Catherine Slack
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View article: Supporting RECs/IRBs to review the enrolment of pregnant/lactating individuals in HIV prevention trials using international ethical guidance
Supporting RECs/IRBs to review the enrolment of pregnant/lactating individuals in HIV prevention trials using international ethical guidance Open
There are notable data gaps for safety, dosing and effectiveness of many health products for pregnant and lactating individuals. There have been growing calls to timeously include this population in clinical trials to generate evidence-inf…
View article: Better engagement, better evidence: working in partnership with patients, the public, and communities in clinical trials with involvement and good participatory practice
Better engagement, better evidence: working in partnership with patients, the public, and communities in clinical trials with involvement and good participatory practice Open
In May 2022, member states of WHO adopted the World Health Assembly WHA75.8 resolution on strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination. The resoluti…
View article: The “3 Ps” of EmPowerment, Partnership and Protection - Stakeholder Perceptions of Beneficial Outcomes of Engagement in HIV Prevention Trials
The “3 Ps” of EmPowerment, Partnership and Protection - Stakeholder Perceptions of Beneficial Outcomes of Engagement in HIV Prevention Trials Open
Background: Stakeholder engagement is increasingly recognized as a key component of ethical research in leading ethics guidelines. Ethics commentators have also argued that engagement has several beneficial outcomes for the field. Aim: Thi…
View article: Adolescent self-consent to medical interventions in South Africa
Adolescent self-consent to medical interventions in South Africa Open
South African law provides that children under 18 years old can self-consent to medical treatments and terminations of pregnancy.An article published by van Heerden et al. in the South African Journal of Child Health in 2020 found that chi…
View article: “<i>It’s Almost as if Stakeholder Engagement is the Annoying ‘Have-to-do'…</i>”: Can Ethics Review Help Address the “3 Ts” of Tokenism, Toxicity, and Tailoring in Stakeholder Engagement?
“<i>It’s Almost as if Stakeholder Engagement is the Annoying ‘Have-to-do'…</i>”: Can Ethics Review Help Address the “3 Ts” of Tokenism, Toxicity, and Tailoring in Stakeholder Engagement? Open
Ethics guidance recommends that researchers engage stakeholders and that RECs review research for such engagement. The ethics review process may present a unique opportunity to support stakeholder engagement practices for HIV prevention st…
View article: Shifts in UNAIDS ethics guidance and implications for ethics review of preventive HIV vaccine trials
Shifts in UNAIDS ethics guidance and implications for ethics review of preventive HIV vaccine trials Open
Introduction A major change in the ethics framework for preventive HIV vaccine trials worldwide is the release of the UNAIDS 2021 ethical considerations in HIV prevention trials . This new guidance comes at an exciting time when there are …
View article: How can research ethics committees help to strengthen stakeholder engagement in health research in South Africa? An evaluation of REC documents
How can research ethics committees help to strengthen stakeholder engagement in health research in South Africa? An evaluation of REC documents Open
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 researc…
View article: Three billboards to support ethical-legal adolescent HIV prevention research in Eastern and Southern Africa
Three billboards to support ethical-legal adolescent HIV prevention research in Eastern and Southern Africa Open
This chapter explores the ethical-legal complexities of running HIV prevention studies in Eastern and Southern Africa (ESA). It uses a recent report by UNFPA, Harmonizing the Legal Environment for Adolescent Sexual and Reproductive Health …
View article: Be legally wise: When is parental consent required for adolescents’ access to pre-exposure prophylaxis (PrEP)?
Be legally wise: When is parental consent required for adolescents’ access to pre-exposure prophylaxis (PrEP)? Open
We recommend that service-providers should take steps to ensure that those persons who meet an age requirement for self-consent, also meet the capacity requirement, and that best practices in this regard be shared. We also recommend that p…
View article: An open‐label, randomized crossover study to evaluate the acceptability and preference for contraceptive options in female adolescents, 15 to 19 years of age in Cape Town, as a proxy for HIV prevention methods (UChoose)
An open‐label, randomized crossover study to evaluate the acceptability and preference for contraceptive options in female adolescents, 15 to 19 years of age in Cape Town, as a proxy for HIV prevention methods (UChoose) Open
Introduction Young women in Southern Africa have extremely high HIV incidence rates necessitating the availability of female‐controlled prevention methods. Understanding adolescent preference for seeking contraception would improve our und…
View article: “Why Don’t You Go Into Suburbs? Why Are You Targeting Us?”: Trust and Mistrust in HIV Vaccine Trials in South Africa
“Why Don’t You Go Into Suburbs? Why Are You Targeting Us?”: Trust and Mistrust in HIV Vaccine Trials in South Africa Open
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 activitie…
View article: Research ethics committees in a tight spot: Approving consent strategies for child research that are prima facie illegal but are ethical in terms of national guidelines
Research ethics committees in a tight spot: Approving consent strategies for child research that are prima facie illegal but are ethical in terms of national guidelines Open
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 protectin…
View article: Strengthening stakeholder engagement through ethics review in biomedical<scp>HIV</scp>prevention trials: opportunities and complexities
Strengthening stakeholder engagement through ethics review in biomedical<span>HIV</span>prevention trials: opportunities and complexities Open
Introduction Clinical trials of biomedical HIV prevention modalities require the cooperation of multiple stakeholders. Key stakeholders, such as community members, may have stark vulnerabilities. Consequently, calls for HIV prevention rese…
View article: Feasibility and acceptability of conducting HIV vaccine trials in adolescents in South Africa: Going beyond willingness to participate towards implementation
Feasibility and acceptability of conducting HIV vaccine trials in adolescents in South Africa: Going beyond willingness to participate towards implementation Open
This trial showed that adolescents can be recruited, enrolled and retained in clinical prevention trials with parental support. While promising, these results were tempered by the coupling of sexual-risk eligibility criteria and the requir…
View article: Feasibility and acceptability of conducting HIV vaccine trials in adolescents in South Africa: Going beyond willingness to participate towards implementation
Feasibility and acceptability of conducting HIV vaccine trials in adolescents in South Africa: Going beyond willingness to participate towards implementation Open
Background. HIV/AIDS remains a leading cause of death in adolescents (aged 15 - 25 years), and in sub-Saharan Africa HIV-related deaths continue to rise in this age group despite a decline in both adult and paediatric populations. This is …
View article: Defining and Negotiating the Social Value of Research in Public Health Facilities: Perceptions of Stakeholders in a Research‐Active Province of South Africa
Defining and Negotiating the Social Value of Research in Public Health Facilities: Perceptions of Stakeholders in a Research‐Active Province of South Africa Open
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 valu…
View article: Addressing legal and policy barriers to male circumcision for adolescent boys in South Africa
Addressing legal and policy barriers to male circumcision for adolescent boys in South Africa Open
With millions of adolescents becoming infected with HIV globally, it is essential that barriers to much-needed interventions are reduced for at-risk adolescents. In this article we review the legal and policy framework in South Africa for …
View article: Addressing legal and policy barriers to male circumcision for adolescent boys in South Africa : in practice - medicine and the law
Addressing legal and policy barriers to male circumcision for adolescent boys in South Africa : in practice - medicine and the law Open
With millions of adolescents becoming infected with HIV globally, it is essential that barriers to much-needed interventions are reduced for at-risk adolescents. In this article we review the legal and policy framework in South Africa for …
View article: Addressing legal and policy barriers to male circumcision for adolescent boys in South Africa
Addressing legal and policy barriers to male circumcision for adolescent boys in South Africa Open
With millions of adolescents becoming infected with HIV globally, it is essential that barriers to much-needed interventions are reduced for at-risk adolescents. In this article we review the legal and policy framework in South Africa for …
View article: “. . . I’ve Gone Through This My Own Self, So I Practice What I Preach . . . ”
“. . . I’ve Gone Through This My Own Self, So I Practice What I Preach . . . ” Open
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 s…
View article: HIV testing of children is not simple for health providers and researchers: Legal and policy frameworks guidance in South Africa
HIV testing of children is not simple for health providers and researchers: Legal and policy frameworks guidance in South Africa Open
Antiretroviral treatment coverage for children and adolescents is significantly lower than that for adults. A first step in improving this situation is ensuring increased access to HIV counselling and testing services. Current legal and po…
View article: Child research in South Africa: How do the new regulations help?
Child research in South Africa: How do the new regulations help? Open
Child research is governed by legal norms in the National Health Act (2003) and the Regulations. There is increasing harmony between the two on many issues, including the conditions under which children should be enrolled in research. The …
View article: Towards a Science of Community Stakeholder Engagement in Biomedical HIV Prevention Trials: An Embedded Four-Country Case Study
Towards a Science of Community Stakeholder Engagement in Biomedical HIV Prevention Trials: An Embedded Four-Country Case Study Open
This multiple case study revealed common themes underlying community stakeholder engagement across four country settings that largely mirror GPP goals and the GPP Blueprint, as well as highlighting challenges in the implementation of impor…
View article: Boni mores and consent for child research in South Africa
Boni mores and consent for child research in South Africa Open
Consent is required for almost all health research. In order for consent to be valid a number of requirements must be met including that the consent cannot be contra bonos mores or contrary to public policy. This principle has its roots in…
View article: I’m Positive, But I’m Negative
I’m Positive, But I’m Negative Open
HIV vaccine trials (HVTs) are ethically complex, and sound informed consent processes should facilitate optimal decision-making for participants. This study aimed to explore representations of critical HVT-related concepts to enhance the c…