Opportunity Information: Apply for RFA HD 16 021

The Multidisciplinary Approaches for Developmental Research with Individuals with DSD (R01) funding opportunity (RFA-HD-16-021) is a National Institutes of Health discretionary grant program designed to support research focused on people with disorders of sex development (DSD) and their families. The central purpose is to strengthen the evidence base for clinical and developmental decision-making in these relatively rare conditions, where patient numbers are often small, practices vary, and long-term outcomes are not always well characterized. A major theme of the announcement is building coordinated, multidisciplinary work that can generate more reliable conclusions than isolated single-site studies, while also encouraging collaboration and data sharing through a consortium-like approach.

The FOA invites projects that fit within one of five broad research areas. First, it supports efforts to improve DSD diagnosis, which can include refining diagnostic pathways, integrating genetic or endocrine testing more effectively, or reducing time-to-diagnosis and misclassification. Second, it welcomes studies on outcomes related to genitosurgery and gender assignment, including both medical endpoints and longer-term developmental consequences; this area is meant to address questions about the benefits, risks, timing, and downstream implications of early clinical decisions. Third, it prioritizes research on psychosocial and functional impacts across development, such as mental health, quality of life, family functioning, peer relationships, sexual health, fertility-related concerns, stigma, and other real-world outcomes that shape day-to-day well-being from childhood through adulthood. Fourth, the FOA calls for work that improves clinical management more broadly, which can include care models, shared decision-making approaches, multidisciplinary clinic structures, provider communication, ethical considerations in care delivery, and interventions that make care more consistent and patient-centered. Fifth, it encourages longitudinal follow-up of DSD cohorts to establish treatment outcomes and better characterize cancer risks and cancer-related health issues, reflecting the need for long-term surveillance data that is often missing for rare conditions.

A defining objective is to move the field toward a stronger scientific foundation for maximizing developmental outcomes. In practice, that means producing data that can guide clinical choices and family counseling with more confidence, including understanding what outcomes look like over time and what factors predict better or worse trajectories. The FOA also explicitly aims to create a network of researchers who collaborate and share data, which is particularly important for DSD research because combining cohorts and harmonizing measures across sites can improve statistical power, comparability, and generalizability.

The opportunity uses the NIH R01 research project grant mechanism. The listed award ceiling is $499,999, indicating an upper bound on the total award amount as presented in the source summary. The original closing date shown is 2015-12-09, and the opportunity record creation date is 2015-09-14, which situates it as a specific dated solicitation rather than an open-ended program announcement. The CFDA numbers associated with the opportunity are 93.394, 93.395, 93.399, and 93.865, reflecting the federal assistance listings tied to the NIH programs involved.

Eligibility is intentionally broad, spanning many organization types that could contribute to multidisciplinary DSD research. Eligible applicants include public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (other than small businesses) as well as small businesses, and multiple levels of government (state, county, city/township, and special district governments). Independent school districts, public housing authorities/Indian housing authorities, and federally recognized tribal governments are also eligible, along with tribal organizations that are not federally recognized governments. In addition, the FOA highlights other eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, regional organizations, and non-U.S. entities (foreign organizations). This breadth signals an interest in reaching specialized clinical centers, academic research teams, community partners, and institutions serving populations that are often underrepresented in research.

Overall, this FOA is best understood as an NIH effort to push DSD research toward coordinated, outcomes-oriented science that addresses both medical and psychosocial dimensions, supports long-term follow-up where it is most needed, and builds shared infrastructure for collaboration and data sharing so that findings can be more robust and clinically useful.

  • The National Institutes of Health in the education, health, income security and social services sector is offering a public funding opportunity titled "Multidisciplinary Approaches for Developmental Research with Individuals with DSD (R01)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.394, 93.395, 93.399, 93.865.
  • This funding opportunity was created on 2015-09-14.
  • Applicants must submit their applications by 2015-12-09. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Each selected applicant is eligible to receive up to $499,999.00 in funding.
  • Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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Frequently Asked Questions (FAQs)

What is the "Multidisciplinary Approaches for Developmental Research with Individuals with DSD (R01)" opportunity?

This is a National Institutes of Health (NIH) discretionary funding opportunity (RFA-HD-16-021) that uses the NIH R01 research project grant mechanism to support research focused on individuals with disorders of sex development (DSD) and their families. The emphasis is on building a stronger evidence base for clinical and developmental decision-making in DSD, especially because these conditions are relatively rare and long-term outcomes are not always well characterized.

What is the central purpose of this FOA?

The central purpose is to strengthen the scientific evidence that informs clinical care and developmental decision-making for people with DSD and their families. The FOA highlights the challenges of small patient numbers, variable clinical practices, and limited long-term outcome data, and it encourages coordinated research that can produce more reliable and clinically useful conclusions.

Why does the FOA emphasize multidisciplinary and coordinated research?

DSD conditions are relatively rare, which often makes single-site studies underpowered and harder to generalize. The FOA promotes coordinated, multidisciplinary approaches so that researchers can combine expertise, harmonize methods, and produce findings that are more robust than isolated studies.

Does the FOA encourage collaboration and data sharing?

Yes. A defining objective is to create a network of researchers who collaborate and share data in a consortium-like approach. This is intended to improve statistical power, comparability across sites, and the generalizability of results by combining cohorts and harmonizing measures.

What types of research topics are invited under this funding opportunity?

The FOA invites projects that fit within one of five broad research areas: (1) improving DSD diagnosis, (2) outcomes related to genitosurgery and gender assignment, (3) psychosocial and functional impacts across development, (4) improving clinical management more broadly, and (5) longitudinal follow-up of DSD cohorts to establish treatment outcomes and better characterize cancer risks and cancer-related health issues.

What does "improving DSD diagnosis" include in this FOA?

This area can include refining diagnostic pathways, integrating genetic or endocrine testing more effectively, and reducing time-to-diagnosis and misclassification.

What kinds of studies are included under outcomes related to genitosurgery and gender assignment?

This research area includes studying outcomes tied to genitosurgery and gender assignment decisions, including medical endpoints as well as longer-term developmental consequences. The FOA frames this work as addressing questions about benefits, risks, timing, and downstream implications of early clinical decisions.

What does the FOA mean by psychosocial and functional impacts across development?

This area includes outcomes that affect real-world well-being from childhood through adulthood, such as mental health, quality of life, family functioning, peer relationships, sexual health, fertility-related concerns, stigma, and related day-to-day functioning.

What types of projects fall under "improving clinical management"?

This area can include studies of care models, shared decision-making approaches, multidisciplinary clinic structures, provider communication, ethical considerations in care delivery, and interventions aimed at making care more consistent and patient-centered.

What does the FOA say about longitudinal follow-up and cancer risk?

The FOA encourages longitudinal follow-up of DSD cohorts to establish treatment outcomes over time and to better characterize cancer risks and cancer-related health issues. This reflects the gap in long-term surveillance data for rare conditions.

What is the overall scientific goal of the FOA?

The FOA aims to move the field toward a stronger scientific foundation for maximizing developmental outcomes. In practical terms, that means generating data that can guide clinical choices and family counseling with more confidence, including how outcomes evolve over time and which factors predict better or worse trajectories.

What grant mechanism is used for this opportunity?

The opportunity uses the NIH R01 research project grant mechanism.

What is the listed award ceiling for this opportunity?

The listed award ceiling is $499,999, which is presented as an upper bound on the total award amount in the provided source summary.

What are the key dates mentioned for this FOA?

The opportunity record creation date is 2015-09-14, and the original closing date shown is 2015-12-09. These dates indicate it is a specific dated solicitation rather than an open-ended program announcement.

Which CFDA numbers are associated with this opportunity?

The CFDA numbers listed are 93.394, 93.395, 93.399, and 93.865.

Who is eligible to apply?

Eligibility is broad and includes public and private institutions of higher education; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations (including small businesses and other than small businesses); and multiple levels of government (state, county, city/township, and special district governments). Additional eligible applicants include independent school districts, public housing authorities/Indian housing authorities, federally recognized tribal governments, and tribal organizations that are not federally recognized governments.

Are institutions serving underrepresented populations specifically mentioned as eligible?

Yes. The FOA highlights eligibility for Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities, and Tribally Controlled Colleges and Universities.

Are faith-based or community-based organizations eligible?

Yes. Faith-based or community-based organizations are listed among eligible applicants.

Are U.S. territories, regional organizations, and federal agencies eligible?

Yes. The FOA includes eligible federal agencies, U.S. territories or possessions, and regional organizations as eligible applicants.

Are non-U.S. (foreign) organizations eligible to apply?

Yes. Non-U.S. entities (foreign organizations) are explicitly listed as eligible applicants.

What kind of research approach does this FOA seem to prioritize for rare conditions like DSD?

The FOA prioritizes approaches that improve the reliability and usefulness of results in rare conditions, including coordinated multi-site work, multidisciplinary teams, harmonized measures, cohort combination where appropriate, and data sharing to strengthen statistical power and comparability.

Who is the research intended to benefit?

The FOA is focused on research that benefits individuals with DSD and their families, with the goal of improving clinical and developmental decision-making and strengthening the evidence used in care and counseling.

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