Notice Number: NOT-HL-17-542

Key Dates
Release Date: October 18, 2017

Issued by
National Heart, Lung, and Blood Institute (NHLBI)

Purpose

The purpose of this Notice is to inform the scientific community that the National Heart, Lung, and Blood Institute (NHLBI) plans to fund an Exam 4 in the Jackson Heart Study (JHS) from approximately February 16, 2020 through November 15, 2022. 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 JHS’s objectives.

This Notice allows interested researchers approximately 30 months before the expected start of the JHS Exam 4 to develop their research hypotheses and designs; comply with any applicable cohort study-specific and NIH $500K policies; 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.

Background

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 for decision-making about renewal of funding for study infrastructure separate from peer review of innovative research content. As this Notice describes, peer-reviewed investigator-initiated research projects will provide innovative content in JHS Exam 4 as called for by the Working Group.

Additional Information

NHLBI’s contract funding for the next project period of the JHS is expected to begin on or about August 16, 2018, for a six-year duration. The JHS Exam 4 is expected to commence approximately 18 months later, on February 16, 2020. 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 JHS.

Interested investigators are not required to be JHS investigators, but they must submit and receive approval of a proposal to conduct a JHS ancillary study, per the JHS Ancillary Study Policies accessed at https://www.jacksonheartstudy.org/Research/Ancillary-Studies. They will be expected to work collaboratively with the JHS investigators and to follow JHS policies and procedures. They will also be expected to comply with JHS and NHLBI requirements for sharing of collected ancillary study data with the JHS. 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 desiring data for their analyses beyond what will be obtained via the core Exam 4 components must plan and budget for the additional data collection in their grant applications. The core components of the JHS Exam 4 include: reception and consent; update of demographic information, smoking history, family history, psychosocial survey, medical history update including medications, dietary assessment, and cognitive assessment; anthropometry; blood pressure; echocardiography; brain MRI; and urine collection and phlebotomy to collect blood 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, cystatin C, creatinine, and urinary albumin/creatinine ratio.

Timing for Submission of Grant Applications

Grant applications submitted for October 2018 and January 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 coordinate and cooperate with the JHS in the planning process for conduct of Exam 4. Further information about application submission timing considerations is available on the NHLBI Epidemiology Digital Forum at https://nhlbiepi.wordpress.com/

Inquiries

Please direct all inquiries to:

Cheryl Nelson, MSPH
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0451
Email: nelsoncr@mail.nih.gov