Disorders/Differences of Sex Development (DSD) - Translational Research Network

摘要 项目摘要/摘要 拟议的生物伦理问题研究行政补编的重点是支持 发展旨在为未来政策方向提供信息的证据基础需要知情同意 非典型体细胞性发育的未成年人的择期泌尿生殖外科手术的实践，即差异 性发育障碍(DSD)。DSD是先天性疾病，在这种情况下，染色体、性腺或 解剖性发育是不典型的。DSD包括一系列的医疗状况，这些疾病加在一起， 发病率约占人口的1%，并与不孕不育增加、性腺癌风险、 性别焦虑症，心理社会苦恼，以及患者心理社会适应的普遍挑战 他们的家人。对于每个新发现的DSD患者，有多种临床管理选项可供选择 考虑一下，其中大多数在情感和伦理上都是具有挑战性的。一个引发争论和关注的话题 跨专业人士、倡导者和患者社区，涉及在以下情况之前知情同意的充分性 未成年人的择期泌尿生殖外科手术。 知情同意不仅意味着一种形式，而且意味着一种过程，以及作为这一点的记录的签署文件 进程。对当前知情同意做法的一个重大关切涉及决策者的访问 对所有信息材料的理解，以做出明智的决定，并结合权衡 根据个人价值观和喜好考虑潜在的危害和好处。现行手术知情同意书 然而，在DSD中用于泌尿生殖外科手术的文档通常与任何其他文档相同 外科手术。 鉴于围绕同意程序的具体关切和争议，代理的现状 对于选择性和不可逆转的外科手术，知情的“许可”似乎是不够的。原因尚不清楚。 没有使用更详细和特定于DSD的语言和表格，在实施中存在哪些障碍 添加了详细信息的表格。这个项目的目标是设计新的手术同意书(或语言 可纳入既定表格或作为既定表格的必要附录)。这将是 通过创建关于标准手术通知的当前特征的知识库来完成 同意文件和应包括的内容(通过专家意见调查)，全面比较 确定的需求与当前状态的对比，以建议的语言形式总结调查结果 纳入标准化的知情同意文件，并系统地识别和编目 改变现行知情同意文件的障碍延伸到法律和政策领域。

ABSTRACT Project Summary / Abstract The focus of the proposed administrative supplement for research on bioethical issues supporting the development of an evidence base intended to inform future policy directions involves informed consent practices for elective urogenital surgery in minors born with atypical somatic sex development, i.e., differences / disorders of sex development (DSD). DSD are congenital conditions in which chromosomal, gonadal, or anatomic sex development is atypical. DSD comprise a spectrum of medical conditions that, collectively, have an incidence of ~1% of the population and are associated with increased infertility, risks of gonadal cancer, gender dysphoria, psychosocial distress, and pervasive challenges to psychosocial adaptation for patients and their families. For every person with a newly identified DSD, there are multiple clinical management options to consider, most of which are emotionally and ethically challenging. One topic triggering debate and concern across professional, advocacy, and patient communities involves the adequacy of informed consent prior to elective urogenital surgery in minors. Informed consent implies not just a form, but a process, and signed documentation serving as a record of that process. A significant concern regarding current informed consent practices involves decision makers’ access to and understanding of all information material to making an informed decision, combined with weighing potential harms and benefits in light of personal values and preferences. Current surgical informed consent documents used for urogenital surgery in DSD are, however, generally the same as those for any other surgical procedure. Given specific concerns and controversies surrounding consent procedures, the status quo regarding proxy informed “permission” for elective and irreversible surgical procedures appears inadequate. It is unclear why more detailed and DSD-specific language and forms are not in use and what barriers exist in implementation of forms with augmented details. The goal of this project is to design new surgical consent forms (or language that can be incorporated into, or function as a required addendum to, established forms). This will be accomplished by creating a knowledge base regarding current the features of standard surgical informed consent documents and what should be included (via expert opinion survey), comprehensively comparing identified needs vs the current status, summarizing findings in the form of proposed language intended for inclusion in standardized informed consent documents, and systematic identification and cataloguing of barriers to altering current informed consent documents extending into legal and policy-level realms.