Framingham Heart Study - GUIDE FOR INVESTIGATORS - II - Steps to Applying to FHS and Sponsors for inclusion in FHS Generation 3 Cohorts’ Exam 4 Collaboration

Sep 26, 2026

Uploaded by Asher

Guide for Investigators - II explains how to apply to the Framingham Heart Study (FHS) and coordinate with sponsors for inclusion in FHS Generation 3 Cohorts’ Exam 4 collaboration. It outlines a staged workflow: securing FHS Executive Committee approval via an online application, confirming appropriate budget support with the FHS Director of Finance and Administration, applying to sponsors with possible Letters of Support, and submitting JIT and NoA notifications. It also details review timelines, reasons for governance and feasibility checks, and invitation to the Gen 3 Exam 4 Examination Committee for practical planning and PI responsibilities.

LanguageEnglish

CategoryExam

FormatPDF

Pages14

Reading Time35 min

AccessFree to download

Step 1: What & Why

Step 1: How

Step 1: When

Step 2

Step 3

Step 4

Step 5

Step 6

Framingham Heart Study GUIDE FOR INVESTIGATORS – II Steps to Applying to FHS and Sponsors for inclusion in FHS Generation 3 Cohorts’ Exam 4 What are the steps to Gen 3 Exam 4 Collaboration? | Step 1
Study PI obtains FHS EC Approval
via the
FHS Research App |
Study PI confirms
appropriate budgetary
support with FHS
Director of Finance & Admin
Step 2 | | Step 3
Study PI
applies to
Sponsors | | Study PI notifies FHS of
Step 4

JIT Request
OR
intent toresubmit to
Sponsor | | Step 5
Study PI
notifies FHS when they
receive NoA | |

FHS invites Study PI to join Exam Planning Committee
Step 6 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | | | | | | | | Step 1: WHAT & WHY WHAT: Applications for research need to be submitted on-line for FHS Executive Committee (EC) approval prior to submission to a sponsor for funding . [https://www.framinghamheartstudy.org/fhs-for-researchers/data-sharing-principles/](https://www.framinghamheartstudy.org/fhs-for-researchers/data-sharing-principles/) WHY: 􀂃 The FHS infrastructure is supported by a contract between the NHLBI and Boston University School of Medicine . 􀂃 The policies of NHLBI and Boston University are the basis of governance of the Framingham Heart Study. 􀂃 Research using FHS resources requires review and approval by at least one of the FHS Review Committees, in this case FHS EC approval is required. 􀂃 Reviews consider feasibility, scientific merit, mission and appropriate use of FHS resources . Guide to Investigators Interested in FHS Gen 3 Exam 4 Step 1: HOW Start an on-line application for FHS based research: [https://www.framinghamheartstudy.org/research-application/](https://www.framinghamheartstudy.org/research-application/) 􀂃 For help in opening an FHS account to submit an application, contact Heather Arruda at [harruda@bu.edu](harruda@bu.edu). 􀂃 For help with completing the application contact FHSEC@BU.EDU (Conversations with FHS administrators before completing your submission can save PIs and reviewers weeks of post-submission correspondence.) 􀂃 After submission of your application, it will routed to the appropriate Review Committee(s) . 􀂃 For help understanding FHS Executive Committee procedures, contact FHSEC@BU.EDU Step 1 : WHEN To meet grant deadlines, please submit FHS applications as soon as possible . The more complex the research project, the more time needed for review and approval . 􀂃 Submit your FHS application at least two full months before your chosen grant proposal submission deadline . 􀂃 Plan this long lead time is imperative for you to receive FHS approval of Gen 3 Exam 4, projects since they involve new contact with FHS participants with in the FHS exam . 􀂃 All such projects are coordinated for participant burden and timing. A two-stage process of review is used: 1. Applications requesting specimens should be submitted based on the Laband/or DNA Committee(s) posted submission deadlines . Allow at least two full months for review . 2. Those reviews are then followed by an FHS Executive Committee review to obtain ‘Approval in Concept’ for submission of a proposal by the PI to a sponsor. Step 2 WHAT & WHEN: While you submit your project to the FHS Executive Committee to consider project feasibility, scientific merit, mission and appropriate use of FHS resources, you should contact the FHS Director of Finance and Administration . WHY: FHS projects require the integration of resources and operational procedures with the core examination . This seamless integration requires inclusion of personnel effort and other costs within your project budget. HOW: Email FHSEC@BU.EDU to be connected with the FHS Director of Finance and Administration Step 3 Apply to Sponsors! If needed, ask for a Letter of Support from the FHS PI and Executive Committee to attach to your application

FAQs

What is the overall process to collaborate on FHS Generation 3 Cohorts’ Exam 4?

Submit an online FHS application for Executive Committee approval, confirm budget support with the Director of Finance and Administration, apply to sponsors (optionally with a Letter of Support), then notify FHS with JIT and NoA details before joining Exam planning activities.

Why is FHS Executive Committee approval required before submitting to sponsors?

FHS infrastructure is governed through contracts and institutional policies, and research using FHS resources requires review for feasibility, scientific merit, mission alignment, and appropriate use of FHS resources.

When should investigators submit FHS applications to meet grant deadlines?

Submit as soon as possible and at least two full months before the sponsor grant proposal deadline, allowing extra time for complex projects and the two-stage review process.

Sep 26, 2026

Uploaded by Asher