result in deductive disclosure, as colleagues 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 large organisation conducts a data protection impact assessment for its testing programme. It establishes clear workflows for handling data at every stage, and ensuring full compliance with the principles specified in the General Data Protection Regulation. Data is pseudonymised or anonymised where possible. The organisation 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 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. The organisation issues a privacy notice with information on sharing of personal data.

  • An organisation develops a clear workflow for notifying public health authorities of confirmed positive tests, making it clear to staff that this will activate contact tracing.

  • An organisation 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.

  • An organisation specifies that those who are deemed close contacts by virtue of sharing the same environment in the workplace will be notified that there has been a positive test, but not the name of the individual who has tested positive. It acknowledges that people may be able to work out who has tested positive, but also says it is taking all possible steps to protect confidentiality so, for example, will not confirm “guesses”.

  • An organisation seeks the consent of staff 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 for this purpose are reassured that there will be no detriment to them.

Communication

Make clear communication with 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 about all aspects of the programme in a range of accessibility-friendly formats.Be mindful of need for programme trustworthiness, ensuring that communication is respectful and well-judged and addresses issues of equality, diversity and inclusion appropriately.Provide a way for staff to provide feedback and to raise concerns about the programme, for example anonymous reporting through a programme website, and ensure there is a system for acknowledging and addressing the issues raised.

How might these recommendations be put into practice?

Some hypothetical examples:

  • An organisation develops a sound communications plan for the programme. It understands that staff need clear information about a range of topics surrounding a testing programme, but is also attentive to the need to avoid information overload. It designs concise brochures, posters, website and emails, using appropriate language and images that are accessibility-compliant and respectful of diversity. It offers clear signposting to more detailed information. It emphasises consistently the importance of isolation in response to a positive test. In all communication, the organisation strongly emphasises the need for all measures for reducing infection risk, stressing that testing is just one of these.

  • An organisation identifies email is an efficient and acceptable way of communicating with staff about the programme. It supplements email communication with other resources, including a dedicated and regularly updated programme website. Links are provided to brief videos showing how to administer nasal swabs and other advice about the programme, featuring staff from diverse backgrounds.

  • An organisation 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, it emphasises someone can test positive even if they have tried their best to follow guidelines.

  • An organisation 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.

Ethical framework for asymptomatic COVID-19 testing

Staff in workplaces

Contributors

Dr Jan van der Scheer, THIS Institute; Dr Akbar Ansari, THIS Institute; Dr Meredith McLaughlin, THIS Institute; Dr Caitríona Cox, THIS Institute; Dr Kathleen Liddell, University of Cambridge; Dr Jenni Burt, THIS Institute; Jenny George, RAND Europe; Dr Becky Kenny, THIS Institute; Ruth Kern, THIS Institute; Brandi Leach, RAND Europe; Dr James McGowan, THIS Institute; Kate Morley, RAND Europe; Dr Janet Willars, University of Leicester; Professor Mary Dixon-Woods, THIS Institute

Funding

This project is supported by the Wellcome Trust and led independently by THIS Institute. 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 survey and interview consultation received approval from the University of Cambridge Psychology Research Ethics Committee. The views expressed in this article are those of the authors and not necessarily those of the Wellcome Trust.

THIS Institute
University of Cambridge
The Health Foundation
Wellcome