PA-19-056 NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
There are many diseases and disorders that disproportionately affect the health of underserved populations in the United States. African-Americans, Hispanic Americans, American Indians, Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, and rural populations experience much higher risks of and poorer health status than the majority population. Several of the diseases that disproportionately afflict underserved populations are high priority research areas for the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH). The NIDDK seeks research to improve understanding of the causes of disparities in health and disability in the United States and reducing/eliminating health disparities directly related to the scientific areas within the mission of the NIDDK https://www.niddk.nih.gov/about-niddk/research-areas.
For the purposes of this Notice of Special Interest (NOSI), the following definition will be utilized:
Health Disparities Research: Research to identify the causes of disparities or identify ways to prevent diagnose or treat disparities in health disparities populations within health disparities populations. The NIH has identified the following types of health disparities populations in the United States and its territories: race/ethnicity (African Americans, Hispanic/Latinos, Asian American, American Indians/Alaska Natives, Native Hawaiians and other Pacific Islanders), low socioeconomic status, sexual and gender minorities, and rural populations.
Objectives and Scope
The overall objective of this NOSI is to understand and mitigate health disparities in the development, diagnosis, and treatment of diseases of high priority to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). It is recognized that both biologic and non-biologic factors may be operating in these underserved populations.
Research approaches may include metabolic, genetic, genomic, proteomic, proteogenomics, behavioral, clinical and/or epidemiologic studies in representative populations. Advantage might be taken of extant cohort studies that have been established for investigation of diabetes or other diseases. Collaboration among investigators of these established cohorts would be desirable, so that these studies might jointly develop protocols and evaluate findings. Alternatively, investigators may propose to start a new cohort, appropriately powered, to capture the current risks and outcomes in the era of new medications for some of the diseases. Such studies of current risks might appropriately be based in large HMOs or clinical practices with structure and data management practices conducive to efficient and cost-effective analyses.
Appropriate topics for investigation in NIDDK diseases would include but are not limited to:
This NOSI will only support health disparities or minority health research that occurs in the United States and within the health disparities populations (US racial/ethnic minority, low socioeconomic status, sexual and gender minorities and rural populations).
This NOSI will not accept clinical trials.
This NOSI will not support multi-center clinical studies.
A study is considered to be "multi-center" if three or more sites are involved in the actual conduct of the study. A study will not be considered to involve multiple centers if participant recruitment occurs at three or more locations but all interventions and/or outcomes assessments are performed by a single study team. Program Directors or Principal Investigators (PDs/PIs) who would like to submit a multi-center clinical study or trial should review other NIDDK funding mechanisms such as the NIDDK U34 Multi-center Clinical Studies program (or reissues) and may refer to NOT-DK-14-025: Clarification of NIDDK Policy: Investigator-Initiated Multi-Center Clinical Studies.
Basic science studies for health disparities at NIDDK are allowed, where scientifically appropriate. Animal research is allowed if the research is a clinically relevant model of a NIDDK mission area disease in a minority population. For example, an animal model of Apolipoprotein L1 (ApoL1) in chronic kidney disease is appropriate for this FOA because ApoL1 has been shown to be closely associated with chronic kidney disease in African Americans. Similarly, research on animal models investigating genetic variants shown to alter risk of diabetes in United States minority populations, such as SLC16A11 which increases risk in Hispanics is also appropriate. An application in basic science/animal studies should be hypothesis driven (not an initial hypothesis generating) study.
Investigators are encouraged to contact the NIDDK disease area program director to discuss a planned application when there is a question regarding the application being appropriate for this announcement.
Application and Submission Information
This notice applies to due dates on or after February 5, 2020 and subsequent receipt dates through January 8, 2023.
Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcement through the expiration date of this notice.
All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions: