# Trust, but Verify: Informed Consent, AI Technologies, and Public Health Emergencies
## 4 Informed Consent
### Applied Research Ethics  
Research ethics relates to more general applied ethical principles, which helps contextualise issues pertaining to informed consent. Research ethics review is often based on recommendations from the Belmont Report [25], which echo similar values in medical ethics [31], and assumes that activity is research [32] rather than service evaluation, for instance. The primary focus includes:  
* _Participant Autonomy_ or _Respect for the Individual_: a guarantee to protect the density of the participant as well as respecting their willingness or otherwise to take part. This assumes that the researcher (including those involved with clinical research) have some expectation of outcomes and can articulate them to the potential participant. Deception is possible under appropriate circumstances [33], including the use of placebos. Big data requires careful thought, since it shifts the emphasis away from individual perspectives [34]. In so doing, a more societally focused view may be more appropriate [35]. Originally, autonomy related directly to the informed consent process. However, the potential for big data and AI-enabled approaches suggests that this may need rethinking.
* _Beneficence_ and _non-malevolence_: ensuring that the research will treat the participant well and avoid harm. This principle, most obvious for medical ethics, puts the ons on the researcher (or data scientist) to understand and control outcomes (see also [15; 17]). Although there is no suggestion that the researcher would deliberately wish to cause harm, unsupervised learning may impact expected outcomes. Calls for transparency and the human-in-the-loop to intervene if necessary [8; 17] imply a recognition that predictions may not be fixed in advance. Once again, the informed nature of consent might be difficult to satisfy.
* _Justice_: to ensure the fair distribution of benefits. The final principle highlights a number of issues. The CARE Principles [36], originally conceived in regard to indigenous populations, stress the importance of ensuring that all stakeholders within research at least are treated equitably. For all its limitations, the trolley car dilemma [37] calls into question the assessment of justice. During a public health emergency, and inherent in contact tracing, the issue is whether justice is better served by protecting the rights of the individual especially privacy over a societal imperative.  
In general ethics terms, autonomy, benefence/non-malevolence, and justice reflect a Kantian or deontological stance: they represent the rules and obligations which govern good research practice (for a useful summary on applied ethical theories, see [38]). Utilitarianism--justifying the means on the basis of potential benefits--is subordinate to such obligations. However, [PERSON] justice theory and different outcomes to the trolley-car dilemma motivate a re-evaluation of a simple deontological versus utilitarian perspective. Further, the socially isolating effect of the COVID-19 pandemic raises the question as to whether a move away from focusing on the individual and considering instead the individual as defined by the collective community is more appropriate (see [39]). Indeed, the challenge comes when applying ethical principles in specific research environments [40; 41], or medical situations [27]. Ethics review must therefore balance the potentially competing interests and expectations of research participants, researchers and the potential benefit to the community at large in determining what is ethically acceptable. At the same time, it is essential to consider whether the researcher or any other stakeholder can truly assess what the potential outcomes might be. In either case--individual versus community benefit, and the overall knowledge and transparency of the research involved--there needs to be an ongoing negotiation amongst stakeholders to agree on an acceptable approach.