The South African Medical Research Council's Guidelines on Ethics for Medical Research - implications for HIV preventive vaccine trials with children

Children are at risk of HIV infection, stand to benefit from the development of HIV preventive vaccines,  and  therefore should be enrolled in trials of HIV vaccines in order to generate relevant safety, immunogenicity and efficacy data. In South Africa, the national vaccine initiative is considering the future conduct of trials  involving  children; this requires an analysis of the current ethical framework, including elements that facilitate or constrain the conduct of such trials. In this article, we examine the Medical Research Council   (MRC)'s Guidelines on Ethics for Medical Research: General Principles (Book 1), and their provis ons on  research involving children. We argue that this set of influential guidelines includes provisions on research with  children that are conceptually problematic and may prohibit critical research with healthy (but at-risk) child participants, including trials of HIVpreventive vaccines. We recommend that Book 1 provisions should be redrafted to reflect a balance between protecting children from research-related risks and testing interventions critical to their health

How well does South Africa's National Health A.ct regulate research involving children?

Currently there are no laws in South Africa regulating the rights of research participants. The National  Health Act is the first attempt by the legislature to use the law to protect research participants, including children. This article describes the strengths and limitations of the provisions, implications for  researchers and research ethics committees, and makes recommendations. Strengths of the Section include that it enables the Minister of Health to issue regulations detailing protections for research participants, it supplements existing law on consent, it introduces the concept of the 'best interests' of the child and it creates procedural safeguards. Limitations of the Section include that it does not set an independent age for consent to research, it focuses on informed consent and not other protections, it is inconsistent with existing or draft legislation and ethical guidelines, and it retains the contested  distinction between 'therapeutic' and 'non-therapeutic' research. Poor drafting and inconsistencies also impede interpretation. The implications for researchers are that it facilitates socalled 'non-therapeutic' research on children. However, procedural burdens for obtaining consent are created. Research Ethics Committees (RECs) will have to work with the 'therapeutic' and 'non-therapeutic' distinction as well as new concepts such as 'best interests' of the child, and ensure that consent procedures comply with the Act. We conclude that while the Act is an important development in the law, it is flawed in places. We recommend that amendments be made and that capacity development be provided to stakeholders

Implications of the ethical-legal framework for adolescent HIV vaccine trials – report of a consultative forum

The ethical-legal framework in South Africa is in a period of transition, with a number of new developments changing the substantive principles and procedures for health research in the country. Some of the changing dynamics include both law reform and the review of ethical guidelines. This changing environment poses many complexities for researchers, research ethics committees and participating communities involved in planning, implementing and reviewing research with child participants, including HIV vaccine trials. This paper presents the major themes and outcomes of a consultative meeting convened by the HIV AIDS Vaccines Ethics Group in July 2004 for key stakeholder groups. At this forum participants discussed the complexities posed by a transitional and sometimes contradictory ethical-legal framework and how the framework could be improved to simultaneously promote critical research and the welfare of child participants

Child research in South Africa: How do the new regulations help?

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 most striking disjuncture in the ethical-legal framework remains the allowable consent strategy for child research, where the law requires mandatory parental or legal guardian consent for all child research, while ethical guidelines afford research stakeholders the discretion to implement exceptions to this approach in specific justifiable circumstances

HIV vaccine research - South Africa\'s ethical-legal framework and its ability to promote the welfare of trial participants

No abstract. South African Medical Journal Vol. 95 (8) 2005: 598-60

Child consent in South African law: Implications for researchers, service providers and policy-makers

A letter providing updated information on an orginal article published in 2010

Florida Public School Administrators\u27 Knowledge Of Legal Issues Related To Search And Seizure

School officials trying to deter drug use, combat crime, and shore up security are conducting searches that are landing school in legal trouble for violating students\u27 constitutional rights. In 1993, West Virginia Supreme Court ruled that a strip search of a student suspected of stealing money was illegal (State of West Virginia ex rel Gilford v. Mark Anthony B., 1993). In another case, a federal appellate court held that a strip search of a student for suspected drug possession was reasonable, although no drugs were found (Cornfield v. Consolidated High School District No. 230, 1993). Improper searches of students, lockers and automobiles can result in hundreds of thousands of dollars in civil liability, costs and attorney fees. This study collected data on administrative knowledge in the area of search and seizure. The analyzed data served to (a) determine if administrators across the state of Florida have a general understanding of the laws regarding search and seizure; (b) identify demographic areas that demonstrate a lack of knowledge related to search and seizure; and (c) suggest improvements to current educational leadership courses of study, state-wide staff development offerings, and ideas for possible conference topics. The study involved responses from questionnaires received from 139 public school administrators in Florida (17% of the 810 randomly sampled elementary, middle, and high school principals). Analysis of data revealed that more than one-third of the respondents fell below the mean, with no significant difference between building levels or metropolitan statistical area

Shifts in UNAIDS ethics guidance and implications for ethics review of preventive HIV vaccine trials.

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 multiple HIV vaccine efficacy trials in the field. Research Ethics Committees (RECs) or Institutional Review Boards are a most likely audience for these guidelines. Our objective is to highlight shifts in ethics recommendations from the earlier 2012 UNAIDS guidance. DISCUSSION: We review recommendations related to four key issues, namely standard of prevention, post-trial access to safe and effective vaccines, enrolment of adolescents and enrolment of pregnant women. We outline implications and make recommendations for the ethics review process, including suggested lines of inquiry by RECs and responses by applicants. CONCLUSIONS: There have been several shifts in the UNAIDS ethics guidance with implications for HIV vaccine researchers submitting applications for initial ethics review or re-certification, and for RECs conducting such reviews. This review may assist RECs in a more efficient and consistent application of ethics recommendations. However, additional tools and training may further help stakeholders comply with new UNAIDS ethics recommendations during protocol development and ethics review

Exploring the ancillary-care experiences of stakeholders in South African HIV vaccine trials.

Doctor of Philosophy. University of KwaZulu-Natal, Pietermaritzburg 2015.A controversial debate in research ethics comprises the responsibilities of sponsors and researchers to address participants’ medical needs in low-resource settings when this would not service the scientific objectives of the research, nor keep participants safe – their so-called ‘ancillary-care’ responsibilities – particularly when responses might be costly or demanding. The ancillary-care debate partially emerged out of the field of HIV vaccine trials. There has been surprisingly little effort to systematically explore the practices and perspectives of researchers (and other key role-players) regarding ancillary care in such trials. This qualitative study aimed to explore the experiences of key stakeholders involved in HIV vaccine trials in South Africa, specifically: their practices, how such practices are made sense of or understood, and contemporary concerns and complexities. It was funded by the Wellcome Trust Biomedical Ethics Program (087429/Z/08/Z). Semi-structured interviews were conducted with representatives of the coordinating network as well as Research Ethics Committees, Community Advisory Boards and research staff at five sites in the country implementing two HIV vaccine trial protocols. Key documents were obtained, including protocols, informed consent forms and supporting documentation. The study obtained necessary ethical approvals (UKZN BREC BE 241/09) and written consent was provided for study participation. Data was analyzed using Thematic Analysis to develop themes that captured meanings attributed by interviewees to their practices and experiences. Five master themes were developed namely Reciprocating, Engaging, Benefitting; as well as Reconciling, Privileging, Line-drawing, and Partnering. These master themes, and sub-themes, are discussed in terms of the ancillary-care literature. The study sets out implications of stakeholders’ ancillary-care experiences for leading accounts of ancillary care, as well as for current ethical guidelines. Recommendations are made to refine guidance so it is more responsive to the concerns and complexities experienced by stakeholders in the field. Recommendations are made to strengthen the practices of core stakeholders. It is hoped that through refined guidance and strengthened practices this study can contribute to the ethical rigor with which such trials are implemented

Ethical dilemmas in psychological practice : a survey of clinical psychologists.

Thesis (M.A.)-University of Natal, Pietermaritzburg, 1997.This study explored a sample of clinical psychologists' preferred resolutions to a series of hypothetical ethical dilemmas and their primary reasons for these choices. The relationship of various professional characteristics to choices and reasons was assessed. Ethical dilemmas volunteered by respondents were analyzed. Results indicated a general lack of consistency in decision making among psychologists in both actions taken to resolve dilemmas and reasons chosen to justify these actions. On the whole, psychologists with different characteristics did not differ in their choice of response to ethical dilemmas or their reasons for these choices. It is argued that diversity in professional decision making, and the ethical dilemmas volunteered by the profession, may serve as useful indices of those ethical issues that pose difficulties for professionals. These results are discussed in the light of similar findings and in the context of current ethical regulations