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.
Ethics and medical research in children
The ethics of clinical research is based on several well‐known guidelines and documents. The guidelines vary between countries, but the principles of respect for persons, beneficence, and justice are constant. These principles are reflected in requirements to obtain free and informed consent, to minimize risk or harm, and to not overly burden or disadvantage particular populations. For research to be ethical, it must also be of such a standard, and be conducted in such a manner that it will generate knew and useful knowledge. Children have limited capacity for understanding and may be more open to coercion. Therefore, they are regarded as a particularly vulnerable population, and specific clauses regarding children are incorporated into many guidelines. A key concept in these clauses is the degree of risk acceptable for children involved in research. While it is generally agreed that children require particular attention because of their vulnerability, there is also increasing concern that children in general should not be disadvantaged by lack of knowledge due to reduced research activity. Finally, an increasingly active area of research in children involves genetics and biobanking. Research in these areas raises new and challenging ethical issues.
La inseguridad jurídica en normas de contratación estatal
It is established by different studies that the issue of government procurement has been marred by several factors, the test objective to publicize these factors, we take as starting point the constant conflict between the branches of government to try and organize this subject; will collect and analyze diverse regulatory and case material in order to achieve evidence and demonstrate the different concepts of constant change that produces excessive regulation of the subject procurement and is in turn causing rapid changes that result in legal uncertainty for our law on the Contract Status.