Consent in paediatric research: an evaluation of the guidance provided in the 2007 NHMRC National statement on ethical conduct in human research.

In 2007, the National Health and Medical Research Council (NHMRC) released a revised National statement on ethical conduct in human research. Public submissions in the review process leading to the 2007 statement highlighted four main areas of concern: children's competence to consent, mature minors and the requirement for parental consent, whether children can refuse to participate, and the provision of information to children. A useful addition to the statement is the concept of levels of maturity, which help determine whether a child or young person's consent is necessary and/or sufficient for participation in research. Changes in terminology ("capacity" instead of "competence" and introduction of the term "vulnerability") have the potential to create confusion, as the new terms are not clearly defined, and capacity is used in several senses.

Ethics and the proposed treatment for a 13-year-old with atypical gender identity.

The case of a 13-year-old girl given permission by the Family Court of Australia to begin a sex-change process involves complex issues. Nevertheless, the ethical justification for the decision is not complicated. In this case, it can be argued that the net benefit eclipses concerns about competence, autonomy and the appropriateness of the intervention. The debate this case generated in the media reminds us that one of the essential tasks in ethics debates is to get our facts straight.