FHS Service Center

Reimbursement costs for providing FHS data or materials to ancillary studies

The success of the Framingham Heart Study (FHS) is due in large part to the contributions of ancillary studies over the decades. Providing data, materials or other research and administration services to ancillary studies involves costs which can vary widely and may individually be quite modest, but none of these costs are covered by the FHS contract. The cost to FHS to service ancillary studies needs to be reimbursed by the Principal Investigators (PI) of ancillary studies.

PIs of ancillary studies supported by grants or subcontracts work with FHS grant managers to fund the costs to FHS associated with the study. Alternatively, FHS will invoice investigators based on Framingham Study Service Center posted fees. Requests for datasets for approved manuscripts, pilot work or for grant submissions will be charged a base cost of $1,000.00. Additional costs may be charged depending on the complexity of the request and the amount of data requested. Exceptions may be requested. These will be considered on a case by case basis. Quality control, archiving, tracking and preparation for data sharing is included in the cost of the original data or material distribution fee.

The time to complete a service request for data and materials depends upon the size and complexity of the project as well as the completeness of the information provided by the requestor. Requests for additional work after a project has been completed may result in additional costs. The FHS makes every effort to accommodate ancillary requests, however, please note that work on FHS contract deliverables takes priority over ancillary requests.

Please contact the FHS Administrators at fhs@bu.edu with any questions.

Please contact the FHS Data Team at fhsdata@bu.edu with any technical questions regarding data availability and data cost

Data Requests

Service Type	Fee
Simple Data Request	$3,000
Moderate Data Request	$5,000
Advanced Data Request	$10,000

Data request cost categories:

Simple = 15 phenotype datasets.
Moderate = 16-49 phenotype datasets.
Advanced = 50+ phenotype datasets.

Materials Requests

Service Type	Fee
DNA/aliquot	$5.00
Biospecimen Tier 1 One shipment of specimens One dataset produced Specimen set includes full exam cycle Standard specimen cryovials	$5.00
Biospecimen Tier 2 Multiple shipments of specimens Multiple datasets produced Non-standard specimen vials or plates Custom, or split-cycle specimen set, or other extra handling *	$7.50

Service Type

Fee

DNA/aliquot

$5.00

Biospecimen Tier 1

One shipment of specimens
One dataset produced
Specimen set includes full exam cycle
Standard specimen cryovials

$5.00

Biospecimen Tier 2

Multiple shipments of specimens
Multiple datasets produced
Non-standard specimen vials or plates
Custom, or split-cycle specimen set, or other extra handling *

$7.50

*An example of extra handling is reorganization of specimens in an investigator-defined arrangement, such as randomization or pairing of case/control specimens.

BU and BMC investigators should contact the FHS Ancillary Study Coordinator at fhsanc@bu.edu

Additional Details - 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

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

1. Ensure all required paperwork is correctly completed and processed before data are sent

- - DMDA
  - IRB Approval
  - Third Party Agreement, when necessary
  - Invoicing

1. Apply correct ID system to data

- - Create project specific random IDs, when appropriate
  - Swap to different ID system, when appropriate
  - Apply consent restrictions

1. Create distribution dataset

- - Bundle all datasets
  - Bundle all related documentation

1. Data transfer

- - Set up a secure transfer
  - Additional costs may apply for additional transfers

1. Up to 3 hours of additional consultation (up to 5 hours for large-scale distributions)

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.

1. Prepare manifest.
2. 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]

1. 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

1. Consult with investigators upon final data submission.
2. Remove any information from samples or data where participants’ identity cannot be confirmed and/or have withdrawn consent.
3. Prepare dataset documentation.
4. 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

1. Organize return of specimens to the FHS when needed. Inventory specimen set and update biorepository records.