Notice Number: NOT-HL-18-607
Release Date: March 16, 2018
National Heart, Lung, and Blood Institute (NHLBI)
The purpose of this Notice is to inform the scientific community that the National Heart, Lung, and Blood Institute (NHLBI) plans to fund a Phase VII Exam in the Strong Heart Study (SHS) from approximately November 15, 2021 through November 14, 2023. The exam is intended in part to serve as a platform for additional, independently funded exam components via investigator-initiated grants or other independently funded projects to enrich the exam data collection with additional hypothesis-driven content. The research aims of such exam-related ancillary projects need not be limited to those within the mission of the NHLBI but must be consistent with and/or complement the SHS’s objectives.
This Notice allows interested researchers approximately 42 months before the expected start of the SHS Phase VII exam to develop their research hypotheses and designs; comply with any applicable cohort study-specific requirements (e.g., obtaining approvals from tribal partners) and NIH $500K requirements; submit and, if necessary, re-submit their grant applications; receive funding awards; and participate in exam planning and coordination prior to the exam start.
THIS IS NOT A FUNDING OPPORTUNITY ANNOUNCEMENT. NO SOLICITATION FOR GRANT APPLICATIONS WILL BE ISSUED FOR THIS PURPOSE. APPLICANTS MUST USE EXISTING PARENT OR OTHER FUNDING OPPORTUNITY ANNOUNCEMENTS AS APPROPRIATE.
The NHLBI is implementing this plan in response to the report, “Strategic Transformation of Population Studies: Recommendations of the Working Group on Epidemiology and Population Sciences from the National Heart, Lung, and Blood Advisory Council and Board of External Experts” (Roger VL et al, Am J. Epidemiol 2015;181(6):363-367). In its report, the Working Group offered seven recommendations to the NHLBI to take advantage of new scientific opportunities and delineate future directions for the Institute’s epidemiology research portfolio on heart, lung, blood, and sleep diseases. The seventh recommendation was to “implement a competitive peer review–based model for its portfolio of large epidemiologic and population studies.” Within this recommendation, the NHLBI was advised to adopt a model for its existing cohort studies in which decision-making about renewal of funding for study infrastructure is separated from peer review of innovative research content. As this Notice describes, peer-reviewed investigator-initiated research projects will provide this innovative content and serve as the “predominant driver of the research agenda” in the SHS Phase VII exam, as called for by the Working Group.
NHLBI’s contract funding for the next project period of the SHS is expected to begin on or about November 15, 2018, for a seven-year duration. The SHS Phase VII exam is expected to commence three years later, on November 15, 2021. This Notice is being released now to allow ample time for interested researchers to develop NIH grant applications to fund exam components addressing innovative research questions in the SHS.
Interested investigators are not required to be SHS investigators, but they must submit and receive approval of a proposal to conduct an SHS ancillary study, per the SHS Ancillary Study Policies which can be accessed via the following URL: http://www.strongheartstudy.org/Research/AncilliaryandSub-Studies/ProposeanAncillaryorSub-study.aspx. Proposals must be approved by participating tribes as well as the SHS Steering Committee and relevant IRBs. Investigators will be expected to work collaboratively with the SHS investigators and to follow SHS policies and procedures. They will also be expected to comply with SHS and, if approved by tribal partners, NHLBI requirements for sharing of collected ancillary study data with the SHS. The NHLBI Policy for Data Sharing from Clinical Trials and Epidemiological Studies is at https://www.nhlbi.nih.gov/grants-and-training/policies-and-guidelines/nhlbi-policy-for-data-sharing-from-clinical-trials-and-epidemiological-studies. Alternative data sharing plans might be utilized, upon approval by tribal partners and the NHLBI.
Researchers desiring data for their analyses beyond what will be obtained via the core Phase VII components must plan and budget for the additional data collection in their grant applications. The core components of the Phase VII exam include: reception and consent; update of demographic information, smoking history, and medical history update including medications; anthropometry; blood pressure; and urine collection and phlebotomy for analytes measured in real time and for future research purposes. Laboratory assays to be funded as part of the core exam include fasting glucose, total cholesterol, HDL cholesterol, triglycerides, hemoglobin A1c, and urinary creatinine and albumin. Collection of any additional data required to address an application's specific aims must be planned and budgeted in the grant application.
Researchers who submit grant applications for October 2019 or January 2020 Council Cycle receipt dates (as described at https://grants.nih.gov/grants/how-to-apply-application-guide/due-dates-and-submission-policies/due-dates.htm) will have adequate time, if funded as new (A0) or resubmission (A1) applications, to cooperate with the SHS in the planning process for conduct of the Phase VII exam. Further information about application submission timing considerations is available on the NHLBI Epidemiology Digital Forum at https://nhlbiepi.wordpress.com/.
Please direct all inquiries to:
National Heart, Lung, and Blood Institute (NHLBI)