NHLBI Announces Plan to Fund a Women's Health Initiative Home-Based Exam in the Long Life Study 2 Cohort

Notice Number: NOT-HL-20-750

Key Dates
Release Date: January 24, 2020

Related Announcements

Issued by
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 home-based exam in the Long Life Study 2 Cohort of the Women's Health Initiative (WHI) (https://www.whi.org/ and https://www.whi.org/studies/SitePages/Long%20Life%20Study.aspx). The examination is expected to begin in April 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 WHI study objectives.

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.



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 WHI's exam, as called for by the Working Group.

Additional Information

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 WHI.

Interested investigators are not required to be WHI investigators, but they must submit and receive approval of a proposal to conduct a WHI ancillary study, per the WHI research proposal policies accessed at https://www.whi.org/researchers/SitePages/Ancillary%20Studies%20Overview.aspx. They will be expected to work collaboratively with the WHI investigators and to follow WHI policies and procedures. They will also be expected to comply with WHI and NHLBI requirements for sharing of collected ancillary study data with the WHI 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 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 WHI's limited exam may include: heart rate, blood pressure, phlebotomy, anthropometry, and limited measures of physical function. Final protocol will be developed in conjunction with the WHI Steering Committee and reviewed by the WHI DSMB. Laboratory assays that are likely to be funded as part of the core limited exam include CVD biomarkers, glucose, insulin, hemoglobin. Collection of any additional data required to address an application's specific aims must be planned and budgeted for in the grant application.

Timing for Submission of Grant Applications

Grant applications submitted by the standard January 2021Council 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 WHI in the planning process for conduct of the 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:

Shari Eason Ludlam, MPH
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-6667
Email: ludlams@mail.nih.gov