A critical evaluation of the consent requirement for child participation in health research
__________________________________________________________________ In the context of medical research, children are especially vulnerable to exploitation. As a result several codes of research ethics emphasise the need for special protection. Prior to the implementation of the National Health Act children participating in medical research enjoyed limited legal protection. Instead, research and ethical committees relied on non-research law and ethical guidelines to identify protective measures for children. The National Health Act establishes a platform for developing a wide range of legal norms for research on human subjects and supplements and strengthens the already existing principles related to informed consent. The Act deals specifically with consent for child participation in research. Section 71 requires written consent from a parent or legal guardian for a child to participate in all research conducted with minors, irrespective of age. In addition, minors with sufficient understanding must consent alongside their parents or legal guardians. While the purpose of the Act is to provide legal protection to participants, it fails to take into account the emerging autonomy of the adolescent sufficiently and ignores the fact that many children do not have parents or legal guardians and are cared for by alternative caregivers. These stricter controls are in contravention with other legislation such as the Children’s Act and Choice on Termination of Pregnancy Act, and may also undermine the constitutional rights of children. The study critically evaluates the consent requirements of the National Health Act with reference to the evolving capabilities of children and the exercise of their parents’ or caregivers’ parental or similar responsibilities and rights, and relevant suggestions are made.
Voluntary informed consent and good clinical practice for clinical research in South Africa: ethical and legal perspectives.
Most differences, shortcomings and contradictions regarding voluntary informed consent for participation in clinical research relate to the South African-specific guidance documents, i.e. South African Guidelines for Good Practice in the Conduct of Clinical Trials with Human Participants in South Africa (2006) and Ethics in Health Research: Principles, Structures and Processes (2004). These documents do not fulfil all the ethical and legal requirements for voluntary informed consent for clinical research participation in South Africa. International guidance documents reflect the minimum of the ethical requirements for the conduct of clinical research. Country-specific documents should be updated and aligned with relevant legislative and legal principles of that jurisdiction to ensure that research participants are adequately protected. The South African-specific guidance documents therefore require revision to address these deficiencies.
The Area of Freedom, Security and Justice ten years on: Successes and future challenges under the Stockholm Programme. CEPS Paperbacks. June 2010
This book celebrates the tenth anniversary of the Area of Freedom, Security and Justice (AFSJ) by bringing together the views of key practitioners and policy-makers who have played an outstanding role in thinking about and shaping EU policies on freedom, security and justice. 
 
Ten years ago, the member states transferred competences to the EU for law and policy-making in the fields of immigration, asylum and border controls, and began the transfer process for criminal justice and policing. This decade of European cooperation on AFSJ policies has experienced very dynamic convergence, the enactment of a large body of European law and the setting-up of numerous EU agencies working in these domains. Such dynamism in policy-making has not been without challenges and vulnerabilities, however. As this collective volume shows, the main dilemmas that lie ahead relate to an effective (while more plural) institutional framework under the Treaty of Lisbon, stronger judicial scrutiny through a greater role for national courts and the Court of Justice in Luxembourg, better mechanisms for evaluating and monitoring the implementation of EU AFSJ law and a more solid fundamental rights strategy. The contributions in this volume address the progress achieved so far in these policy areas, identify the challenges for future European cooperation in the AFSJ and put forward possible paths for making more progress in the next generation of the EU’s AFSJ.