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.
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Principles of Distribution for Living Tissue/Cell Resources

Preamble

This policy pertains to the distribution of living tissues/cells collected from Framingham Heart Study participants with the express purpose of research.

Examples of the types of living tissues/cells would include but are not limited to:

Decisions regarding research requests for live cells or tissues will be subject to the following principles:

Review

  1. Transparent scientific review of proposals requesting the distribution of living tissue/cell resources will be conducted by a Panel of Experts with appropriate expertise and predefined review procedures overseen by the Executive Committee and guided by the FGSC.
  2. For non-renewable living tissue/cell resources, priority will be given to proposals with extremely high scientific merit or proposals that will generate a resource that can be shared widely among investigators.
  3. The merit, priority and timing of scientific proposals for non-renewable genomic resources will take into account the timing of the examination when the resource was collected, the scarcity of the overall available resource, and the resources available to distribute the tissues/cells.
  4. Approvals for use of tissues/cells must be consistent with participant informed consent and NHLBI and BU distribution policies as described in the Data and Materials Distribution Agreement; appropriate IRBs and oversight bodies will be consulted when questions arise about specialized uses.
  5. Procedures for storage and use of tissues/cells must provide details of safeguards to protect the privacy and confidentiality of research participants.
  6. Tissues/cells may not be used for therapeutic uses.
  7. Procedures for use of tissues/cells that involve creation of hybrid human/animal cells/tissues and/or injection of FHS cells into animals must be specified in an IRB approved request to use the tissues/cells and must be consistent with the original FHS informed consent.

Distribution

  1. Distribution will be conducted transparently and as early as possible after completion of internal QC protocols, with equal opportunity for access by all investigators with approved proposals.
  2. The FHS/BU Genetics Lab may need to set aside special personnel and procedures for collection, storage and distribution. Specific requirements and costs for access to live tissues will be provided on the FHS website. Specific costs and timelines may vary on a case by case basis.

Return

  1. Investigators must provide a procedure for the storage and eventual return or destruction of unused material. The unused material should be returned or destroyed according to a predetermined protocol within 3 months of the completion of the project.
  2. Investigators must provide a manual of procedures (MOP) for each specific experimental protocol performed on tissues/cells distributed to them by FHS, including secondary uses of cells, storage conditions, controls used and QC metrics.
  3. Data generated, including biosample extraction yields and assay data and research profiling (e.g. of DNA, RNA, or protein) of tissues/cells, must be returned to FHS in data formats specified by the FHS within 6 months of the generation of data. Data will be posted at dbGaP or a similar repository as required by NHLBI and BU.
  4. Redistribution of primary tissues/cells, derived tissues/cells (e.g. iPS or differentiated tissues), and/or any other cell products (e.g. RNA, DNA, metabolites or proteins) by recipients is prohibited.

Oversight and Communication

  1. The Framingham Heart Study Executive Committee will ratify and oversee the implementation of this policy, in consultation with NHLBI, Boston University and relevant Oversight Committees.
  2. We will seek the endorsement of appropriate oversight committees, including the BU IRB, the FHS OSMB, the FHS Ethics Advisory Board, etc.
  3. There should be a process of education and information (e.g. via newsletters) for FHS Participants regarding Distribution for Living Tissue/Cell Resources.

Last Updated: Legacy Policy