Consent and recent global events
or... are inducements like gift cards and lottery tickets part of collecting valid informed consent to a medical treatment?
When we last boarded the Law, Health and Technology Gondola and took a journey down Consent Lane, we looked at the potential issues that arise with consent in modern society through the lenses of four common examples: cookie consent, medical consent, loyalty scheme consent and connected vehicle consent. Each example reminded us that consent can be like a carrot and stick… in order to get the carrot we often end up allowing ourselves to be hit with the stick. That in some way consent is like any other contract - you give something up to get something… or for what lawyer types call valuable consideration.
In this post we are going to look at how we are using consent today in light of the most recent global events.
Part 5: How are we using consent today?
Consent is collected in different ways that in a given situation may or may not be interchangeable. In some situations the consentee may be required to read and sign an information form with an ultimate statement to the effect that they have read and understood the contents with the possible inclusion that they will not hold the consentor liable for outcomes disclosed in the document or for the consentee’s failure to read the document (sometimes referred to as a waiver). While regulations may require these documents in some consent situations1, it has also become permissible to substitute verbal consent where necessary2 (Gordon, 2000). When collecting consent using an electronic interface (often referred to as e-Consent), the checkbox is rapidly becoming our modern-day proxy for the prescribed clear affirmative action3 (Chen et al, 2019; Derse et al, 2021). However, there are numerous drawbacks4 that mean we can never be assured that checkbox consents are valid informed consent (Derse et al, 2021). Many forms of electronic consent do not even respect autonomy because they present the consentee with what amounts to a forced choice dilemma - consent to all the terms and conditions we say or do not use our software, service or device (Bashir et al, 2015). Studies have highlighted issues with consent collected using traditional online computing interfaces, with one of the most significant issues being that users almost universally do not read or, where the user must click-thru or follow a link, even access the agreement terms (Luger, 2012; Pattinson, 2020). It is suggested that this is strong evidence that communicating terms and conditions or other important information necessary to informed consent is not always effective - that when important information and legal terms are presented in text, at best some users will skim before hurriedly agreeing, and at worst, most ignore the text and just agree in order to get past the consent screen and continue (Pattinson, 2020). It is also common for these interfaces to use ‘nudging’5 - these are the ‘dark patterns’ discussed earlier that are used to influence people to make privacy eroding choices that, in hindsight, many would not normally make (Graßl et al, 2021; Habib et al, 2022; Pattinson, 2020).
Recent global events have given rise to new levels of disregard for the necessary elements of autonomy, certainty and capacity - ostensibly in the name of public health. Examples include:
Global Events Affecting Consent: Vaccine Mandates and Consent Manipulation
The practice of governments seeking to make childhood vaccination mandatory has remained a controversial issue (Attwell et al, 2021). However, what can be worse is when government’s impose a no-choice situation that for many amounts to a mandate, while deceptively avoiding making it expressly mandatory. Australia’s No Jab, No Pay legislation6 linked access to childcare payments and social welfare to children’s vaccination status. The policy only served to discriminate against families that often had lower education and income levels and needed benefits to survive, while leaving better educated and financially secure families who choose not to vaccinate unaffected (Trent et al, 2019; Yang & Studdert, 2017).
Trent et al (2019) sought to promote that No Jab No Pay had strong parental support. They conducted a self-selected survey where 79% of responding parents were rejected for failure to meet strict criteria7, leaving only the responses of 411 participants for inclusion (Trent et al, 2019). Of those, 44% directly acknowledged the imposition of coercion to consent as they reported vaccinating their child only because they needed the financial incentives tied to No Jab, No Pay8. Additionally, a further 18% expressly stated they were not in favour of the policy at all. Rather than demonstrating the strong support conclusion they sought to promote, these results actually showed that in spite of many giving in to the dictate in order to pay bills and put food on the table, almost two-thirds (62%) of parents in the study were clearly opposed to the vaccine policy and its no-choice coercive nature.
It was also no surprise that the threat of Covid-19 vaccine mandates quickly became a divisive issue for communities in many countries, both online and offline. When the first vaccine mandate was imposed on care home workers in the United Kingdom, 8% job losses were expected as existing staff refused to comply with the mandate in an industry that already had more than 12% job vacancies (Samuel, 2021). Studies after the mandate came into effect show that between 12%9 and 16%10 of aged care staff, an estimated 40,000 workers, refused the Covid-19 injections and had to either be redeployed to non-care related roles or, as most were, dismissed from their jobs (Iacobucci, 2022). Seemingly emboldened by the mandate against aged care staff, the government then enacted a similar mandate for NHS workers11. However, it was widely reported that 70,000 - 80,000 frontline NHS staff were refusing the Covid-19 injections (Iacobucci, 2022; Mathews & Dollimore, 2022). In response to large-scale protests12 in London and other metropolitan centres, and with reference to the system-wide effect that loss of that many staff would have, three days before the mandate was to come into effect the government announced its withdrawal (Iacobucci, 2022; Mathews & Dollimore, 2022; Sikh for Truth, 2021).
In Canada, pop-up vaccination events were held where children were persuaded to accept Covid-19 injections in return for free ice-creams. Mainstream media fact checkers alternated between headlines outright denying ice creams were offered at these events (AFP, 2021) or diverting the story onto what they decided were false claims of parents being prevented by police from stopping their children receiving the injections (Associated Press, 2021). As seen in the excerpt shown in Figure 1, the fact checkers actually conceded that children had in fact been incentivised with free ice creams at these vaccination sites (Associated Press, 2021).
Figure 1: Fact Checker admission from The Oregonian newspaper (Associated Press, 2021)
Other examples include a ‘weird’, ‘bizarre’, ‘creepy and inappropriate’ promotional video that was released by a youth affairs advocacy in Victoria, Australia showing a 14 year old girl being coaxed by her much older13 same-sex partner to go on a ‘vax date’ and get vaccinated against her parents express wishes (Chung, 2022; McPhee, 2022). Also, even before Covid-19 injections were considered for use with young children, a series of books14 was published for children aged 5 years and under that were intended to ‘nudge’ children to want Covid-19 vaccination. Each book depicts a small girl called Maxine and a variety of animals who we are told are afraid of getting ‘needles’. Maxine doesn’t want the needle but is eventually forced to accept it by her parents. She is eventually distracted by how wonderful the paediatricians office is such that one book ends with her ‘playing doctor’ with one of her friends. Finally, there were also the CDC-released videos and tweets proclaiming Sesame Street characters Elmo and Big Bird had been vaccinated against Covid-19.
In both Australia and America adults and teens have been offered cash incentives, gift cards, hamburgers and lottery and raffle tickets15 in return for consenting Covid-19 injections (Associated Press (b), 2021; Hogan, 2021; Lenthang, 2021; McMillan, 2021; Persad & Emanuel, 2021). While some authors claimed these offers were ethical by application of the misplaced belief that Covid-19 injections stop transmission16 (Persad & Emanuel, 2021), others point out that any use of coercion, persuasion or manipulation to achieve consent is unacceptable (LaPar et al, 2022).
Many continue to consider the mandate and manipulation situations described above to be decisions made in circumstances of valid informed medical consent. This work has already seen that consent must always be the voluntary choice of the competent consentee, made in circumstances that are free from coercion. However, while mandates occupy a position of no-choice and therefore are never a form of valid consent, consent manipulation creates an intentional lack of effective consent under the guise of being valid consent (Flick, 2016). Consent manipulation is indifferent to autonomy, competence and voluntariness17 (Flick, 2016). It is clear from some examples that consentors deliberately distract the consentee’s attention away from information disclosure and toward the promise of a potential prize or reward. This only serves to reduce the validity of consent while encouraging the consentee to make a decision that may not always be in their best interest.
Global Events Affecting Consent: Organ Donation
A shortage of willing donors has motivated development of new technologies for maintaining donor organ viability for longer (Tatum et al, 2021). It has also resulted in at least four different regulatory approaches to resolving the donor organ shortage known as: Opt In; Opt Out; Mandated choice; and Mandatory donor.
Opt In: An opt in approach does not assume consent to donation, leaving it for the individual to voluntarily nominate as an organ donor.
Opt Out: Intended to boost numbers of available organs, an opt out approach presumes consent for organ donation unless the individual expressly indicates they do not wish it to occur (Becker et al, 2022). An example of opt out legislation can be found in England’s Organ Donation (Deemed Consent) Act 2019 that amends the Human Tissue Act 2004 with the addition of a deemed consent clause18.
Mandatory donor: This approach makes organ donation mandatory for everyone and removes any individual right for changing this statutorily fixed donor status.
Mandated choice: This approach does not create the no-choice or presumed consents of the mandatory or opt out approaches. Rather, it mandates what some consider to be a more ethical requirement for the individual to elect whether or not they consent to organ donation contemporaneous to some other act or undertaking, for example: when receiving their drivers’ license or voting in national elections (Symons & Poulden, 2022).
The four approaches can be divided into: explicit consent (default opt-in or mandated choice) in which the starting position is effectively that of no action can be taken until the individual makes a clear decision regarding their participation in organ donation; presumed consent (default opt-out) in which the person is made an organ donor until they signal their clear intention to withdraw from organ donation; and no-choice (mandatory donor) in which the individual is always an organ donor by force of legislation. Recent studies have found that people are sensitive to the framing of these organ donation legislative approaches - with the mandatory no-choice and presumed consent approaches being associated with lower levels of willingness to donate (Lin et al, 2018). It is also clear that the only way we can really know the individual’s position regarding organ donation is through their clear expression (Lin et al, 2018; Formoso et al, 2021). In any event, when compared with opt in, the opt out approach has not resulted in higher levels of organ donation (Etheredge, 2021) and as a ‘nudge’ intended to increase organ donation, may actually be backfiring[4] (Lin et al, 2018; Osman et al, 2020). A nudge is an approach in choice architecture that seeks to modify the behaviour of an individual or group towards some preferred choice without prohibiting the alternative or nonpreferred options.
Summary and Conclusion
In summary, practical models of consent tend towards presenting a notional description of consent that lacks one or more necessary elements, and makes their definition or characterisation incomplete. The complete definition for consent is characterised by the presence of eight necessary elements - revocability, intentionality, autonomy, capacity, certainty, understanding, purpose, and specificity. This five-part post on consent (one, two, three, four and this one) has seen description of a new framework for consent built of three layers of models - the philosophical models that describe an overarching theory for consent as a normative ethical proposition; the practical models that are distinguished by how the necessary elements of consent apply in the process of consent; and the application models that describe how individuals interact with and provide consent. The philosophical model informs the underlying process of the practical model, and the application model is the everyday manifestation of the practical model that interacts with the consentee and captures the consent decision. We have also discussed four common application models of consent and in this post, recent issues arising out of their ongoing development and use. The present-day examples in this post demonstrate that the consent process may have failed to live up to the ethical standards of our modern understanding of valid informed consent. While this first incursion into issues in contemporary consent has come to a close, it is clear that the overall consent conversation is far from concluded.
In the next series on consent, we will look at the triumverate of consent approaches for minors - Surrogate (or parental) consent, judicial consent (court orders) and Gillick competence. We will do this over another series of posts that also review 20 court judgements on consent for minors handed down between 2019 and 2022.
For example, Federal Regulations for consent to Human Research in America generally require that consent is documented using a written document that is signed by each participant.
Gordon highlights that some people may wish to consent but may be reticent to sign a consent document as a result of either racial, educational or visual impairment issues.
Article 4 of EU GDPR defines consent as: any freely given, specific, informed and unambiguous indication of the data subject's wishes by which he or she, by a statement or by a clear affirmative action, signifies agreement to the processing of personal data relating to him or her
Including that the consentor collecting e-consent online cannot see the consentee in order to ascertain whether the information was read, how well it has been understood, or whether the person even has capacity to consent. The consentor must also remember that some regulation like the UE’s GDPR, as ruled in a 2019 judgement in case C-673/17 (Planet49) of the Court of Justice of the European Union (CJEU), does not allow the use of pre-selected checkboxes as a valid form of consent
Less egregious dark patterns ‘nudging’ might include pre-selected options which effect automatic consent if the consentee clicks through in a hurry. More controversial nudging include the use of words to shame or guilt the person for denying consent, text like that seen when people attempt to cancel an Amazon Prime subscription which presents multiple options couched in similarly sounding language that has the power to confuse some users into believing they are cancelling the service when they are in fact agreeing the opposite, or as with the Mozilla Firefox update pop-ups, use of colour or other visual cues intended to elicit the desired response from the distracted or impatient user.
Which while related is separate to the No Jab No Play legislation that requires a childcare centre to confirm vaccination status or the existence of an exemption before enrolling an infant in childcare.
Their child had to still be under 5 years of age when the survey closed.
It is clear from the responses of close to half of parents in the study that they only vaccinated their child because they felt forced into a no-choice situation as a result of needing the social welfare financial support. In order to draw their policy-favourable conclusion the study’s authors ignored this obvious cue that the policy was coercive for these parents and misclassified them as being supportive of the No Jab, No Pay policy.
Unison Survey reported in May 2021 state that 12% of respondents in a 4000-person study had refused to receive the Covid-19 injections - https://www.unison.org.uk/news/press-release/2021/05/care-staff-more-likely-to-decline-jab-if-threatened-by-employers-says-unison-survey/.
UK Government figures reported in November 2021 state that only 84.1% of care home workers consented to receive their first injection - https://www.gov.uk/government/consultations/making-vaccination-a-condition-of-deployment-in-older-adult-care-homes/outcome/making-vaccination-a-condition-of-deployment-in-care-homes-government-response
Primarily affecting nurses, midwives, healthcare assistants, physiotherapists etc.
Which videos and academic observer estimates show included more than 300,000 people. The protests were wildly underreported by the media as conversely being either only ‘hundreds’ or ‘thousands’ of protesters. The media also used purple prose and deliberately misleading terms to claim ‘nurses were joining anti-vaxxers’. The majority of attendees were pro-choice as opposed to anti-vaccination, and were protesting introduction of NHS vaccine mandates and population-wide proof-of-vaccination mandates (i.e. Covidpass)
When the older girlfriend shows her vaccination passport, it can clearly be seen that she is represented as being born in 1975 and hence, 46 years old.
These include: “Maxine gets her vaccine” by Elena Bruun, and “Maxine’s critters get the vaccine jitters” by Jan Zauzmer. Bruun describes herself as a marriage and family therapist and mental health counsellor and does not possess medical qualifications. Zauzmer is a law school graduate who has written ‘nudge’ books for children on a range of controversial topics including vaccination and voting.
Many with seven-figure prizes.
Even pro-vaccination stalwarts like Bill Gates, Anthony Fauci and members of the WHO have publicly acknowledged that the Pfizer and Moderna mRNA Covid-19 injections have not prevented transmission or infection in the way they had originally expected.
Which the authors describe as the most important aspects of informed medical consent.
Organ Donation (Deemed Consent) Act 2019, section 1(4) extends section 6 of the Human Tissue Act 2004 with: (6B) The person concerned is to be deemed, for the purposes of subsection (6)(ba), to have consented to the activity unless a person who stood in a qualifying relationship to the person concerned immediately before death provides information that would lead a reasonable person to conclude that the person concerned would not have consented.