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FHS Data/Biospecimen Request​

Investigators seeking FHS data that is not available through dbGaP or BioLINCC or seeking biological specimens may submit a proposal through the FHS web-based research application. The FHS welcomes proposals from outside investigators. Proposals may involve the use of existing data, the collection of new data, either directly from participants or from previously collected samples, images, or other materials (e.g., medical records). The FHS Repository also has biological specimens available for genetic and non-genetic research proposals. Specimens include urine, blood, brain tissue, as well as DNA. After submission, proposals will be presented to the appropriate FHS review committee to determine feasibility and compliance with FHS policies.

External Data Repositories

FHS clinical and research data is stored in the following repositories and may be accessed by application. These repositories are managed and administered independently of the Framingham Heart Study. There are no fees charged for data accessed through dbGaP or BioLINCC. Please check the following repositories before applying for data through FHS:

Request via FHS​

This step-by-step manual is created to guide external research organizations/institutes through the Framingham Heart Study (FHS) data/biosample request process. Should you require more information, you may either visit the official website at https://www.framinghamheartstudy.org/fhs-for-researchers/research-application-faq/ or reach out to the FHS team you are collaborating with.

Checklist for FHS data request:​

  • Approved FHS Research Proposal
  • Approval from YOUR OWN Institutional Review Board (IRB)
  • Completed Data and Materials Distribution Agreement (DMDA)
  • Data Request Form
  • Fees for Data Transfer
reminder

Any missing component will delay your data request!

FHS Research Proposal​

In order to initiate the FHS data request process, you must have an approved FHS research proposal. Check with the FHS team you are collaborating with. If your research project is part of an existing approved FHS research proposal, you may skip this section. To submit a proposal, go to https://wwwapp.bumc.bu.edu/fhsresapp

  1. Create a user account. It may take up to 1-2 weeks before you are granted access to your account. If you are a returning research collaborator, simply log into your account.
  2. Once you log in, click on the “Create a new data application”.
  3. Enter all the information that is required for your research proposal.
  4. Once you submit your proposal, you will receive a confirmation notification. You will need to wait for a few weeks for the FHS respective committees to review and come to a decision.
  • If you request for biological specimens, your proposal need to be approved by the respective committee
  • Likewise, for any request involving genetic information, a decision must come from FHS DNA committee
  1. You will be notified about the decision regarding your proposal submission

IRB Approval​

  1. For all FHS research proposals, regardless of its nature (i.e. requesting for existing data only or collecting new data), you must establish an IRB of your own. The FHS committee will not allow you to ride on the FHS IRB.
  2. The IRB that you established MUST recognize and accept dual IRB oversight for all FHS research projects. There is no exception to this rule. FHS committee will not defer its oversight to your IRB.
  3. If you are requesting for FHS data only (i.e. not collecting new data directly from participants), you may set up a data repository IRB for expedited review. DO NOT request for an exemption (i.e. DO NOT CITE 45CFR46(b))
  4. You must start this process early as the FHS committee may enquire about the status of your IRB approval when they review your research proposal.
  5. By the time you submit the DMDA, you must already receive approval from your IRB.

Data and Materials Distribution Agreement (DMDA)​

To protect the confidentiality and privacy of FHS participants and their families, investigators granted access to Data and Materials must adhere to the requirements of this DMDA. Failure to comply with the DMDA could result in its termination, denial of further access to FHS and other NHLBI resources and may leave violators liable to legal action on the part of FHS participants, their families, Boston University, or the U.S. Government.

notice

The terms of the DMDA are mandated by the NHLBI, therefore, they are non-negotiable, and no wording can be changed 

Data Request Form & Data Transfer Fee​

Data Request Form​

The description of the FHS data can be found: https://wwwapp.bumc.bu.edu/fhsresapp/Public/DataSetList If in doubt, contact your FHS research partner for assistance.

Data Transfer Fee​

Providing data, materials or other research and administration services to ancillary studies involves a number of costs which can vary widely and may individually be quite modest, but none of these costs are covered by the FHS contract.

info

In order for data to be transferred outside of FHS, reimbursement costs must be paid for. For more information, go to https://www.framinghamheartstudy.org/fhs-for-researchers/fhs-service-center/