Douglas Wassenaar

University of KwaZulu-Natal | ukzn · School of Applied Human Sciences

Journal editors instruct authors to describe human participant protections in original research reports. However, little is known about African biomedical journal authors’ adherence to such journal editors’ instructions. This study investigated changes in editors’ instructions to authors and authors’ reporting of research ethics information in sele...

The ethical imperative of community engagement for health research is based on the principle that individuals are interrelated and that decisions are made within a social context. Collaboration between researchers and communities is not only an expression of respect, but also benefits research by building trust, which contributes to the acceptabili...

This study aimed examin the factors associated with the uptake and non-acceptance of COVID-19 vaccine booster doses among healthcare workers (HCWs) in South Africa. We used a mixed-methods design with data from a web-based self-administered survey followed by semi-structured in-depth interviews (IDIs) with selected participants. Of the 6235 HCWs in...

Background Studies have shown that healthcare workers (HCWs) are considered trusted sources of coronavirus disease 2019 (COVID-19) information in their communities, ideally placing them as effective vaccine advocates. However, limited data exist on the role of HCWs in the promotion of vaccines, and whether they feel adequately equipped to fulfil th...

While the ethics of involuntary admission for psychiatric inpatient care is widely contested, the practice is legally permissible across most jurisdictions. In many countries, laws governing the use of involuntary admission set out core criteria under which involuntary admission is permitted; these parameters broadly related to either risk of harm...

Healthcare workers (HCWs) were the first population group offered coronavirus disease 2019 (COVID-19) vaccines in South Africa because they were considered to be at higher risk of infection and required protecting as they were a critical resource to the health system. In some contexts , vaccine uptake among HCWs has been slow, with several studies...

Background: Implementation of appropriate informed consent has become a cornerstone for the use of biological materials and data from clinical care to use in research. During 2017-2018, the Ugandan National Biorepository has since sought prior informed consent for long-term storage and use of remnant clinical human biological materials, where a sho...

Smartphones with Global Positioning System (GPS) apps offer simple and accurate tools to collect data on human mobility. However, their associated ethical challenges remain to be assessed. We used the Emanuel framework to assess the ethical concerns of using smartphone GPS to record mobility patterns of young adults in rural South Africa for a larg...

The COVID-2019 pandemic caused disruption of health services globally due to increased need for critical care facilities and collateral damage to routine healthcare services. Global and local research into disease pathogenesis and management strategies is central to a public health emergency response. South African legislation mandates that no heal...

For results to have maximum impact and relevance in a public health emergency, ethics review and approval must be rapid and timeous, without compromising the rigour and quality of the review.

COVID-19, the disease caused by severe acute respiratory syndrome coronavirus 2, has affected most parts of the globe since its first appearance in the city of Wuhan, China, in December 2019. As a result, the World Health Organization declared the virus a global public health crisis and a pandemic within 2 weeks, after the virus had spread to 114 c...

Background. All health researchers in South Africa (SA) are explicitly encouraged by the ethicolegal framework to engage stakeholders meaningfully in their research. Research ethics committees (RECs) have a role to play in shaping researchers’ practices in this regard, but very little research has explored how RECs might best achieve this. Objectiv...

The DRILL programme at the University of KwaZulu-Natal (UKZN), Durban, South Africa, nurtures a selected talented group of early-career researchers (DRILL fellows) and is a move towards active, focused development of research leadership capacity and research. In this regard, the shift has been from a more unstructured (laissez-faire) to an increasi...

Background: The prevention of HIV remains an ongoing global concern. The safety and welfare of participants in these trials are imperative. Research Ethics Committees (RECs) review all reports of serious adverse events, adverse events and social harms arising in the course of such trials. There is little guidance for RECs on how to respond appropr...

Background: In the last decade, Low- and Middle-Income Countries (LMICs) have set up Biobanks to collect human biological materials and associated data for genomic research and public health purposes. Biobanking gives rise to ethical challenges, such as informed consent, benefit sharing, confidentiality, ownership, commercialization and public part...

There has been a recent increase in debates on the ethics of social media research, passive sensor data collection, and big data analytics. However, little evidence exists to describe how people experience and understand these applications of technology. This study aimed to passively collect data from mobile phone sensors, lapel cameras, and Blueto...

Background: HIV molecular epidemiology is increasingly recognized as a vital source of information for understanding HIV transmission dynamics. Despite extensive use of these data-intensive techniques in both research and public health settings, the ethical issues associated with this science have received minimal attention. As the discipline evol...

The burgeoning increase in Internet access and use in South Africa and globally has opened a new doorway for provision of mental health services online. This descriptive study focuses specifically on psychotherapeutic services provided by South African psychologists. Draft guidelines for online therapy were developed and a sample of South African r...

Background. Current research ethics guidelines and legislation provide research ethics committees (RECs) with the prerogative to review and approve the ethical acceptability of human research before commencement. However, individual REC members’ views on the ethical issues identified behind closed doors remain largely empirically unexplored. Object...

The reduced costs of DNA sequencing and the use of such data for HIV‐1 clinical management and phylogenetic analysis have led to a massive increase of HIV‐1 sequences in the last few years. Phylogenetic analysis has shed light on the origin, spread and characteristics of HIV‐1 epidemics and outbreaks. Phylogenetic analysis is now also being used to...

Suicide remains a serious public health problem nationally and globally. Rates of completed suicide in South Africa are reported to be 13.25 per 100,000. Data are needed to assist in the understanding of suicide and to inform evidence-based prevention efforts. This article presents the first known thematic analysis of suicide notes from South Afric...

The use of phylogenetics in HIV molecular epidemiology has considerably increased our ability to understand the origin, spread, and characteristics of HIV epidemics. Despite its potential to advance knowledge on HIV transmission dynamics, the ethical issues associated with HIV molecular epidemiology have received minimal attention. In-depth intervi...

In South Africa, biomedical research cannot commence until it has been reviewed and approved by a local research ethics committee (REC). There remains a dearth of empirical data on the nature and frequency of ethical issues raised by such committees. This study sought to identify ethical concerns typically raised by two South African RECs. Meeting...

Trust is a key element of high-quality stakeholder relations, which are themselves essential for the success of HIV vaccine trials. Where trust is absent, community stakeholders might not volunteer to become involved in key trial activities, and potential participants might not volunteer for enrollment. We explored site staff and Community Advisory...

It is an internationally accepted principle that ethics norms should be applied and enforced in research with humans through ethics review by research ethics committees (RECs). This places RECs at the very heart of the system for protecting participants and enforcing their rights. In the South African ethical-legal framework for child research, the...

Students, especially women, are in the highest HIV incidence group in Sub-Saharan Africa. Willingness to participate is a crucial element in recruitment of participants for clinical trials, including HIV prevention trials. There is increasing incidence of HIV among university students, highlighting the importance of evaluating their willingness to...

HIV prevention trials provide a prevention package to participants to help prevent HIV acquisition. As new prevention methods are proven effective, this raises ethical and scientific design complexities regarding the prevention package or standard of prevention. Given its high HIV incidence and prevalence, South Africa has become a hub for HIV prev...

Health research in resource-limited, multi-cultural contexts raises complex ethical concerns. The term ‘over-researched community’ (ORC) has been raised as an ethical concern and potential barrier to community participation in research. However, the term lacks conceptual clarity and is absent from established ethics guidelines and academic literatu...

Risk of HIV infection and transmission amongst African university students is rising. Most HIV prevention interventions focus on adolescent girls and young women (AGYWs) (aged 10 – 24) with little focus on young men who are also affected by the epidemic. Young mens’ interest in HIV prevention is pertinent, especially in a patriarchal society such a...

Health research initiatives worldwide are growing in scope and complexity, particularly as they move into the developing world. Expanding health research activity in low‐ and middle‐income countries has resulted in a commensurate rise in the need for sound ethical review structures and functions in the form of Research Ethics Committees (RECs). The...

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...

While obtaining voluntary informed consent for research participation is an ethical imperative, there appears to be little consensus regarding what constitutes a voluntary consent decision. As a result, considerable controversy exists in the research ethics literature, with researchers and ethicists advancing numerous concerns about the voluntarine...

Editorial: JERHRE's Journey: a View from Departing and Incoming Editors

This article reports on qualitative research conducted in KwaZulu-Natal, South Africa, among researchers and gate-keepers of health facilities in the province. Results suggest disparate but not irreconcilable perceptions of the social value of research in provincial health facilities. This study found that researchers tended to emphasize the contri...

The growing importance of health systems research has opened debate about appropriate ethical frameworks and guidelines for the ethical review and conduct of health systems research. In this article we consider a detailed proposal from Hyder et al. (2014) and consider it in relation to the conventional criteria for ethics review of clinical researc...

There has not been enough study of the processes by which site staff help participating community members and potential participants to understand complicated concepts for HIV vaccine trials. This article describes strategies reported in six focus group discussions with Community Advisory Board members, educators, and consent counselors at an activ...

Ethics review of psychological and sociobehavioural research is increasingly required by leading South African research institutions and universities, following international trends, and national statutory developments. Local and international scholarly journals are also more routinely requesting proof of ethics approval before accepting empirical...

Accessing research participants within some social institutions for research purposes may involve a simple single administrative event. However, accessing some institutions to conduct research on their data, personnel, clients or service users can be quite complex. Research ethics committee chairpersons frequently field questions from researchers w...

Efforts to strengthen the capacity of research ethics committees in Africa to date have largely targeted their chairs and members, neglecting an explicit focus on research ethics committee administrators, who often manage the reviews and the review committees. The concept of an administrator as a key role player in research ethics review in Africa...

Background Findings from several studies (Kirigia et al., 2005; Milford et al., 2006) indicate a need for increased and ongoing research ethics training for African REC members. Research Ethics Capacity Building (RESCAP)-Medical Education Partnership Initiative (MEPI) is a minor component of a training grant awarded to UKZN by the National Institut...

The abundance of South African clinical and public health research data has the potential to unlock important and valuable future advances in biomedical science. Amid increasing calls for more effective sharing of individual-level data, commitment to promote access to research data is evident within South Africa’s public research sector, but nation...

Sharing individual-level data from clinical and public health research is increasingly being seen as a core requirement for effective and efficient biomedical research. This article discusses the results of a systematic review and multisite qualitative study of key stakeholders’ perspectives on best practices in ethical data sharing in low- and mid...

Research Ethics Committees (RECs) are mandated to protect human participants by conducting ethical reviews of biomedical research. To date, there is a dearth of information on the structure, functioning, and outcomes of RECs in Africa. This article reviews empirical studies investigating African RECs, with the aim of providing an overview of what i...

The conceptual complexity of the term voluntariness has resulted in relatively few empirical studies of the voluntariness component of consent to research. As the call for a formal assessment of voluntariness to be incorporated into the consent process intensifies, more researchers are responding to the challenge of developing a valid and reliable...

Blessing Salaigwana and Spencer Denny presented stakeholder views of key features of good/ethical data sharing within a South African context based on a multisite study where they sampled purposefully three different research organizations: two mostly involved in biomedical research, and the third mostly in social science research. Denny presented...

A frican researchers and their collaborators have been making significant contributions to useful research findings and discoveries in A frica. Despite evidence of scientific misconduct even in heavily regulated research environments, there is little documented information that supports prevalence of research misconduct in A frica. Available litera...

The Emanuel, Wendler, and Grady framework was designed as a universal tool for use in many settings including developing countries. However, it is not known whether the work of African health research ethics committees (RECs) is compatible with this framework. The absence of any normative or empirical weighting of the eight principles within this f...

A key challenge in addressing the shortage of health care workers in resource-constrained environments is ensuring that there is optimal academic capacity for their training. South Africa's University of KwaZulu-Natal has placed academic and research capacity building at the heart of its program with the Medical Education Partnership Initiative in...

The Global Forum on Bioethics in Research (GFBR) served as a global platform for debate on ethical issues in international health research between 1999 and 2008, bringing together research ethics experts, researchers, policy makers and community members from developing and developed countries. In total, nine GFBR meetings were held on six continent...

The last fifteen years have witnessed a significant increase in investment in research ethics capacity development throughout the world. We examine nine research ethics training programs that are focused on Sub-Saharan Africa and supported by the US National Institutes of Health. We collected data from grants awards' documents and annual reports su...

Key Message: Mapping African Research Ethics Review Capacity (MARC) Project developed an interactive web-based resource map of African RECs.

This paper describes the development of an online learning course aimed at building capacity in the field of research ethics. E-Learning is a popular tool to train large numbers of students and professionals across the world. This learning tool has been adapted to different fields and disciplines. In developing countries, there is a need to improve...

Key Message: Ethics review of social and behavioural research has attracted controversy since the introduction of the research ethics committee system. In this chapter we present arguments for and against ethics review of social and behavioural studies with a view to demonstrating the value and utility of ethics review for such studies. The unique...

Concerns have been raised about the limits of understanding of consent by clinical trial participants in developing countries. Consequently, this empirical study was conducted in Malawi to assess microbicide trial participants’ understanding of randomization, double-blinding, and placebo use. The study used a combination of quantitative and qualita...

Concern has been voiced in the research ethics literature that under U.S. federal regulations U.S. sponsors, particularly the NIH, are not required to provide compensation for the treatment of research-related injury for trial participants or to allow grant funds to be used by investigators for appropriate insurance. This is problematic in developi...

Although the ethics of social science research has not enjoyed as much scholarly attention as the ethics of biomedical research, social scientists continue to debate the relevance of research ethics and ethics review to social science research. Like social scientists, biomedical scientists have also objected to ethical review of biomedical research...

Background The intervention reported in this paper was a follow up to an empirical study conducted in Malawi with the aim of assessing trial participants’ understanding of randomisation, double-blinding and placebo use. In the empirical study, the majority of respondents (61.1%; n=124) obtained low scores (lower than 75%) on understanding of all th...

Health research initiatives worldwide are growing in scope and complexity, particularly as they move into the developing world. Expanding health research activity in low- and middle-income countries has resulted in a commensurate rise in the need for sound ethical review structures and functions in the form of Research Ethics Committees (RECs). Yet...

This article describes the ethical analysis of an eating disorder study in which a university-based researcher in South Africa set out to establish the cross-cultural validity of the Eating Disorders Inventory. The following ethical issues are considered in the analysis: study design, social value, study population, risks and benefits, oversight, i...

In response to criticism of ethical review of a South African clinical trial, we contrast aspects of the United States Common Rule with South African research ethics requirements. In the USA the Common Rule does not apply to all health research and allows many exemptions from ethics review and waivers of informed consent. At a structural level rese...

Paying research participants in developing countries like Uganda raises ethical concerns over potential for undue inducement. This article, based on an exploratory study, reviewed 49 research protocols from a national HIV/AIDS research ethics committee database. Payments mainly adhered to the reimbursement and compensation payment models. Offers ma...

Africa continues to bear a disproportionate share of the global HIV/AIDS, tuberculosis (TB) and malaria burden. The development and distribution of safe, effective and affordable vaccines is critical to reduce these epidemics. However, conducting HIV/AIDS, TB, and/or malaria vaccine trials simultaneously in developing countries, or in populations a...

We report the findings of a preliminary study of social science researchers' experiences of ethics review from a developing country perspective. Social science researchers' experiences of ethics review were coded as negative (42.6%), positive (21.3%), or mixed (36.2%). Ethics review was primarily experienced as negative for pragmatic reasons such a...

A recent paper presents an argument and mechanism for the possible stopping of clinical trials early based on opportunity costs. Although we agree that the costs and opportunity costs of clinical trials need to be reduced wherever possible, we raise concerns about the motivation and mechanism for stopping clinical trials early raised by Lavery et a...

This study investigated homicide-suicide in Durban, South Africa, for the years 2000 to 2001. The incidence was 0.89 per 100,000, higher than the international average. A majority of perpetrators (91%) and victims (87%) were Black African, proportional to their representation in the population. Perpetrators were typically men (in 95% of cases), old...

A preliminary study aimed at investigating the potential impact of relationships on decision-making process and autonomy of women was conducted in Harare, Zimbabwe. The majority of women surveyed (87.6%) were prepared to consult their husbands, whereas only 46.6% said they would consult their relatives prior to participation in health research. Onl...

The African AIDS Vaccine Programme, formed in 2000, is a network of African HIV vaccine stakeholders, led by Africans across the continent, with a vision of an African continent without AIDS.

This paper reports on a multidisciplinary meeting held to discuss ethical issues in medical research in the developing world. Many studies, including clinical trials, are conducted in developing countries with a high burden of disease. Conditions under which this research is conducted vary because of differences in culture, public health, political...

The management of suicidal behaviour tends to evoke a range of feelings and responses in health practitioners. These include anxiety, confusion, hostility, avoidance and a host of other negative feelings, many of which may be due to uncertainty and perceived impotence in dealing with the patient's self-destructive ideas and behaviours. Adolescents...

The new National Health Act has clarified that children may take part in "non-therapeutic" research (NTR) and the age at which they may provide independent consent to such research, viz. at legal majority. However, the Act will require consent from the Minister of Health for all research classed as NTR and involving minors regardless of the level o...

HIV disproportionately affects women in developing countries, especially in Southern Africa. Women thus stand to benefit most from a successful HIV vaccine and must participate in trials to test appropriate, gender-specific products. Several HIV vaccine efforts are currently underway in Africa. Participation in HIV vaccine trials requires that part...

This report summarizes the discussions and recommendations from a consultation held in Gaborone, Botswana (16–19 March 2006), organized by the joint World Health Organization (WHO)/United Nations Programme on HIV/AIDS (UNAIDS) HIV Vaccine Initiative (HVI) and the African AIDS Vaccine Programme (AAVP). The consultation considered key challenges and...

Ethical issues in international collaborative research are multiple and complex, and the applicable ethical guidance is diverse and sometimes contradictory Council for International Organizations of Medical Sciences CIOMS, 2002; Nuffield Council on Bioethics, 2002; World Medical Association, 2004. Research with children is similarly fraught with et...

Ethical dilemmas in biomedical research, especially in vulnerable populations, often spark heated debate. Despite recommendations and guidelines, many issues remain controversial, including the relevance, prioritisation and application of individual voluntary informed consent in non-Western settings. The voices of the people likely to be the subjec...

HIV treatment for participants who become infected during HIV vaccine trials has been the focus of ethical controversy. The obligations of sponsors to ensure that participants have access to antiretrovirals have been a particular focus of this debate. This paper presents three arguments that have been made in this regard, and some of their limitati...

The reign of apartheid in South Africa was characterized by systematic violation of the human rights of the Black population. Ruling institutions of the country perpetuated and enforced such violations. Consequently, Black South Africans may be apprehensive of scientific research in which the Black population is targeted for participants, regardles...

Rates of out-patient psychotherapy follow-up after hospitalisation for non-fatal suicidal behaviour (NFSB) are reported to be poor internationally. A study at a South African general hospital revealed that over a 12-month period 201 patients were admitted and referred for psychological consultation following NFSB. All first appointments were kept....

We assessed the prevalence of eating disorder symptoms in Black South African men and also explored their possible links with acculturation. The Eating Disorders Inventory (EDI) and the South African Acculturation Scale (SAAS) were administered to a sample of undergraduate students consisting of 50 Black women, 50 Black men and 50 White men. The Bl...

To investigate the precipitants of non-fatal suicidal behaviour in women using a gender-based comparison. A retrospective analysis of case records. Data were analysed using chi-square tests of significance. One hundred men and 100 women admitted for non-fatal suicidal behaviour at a general hospital. Subjects' biographical details and self reports...

Little published research exists on non-fatal suicidal behaviour amongst persons of African descent This investigation sampled 82 patients of African descent who presented with non-fatal suicidal behaviour at psychological clinics in general hospitals in Pietermaritzburg (South Africa). Over half of the sample engaged in suicidal behaviour over the...