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During the 2014-2015 Ebola outbreak in Guinea, Liberia and Sierra Leone, many opposed the use of individually randomised controlled trials to test candidate Ebola vaccines. For a raging fatal disease, they explained, it is unethical to relegate some study participants to control arms. In Zika and future emerging infections, similar opposition may hinder urgent vaccine research, so it is best to address these questions now. This article lays out the ethical case for individually randomised control in testing vaccines against many emerging infections, including lethal infections in low-income countries, even when at no point in the trial do the controls receive the countermeasures being tested. When individual randomisation is feasible-and it often will be-it tends to save more lives than alternative designs would. And for emerging infections, individual randomisation also tends as such to improve care, access to the experimental vaccine and prospects for all participants relative to their opportunities absent the trial, and no less than alternative designs would. That obtains even under placebo control and without equipoise-requiring which would undermine individual randomisation and the alternative designs that opponents proffered. Our arguments expound four often-neglected factors: benefits to non-participants, benefits to participants once a trial is over including post-trial access to the study intervention, participants' prospects before randomisation to arms and the near-inevitable disparity between arms in any randomised controlled trial. [ABSTRACT FROM AUTHOR]

With the expansion of antiretroviral treatment programmes, many children and adolescents with HIV in sub-Saharan Africa could expect to live healthy lives. Yet adolescents have the highest levels of poor antiretroviral adherence and of loss to follow-up compared with other age groups. This can lead to increased morbidity and mortality, to the development of drug-resistant strains, and to high societal costs. While financial incentives have been extensively used to promote medication adherence among adults, their use among adolescents remains rare. And while there is a large body of ethical literature exploring financial incentives among adults, little philosophical thought has gone into their use among adolescents. This paper explores three oft-mentioned ethical worries about financial incentives for health behaviours and it asks whether these concerns are more serious in the context of incentives for improving adolescent adherence. The three worries are that such incentives would unduly coerce adolescents' decision-making, would compromise distributive justice and would crowd out intrinsic motivations and non-monetary values. Our tentative conclusion is that more empirical investigation of these concerns is necessary, and that at this point they are not compelling enough to rule out trials in which adolescents are incentivised for antiretroviral adherence. [ABSTRACT FROM AUTHOR]

This article lays out a wide spectrum of candidate ethical solutions for the challenge on which this JME symposium focuses: the benefit:risk ratio challenge to some early-phase HIV cure and remission studies. These candidate solutions fall into four categories: ones that seek to reduce risks in early-phase HIV cure and remission studies, ones that enhance the benefits for these studies' participants (or show that those were adequate in the first place), ones that focus on participants' free and informed consent to participate and ones according to whom the large benefits to non-participants can defeat considerations about individual participant net risks. In so doing, this article also structures the rest of the symposium. [ABSTRACT FROM AUTHOR]

Increasingly, bioethicists defend informed consent as a safeguard for trust in caretakers and medical institutions. This paper discusses an 'ideal type' of that move. What I call the trust-promotion argument for informed consent states: 1. Social trust, especially trust in caretakers and medical institutions, is necessary so that, for example, people seek medical advice, comply with it, and participate in medical research. 2. Therefore, it is usually wrong to jeopardise that trust. 3. Coercion, deception, manipulation and other violations of standard informed consent requirements seriously jeopardise that trust. 4. Thus, standard informed consent requirements are justified. This article describes the initial promise of this argument, then identifies challenges to it. As I show, the value of trust fails to account for some commonsense intuitions about informed consent. We should revise the argument, commonsense morality, or both. [ABSTRACT FROM AUTHOR]

The author discusses aspects of informed consent reconciliation with requirements of prescription drugs. He mentions the need for doctors and pharmacists to allow universal access to any treatments they offer as well as the rights of citizens of self-medication and abreast consent. He also notes then support of health outcome and welfare promotions as well as patient autonomy respect to a drug access policy.

This response to Gail Henderson et al argues that they were right that interviewees' appraisals of cure study participation should inform (future) protocol review decisions, but wrong to take these appraisals at face value. [ABSTRACT FROM AUTHOR]

This piece introduces the JME symposium 'The benefit/risk ratio challenge in clinical research, and the case of HIV cure.' [ABSTRACT FROM AUTHOR]

This is an afterword to the JME symposium on the benefit/risk ratio challenge in clinical research, and the case of HIV cure. It notes implications of the symposium for research ethics in general. [ABSTRACT FROM AUTHOR]

The author presents his views on the comments made by researchers Sissela Bok and Torbjörn Tännsjö for his article "Using informed consent to save trust" which published in a 2014 issues of the periodical. Topics discussed include the trust-based argument on utilitarianism, the role of trusts to promote social stability and the importance of commonsense morality to deny informed consent rights in patients who lack decisional capacity.

The article discusses a study examining characteristics of medical students that can be used as predictors of career practice location by tracking the graduates of Nepal's first medical college. Participants included 710 of the 727 graduates of the college. Findings suggested a number of characteristics, including paramedical background, rural birthplace, and lower academic rank, were associated with a doctor remaining in Nepal and with working outside the capital city of Kathmandu.

Despite their clearly demonstrated safety and effectiveness, approved vaccines against COVID-19 are commonly mistrusted. Nations should find and implement effective ways to boost vaccine confidence. But the implications for ethical vaccine development are less straightforward than some have assumed. Opponents of COVID-19 vaccine challenge trials, in particular, made speculative or empirically implausible warnings on this matter, some of which, if applied consistently, would have ruled out most COVID-19 vaccine trials and many non-pharmaceutical responses., Competing Interests: Competing interests: NE serves on the Advisory Board of challenge trial volunteer organisation 1DaySooner (a non-profit promoting human challenge trials in COVID-19), an unpaid position., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Research with enhanced potential pandemic pathogens (ePPP) makes pathogens substantially more lethal, communicable, immunosuppressive or otherwise capable of triggering a pandemic. We briefly relay an existing argument that the benefits of ePPP research do not outweigh its risks and then consider why proponents of these arguments continue to confidently endorse them. We argue that these endorsements may well be the product of common cognitive biases-in which case they would provide no challenge to the argument against ePPP research. If the case against ePPP research is strong, the views of professional experts do little to move the needle in favour of ePPP research., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Notwithstanding the success of conventional field trials for vaccines against COVID-19, human challenge trials (HCTs) that could obtain more information about these and about other vaccines and further strategies against it are about to start in the UK. One critique of COVID-19 HCTs is their distinct paucity of information on crucial population groups. For safety reasons, these HCTs will exclude candidate participants of advanced age or with comorbidities that worsen COVID-19, yet a vaccine should (perhaps especially) protect such populations. We turn this cliché on its head. The truth is that either an HCT or a field trial has intrinsic generalisability limitations, that an HCT can expedite protection of high-risk participants even without challenging them with the virus, and that an important route to obtaining results generalisable to high-risk groups under either strategy is facilitated by HCTs., Competing Interests: Competing interests: NE serves on the Board of Advisor of 1DaySooner, an unpaid position., (© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

In spring, summer and autumn 2020, one abiding argument against controlled human infection (CHI) studies of SARS-CoV-2 vaccines has been their impact on local communities. Leading scientists and bioethicists expressed concern about undue usage of local residents' direly needed scarce resources at a time of great need and even about their unintended infection. They recommended either avoiding CHI trials or engaging local communities before conducting any CHIs. Similar recommendations were not made for the alternative-standard phase III field trials of these same vaccines. We argue that the health effects of CHI studies on local residents not participating in the study tend to be smaller and more positive than those of field trials. That is all the more so now that tested vaccines are being rolled out. Whether or not local community engagement is necessary for urgent vaccine studies in the pandemic, the case for its engagement is stronger prior to field trials than prior to CHI studies., Competing Interests: Competing interests: NE serves on the advisory board for challenge trial intended-volunteer group 1DaySooner, an unpaid position., (© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.)

To counter the pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), some have proposed accelerating SARS-CoV-2 vaccine development through controlled human infection (or 'challenge') trials. These trials would involve the deliberate exposure of relatively few young, healthy volunteers to SARS-CoV-2. We defend this proposal against the charge that there is still too much uncertainty surrounding the risks of COVID-19 to responsibly run such a trial., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)