Progress in precision medicine is being achieved through the design of clinical trials that use genetic biomarkers to guide stratification of patients and assignation to treatment or control groups. Genetic analysis of biomarkers is, therefore, essential to complete their objectives, and this involves the study of biological samples from donor patients that have been recruited according to criteria previously established in the design of the clinical trial. Nevertheless, it is becoming very common that, in the solicitation of biological samples, purposes (...) that are beyond the objectives of the stated therapeutic trial research are introduced, like the development of ill-explained exploratory studies or the use in unspecified future research. In the digital era, the sequencing of patients’ DNA needs to be considered as a serious security matter, not only for the patients, but also for their relatives. Genetic information may be easily stored, even forever, in digital files. This engenders a permanent risk of being stolen or misused in many ways. Furthermore, re-identification of sample donors is technically feasible through their genetic data. For these reasons, genetic analysis of samples collected in clinical trials should be restricted to the accomplishment of their main objectives or well justified goals. (shrink)

The ‘right not to know’ can be used by patients as a safeguard against the effects that certain medical information can have on their well-being. At first glance, one might reason it suitable for a patient to enact their RNTK. However, although Davies states that RNTK gives people the ability to both protect themselves from self-perceived harm and exercise their autonomy, I will argue that ‘not knowing’ hinders patients’ ability to exercise their existential freedom and represents what Sartre calls an (...) instance of ‘bad faith’. Davies argues that the RNTK takes precedence over many related issues and objections associated with a patient’s decision to implement such a resolution.1 Fundamentally, the RNTK gives patients power to protect themselves from subjective harm and to exercise their autonomy. In most cases, objectors of RNTK cite the negative impact on the patient’s state of health, which affects not only the patient but also those persons who would also be negatively affected by patient health outcomes. For the majority of objectors, patients have moral obligations to lessen the degree of burden on others, which refusal can initiate. However, Davies concludes, ‘…the burden placed on others is not sufficiently significant …. (shrink)

There is an ongoing debate in medicine about whether patients have a ‘right not to know’ pertinent medical information, such as diagnoses of life-altering diseases. While this debate has employed various ethical concepts, probably the most widely-used by both defenders and detractors of the right is autonomy. Whereas defenders of the right not to know typically employ a ‘liberty’ conception of autonomy, according to which to be autonomous involves doing what one wants to do, opponents of the right not to (...) know often employ a ‘duty’ understanding, viewing autonomy as involving an obligation to be self-governing. The central contribution of this paper is in showing that neither view of autonomy can reasonably be said to support the extreme stances on the right not to know that they are sometimes taken to. That is, neither can a liberty view properly defend a right not to know without limits, nor can a duty view form the basis of an absolute rejection of the right not to know. While there is still theoretical distance between these two approaches, we conclude that the views are considerably closer on this issue than they first appear, opening the way for a possible compromise. (shrink)

Response to commentaries on 'The right not to know and the obligation to know'.

Biomarker-based predictive tests for subjectively asymptomatic Alzheimer’s disease (AD) are utilized in research today. Novel applications of artificial intelligence (AI) promise to predict the onset of AD several years in advance without determining biomarker thresholds. Until now, little attention has been paid to the new ethical challenges that AI brings to the early diagnosis in asymptomatic individuals, beyond contributing to research purposes, when we still lack adequate treatment. The aim of this paper is to explore the ethical arguments put forward (...) for AI aided AD prediction in subjectively asymptomatic individuals and their ethical implications. The ethical assessment is based on a systematic literature search. Thematic analysis was conducted inductively of 18 included publications. The ethical framework includes the principles of autonomy, beneficence, non-maleficence, and justice. Reasons for offering predictive tests to asymptomatic individuals are the right to know, a positive balance of the risk-benefit assessment, and the opportunity for future planning. Reasons against are the lack of disease modifying treatment, the accuracy and explicability of AI aided prediction, the right not to know, and threats to social rights. We conclude that there are serious ethical concerns in offering early diagnosis to asymptomatic individuals and the issues raised by the application of AI add to the already known issues. Nevertheless, pre-symptomatic testing should only be offered on request to avoid inflicted harm. We recommend developing training for physicians in communicating AI aided prediction. (shrink)