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.
Consent laws influencing children's access to health care services : child health
Making health care services accessible to everyone is a duty imposed by the Constitution, yet it remains one of the greatest challenges to our transitional health care system. Legislation aimed at improving access to health care has increased over the last few years, testing health workers' ability to practically implement such laws. Children are a particularly vulnerable group within society and should have their health needs addressed at all levels of service provision. However, in most instances children are unable to access necessary health care services on their own and require the prior consent of a legally qualified third party in order to obtain health care. Health legislation further restricts children's ability to consent by setting age limitations resulting in the suspension or prevention of access to health care services for many children in South Africa. Once it is operational, the long awaited Children's Act will increase access to health care for children by lowering the age of consent but it is also likely to add to existing implementation challenges currently faced by health care workers.
Ethical and practical challenges in implementing informed consent in HIV/AIDS clinical trials in developing or resource-limited countries
Background/rationale: Ethical issues regarding HIV/AIDS human research in the developing world remain under continuous evaluation; a critical area of concern includes informed consent. This paper reviews several of the most important ethical and practical aspects of informed consent in HIV research in developing countries. Enhancement of overall understanding of such key issues might promote higher ethical standards of future research. Objectives: The major objective was to address informed consent in human research in non-Western societies, and specifically in HIV clinical trials of affected adults. Secondary end-points included the consent complexities in HIV research involving vulnerable patient populations in resource-limited nations, such as children, adolescents and women. Methods: A systematic review of the published literature using MEDLINE and EMBASE from 1998 until December 2008 was performed, using the search terms ‘HIV/AIDS’, ‘informed consent’, ‘clinical trials’, ‘developing world’. Results: Ethical complexities such as participants' diminished autonomy, coercion or monetary inducement, language difficulties, illiteracy or lack of true understanding of the entire study, cultural barriers mainly due to communitarianism and social diversities were identified in the 44 studies reviewed. Informed consent of vulnerable patient populations must be tailored to their sex and developmental age, while counselling is fundamental. Children and adolescents' assent must be ensured. Local language is to be used, while trusted community leaders and local cultural representatives may convey information. Discussion: Despite the heterogeneity of studies, similarities were identified. Providing adequate and comprehensive information and assessing the true understanding of the research represent fundamental prerequisites. Potential solutions to the critical areas of concern include peer counselling and meetings with local community leaders or local cultural representatives. Conclusions: International investigators of HIV human research should bear in mind these ethical issues and their potential solutions, when trying to ensure ethical research conduct, based on a truly informed and culturally relevant consent.