Trust and the Goldacre Review: why trusted research environments are not about trust
Introduction The significance of big data for driving health research and improvements in patient care is well recognised. Along with these potential benefits, however, come significant challenges, including those concerning the sharing and linkage of health and social care records. Recently, there has been a shift in attention towards a paradigm of data sharing centred on the ‘trusted research environment’ (TRE). TREs are being widely adopted by the UK’s health data initiatives including Health Data Research UK (HDR UK),1 Our Future Health2 and Genomics England.3 A recent review commissioned by the UK&rs...
Source: Journal of Medical Ethics - September 22, 2023 Category: Medical Ethics Authors: Graham, M., Milne, R., Fitzsimmons, P., Sheehan, M. Tags: Open access Current controversy Source Type: research
Replication crisis and placebo studies: rebooting the bioethical debate
A growing body of cross-cultural survey research shows high percentages of clinicians report using placebos in clinical settings. One motivation for clinicians using placebos is to help patients by capitalising on the placebo effect’s reported health benefits. This is not surprising, given that placebo studies are burgeoning, with increasing calls by researchers to ethically harness placebo effects among patients. These calls propose placebos/placebo effects offer clinically significant benefits to patients. In this paper, we argue many findings in this highly cited and ‘hot’ field have not been independe...
Source: Journal of Medical Ethics - September 22, 2023 Category: Medical Ethics Authors: Blease, C., Colagiuri, B., Locher, C. Tags: Clinical ethics Source Type: research
Decommodifying the most important determinant of health
Among the most harrowing visuals of Britain’s ongoing ‘cost of living crisis’ are the security tags that began to appear on cheese, butter, chicken, sweets and infant formula milk in 2022. A week’s worth of formula milk—the sole or main food of the vast majority of infants for the first 6 months of life—now costs between £9.39 and £15.95.1 Low-income households are entitled to a ‘Healthy Start’ welfare payment, intended to avert malnutrition among the poorest children, but the weekly allowance is just £8.50.2 There are reports of parents watering down formul...
Source: Journal of Medical Ethics - September 22, 2023 Category: Medical Ethics Authors: Shahvisi, A. Tags: Editorial Source Type: research
TREs are still not about trust
In our recent paper ‘Trust and the Goldacre Review: Why TREs are not about trust’1 we argue that trusted research environments (TREs) reduce the need for trust in the use and sharing of health data, and that referring to these data storage systems as ‘trusted’ raises a number of concerns. Recent replies to our paper have raised several objections to this argument. In this reply, we seek to build on the arguments presented in our original paper, address some of the misunderstanding of our position expressed in these replies, and sketch out where further research is needed. Trustworthiness signalling ...
Source: Journal of Medical Ethics - August 30, 2023 Category: Medical Ethics Authors: Graham, M., Milne, R., Fitzsimmons, P., Sheehan, M. Tags: Response Source Type: research
Trusted research environments are definitely about trust
In their highly topical paper, Graham et al argued that Trusted Research Environments (TREs) are not actually about trust because they reduce or remove ‘...the need for trust in the use and sharing of patient health data’. We believe this is fundamentally mistaken. TREs mitigate or remove some risks, but they do not address all public concerns. In this regard, TREs provide evidence for people to decide whether the bodies holding and using their data can be trusted. TREs may make it easier for people to trust but there is still a need for that trust. (Source: Journal of Medical Ethics)
Source: Journal of Medical Ethics - August 30, 2023 Category: Medical Ethics Authors: Affleck, P., Westaway, J., Smith, M., Schrecker, G. Tags: Response Source Type: research
Loneliness at the age of COVID-19
Loneliness has been a major concern for philosophers, poets and psychologists for centuries. In the past several decades, it has concerned clinicians and public health practitioners as well. The research on loneliness is urgent for several reasons. First, loneliness has been and still is extremely ubiquitous, potentially affecting people across multiple demographics and geographical areas. Second, it is philosophically intriguing, and its analysis delves into different branches of philosophy including phenomenology, existentialism, philosophy of mind, etc. Third, empirical research has shown that loneliness is a significan...
Source: Journal of Medical Ethics - August 30, 2023 Category: Medical Ethics Authors: Lederman, Z. Tags: COVID-19 Extended essay Source Type: research
Expanding health justice to consider the environment: how can bioethics avoid reinforcing epistemic injustice?
We are in the midst of a global crisis of climate change and environmental degradation to which the healthcare sector directly contributes. Yet conceptions of health justice have little to say about the environment. They purport societies should ensure adequate health for their populations but fail to require doing so in ways that avoid environmental harm or injustice. We need to expand our understanding of health justice to consider the environment and do so without reinforcing the epistemic injustice inherent in the field of bioethics. This paper considers what work in philosophy related to the environment should be appl...
Source: Journal of Medical Ethics - August 30, 2023 Category: Medical Ethics Authors: Pratt, B. Tags: Original research Source Type: research
Herd immunity, vaccination and moral obligation
The public health benefits of herd immunity are often used as the justification for coercive vaccine policies. Yet, ‘herd immunity’ as a term has multiple referents, which can result in ambiguity, including regarding its role in ethical arguments. The term ‘herd immunity’ can refer to (1) the herd immunity threshold, at which models predict the decline of an epidemic; (2) the percentage of a population with immunity, whether it exceeds a given threshold or not; and/or (3) the indirect benefit afforded by collective immunity to those who are less immune. Moreover, the accumulation of immune individua...
Source: Journal of Medical Ethics - August 30, 2023 Category: Medical Ethics Authors: Bullen, M., Heriot, G. S., Jamrozik, E. Tags: Open access Original research Source Type: research
Setting a human rights and legal framework around 'the ethics of consent during labour and birth: episiotomies
We commend the authors for their comprehensive discussion on consent and episiotomies.1 They correctly observe that informed consent for all proposed interventions in maternity care is always necessary. The claim that consent for maternity health services does not always have to be fully informed or explicit, however, is erroneous. We are especially concerned with, and surprised by, the endorsement of ‘opt-out consent’. ‘Opt-out consent’ (a.k.a. substitute decision making) is already standard practice in maternity healthcare, with obstetric violence a normalised response to conclusive refusals or re...
Source: Journal of Medical Ethics - August 30, 2023 Category: Medical Ethics Authors: Kumar-Hazard, B., Dahlen, H. G. Tags: Commentary Source Type: research
Consent and episiotomies: do not let the perfect be the enemy of the good
We read commentaries on our feature article ‘The ethics of consent during labour and birth: episiotomies’1 with gratitude and interest. Nearly all commenting authors agree that consent for in-labour procedures is necessary and ideally given at the point of intervening. Both Shalowitz & Ralston and Stirrat note that this is already required by professional statements and guidelines in the USA2 and UK3, respectively, but also note that practice does not yet conform. The Americans authors helpfully emphasise the importance of multilevel institutional measures for closing this gap, including consent policies an...
Source: Journal of Medical Ethics - August 30, 2023 Category: Medical Ethics Authors: Kingma, E., van der Pijl, M., Verhoeven, C., Hollander, M., de Jonge, A. Tags: Commentary Source Type: research
Informed decision-making in labour: action required
The timely feature article by van der Pijl et al1 highlights not only the widespread frequency with which unconsented episiotomies and other procedures during labour are reported by women but also that there is hardly any discussion in the literature on the ethics of consent for procedures in labour. Those national and international bodies with responsibility for midwifery and obstetric practice need not only to recognise but also act to remedy this unacceptable situation. The studies quoted used the recollection of women in reporting consent or lack of it and, although this is an entirely appropriate measure, it gives no ...
Source: Journal of Medical Ethics - August 30, 2023 Category: Medical Ethics Authors: Stirrat, G. M. Tags: Commentary Source Type: research
Safeguards for procedural consent in obstetric care
Van der Pijl et al outline data suggesting an alarmingly high incidence of violation of the bodily integrity of patients in labour, including episiotomies performed without patients’ consent, or over their explicit objection.1 Similar data have been reported from the USA and Canada.2 The authors appropriately conclude that explicit consent is required at the time of all invasive obstetrical procedures, including episiotomy. Commonsense adjustments to the duration and detail of consent under conditions of clinical urgency are appropriate and should be familiar to any clinician involved in perinatal care, as well as no...
Source: Journal of Medical Ethics - August 30, 2023 Category: Medical Ethics Authors: Shalowitz, D. I., Ralston, S. J. Tags: Commentary Source Type: research
Extending the ethics of episiotomy to vaginal examination: no place for opt-out consent
van der Pijl et al1 argue that if ‘stakes are high’ and there is ‘clear conviction by the care provider’ that it is ‘necessary’, episiotomy may be given after ‘opt-out consent’. Here I caution against the applicability of their approach to vaginal examination (VE): another routine intervention in birth to which they suggest their discussion may apply. I highlight three concerns: first, the subjective and unjustified nature of assessments of ‘necessity’; second, the inadequacy of current consent practices in relation to VE; and third, the significant risk of perpet...
Source: Journal of Medical Ethics - August 30, 2023 Category: Medical Ethics Authors: Brione, R. Tags: Commentary Source Type: research
Birth, trust and consent: reasonable mistrust and trauma-informed remedies
In ‘The ethics of consent during labour and birth: episiotomies,’ van der Pijl et al1 respond to the prevalence of unconsented procedures during labour, proposing a set of necessary features for adequate consent to episiotomy. Their model emphasises information sharing, value exploration and trust between a pregnant person and their healthcare provider(s). While focused on consent to episiotomy, van der Pijl et al contend their approach may be applicable to consent for other procedures during labour and beyond pregnancy-related care. One feature of their model for adequate informed consent is trust in the syste...
Source: Journal of Medical Ethics - August 30, 2023 Category: Medical Ethics Authors: Lanphier, E., Lomotey-Nakon, L. Tags: Commentary Source Type: research
Episiotomies and the ethics of consent during labour and birth: thinking beyond the existing consent framework
We agree with van der Pijl et al that the question of how to ensure consent is obtained for procedures which occur during labour and childbirth is vitally important, and worthy of greater attention.1 However, we argue that the modified opt-out approach to consent outlined in their paper may not do enough to protect the choice and agency of birthing people. Moreover, while their approach reflects a pragmatic attempt to facilitate legal clarity and certainty in this context, this is not necessarily responsive to the messy realities of decision-making during labour (and beyond). We outline some of our concerns with their prop...
Source: Journal of Medical Ethics - August 30, 2023 Category: Medical Ethics Authors: Nelson, A., Clough, B. Tags: Commentary Source Type: research
