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.

Streamlining ethics review for international health research.

Single-site review means protection and efficiency.

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.

Regulation of Biobanks in South Africa.

The availability of biological samples and data is critical for the establishment of biobanks for health research purposes. Such availability should be ensured in accordance with relevant national legislation and ethical principles. In this article, we consider the extent to which the current legal and ethical regulatory frameworks in South Africa are capable of governing the use of stored biological samples in a manner that facilitates health research while at the same time protecting the interests of sample donors. These two attributes are essential for establishing biobanks in the country. Our evaluation of the frameworks is based on desk review of the current literature with a special focus on oversight mechanisms in place that ensure compliance with national legislation and ethical review processes to facilitate future and secondary uses of data, the extent to which informed consent policies foster sharing of research samples, data and protocols as well as mechanisms for safeguarding confidentiality. We established that there is an urgent need to streamline South Africa's legal and ethical frameworks because they are currently ambiguous and disjointed. There is equally a need to bring the frameworks in line with the current developments at the national and international levels.

The ethical and legal regulation of HIV-vaccine research in Africa: lessons from Cameroon, Malawi, Nigeria, Rwanda and Zambia.

Ethical and legal frameworks are important for ensuring that the goals of scientific research are realised while at the same time the rights and welfare of human participants are adequately protected. A balance in attaining these two goals can be achieved if such frameworks provide for legally binding structures and processes to oversee, regulate, and monitor research on human participants according to accepted norms and standards. From 2007 to 2009, an ethical/legal audit, sponsored by the WHO/UNAIDS Ethics, Law and Human Rights Working Group of the African AIDS Vaccine Programme (AAVP ELH), was conducted in regard to five African countries (Cameroon, Malawi, Nigeria, Rwanda and Zambia) to determine whether these countries have adequate laws, ethical guidelines and policies in place to regulate HIV-vaccine research. This article discusses the findings of the audit with a view to highlighting key lessons that can be learnt from these countries. The article provides the context of the audit by highlighting its rationale, aims and methods. We discuss the general findings of the audit and the complex issues arising from HIV-vaccine research, specifically. Lastly, we propose specific ways in which the ethical/legal frameworks guiding research with human participants in these countries can be improved.

The role of law in the regulation of HIV-vaccine research in South Africa and Kenya.

Law is an important regulatory mechanism, particularly for creating an enabling research environment. However, the manner in which law addresses issues related to medical research, and HIV-vaccine research in particular, is at times inadequate and of great concern to the stakeholders involved in such research. The challenges for law as a regulatory mechanism in this regard are twofold: the complexity of issues related to HIV-vaccine research, and the apparent disconnection between the legal and ethical frameworks that are applied in the regulation of these issues. This article analyses the extent to which these challenges have been addressed in South Africa and Kenya. Especially, it highlights the lessons that can be drawn from the two countries in establishing a suitable ethical-legal framework for HIV-vaccine research.

Module two: informed consent.

The objective of this module is to familiarise you with the concept of informed consent, its ethical basis, its elements, and typical problems that are encountered even by the most well intentioned researchers when trying to achieve genuine informed consent.