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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]

Unprecedented global effort is under way to facilitate the testing of countermeasures in infectious disease emergencies. Better understanding of the various options for trial design is needed in advance of outbreaks, as is preliminary global agreement on the most suitable designs for the various scenarios. What would enhance the speed, validity, and ethics of clinical studies of such countermeasures? Focusing on studies of vaccine efficacy and effectiveness in emergencies, we highlight three needs: for formal randomized trials— even in most emergencies; for individually randomized trials—even in many emergencies; and for six areas of innovation in trial methodology. These needs should inform current updates of protocols and roadmaps. [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]

The goal of achieving Universal Health Coverage (UHC) can generally be realized only in stages. Moreover, resource, capacity, and political constraints mean governments often face difficult trade-offs on the path to UHC. In a 2014 report, Making fair choices on the path to UHC, the WHO Consultative Group on Equity and Universal Health Coverage articulated principles for making such trade-offs in an equitable manner. We present three case studies which illustrate how these principles can guide practical decision-making. These case studies show how progressive realization of the right to health can be effectively guided by priority-setting principles, including generating the greatest total health gain, priority for those who are worse off in a number of dimensions (including health, access to health services, and social and economic status), and financial risk protection. They also demonstrate the value of a fair and accountable process of priority setting. [ABSTRACT FROM AUTHOR]

Some thinkers oppose the exchange of money for human organs and tissue, surrogacy services, and works of art, and the "commodification" of many areas of cultural life. One source of concern is said to be the alleged "incommensurability" of money with the relevant value-bearers, sometimes put in terms of their "incomparability," "nonsubstitutability," "nontradeability," "(market)-inalienability," or "irreplaceability." Whichever term is used, the objection may be summed up as follows: the fact that value-bearers A and B (e.g., a kidney and $10,000) are incommensurate (or incomparable, nontradeable, and so forth), or that they are perceived as such, provides a sound, powerful reason to ban or at least to refuse trade between them. Let us refer to this type of objection to certain exchanges as the incommensurability objection. This article's main contention is that the incommensurability objection fails. We believe that even if value bearers A and B are incommensurable (or incomparable, and so forth), or widely perceived as such, that does not provide a sound, powerful reason against trading them for each other. Our argumentative strategy is as follows: We present seven conceptions of incommensurability (and the like), which we call (a) "no betterness and equality," (b) "no common scale," (c) "no ground for comparison," (d) "occasion for reasonable regret," (e) "betterness regardless of numbers," (f) incompatibility, and (g) and "status difference." We then review candidate rationales for banning or avoiding trade of one value bearer for another on grounds of their incommensurability (and the like), and show the failure of these accounts on each of these conceptions of incommensurability (and the like). Our discussion also sheds light on contemporary cultural conservatism. Unlike economic conservatives like Law and Economics thinkers, contemporary cultural conservatives such as some members of the Committee on Social Thought often raise incommensurability objections to extending the market and its logic to various areas of life. We believe that this characterization of contemporary cultural conservatives capturers a deeper feature than a prevalent characterization among philosophers as clinging to a perceived past. We also believe that our case against the incommensurability objection exposes a weakness of contemporary cultural conservatism. [ABSTRACT FROM AUTHOR]

Electronic adherence monitors (EAMs) record and report an array of health behaviors, ranging from taking daily medications to wearing medical devices. EAMs are utilized in research worldwide and are being investigated for clinical use. However, there is also growing popular concern about the extent to which electronic devices may be used to monitor individuals, including allegations in the media that EAMs represent a move towards "Big Brother" in medicine. Here, we highlight the unique benefits as well as the potential ethical challenges that electronic adherence monitoring generates. These challenges surround autonomy, privacy and confidentiality, trust, and ancillary care obligations. We describe key questions within each of these domains that warrant further investigation, and present potential solutions to many of the concerns raised. [ABSTRACT FROM AUTHOR]

Background Incidences of basal cell carcinoma ( BCC) on the lower extremities in elderly patients are rising. Surgical approaches to the treatment of BCC are subject to possible difficulties in healing, failure of skin grafts, and wound infection. This study assessed the efficacy of intralesional cryosurgery in the treatment of BCC of the lower limbs in elderly patients. Methods This study included eight patients aged >60 years in whom a total of 10 nodular or superficial BCCs of the lower limbs were confirmed by biopsy. The patients' medical histories revealed comorbidities including hypertension, diabetes, hypercholesterolemia, venous insufficiency, and deep vein thrombosis of the legs, congestive heart failure, chronic renal failure, and ischemic heart disease. Using liquid nitrogen, an intralesional cryosurgery needle (CryoShape) was inserted into the tumor to facilitate its complete freezing. Treatment success was confirmed by biopsy taken approximately 3 months after complete healing of the cryo-wound. Results The average size of the lesions treated was 2.49 cm2 (16.4 × 15.2 mm). Mean recovery time was 79.9 days. Biopsies were obtained at a mean of 85.3 days after the wound had healed. All 10 biopsies verified the complete destruction of the tumor. There was no evidence of wound infection or tumor recurrence over a follow-up period of 28 months. Conclusions This study demonstrates that a single intralesional cryosurgery session can completely eradicate BCC on the lower extremities in elderly patients. This technique is associated with relatively minor complications, is well tolerated, and represents a safe and effective therapeutic modality for BCC of the lower limbs. [ABSTRACT FROM AUTHOR]

Responding to critical shortages of physicians, most sub-Saharan countries have scaled up training of non-physician clinicians (NPCs), resulting in a gradual but decisive shift to NPCs as the cornerstone of healthcare delivery. This development should unfold in parallel with strategic rethinking about the role of physicians and with innovations in physician education and in-service training. In important ways, a growing number of NPCs only renders physicians more necessary -- for example, as specialized healthcare providers and as leaders, managers, mentors, and public health administrators. Physicians in sub-Saharan Africa ought to be trained in all of these capacities. This evolution in the role of physicians may also help address known challenges to the successful integration of NPCs in the health system. [ABSTRACT FROM AUTHOR]

In July 2010, the World Health Organization (WHO) published recommendations on Increasing access to health workers in remote and rural areas through improved retention. (1) The report outlines principles and [...]

The article presents author's comments on the guidance for research on human subjects. It mentions that the U.S. law defines participants as people, about whom data are obtained through intervention or interaction. It focuses on the U.S. law governing federally funded research that do not address risk to nonparticipants.