Jerome Amir Singh

World Health Organisation; Academy of Science of South Africa; University of Toronto; University of KwaZulu-Natal

Adaptive Clinical Trials (ACT) differ from conventional clinical trials because they permit continual modifications to key components of trial design during the trial. ACTs have grown in prevalence in recent years, with Adaptive Platform Trials (APTs), in particular, having demonstrated their significant scientific, clinical, and public health util...

While Adaptive Clinical Trials (ACTs) have grown in prevalence, prominence, and impact, the ethical issues implicit in such trial designs, particularly in the context of public health emergencies, have been afforded relatively scant attention. This work argues that the ethical dimensions of ACTs should be considered at trial conception, factored in...

Background This exploratory analysis investigates the prevalence and risk factors of neurocognitive toxicity in postpartum women on HIV treatment in response to a concern of an Isoniazid Preventive Therapy (IPT)/Efavirenz interaction. Trial Design Pregnant women on HIV treatment from countries with high TB prevalence were randomized in IMPAACT P10...

This is a book about several specific and serious challenges that bioethics has to deal with in our time, particularly in the South African context. From an almost non-existent ‘science’ at the beginning of the 20th century, not receiving systematic reflection in intellectual circles such as universities, bioethics has grown with unprecedented stri...

Despite tremendous efforts in fighting HIV over the last decades, the estimated annual number of new infections is still a staggering 1.5 million. There is evidence that voluntary medical male circumcision (VMMC) provides protection against men’s heterosexual acquisition of HIV-1 infection. Despite good progress, most countries implementing VMMC fo...

While the COVID-19 pandemic has captured the attention of the global community since the end of 2019, deadly health pandemics are not new to Africa. Tuberculosis (TB), malaria and human immunodeficiency virus (HIV) count amongst other serious diseases that have had a catastrophic impact on the African continent. Effective responses to such pandemic...

The exclusion of pregnant and breastfeeding women (PBW) from clinical research has precipitated critical knowledge gaps, thereby delaying PBW’s access to better treatment or preventive agents, and drug delivery technologies. The current status quo of blanket exclusion of PBW on precautionary grounds is inequitable and unethical. Instead, exclusion...

The immediate, intermediate, and long-term implications of seismic surveys for hydrocarbon exploration merit noting. If seismic surveys detect feasible hydrocarbon deposits, they effectively serve as a precursor to hydrocarbon extraction and consumption. The additional greenhouse gas emissions that will originate from new oil and gas fields in Sout...

While the degree of COVID-19 vaccine accessibility and uptake varies at both national and global levels, increasing vaccination coverage raises questions regarding the standard of prevention that ought to apply to different settings where COVID-19 vaccine trials are hosted. A WHO Expert Group has developed guidance on the ethical permissibility of...

The Access to COVID-19 Tools Accelerator (ACT-A) is a multistakeholder initiative quickly constructed in the early months of the COVID-19 pandemic to respond to a catastrophic breakdown in global cooperation. ACT-A is now the largest international effort to achieve equitable access to COVID-19 health technologies, and its governance is a matter of...

Introduction While pregnant people have been an important focus for HIV research, critical evidence gaps remain regarding prevention, co-infection, and safety and efficacy of new antiretroviral therapies in pregnancy. Such gaps can result in harm: without safety data, drugs used may carry unacceptable risks to the foetus or pregnant person; without...

COVID-19 vaccine trial designs in the context of authorized COVID-19 vaccines and expanding global access.

Over recent years, the research community has been increasingly using preprint servers to share manuscripts that are not yet peer-reviewed. Even if it enables quick dissemination of research findings, this practice raises several challenges in publication ethics and integrity. In particular, preprints have become an important source of information...

See: https://www.who.int/publications/i/item/9789240029200: The WHO guidance on Ethics & Governance of Artificial Intelligence for Health is the product of eighteen months of deliberation amongst leading experts in ethics, digital technology, law, human rights, as well as experts from Ministries of Health. While new technologies that use artificial...

The threshold level of immunization coverage needed to confer population immunity for COVID-19 is not yet known, although some settings may require up to 85% of the population to be vaccinated for vaccine-induced population immunity to apply. Achieving such a goal may prompt some countries to contemplate mandating COVID-vaccination. However, attain...

Viral variants of concern may emerge with dangerous resistance to the immunity generated by the current vaccines to prevent coronavirus disease 2019 (Covid-19). Moreover, if some variants of concern have increased transmissibility or virulence, the importance of efficient public health measures and vaccination programs will increase. The global res...

For countries to attain vaccine-induced herd immunity, vaccine deployment will have to occur rapidly and seamlessly, and uptake will have to be high. To facilitate the attainment of these goals, policy-makers and clinicians will have to be able to explain COVID-19 vaccines to members of the public in layman’s terms, and be aware of some of the myth...

Verfassungsblog: On Matters Constitutional - Since SARS-COV-2, the causative agent of Coronavirus Disease 2019 (COVID-19), was first identified, reported global infections have well surpassed over one hundred and fifty million people, and millions of individuals have succumbed to the disease. To date, several COVID-19 candidate vaccines have been...

Jerome Amir Singh's affiliation was erroneously given as: Centre for Medical Ethics and Law, Stellenbosch University, Stellenbosch, South Africa. Thecorrect affiliation is: School of Law, Howard College, University of KwaZulu-Natal, Durban, South Africa. The error appears in the Discussion Document by Adams et al. [https://doi.org/10.17159/sajs.202...

The POPIA Code of Conduct for Research, as it is currently being considered, pertains to research conducted in South Africa, which, as part of the research process, uses personal information as defined under POPIA. This Discussion Document outlines the main areas relating to the processing of personal information for research purposes which the pro...

Compelling individuals to be vaccinated with candidate vaccines that have been granted emergency use approval based on limited data, and penalising non-compliance, raises challenging ethics issues. For instance, some individuals may wish to be vaccinated, but may be hesitant to be vaccinated with particular vaccine candidates. On the other hand, so...

The provision of a COVID-19 candidate vaccine under emergency use designation to millions of people raises urgent questions about the continuation of the control-group arm of these and other trials, and whether trial blinding is still warranted. Current research-ethics guidance documents were not drafted with emergency-use deployment in mind. Given...

The conduct of COVID-19 vaccine trials in the context of a candidate vaccine being issued with Emergency Use Designation raises challenging ethical questions, including in relation to the use of placebo controls and unblinding of trial participants in current and future COVID-19 vaccine trials. This policy brief was developed by the WHO Access to C...

An efficacious COVID-19 vaccine is currently the world's leading research priority. Several nations have indicated that if there is a compelling case for use of a vaccine before it is licensed, they would be prepared to authorise its emergency use or conditional approval on public health grounds. As of Dec 1, 2020, several developers of leading COV...

Ethics and vector-borne diseases: WHO guidance.

The continued need for placebo-controls in COVID-19 vaccine trials

This discussion paper addresses the safety of HIV cure studies, particularly those involving stopping antiretroviral therapy, known as an analytic treatment interruption (ATI) in the context of the SARS-CoV-2 pandemic. More than 30 studies listed on ClinicalTrials.gov include an ATI and many others were planned to begin over the next 12 months but...

Background Hepatitis B virus (HBV), Human Immunodeficiency virus (HIV) and Tuberculosis (TB) are common infections in South Africa. We utilized the opportunity of care provision for HIV-TB co-infected patients to better understand the relationship between these coinfections, determine the magnitude of the problem, and identify risk factors for HBV...

An efficacious COVID-19 vaccine is currently the world’s leading research priority. Because of the extraordinary threat to global health posed by the COVID-19 pandemic, global regulators have decided that while it is necessary to characterize the immune response induced by a SARS-CoV-2 vaccine candidate by collecting data in animals, the efficacy o...

While governments have been focusing on the unprecedented disruption to the global economy caused by coronavirus disease 2019 (COVID-19) and the urgent need for COVID-19 research, other health research has become a casualty of the pandemic. Major research operations that are unrelated to COVID-19 have been significantly diminished or suspended enti...

Since SARS-CoV2 was declared a Public Health Emergency of International Concern, those tasked with the stewardship of public health at a global, regional, and local level-policymakers, politicians, scientists, drug regulators, health officials, professional associations, journal editors, publishers, and clinicians-have displayed rushed decisions an...

While governments have been focusing on the unprecedented disruption to the global economy caused by coronavirus disease 2019 (COVID-19) and the urgent need for COVID-19 research, other health research has become a casualty of the pandemic. Major research operations that are unrelated to COVID-19 have been significantly diminished or suspended enti...

In response to provocative comments by 2 European clinicians and scientists, the World Health Organization Director General has declared that Africa will not host COVID-19 vaccine trials. Such a stance risks stigmatizing COVID-19 vaccine trials in Africa and depriving Africa of critical research. To the contrary, there is a critical need for Africa...

Since community transmission of COVID-19 became established in South Africa, individuals who test positive for COVID-19 and who do not require hospitalisation have been permitted to self-isolate in their homes to reduce the burden on the health system. The Premier of KwaZulu-Natal Province has since announced that self-isolation will no longer be p...

This interim guidance is intended to inform public health programmes and governments that are considering whether to develop or implement digital proximity tracking technologies for COVID-19 contact tracing. The document covers ethical principles, technical considerations and requirements that are consistent with these principles; and how to achiev...

Since community transmission of COVID-19 became established in South Africa, individuals who test positive for COVID-19 and who do not require hospitalisation have been permitted to self-isolate in their homes to reduce the burden on the health system. The Premier of KwaZulu-Natal Province has since announced that self-isolation will no longer be p...

Since the World Health Organization declared coronavirus disease 2019 (COVID-19) a Public Health Emergency of International Concern, COVID-19 infection and the associated mortality have increased exponentially, globally. South Africa (SA) is no exception. Concerns abound over whether SA’s healthcare system can withstand a demand for care that is di...

Less than 3 months after the World Health Organization (WHO) declared COVID-19 a Public Health Emergency of International Concern, and within a month of the WHO declaring COVID19 a global pandemic, COVID-19 infections and fatalities have grown exponentially, globally. Now, more than ever, the world needs responsible political leadership, evidence-b...

Artificial Intelligence (AI) offers unprecedented opportunities and challenges for humanity. If AI can be positioned and leveraged correctly, it can rapidly accelerate progress on achieving the United Nations’ Sustainable Development Goals (SDGs), including SDG #3: ‘Ensure healthy lives and promote wellbeing for all at all ages’. Achieving this goa...

Background: The development of the CRISPR/Cas9 gene editing system has generated new possibilities for the use of gene drive constructs to reduce or suppress mosquito populations to levels that do not support disease transmission. Despite this prospect, social resistance to genetically modified organisms remains high. Gene drive open field researc...

Human genomic mapping has advanced molecular medicine health care and created a transformative paradigm shift towards Precision Medicine. In 2015, President Obama launched the PM initiative, encapsulated as “unique individualized data-driven treatments”. Since then, this field is rapidly advancing both curative treatment and disease prevention by a...

TDR and WHO’s Global Health Ethics team have jointly developed a training course on the important ethical considerations in implementation research (IR), with guidance for course facilitators and participants. The ultimate aim of these training materials is to help strengthen national and international capacity for review and conduct of IR.

Introduction Fueled by a constant barrage of media coverage showcasing the success of increasingly younger stars of modeling, sports, entertainment, performing arts, and industry-many of whom have been 'airbrushed' to look flawless in printed and social media-success, fame and wealth are increasingly becoming associated with youthfulness and beauty...

Gene drive technology offers the promise for a high-impact, cost-effective, and durable method to control malaria transmission that would make a significant contribution to elimination. Gene drive systems, such as those based on clustered regularly interspaced short palindromic repeats (CRISPR)/CRISPR associated protein, have the potential to sprea...

This research report turns its attention to this access to modern contraceptive methods, as well as all other sexual and reproductive health (SRH) services. There are many barriers for adolescents around the globe - the majority of citizens in many countries – to access SRH services. Distance from services, lack of transport, lack of available comm...

This research report turns its attention to this access to modern contraceptive methods, as well as all other sexual and reproductive health (SRH) services. There are many barriers for adolescents around the globe - the majority of citizens in many countries – to access SRH services. Distance from services, lack of transport, lack of available comm...

This research report turns its attention to this access to modern contraceptive methods, as well as all other sexual and reproductive health (SRH) services. There are many barriers for adolescents around the globe - the majority of citizens in many countries – to access SRH services. Distance from services, lack of transport, lack of available comm...

This research report turns its attention to this access to modern contraceptive methods, as well as all other sexual and reproductive health (SRH) services. There are many barriers for adolescents around the globe - the majority of citizens in many countries – to access SRH services. Distance from services, lack of transport, lack of available comm...

This research report turns its attention to this access to modern contraceptive methods, as well as all other sexual and reproductive health (SRH) services. There are many barriers for adolescents around the globe - the majority of citizens in many countries – to access SRH services. Distance from services, lack of transport, lack of available comm...

This research report turns its attention to this access to modern contraceptive methods, as well as all other sexual and reproductive health (SRH) services. There are many barriers for adolescents around the globe - the majority of citizens in many countries – to access SRH services. Distance from services, lack of transport, lack of available comm...

This research report turns its attention to this access to modern contraceptive methods, as well as all other sexual and reproductive health (SRH) services. There are many barriers for adolescents around the globe - the majority of citizens in many countries – to access SRH services. Distance from services, lack of transport, lack of available comm...

This research report turns its attention to this access to modern contraceptive methods, as well as all other sexual and reproductive health (SRH) services. There are many barriers for adolescents around the globe - the majority of citizens in many countries – to access SRH services. Distance from services, lack of transport, lack of available comm...

This research report turns its attention to this access to modern contraceptive methods, as well as all other sexual and reproductive health (SRH) services. There are many barriers for adolescents around the globe - the majority of citizens in many countries – to access SRH services. Distance from services, lack of transport, lack of available comm...

This research report turns its attention to this access to modern contraceptive methods, as well as all other sexual and reproductive health (SRH) services. There are many barriers for adolescents around the globe - the majority of citizens in many countries – to access SRH services. Distance from services, lack of transport, lack of available comm...

This research report turns its attention to this access to modern contraceptive methods, as well as all other sexual and reproductive health (SRH) services. There are many barriers for adolescents around the globe - the majority of citizens in many countries – to access SRH services. Distance from services, lack of transport, lack of available comm...

This document is designed to inform people involved in sexual and reproductive health research with adolescents. This includes (but is not limited to) researchers, research ethics committee members, programme planners and sponsors.

South Africa’s Children’s Act 38 of 2005 requires health professionals to determine whether a child possesses ‘sufficient maturity’ and ‘mental capacity’ to make decisions about themselves in relation to surgery, treatment, and HIV testing. Similarly, the National Health Act 61 of 2003 requires a child to be ‘capable of understanding’ to provide in...

Participant safety and data integrity, critical in trials of new investigational drugs, are achieved through honest participant report and precision in the conduct of procedures. HIV prevention post-trial access studies in middle-income countries potentially offer participants many benefits including access to proven efficacious but unlicensed tech...

Antiretroviral therapy is not curative. Given the challenges in providing lifelong therapy to a global population of over 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...

The CAPRISA 004 trial, a phase 2b, double-blind, randomised, placebo-controlled trial, revolutionised the HIV prevention arena, particularly the microbicide field, by becoming the first study to demonstrate efficacy of a HIV microbicide product. The trial found that 1% tenofovir gel was 39 % efficacious in preventing vaginal HIV infection, and 51%...

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 part...

Reducing the incidence of malaria has been a public health priority for nearly a century. New technologies and associated vector control strategies play an important role in the prospect of sustained reductions. The development of the CRISPR/Cas9 gene editing system has generated new possibilities for the use of gene-drive constructs to reduce or a...

The Médecins Sans Frontières (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 behavi...

Although transgender women have been included in HIV prevention pre-exposure prophylaxis studies, no pre-exposure prophylaxis study has focused exclusively on transgender persons. Drawing on the cardinal principles of ethics espoused in the Belmont Report, this work highlights, among other issues, that (1) the principle of Justice requires the HIV...

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 tow...

The International AIDS Society (IAS) originally set up its initiative, entitled “Towards an HIV Cure”, to underline the aspiration of identifying a cure in line with a range of programmes from funding agencies and philanthropic organizations. A major component of this initiative was the development of a long-term scientific strategy by a large, mul...

Following the demise of apartheid, human rights in South Africa are now constitutionally enshrined.The right to health in South Africa's Constitution has been credited with transforming the lives of millions of people by triggering programmatic reforms in HIV treatment and the prevention of mother to child transmission (MTCT) of HIV.However, a cons...

Surveillance for human immunodeficiency virus (HIV) in low- and middle-income countries started in the 1980s. However, the questions of whether the results of HIV tests should be given to participants, and if so how, has still not been resolved. In the absence of effective treatment, it was considered acceptable to withhold results from HIV-positiv...

Médecins Sans Frontières (MSF) is one of the world’s leading humanitarian medical organizations. The increased emphasis in MSF on research led to the creation of an ethics review board (ERB) in 2001. The ERB has encouraged innovation in the review of proposals and the interaction between the ERB and the organization. This has led to some of the adv...

Jerome Singh considers how regulatory mechanisms can allow access to experimental interventions in humanitarian emergencies such as the Ebola epidemic.

This chapter discusses the ethical issues raised by the film Kids (1995). The film, focusing on teenagers living in New York City in the mid-1990s, features graphic scenes of teenage sex, violence, and substance abuse. It highlights that teenage sexuality raises numerous moral, ethical, and legal challenges for those involved in their treatment and...

Reimbursement of trial participants remains a frequently debated issue, with specific guidance lacking. Trials combining post-trial access and implementation science may necessitate new strategies and models. CAPRISA 008, a post-trial access study testing the feasibility of using family planning services to rollout a prelicensure HIV prevention int...

South Africa, the country with the largest HIV epidemic worldwide, has been scaling up treatment since 2003 and is rapidly expanding its eligibility criteria. The HIV treatment programme has achieved significant results, and had 1.8 million people on treatment per 2011. Despite these achievements, it is now facing major concerns regarding (i) effic...

Objective: To determine the national distribution of intensive care unit (ICU)/high care (HC) beds and the implications for ICU bed availability in the envisaged national health insurance (NHI) scheme. Methods: A descriptive, non-interventional, observational study design was used. A desk-top audit of all public and private sector ICUs, includin...

Summary The purpose of this paper is to encourage reflection among the global health research community and the research ethics community about how a wide range of ethical, social, and cultural (ESC) influences on the conduct, success, and impact of global health research can best be addressed by consultation services in research ethics (CSRE). We...