Notice Number: NOT-HL-18-668
Release Date: December 11, 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, Exam 7, in the Multi-Ethnic Study of Atherosclerosis (MESA; https://www.mesa-nhlbi.org) from approximately October 19, 2021 through April 18, 2023. The limited exam is intended to serve as a platform for 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 MESA study objectives.
This Notice allows interested researchers approximately 34 months before the expected start of Exam 7 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 MESA's Exam 7, as called for by the Working Group.Additional Information
NHLBI’s contract funding for the next project period of MESA is expected to begin on or about December 19, 2019, for a six-year duration. Exam 7 is scheduled to commence 22 months later, on October 19, 2021. This Notice is being published now to allow ample time for interested researchers to develop NIH grant applications to fund exam components addressing innovative research questions in MESA.
Investigators interested in submitting grant applications involving Exam 7 components are not required to be MESA investigators, but they must submit and receive prior approval of a proposal to conduct a MESA ancillary study, per the MESA Ancillary Study Policies accessed at https://www.mesa-nhlbi.org/ancillary.aspx. They will be expected to work collaboratively with the MESA investigators and to follow MESA policies and procedures. They will also be expected to comply with MESA and NHLBI requirements for sharing of collected ancillary study data with MESA. 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 will be obtained via MESA's core Exam 7 components must plan and budget accordingly in their grant applications. The core components of MESA's limited exam will likely include: reception and consent; update of demographic information, smoking history, and medical history, including medications; anthropometric measurements; blood pressure; and urine collection and phlebotomy both for basic laboratory tests and for storage for future research purposes. Laboratory tests likely to be funded as part of the core limited exam include: serum total cholesterol, HDL-C, triglycerides, fasting glucose, HbA1c, and creatinine; and urinary albumin and creatinine. Collection of any additional data required to address the grant application's specific aims must be planned and budgeted for in the application.
Timing for Submission of Grant Applications
Grants applications submitted by the standard October 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) should allow funded grantees adequate time to cooperate with MESA in the planning process for conduct of Exam 7. 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:
Lorraine Silsbee, MHS
National Heart, Lung, and Blood Institute