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 It is imperative that the recipient agrees not to use the data received, either 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.
The Data and Materials Distribution Agreement describes the following restrictions placed upon the requester as a condition of receiving the data:
Institutional Review Board Approval
Human Subject Protection for Framingham Heart Study Participants
All who request data must comply with the Data and Materials Distribution Agreement for ensuring study subject confidentiality. The IRB at the institution of each requester is responsible for determining whether the project protects the privacy and confidentiality of Framingham participants. An IRB approval (either full approval or expedited approval) is required. The Framingham Heart Study and the NHLBI cannot accept an IRB letter stating that the proposed study is exempt from review as 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 the Distribution Agreement or do not submit an IRB approval will not be sent the requested data or materials.
Information on review, evaluation and approval of proposals can be found on the page entitled Ancillary Studies Review Process and Procedures.
A copy of the IRB approval document and a copy of the proposal should be sent along with the original signed Data and Materials Distribution Agreement Form to:
Elizabeth Wilson
Framingham Heart Study Boston University School of Medicine 715 Albany Street, B-606 Boston, MA 02118 TEL: 617-638-8065 FAX: 617-638-8086 Email: lwilson@bu.edu | |||