Notice Number: NOT-HL-17-563
Release Date: November 28, 2017
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 in the Hispanic Community Health Study/Study of Latinos (HCSH/SOL) (https://sites.cscc.unc.edu/hchs/ ) from approximately November 1, 2019 through October 31, 2022. The limited exam is intended to serve as a platform for additional, independently funded exam components via ancillary studies 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 HCHS/SOL study objectives.
This Notice allows interested researchers approximately 25 months before the expected start of the Visit 3 exam 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.
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 (ancillary studies) will provide this innovative content and serve as the “predominant driver of the research agenda” in HCHS/SOL's Exam 3, as called for by the Working Group.
NHLBI’s contract funding for the next project period of the Hispanic Community Health Study/Study of Latinos is expected to begin on or about December 1, 2018, for a six-year duration. The Visit 3 exam would be expected to commence 11 months later, on November 1, 2019. 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 HCHS/SOL.
Investigators interested in submitting grant applications involving Visit 3 exam components are not required to be HCHS/SOL investigators, but they must submit and receive prior approval of a proposal to conduct an HCHS/SOL ancillary study, per the HCHS/SOL Ancillary Study Policies accessed at https://sites.cscc.unc.edu/hchs/ancillary-studies-pub.They will be expected to work collaboratively with the HCHS/SOL investigators and to follow HCHS/SOL policies and procedures. They will also be expected to comply with HCHS/SOL and NHLBI requirements for sharing of collected ancillary study data with the HCHS/SOL study. The NHLBI Policy for Data Sharing from Clinical Trials and Epidemiological Studies is at https://www.nhlbi.nih.gov/research/funding/human-subjects/data-sharing.
Researchers interested in proposing data collection beyond what would be obtained via the core Visit 3 exam components must plan and budget accordingly in their grant applications. The core components of HCHS/SOL's limited exam include: anthropometric measurements, update of participant personal information, personal medical history and focused health interviews, blood pressure, and phlebotomy for basic laboratory tests (total cholesterol, HDL-C, triglycerides, fasting glucose, and HbA1c) and storage of serum/plasma/whole blood and urine samples for future analyses.
Grant applications submitted by the standard October 2019 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 ) should allow grantees adequate time to cooperate with HCHS/SOL in the planning process for conduct of the Visit 3 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:
John F. Kunz, M.A.
National Heart, Lung, and Blood Institute