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.

Distribution Agreements and IRB Approval

Distribution of data and/or material for an approved ancillary study proposal requires a fully executed Data and Materials Distribution Agreement (DMDA). The investigator initiated DMDA must be accompanied by the review committee approval letter, as well as IRB approval (exemptions are not allowed). The recipient must agree to the following:

  • Use of data for the sole purpose of the approved research project
  • Non-transferability
  • No attempt to identify or contact study participants
  • Compliance with subjects’ informed consent
  • Compliance with relevant IRB requirements
  • Advance notification to the NHLBI and Boston University of upcoming publication
  • Acknowledgment in publications of contributions of Framingham Study Investigators and support of NHLBI for data collection
  • Agreement to return analysis data to NHLBI and Boston University for distribution to subsequent approved ancillary studies
  • Subject confidentiality and agreement to not use the data and/or biological material received, alone or in conjunction with any other information, in any effort whatsoever to establish the individual identities or to make contact with any of FHS participants or their relatives
  • To provide an IRB approval letter (either full approval or expedited approval). EXEMPTIONS ARE NOT PERMITTED. There still exists a possibility an individual could be identified given the large amount of data and because FHS is a study of a single community; access to this data is not available unconditionally to the public but restricted to those agreeing to the terms of the Distribution Agreement. Investigators who do not agree to sign a Distribution Agreement or do not submit an IRB approval letter will not be sent the approved data and/or material

A hard copy or PDF of the review committee approval letter, the IRB approval letter and the proposal should be sent along with the original signed DMDA to:

Heather Arruda
Framingham Heart Study
Boston University School of Medicine
72 E. Concord Street, L5
Boston, MA 02118
TEL: 617-358-3685
FAX: 617-638-8086