Division of Adolescent Medicine, Department of Pediatrics, Indiana University School of Medicine and Department of Philosophy, IUPUI (adjunct), 410 West 10th Street, HS 1001, Indianapolis, IN, 46202, USA.
Good Clinical Practice Alliance-Europe (GCPA), Brussels, Belgium.
Paediatr Drugs. 2018 Jun;20(3):215-222. doi: 10.1007/s40272-017-0280-y.
Children of minor parents are under-represented in clinical trials. This is largely because of the ethical, legal, and regulatory complexities in the enrolment, consent, and appropriate access of children of minor parents to clinical research. Using a case-based approach, we examine appropriate access of children of minor parents in an international vaccine trial. We first consider the scientific justification for inclusion of children of minor parents in a vaccine trial. Laws and regulations governing consent generally do not address the issue of minor parents. In their absence, local community and cultural contexts may influence consent processes. Rights of the minor parent include dignity in their role as a parent and respect for their decision-making capacity in that role. Rights of the child include the right to have decisions made in their best interest and the right to the highest attainable standard of health. Children of minor parents may have vulnerabilities related to the age of their parent, such as increased rates of poverty, that have implications for consent. Neuroscience research suggests that, by age 12-14 years, minors have adult-level capacity to make research decisions in situations with low emotion and low distraction. We conclude with a set of recommendations based on these findings to facilitate appropriate access and equity related to the participation of children of minor parents in clinical research.
未成年父母的子女在临床试验中代表性不足。这主要是由于在招募、同意和未成年父母的子女适当参与临床研究方面存在伦理、法律和监管方面的复杂性。我们采用基于案例的方法，研究了未成年父母子女在一项国际疫苗试验中的适当参与问题。我们首先考虑将未成年父母的子女纳入疫苗试验的科学依据。一般来说，规范同意的法律和法规并没有涉及未成年父母的问题。在没有这些规定的情况下，当地社区和文化背景可能会影响同意过程。未成年父母的权利包括在其作为父母的角色中享有尊严，以及在该角色中尊重其决策能力。儿童的权利包括在其最佳利益下做出决策的权利和获得最高可达健康标准的权利。未成年父母的子女可能存在与父母年龄相关的脆弱性，例如贫困率增加，这对同意有影响。神经科学研究表明，在情绪和注意力不集中的情况下，12-14 岁的未成年人在研究决策方面具有与成年人相当的能力。最后，我们根据这些发现提出了一系列建议，以促进未成年父母子女在临床研究中的适当参与和公平性。
