Appropriate applications and documents are provided for ancillary study proposals. The investigator should review the section on Research Application Overview and determine which application is appropriate for the proposal. All forms, including supplementary and supportive materials, should be completed according to the instructions. The proposal applications often require materials beyond completion of a proposal form. These additions can include, for example, IRB approval, and distribution agreements signed by the investigator's institution. All required materials should be completed and submitted electronically to the FHS contact designated on the application form.
Data and Materials Distribution Agreements describe the following restrictions placed upon the requester as a condition of receiving the data and/or biological materials:
In order to ensure study subject confidentiality it is imperative that the recipient agrees not to 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 the Framingham Study participants or their relatives.
Institutional Review Board Approval
An IRB approval letter (either full approval or expedited approval) is required. The Framingham Heart Study and the NHLBI will not accept an IRB letter stating that the proposed study is exempt from review. There still exists a possibility an individual could be identified given the large amount of data, and as 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 requested data.
A copy of the FHS Executive Committee Approval letter, the IRB approval document and the proposal should be sent along with the original signed appropriate Distribution Agreement to:
Framingham Heart Study
Boston University School of Medicine
72 E. Concord Street, B-601
Boston, MA 02118