Showing papers by "Jerome Amir Singh published in 2016"

International AIDS Society global scientific strategy: towards an HIV cure 2016

Abstract: Antiretroviral therapy is not curative. Given the challenges in providing lifelong therapy to a global population of more than 35 million people living with HIV, there is intense interest in developing a cure for HIV infection. The International AIDS Society convened a group of international experts to develop a scientific strategy for research towards an HIV cure. This Perspective summarizes the group's strategy.

Research Ethics Governance in Times of Ebola

Abstract: The Medecins Sans Frontieres (MSF) ethics review board (ERB) has been solicited in an unprecedented way to provide advice and review research protocols in an 'emergency' mode during the recent Ebola epidemic. Twenty-seven Ebola-related study protocols were reviewed between March 2014 and August 2015, ranging from epidemiological research, to behavioural research, infectivity studies and clinical trials with investigational products at (very) early development stages. This article examines the MSF ERB's experience addressing issues related to both the process of review and substantive ethical issues in this context. These topics include lack of policies regarding blood sample collection and use, and engaging communities regarding their storage and future use; exclusion of pregnant women from clinical and vaccine trials; and the difficulty of implementing timely and high-quality qualitative/anthropological research to consider potential upfront harms. Having noticed different standards across ethics committees (ECs), we propose that when multiple ethics reviews of clinical and vaccine trials are carried out during a public health emergency they should be accompanied by transparent communication between the ECs involved. The MSF ERB experience should trigger a broader discussion on the 'optimal' ethics review in an emergency outbreak and what enduring structural changes are needed to improve the ethics review process.

Developing the ethics of implementation research in health

Abstract: Implementation research (IR) is growing in recognition as an important generator of practical knowledge that can be translated into health policy. With its aim to answer questions about how to improve access to interventions that have been shown to work but have not reached many of the people who could benefit from them, IR involves a range of particular ethical considerations that have not yet been comprehensively covered in international guidelines on health research ethics. The fundamental ethical principles governing clinical research apply equally in IR, but the application of these principles may differ depending on the IR question, context, and the nature of the proposed intervention. IR questions cover a broad range of topics that focus on improving health system functioning and improving equitable and just access to effective health care interventions. As such, IR designs are flexible and often innovative, and ethical principles cannot simply be extrapolated from their applications in clinical research. Meaningful engagement with all stakeholders including communities and research participants is a fundamental ethical requirement that cuts across all study phases of IR and links most ethical concerns. Careful modification of the informed consent process may be required in IR to permit study of a needed intervention. The risks associated with IR may be difficult to anticipate and may be very context-specific. The benefits of IR may not accrue to the same groups who participate in the research, therefore justifying the risks versus benefits of IR may be ethically challenging. The expectation that knowledge generated through IR should be rapidly translated into health policy and practice necessitates up-front commitments from decision-makers to sustainability and scalability of effective interventions. Greater awareness of the particular ethical implications of the features of IR is urgently needed to facilitate optimal ethical conduct of IR and uniform ethical review.

Ethical Issues to Consider in the Design of HIV Prevention Trials Involving Transgender People.

Abstract: Although transgender women (TGW) have been included in HIV prevention pre-exposure prophylaxis (PrEP) studies,1–3 they have comprised only a small minority of participants in studies with men who have sex with men (MSM). No PrEP study has focused exclusively on transgender persons despite HIV risk being disproportionately high in the transgender community4,5 because of a complex range of social factors, including social ejection and marginalization.6,7 Globally, gay men and other MSM are 19 times more likely to be living with HIV than the general population.8 In comparison, a global systematic review and meta-analysis on TGW in 15 countries found that HIV prevalence among TGW is 49 times higher than that in the general adult population.4 It has thus been argued that studies of PrEP use in TGW populations should be designed and tailored specifically for this population, rather than adapted from, or subsumed into, studies of MSM.9 There is a paucity of data regarding transgender men (born biologically female and expressing male gender identities) and HIV risks, suggesting a need for further research on this cohort of the transgender community.10 Given their disproportionate burden of HIV, their historic and ongoing marginalization, and the knowledge gap related to HIV prevention specific to the transgender community, conducting focused HIV prevention research on transgender persons is an ethical imperative. However, the concomitant ethical issues implicit in such research merit exploration. Since its publication in 1978, the Belmont Report has established itself as among the world's foremost research ethics guidance documents and has arguably inspired a plethora of supplemental research ethics frameworks.11–15 The Belmont Report posits three cardinal ethics principles to guide research on human participants: (1) Justice, (2) Respect for persons, and (3) Beneficence. PrEP research centered exclusively on transgender persons considered in the context of these principles will help elucidate the ethical challenges and obligations implicit in such research. Justice One of the core values implicit in the principle of justice is that there must be an equitable distribution of both burdens and benefits related to research participation. More specifically, the principle of justice holds that particular individuals, groups, or communities should neither bear an unfair share of the direct burdens of participating in research nor should they be unfairly excluded from the potential benefits of research participation. Although transgender persons have been included in some MSM HIV prevention studies, it can be argued that the transgender community is distinct enough from the general MSM community to warrant exclusive research focus. To this end, paragraph 13 of the 2013 iteration of the Declaration of Helsinki states: “Groups that are underrepresented in medical research should be provided appropriate access to participation in research.”16 Given the distinct HIV data that characterize the transgender community globally—as compared with the general adult population or even the MSM community—and given the dearth of transgender-specific HIV prevention data, “appropriate access” for transgender persons to participate in HIV prevention research will necessitate HIV prevention trials focusing exclusively on transgender persons. Such research will improve our understanding of issues specific to transgender persons in relation to PrEP access, adoption, adherence, and drug–drug interactions (in the case of transgender persons on hormonal therapy). Furthermore, focused HIV prevention research on transgender persons will evidence a better understanding of the transgender community's risk profile in relation to HIV and sexual transmitted infections, as well as their health needs.