Comparison of Instructions to Authors and Reporting of Ethics Components in Selected African Biomedical Journals: 2008 and 2017.

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 selected African biomedical journals between 2008 and 2017.

Ethical issues associated with HIV molecular epidemiology: a qualitative exploratory study using inductive analytic approaches.

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 evolves, there is reasonable concern that existing ethical and legal frameworks and standards might lag behind the rapid methodological developments in this field.

Experts' Perspectives on Key Ethical Issues Associated With HIV Phylogenetics as Applied in HIV Transmission Dynamics Research.

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 interviews were conducted with scientists from diverse backgrounds to explore their perspectives on ethical issues associated with phylogenetic analysis of HIV genetic data as applied to HIV transmission dynamics studies.

South African Research Ethics Committee Review of Standards of Prevention in HIV Vaccine Trial Protocols.

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 prevention research.

Ethical issues associated with HIV phylogenetics in HIV transmission dynamics research: A review of the literature using the Emanuel Framework.

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 advance our knowledge of the drivers of HIV-1 transmission in order to design effective interventions.

Undue inducement: a case study in CAPRISA 008.

: 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 technologies, ancillary care that often exceeds local standards-of-care, financial reimbursement for participation and possibly unintended benefits if participants choose to share or sell investigational drugs. This case study examines the possibility that this combination of benefits may constitute an undue inducement for some participants in middle-income countries, where economic challenges are prevalent.

Using the Emanuel et al. framework to assess ethical issues raised by a biomedical research ethics committee in South Africa.

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 framework suggests that different health RECs may raise some ethical issues more frequently than others when reviewing protocols.

The use of students as participants in a study of eating disorders in a developing country: case study in the ethics of mental health research.

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, informed consent, and posttrial obligations. The ethics analysis is based on an adaptation of the structured framework proposed by Emanuel et al.

A developing country response to Lavery et al. "In global health research, is it legitimate to stop clinical trials early on account of their opportunity costs?".

Background: A recent paper presents an argument and mechanism for the possible stopping of clinical trials early based on opportunity costs.

Discussion: 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 al.

Summary: We argue that there are already enough acceptable criteria and actors in the clinical trials arena to justify early stoppage of clinical trials, and argue that factors other than efficacy need to be carefully considered, especially in developing country contexts.

WITHDRAWN: Ethical issues and ethics reviews in social science research.

This article has been withdrawn consistent with Elsevier Policy on Article Withdrawal (http://www.elsevier.com/locate/withdrawalpolicy).

The ethical involvement of women in HIV vaccine trials in Africa: discussion paper developed for the African AIDS Vaccine Programme.

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.

One step forward, two steps back--requiring ministerial approval for all "non-therapeutic" health research involving minors.

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 of risk.

Racial differences in public perceptions of voluntariness of medical research participants in South Africa.

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, regardless of the reason for their being selected.