Opportunity Information: Apply for RFA DK 12 017

  • The National Institutes of Health in the food and nutrition health sector is offering a public funding opportunity titled "Expansion of Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) (U01)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847 Diabetes, Digestive, and Kidney Diseases Extramural Research.
  • This funding opportunity was created on Aug 31, 2012 and posted on Aug 31, 2012.
  • Applicants must submit their applications by Nov 29, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Eligible applicants include: Private institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Special district governments Independent school districts For profit organizations other than small businesses County governments City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) State governments Small businesses.
  • Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:

The Expansion of Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) (U01) funding opportunity (RFA-DK-12-017) is a National Institutes of Health (NIH) cooperative agreement designed to bring additional research sites into the existing LURN network. The central goal is to strengthen and broaden ongoing work on lower urinary tract dysfunction (LUTD) by further validating symptom-based measurement tools and improving how researchers identify and describe distinct patient subgroups (phenotypes). In practical terms, NIH is supporting a coordinated, multi-site effort to make sure that symptom instruments and patient-reported outcome (PRO) measures accurately capture the full range of LUTD symptoms in both men and women, including symptoms that may appear early or late, come and go (transient), or persist over time.

A major emphasis of this opportunity is rigorous validation of symptom-based instruments and newly developed PRO measures. The network aims to confirm that these tools reliably measure what patients experience and report, and that they work well across different populations and clinical settings. Because LUTD symptoms can vary significantly by sex, timing, severity, and pattern, the FOA specifically highlights the need to measure and distinguish early, late, transient, and persistent symptoms. This kind of validated measurement is intended to improve research consistency across sites and ultimately make study findings more comparable and clinically meaningful.

The announcement also prioritizes deeper and more comprehensive patient characterization, often described as phenotyping. Added sites are expected not only to recruit participants with LUTD symptoms but also to conduct extensive assessments that help define clinically relevant phenotypes among men and women. The intent is to move beyond broad symptom labels and instead describe subgroups with shared characteristics, which can support better understanding of disease mechanisms, progression patterns, and potentially different responses to treatment. By expanding the network, NIH is aiming for larger and more diverse participant samples, which strengthens statistical power and helps determine whether identified phenotypes hold up across varied patient populations.

Operationally, the new research sites and an expanded Data Coordinating Center (DCC) are expected to adopt and implement study protocols already developed by current LURN investigators. This signals that the network is building on established methods rather than having each new site create its own approach. Key responsibilities for the added sites include following standardized protocols, enrolling and retaining eligible participants, administering and validating the PRO instruments, and completing the required phenotyping activities. The expanded DCC role is to support coordinated data management and study operations across the network, helping ensure that information collected at different sites is consistent, high quality, and suitable for combined analyses.

The award mechanism is a U01 cooperative agreement, which typically means NIH anticipates substantial scientific or programmatic involvement during the project period compared with a standard research grant. The opportunity is listed as discretionary and falls under CFDA 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research). There is no cost sharing or matching requirement.

Eligibility is broad and includes many types of U.S. organizations, such as public and private institutions of higher education, nonprofits (including both 501(c)(3) and certain non-501(c)(3) entities), state and local governments, tribal governments and tribal organizations, public housing authorities, independent school districts, special district governments, and for-profit organizations other than small businesses, as well as small businesses. The FOA also explicitly allows applications from non-U.S. entities (foreign institutions), non-U.S. components of U.S. organizations, and foreign components as permitted under NIH policy. It additionally notes eligibility for categories such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions.

The FOA was posted on August 31, 2012, and the original/current closing date listed is November 29, 2012, with an archive date of December 30, 2012. The NIH is the sponsoring agency, and the full announcement was made available through the NIH grants guide at the link provided in the source information. For access or technical issues, the contact listed is the NIH Office of Extramural Research (OER) Webmaster.

Frequently Asked Questions (FAQs)

1) What is this funding opportunity?

This is the Expansion of Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) (U01) funding opportunity (RFA-DK-12-017). It is an NIH cooperative agreement intended to bring additional research sites into the existing LURN network.

2) What is the main goal of expanding the LURN network?

The central goal is to strengthen and broaden ongoing research on lower urinary tract dysfunction (LUTD) by further validating symptom-based measurement tools and improving how researchers identify and describe distinct patient subgroups (phenotypes).

3) What does the FOA emphasize in practical research terms?

NIH is supporting a coordinated, multi-site effort to ensure that symptom instruments and patient-reported outcome (PRO) measures accurately capture the full range of LUTD symptoms in both men and women, including symptoms that may be early or late, transient (come and go), or persistent over time.

4) What is meant by "rigorous validation" of symptom-based instruments and PRO measures?

The FOA prioritizes confirming that symptom-based instruments and newly developed PRO measures reliably measure what patients actually experience and report, and that these tools perform well across different populations and clinical settings.

5) Why does the FOA highlight early, late, transient, and persistent symptoms?

LUTD symptoms can vary by timing and pattern. The FOA specifically calls out the need to measure and distinguish symptoms that appear early versus late, and those that are transient versus persistent, to improve measurement accuracy and interpretability across studies.

6) How does validated measurement help the research network?

Validated symptom and PRO measurement is intended to improve research consistency across sites, make results more comparable, and increase the clinical meaningfulness of findings generated by the network.

7) What is phenotyping, and why is it a priority here?

Phenotyping refers to deeper and more comprehensive patient characterization. The FOA prioritizes moving beyond broad symptom labels to define clinically relevant subgroups (phenotypes) among men and women with LUTD symptoms. This can support better understanding of mechanisms, patterns of progression, and potentially different responses to treatment.

8) What are new research sites expected to do?

Added sites are expected to recruit participants with LUTD symptoms and conduct extensive assessments needed for phenotyping. They are also expected to implement standardized study protocols developed by current LURN investigators, enroll and retain eligible participants, administer and validate PRO instruments, and complete required phenotyping activities.

9) Are new sites expected to develop their own study protocols?

No. The FOA indicates that new sites are expected to adopt and implement study protocols already developed by current LURN investigators, signaling an expansion built on established methods rather than site-by-site protocol development.

10) What is the role of the Data Coordinating Center (DCC) in this opportunity?

The FOA describes an expanded DCC role to support coordinated data management and study operations across the network. The purpose is to ensure that data collected at different sites are consistent, high quality, and suitable for combined analyses.

11) What is the award mechanism?

The award mechanism is a U01 cooperative agreement.

12) What does a U01 cooperative agreement imply about NIH involvement?

A U01 cooperative agreement typically means NIH anticipates substantial scientific or programmatic involvement during the project period compared with a standard research grant.

13) What NIH program area is associated with this opportunity?

The opportunity is associated with CFDA 93.847, titled Diabetes, Digestive, and Kidney Diseases Extramural Research.

14) Is this opportunity discretionary?

Yes. The opportunity is listed as discretionary.

15) Is cost sharing or a matching requirement required?

No. The FOA states there is no cost sharing or matching requirement.

16) Who is eligible to apply?

Eligibility is broad and includes many types of U.S. organizations, including public and private institutions of higher education, nonprofit organizations (including 501(c)(3) and certain non-501(c)(3) entities), state and local governments, tribal governments and tribal organizations, public housing authorities, independent school districts, special district governments, and for-profit organizations other than small businesses, as well as small businesses.

17) Are foreign (non-U.S.) entities eligible?

Yes. The FOA explicitly allows applications from non-U.S. entities (foreign institutions), non-U.S. components of U.S. organizations, and foreign components as permitted under NIH policy.

18) Does the FOA mention specific institution types or communities as eligible?

Yes. It notes eligibility for categories such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions.

19) When was the FOA posted?

The FOA was posted on August 31, 2012.

20) What is the closing date listed for this opportunity?

The original/current closing date listed is November 29, 2012.

21) What is the archive date?

The archive date is December 30, 2012.

22) Which agency is sponsoring this opportunity?

The sponsoring agency is the National Institutes of Health (NIH).

23) Where was the full announcement made available?

The full announcement was made available through the NIH grants guide at the link provided in the source information.

24) Who is listed as the contact for access or technical issues?

For access or technical issues, the contact listed is the NIH Office of Extramural Research (OER) Webmaster.

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