# Trust, but Verify: Informed Consent, AI Technologies, and Public Health Emergencies
## 4 Informed Consent  
Although the concept can be traced back historically [19], the definition of informed consent was formalised more recently after World War II in the Nuremberg Code [20] and the Helsinki Declaration [21]. The emphasis is on:  
_\"Voluntary agreement to or acquiescence in what another proposes or desires; compliance, concurrence, permission.\"_ ([[https://www.oed.com/oed2/00047775](https://www.oed.com/oed2/00047775)]([https://www.oed.com/oed2/00047775](https://www.oed.com/oed2/00047775))) (accessed on 12 May 2021). For technology, terms of use focuses on an agreement between user and provider, defining usage and limiting liability:  
_\"[The] circumstances under which buyers of software or visitors to a public Web site can make use of that software or site\"_[22] as part of a _\"binding contractual agreement\"_[23]. Indeed, [PERSON] and her colleagues [24] and subsequently [PERSON] and [PERSON] make explicit the link between terms of use and:  
_\"Consent [which] permeates both our law and our lives-particularly in the digital context\"_ (The term _consent_ as used here will therefore include _terms of use_) [23]. Figure 2: TPB Interpretation of Behaviours associated with (**a**) _Terms of Use_ and (**b**) _Research Consent_. In a medical or clinical context, and to counter the paternalism of earlier medical practice, the definition makes explicit who the main parties to the agreement are:  
_\"[the] process of informed consent occurs when communication between a patient and physician results in the patient's authorization or agreement to undergo a specific medical intervention\"._ ([[https://www.ama-assn.org/delivering-care/ethics/informed-consent](https://www.ama-assn.org/delivering-care/ethics/informed-consent)]([https://www.ama-assn.org/delivering-care/ethics/informed-consent](https://www.ama-assn.org/delivering-care/ethics/informed-consent))) (accessed on 12 May 2021). There are other concerns, though. For clinical treatment, the patient is reliant on the clinician to improve their well-being, and there is no guarantee that they will understand the implications of the treatment proposed. Further, concerned about their health or general prognosis, they may not be emotionally fit to think objectively about the information that they have been given. Additionally, during a public health emergency, there may be a legal or moral obligation to disclose data, such as infection status. This implies a balance to be struck between individual rights and the common good. In research terms, consent is seen as integral to respect for the autonomy of the research participant:  
_\"Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied.\"_ (Part C (1), [25]). Latterly and with the emphasis on the right to privacy (Art. 8 [14]), consent is defined in data protection legislation 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\"_ (Art. 4(11), [3]). Irrespective of context, all definitions assume the pre-requisite characteristics of voltantiness (freely given) and informed (understanding what another proposes or desires). It is not always clear, however, if these basic requirements are met or even possible. In a clinical context, apart from the assumption that patients are emotionally objective rather than directly reliant on the expertise of the clinician, the stakeholder relationship is unequal. Notwithstanding the right to religious tolerance [19] assuming it be based on true autonomy [26], clinical judgement is subordinate to uninformed or emotionally charged patient preference [27]. Putting clinician and patient on a more equal footing may be preferable and preserve the interests of all parties [28].