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.

Services Included in a Distribution Fee

The distribution fee covers the distribution of archived/existing data or specimens and the processing of ancillary study data returned to Framingham as described below.

Distribution

  1. Distribution of archived/existing data
    1. Consult on data available and applicable to research proposed
      • Review data request form for appropriateness
      • Identify specific datasets to include in the transfer based on the dataset request form submitted by researcher
    2. Ensure all required paperwork is correctly completed and processed before data are sent
      • DMDA
      • IRB Approval
      • Third Party Agreement, when necessary
      • Invoicing
    3. Apply correct ID system to data
      • Create project specific random IDs, when appropriate
      • Swap to different ID system, when appropriate
      • Apply consent restrictions
    4. Create distribution dataset
      • Bundle all datasets
      • Bundle all related documentation
    5. Data transfer
      • Set up a secure transfer
      • Additional costs may apply for additional transfers
    6. Up to 3 hours of additional consultation (up to 5 hours for large-scale distributions)
  2. Distribution of specimens
    1. Review research application and DMDA.
    2. Identify and retrieve appropriate specimen set. Create daughter aliquots if needed.
    3. If these are DNA specimens,
      • Custom aliquotting of DNA to user specification (concentration, amount, plating format).
      • DNA forensic genotyping to ensure sample ID.
    4. Prepare manifest.
    5. Schedule a pre-shipment conference call with representatives from the testing laboratory, the FHS laboratory and data management groups and the ancillary study PI.
      • Description of specimen set [sample type, number, volume, labeling, packaging]
      • Guidelines for care/storage/usage of FHS specimens
      • Shipping information [confirm address, date of shipment, shipping company]
      • Details of assay [analytical measuring range, quality control, estimated timeline]
      • Details of data return [formatting, QC to be reported, secure file transfer]
    6. Organize specimen shipment to testing laboratory

    If the research produces new data on FHS participants, the fees also cover the following items regarding data returned to FHS for distribution to dbGaP, BioLINCC, etc.

    1. Follow-up with investigators at preliminary data return, request reporting changes as needed.
      • Return raw data sets, including images (if applicable) and measurements
      • Return cleaned data sets, including derived measures that are used for publications
      • Return documentation of data cleaning procedures
    2. Consult with investigators upon final data submission.
    3. Remove any information from samples or data where participants’ identity cannot be confirmed and/or have withdrawn consent.
    4. Prepare dataset documentation.
    5. If data is to be deposited into dbGaP
      • Convert IDs to SHARe IDs
      • Prepare sample and subject info files, and related data dictionaries
      • Package data in format required by dbGaP and prepare related documentation
      • Upload data to dbGaP portal
    6. Organize return of specimens to the FHS when needed. Inventory specimen set and update biorepository records.