The Framingham Heart Study is a project of Boston University & the National Heart, Lung, & Blood Institute.
The Framingham Heart Study is a project of Boston University & the National Heart, Lung, & Blood Institute.

Initiation of FHS Ancillary Study Involving Participant Burden

Policy for Initiation of FHS Ancillary Study Involve Participant Burden

Guiding Principles to begin data collection in the FHS Research Center:

    1. Data collection is linked to scientific merit of the aims of the research proposal
    2. Adequate sample size to ensure scientific merit, if investigator proposes data collection in less than full projected sample of the exam cycle
    3. Funding to ensure data collection, data QC, analytic dataset creation with documentation provided to FHS data management for distribution to the wider scientific community
    Michelle St Paul, FHS Project Manger (fhs@bu.edu), or an appointed delegate will serve as a liaison to Study PIs to provide guidance and assist with approvals


Requisite Steps for Project to be Included in FHS Examinations: To be completed by study PI

1. Research proposal submitted to and approved by:

    a. FHS Executive Committee (EC)
    b. FHS Observational Study Monitoring Board (OSMB)
    c. FHS Director of Finance & Administration for budget review
    d. FHS External Peer Review Committee (EPRC) For Non-NIH proposals only (E.g., AHA, Doris Duke, Robert Wood Johnson, Department of Defense, institutional or private funding, etc.)

2. FHS approved research proposal submitted to sponsor for funding consideration a. If the study plan is revised, the research proposal with modification marked must be submitted to FHS EC and OSMB for approval with each new funding submission

3. Once secured, award documentation provided to FHS Director of Finance & Administration for review & approval of FHS Research Center component (e.g. integration fee, Project Manager (if >500K/year), BU subcontract for staffing the project)

4. Examination Committee review including Manual of Procedures for data collection and information for IRB review and informed consent.



Important note regarding alternative (Non-grant) and partial sources of funding:

If alternative funding (1d above or institutional or other private funding) is secured in lieu of NIH grant funding prior to initiation of data collection:

    a) The study plan (if revised) must be approved by the FHS EC, OSMB, and EPRC.
    b) The FHS Director of Finance & Administration must review award documentation to ensure adequate funding for all activities necessary to achieve the aims of the study
    c) Exam Committee review for determine of integration into the overall exam

If partial funding is secured,

    a) A study plan, revised accordingly, must receive approval from the FHS EC and the FHS OSMB.
    b) The study plan must establish the ability to collect at least one year of high quality data or study sample size that achieves scientific merit, obtain a clean dataset, and transfer dataset to public repository.
    c) The FHS Director of Finance & Administration must review budget to ensure adequate funding for all activities necessary to achieve the aims of the study as well as the annual integration fee.
    d) The FHS Exam Committee must complete a review to determine integration into the overall exam



Last Updated: November 25, 2019