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

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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.