Concordance of International Regulation of Pediatric Health Research.

OBJECTIVE: To assess the comparability of international ethics principles and practices used in regulating pediatric research as a first step in determining whether reciprocal deference for international ethics review is feasible. Prior studies by the authors focused on other aspects of international health research, such as biobanks and direct-to-participant genomic research. The unique nature of pediatric research and its distinctive regulation by many countries warranted a separate study. STUDY DESIGN: A representative sample of 21 countries was selected, with geographical, ethnic, cultural, political, and economic diversity. A leading expert on pediatric research ethics and law was selected to summarize the ethics review of pediatric research in each country. To ensure the comparability of the responses, a 5-part summary of pediatric research ethics principles in the US was developed by the investigators and distributed to all country representatives. The international experts were asked to assess and describe whether principles in their country and the US were congruent. Results were obtained and compiled in the spring and summer of 2022. RESULTS: Some of the countries varied in their conceptualization or description of one or more ethical principles for pediatric research, but overall, the countries in the study demonstrated a fundamental concordance. CONCLUSIONS: Similar regulation of pediatric research in 21 countries suggests that international reciprocity is a viable strategy.

A Look at Uganda's Early HIV Prevention Strategies Through a Moderate 'African' Communitarian Lens.

This paper seeks to highlight the benefits of prioritizing moderate African communitarian principles as partly demonstrated in the HIV prevention strategies implemented in Uganda in the late 1980s. Pertinent lessons could be drawn so as to achieve the HIV prevention targets envisioned in the post-2015 development era. Communitarianism emphasizes the importance of communities as part of healthy human existence. Its core ethical values include the virtues of generosity, compassion, and solidarity. Persuasion through communication, consensus through dialogue, and the awareness and commitment to responsibilities towards other members of the community, are chief practices relied upon to achieve appropriate social behaviour. All these elements signify individual rootedness in communities and contribute to the healthy existence of its members. Communitarianism is usually classified as either authoritarian/radical or responsive/moderate, depending on the primacy given to either community interests or the individual will and rights. Moderate communitarianism recognizes the individual's capacity for moral reasoning, virtue and free choice. The ensuing form of society is deemed more ethical as it relies on education in the virtues, moral persuasion and informal social controls, without stifling individual identity, agency, and capacity for self-determination. If moderate African communitarianism, in particular, can to a certain extent be associated with the significant aspects of Uganda's HIV prevention strategies in the stated period, then its present-day relevance for HIV prevention and other public health interventions may be emphasized accordingly. This applies especially in view of the ongoing efforts to achieve a balance between individual and collective interests in bioethics.

Human dignity as a basis for providing post-trial access to healthcare for research participants: a South African perspective.

This paper discusses the need to focus on the dignity of human participants as a legal and ethical basis for providing post-trial access to healthcare. Debate about post-trial benefits has mostly focused on access to products or interventions proven to be effective in clinical trials. However, such access may be modelled on a broad fair benefits framework that emphasises both collateral benefits and interventional products of research, instead of prescribed post-trial access alone (Legal and ethical regulation of biomedical research in developing countries p. 134, 2016). The wording of the current version of the Declaration of Helsinki could in fact be interpreted to broaden the scope to include other collateral benefits by applying such a broad fair benefits framework. We argue that this possibility should be utilised by low and middle income countries' (LMICs) health research ethics committees (RECs) in order to ensure that research participants who enrol in clinical trials so as to receive medical care continue to access care after the trial is concluded, as befits their dignity. Although each LMIC has unique concerns, nonetheless there are common challenges based especially on emerging issues, such as post-trial access to healthcare. Accordingly, the South African perspective is used to draw lessons that can benefit other LMICs.

Parents as partners in adolescent HIV prevention in Eastern and Southern Africa: an evaluation of the current United Nations' approach.

The United Nations's (UN) sustainable development goals (SDGs) include the target (3.3) of ending the HIV/AIDS epidemic by 2030. A major challenge in this regard is to curb the incidence of HIV among adolescents, the number two cause of their death in Africa. In Eastern and Southern Africa, they are mainly infected through heterosexual transmission. Research findings about parental influence on the sexual behavior of their adolescent children are reviewed and findings indicate that parental communication, monitoring and connectedness contribute to the avoidance of risky sexual behavior in adolescents. This article evaluates the extent to which these three dimensions of parenting have been factored in to current HIV prevention recommendations relating to adolescent boys and girls. Four pertinent UN reports are analyzed and the results used to demonstrate that the positive role of parents or primary caregivers vis-à-vis risky sexual behavior has tendentially been back-grounded or even potentially undermined. A more explicit inclusion of parents in adolescent HIV prevention policy and practice is essential - obstacles notwithstanding - enabling their indispensable partnership towards ending an epidemic mostly driven by sexual risk behavior. Evidence from successful or promising projects is included to illustrate the practical feasibility and fruitfulness of this approach.

Gender inequality dynamics in the prevention of a heterosexual HIV epidemic in sub-Saharan Africa.

This paper critiques the approach to the elimination of gender inequality as an HIV prevention strategy in the just ended era of the Millennium Development Goals, with the aim of contributing to the formulation of policy guidelines for sub-Saharan Africa in the Sustainable Development Goals. The aim is to underscore the mutual responsibility of women and men in achieving a sustainable HIV response and ending the epidemic. While taking into account the real vulnerability of women, prevention programmes can reflect gender dynamics more accurately so that attention is given to the role of both sexes in propagating - or stemming - a predominantly heterosexual HIV epidemic. More emphasis could be given to the harm caused to both men and women by certain norms related to masculinity and sexuality, and the subsequent need for combined efforts in reducing intimate partner violence and concurrency. The empowerment and engagement of both women and men as agents of change would need to be dealt with more creatively.

Gender inequality dynamics in the prevention of a heterosexual HIV epidemic in Sub-Saharan Africa

This paper critiques the approach to the elimination of gender inequality as an HIV prevention strategy in the just ended era of the Millennium Development Goals; with the aim of contributing to the formulation of policy guidelines for sub-Saharan Africa in the Sustainable Development Goals. The aim is to underscore the mutual responsibility of women and men in achieving a sustainable HIV response and ending the epidemic. While taking into account the real vulnerability of women; prevention programmes can reflect gender dynamics more accurately so that attention is given to the role of both sexes in propagating - or stemming - a predominantly heterosexual HIV epidemic. More emphasis could be given to the harm caused to both men and women by certain norms related to masculinity and sexuality; and the subsequent need for combined efforts in reducing intimate partner violence and concurrency. The empowerment and engagement of both women and men as agents of change would need to be dealt with more creatively