Ethically designing research to inform multidimensional, rapidly evolving policy decisions: Lessons learned from the PROMISE HIV Perinatal Prevention Trial

Research in rapidly evolving policy contexts can lead to the following ethical challenges for sponsors and researchers: the study’s standard of care can become different than what patients outside the study receive, there may be political or other pressure to move ahead with unproven interventions, and new findings or revised policies may decrease the relevance of ongoing studies. These ethical challenges are considerable, but not unprecedented. In this article, we review the case of a multinational, randomized, controlled perinatal HIV prevention trial, the “PROMISE” (Promoting Maternal Infant Survival Everywhere) study. PROMISE compared the relative efficacy and safety of interventions to prevent mother to child transmission of HIV. The sponsor engaged an independent international ethics panel to address controversy about the study’s standard of care and relevance as national and international guidelines changed. This ethics panel concluded that continuing the PROMISE trial as designed was ethically permissible because: (1) participants in all arms received interventions that were effective, and there was insufficient evidence about whether one intervention was more effective or safer than the other, and (2) data from PROMISE could be useful for a diverse range of stakeholders. In general, trials designed to inform rapidly evolving policy issues should develop mechanisms to revisit social value while recognizing that the value of research varies for diverse stakeholders with legitimate reasons to weigh evidence differently. We conclude by providing four reasons that trials may depart from the standard of care after a change in policy, while remaining ethically justifiable, and by suggesting how to improve existing trial oversight mechanisms to address evolving social value.

Telaah Literatur Kode Etik Auditor: Perspektif Maqashid Syariah Versi Imam Abu Zahrah

This study aims to explore the code of ethics for public accountants that correspond to the Maqashid Shariah Imam Abu Zahrah version and to explain the implementation of the code of ethics of the auditor that has been interpreted in the concept of Maqashid Shariah Imam Abu Zahrah version in practice. The method used in this study is qualitative. Qualitative study is used more emphasis on the study of literature. Study literature by analyzing the code of ethics for public accountants issued by Institut Akuntan Publik Indonesia (IAPI) and The International Ethics Standards Board for Accountants (IESBA), as well as explaining the code of ethics for public accountants based on the perspective of maqashid shariah. The results of this study explain that integrity, objectivity, professional competence, and caring attitude of prudence, confidentiality, professional behavior, and independence have a value of maqashid shariah which includes the elements of self-purification, fairness, and mashlahah.

The Ethics of Liberal Peacebuilding

This chapter explores the normative underpinnings of the scholarly debate on liberal peacebuilding and situates them within international ethics. The debate is relevant for the ethics of global governance more broadly by addressing a theoretical gray zone between the ethics of international intervention and state sovereignty. The chapter argues that instead of rejecting the liberal internationalist objectives of peacebuilding, the critics tend to deny the coherence of liberal peacebuilding with these objectives. This is exemplified by relating the critique to the prevalent positions of John Rawls, Michael Walzer, and Simon Caney in international ethics. The critique challenges descriptive presuppositions of these positions by drawing on critical, poststructural, and postcolonial perspectives.

The continued use of placebo arms in COVID-19 vaccine trials does not adequately protect the well-being of participants

Covid-19 vaccines are a critical tool for controlling the pandemic. While safe and effective vaccines have been developed, research is expected to continue for many years regarding the optimal implementation of existing vaccines in specific settings, and the development of second-generation vaccines that may offer advantages in terms of either efficacy or ease of implementation. Given this context, some commentators have argued that new Covid vaccine trials should be able to use placebo controls, and that existing studies should be able to continue with blinded participants in order to collect high quality, unbiased data. Using international ethics guidance documents, this paper argues against placebo controls, given the existence of proven effective interventions, and against protracted blinding once safety and efficacy milestones have been met. Instead, it advocates for study designs that allow for direct comparison between approved and experimental vaccines, which facilitates both data collection and greater access to vaccines.