In this month’s JME Digest, we will be covering:
Albertsen, A. (2018) ‘Deemed consent: assessing the new opt-out approach to organ procurement in Wales’, Journal of Medical Ethics, vol. 44, pp. 314-318
Paul, A., Merritt, M. and Sugarman, J. (2018) ‘Implementing post-trial access plans for HIV prevention research’, Journal of Medical Ethics, vol. 44, pp. 354-358
Following the controversial decision to introduce a system of deemed consent for organ donation in Wales, Albertsen assesses the new approach. He does this through a consideration of concerns raised prior to the enactment of the Human Transplantation (Wales) Act 2013, concluding that ‘[n]one of these concerns have come to pass’.
Albertsen highlights three main concerns; a decline in the number of both living and deceased donors, and an increase in family refusals. Fewer living donors, he explains has been argued, may result from an increase in deceased donations diminishing urgency, resulting in people feeling they need not make a living donation. This, of course, is not strictly the case as living donors are far better, in terms of quality of organ, for kidneys. The number of deceased donors may decline as a result of public reaction leading to people opting out; here, both Chile and Brazil are cited. Albertsen’s final concern for consideration is the reduction in the number of deceased donors as a result of family refusals.
Despite media reports of the success of the new legislation, some have suggested these are premature conclusions given how little data is available at the moment. Nonetheless, Albertsen addresses the three concerns armed with this little available data. On living donation, he notes how this in fact increased in Wales, whilst dropping in the rest of the UK. He also highlights how the number of registrations rose more in Wales than the UK as a whole, yet counters this with the fact that the number of opt outs also rose. Of course, we could expect more people to opt out in a system where registering ones view is more important, so whether the increased number of opt outs is worrisome it is too soon to say. What is important, states Albertsen, is that opt in rates improved. Actual donor rates may have dropped, but they dropped less than the notable drop in suitable donors in Wales; this is perhaps encouraging, he explains. Finally, on family refusals, Albertsen highlights a sharp increase in family consent rates in Wales between 2014/15 and 2016/17 - far greater than in the UK as a whole.
Paul, Merritt, and Sugarman
The authors examine the obligations of researchers to consider the provision of post-trial access (PTA) to interventions that have been found to be beneficial. This is a growing area of academic debate, with much of the normative literature appealing to principles such as a duty of care, relationship-based responsibilities, and justice, as means to establish an obligation. This article focuses on practical barriers to the implementation of PTA, particularly in the context of HIV prevention research.
An interesting question is raised as to whether a participant losing access to a prevention intervention is an urgent enough risk to necessitate PTA. It is perhaps not as strong a case as the end of a trial for treatment, especially where alternatives are available (such as condoms when it comes to HIV prevention trials). It is noted that in some HIV prevention trials where Truvada has been used, PTA was not important as participants could later access the drug through off-label use; Truvada was available as HIV treatment, but not prevention). However, the authors comment that this approach may entail prohibitive out-of-pocket costs to some participants.
There is a real issue in planning under uncertainty. Researchers will be uncertain as to the effectiveness of an intervention, and the likely availability of it post-trial, leading some to decide against making PTA provisions beforehand. A great example provided is a trial of opioid substitution therapy alongside counselling as a means to reducing HIV incidence in those who inject drugs in China. Assurances had been given that the drug would be provided post-trial if shown to be effective. The trial was ended early due to futility with respect to reducing HIV incidence, but the researchers committed to allowing those on opioid substitution therapy to finish. However, regulatory authorities did not permit this, meaning PTA did not happen. In this example, pre-trial promises were made redundant by factors beyond the control of researchers, so some may say it was somewhat pointless planning in that way.
Another obstacle highlighted is the influence of healthcare professionals. Some trial participants later receiving Truvada through the healthcare system as PTA have felt stigmatised. It may be important to ensure healthcare professionals dealing with the provision of PTA are welcoming and willing to prescribe a newly approved medication, but whether or not this is the responsibility of the research team is another question.
Before participants even reach healthcare professionals providing PTA, there is another issue with some transitioning to the healthcare system. Some may struggle to navigate a complex healthcare system, particularly if there are social and economic barriers to them accessing care - this may be particularly relevant to those in HIV prevention trials if they are groups at high risk of contracting the virus. Some research teams have assisted participants in obtaining insurance, or enrolling in pharmaceutical manufacture-sponsored programmes providing free access, but this is potentially resource intensive. It is important to question, then, whether a referral is sufficient, or whether researchers ought to go to greater lengths to ensure PTA.
The authors stress the importance of ethical guidance responding to the practical realities of implementing PTA. Additional resources, whilst costly, may be necessary. For instance, study teams could, during routine trial visits, discuss with participants potential barriers to PTA - this approach may only require a small additional cost in resources.