Notice Number: NOT-HL-17-572
Release Date: January 12, 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 limited clinic exam cycle in the Offspring and Omni 1 Cohorts of the Framingham Heart Study (FHS) (https://www.framinghamheartstudy.org/) The examination is expected to begin on or about August 1, 2019. 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 FHS study objectives.
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 FHS' exam, as called for by the Working Group.
NHLBI’s contract funding for the next project period of the FHS study is expected to begin on or about April 1, 2019, for a six-year duration. The exam is anticipated to commence 4 months later, on or about August 1, 2019. This Notice is being released now to allow time for interested researchers to develop NIH grant applications to fund exam components addressing innovative research questions in FHS. This Notice allows interested researchers to develop their research hypotheses and designs; comply with any applicable cohort study-specific 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.
Interested investigators are not required to be FHS investigators, but they must submit and receive approval of a proposal to conduct a FHS ancillary study, per the FHS research proposal policies. Interested investigators will be expected to work collaboratively with the FHS investigators and to follow FHS policies and procedures. They will also be expected to comply with FHS and NHLBI requirements for sharing of collected ancillary study data with the FHS study (see the NHLBI Policy for Data Sharing from Clinical Trials and Epidemiological Studies).
Researchers desiring data for their analyses beyond what will be obtained via the core exam components must plan and budget for the additional data collection in their grant applications. The core components of FHS' limited exam may include: reception and consent; update of demographic information, smoking history, and medical history including medications; anthropometry; blood pressure; and urine collection and phlebotomy for analytes measured in real time and for future research purposes. Laboratory assays that are likely to be funded as part of the core limited exam include fasting glucose, insulin, total cholesterol, HDL cholesterol, triglycerides, and serum albumin. Collection of any additional data required to address an application's specific aims must be planned and budgeted for in the grant application.
Grant applications submitted by the standard January 2019 Council Cycle receipt date (as described at https://grants.nih.gov/grants/how-to-apply-application-guide/due-dates-and-submission-policies/due-dates.htm ) should allow grantees adequate time to cooperate with FHS in the planning process for conduct of the exam. Further information about application submission timing considerations is available on the NHLBI Epidemiology Digital Forum.
Please direct all inquiries to:
Brian Kit, MD, MPH
National Heart, Lung, and Blood Institute (NHLBI)