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

> **NIH NIH R01** · UNIVERSITY OF MICHIGAN AT ANN ARBOR · 2022 · $132,600

## Abstract

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.

## Key facts

- **NIH application ID:** 10590830
- **Project number:** 3R01HD093450-05S1
- **Recipient organization:** UNIVERSITY OF MICHIGAN AT ANN ARBOR
- **Principal Investigator:** DAVID Eric SANDBERG
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $132,600
- **Award type:** 3
- **Project period:** 2018-07-15 → 2024-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10590830

## Citation

> US National Institutes of Health, RePORTER application 10590830, Disorders/Differences of Sex Development (DSD) - Translational Research Network (3R01HD093450-05S1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10590830. Licensed CC0.

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