These guidelines were developed by the Cleveland Clinic BioRepository Governance Committee and will be reviewed on a periodic basis and amended as required.

Principles:

  • The Cleveland Clinic BioRepository is a resource to be used to fuel translational research and innovation that leads to improved clinical outcomes and the betterment of patients’ lives.
  • Prioritization of projects will be the responsibility of the Cleveland Clinic BioRepository Steering Committee, in consultation with the Governance Committee when needed.
  • All research projects must be reviewed by the Cleveland Clinic Institutional Review Board and the Cleveland Clinic BioRepository Steering Committee.
  • Proposed research projects can be reviewed and approved as part of the grant funding process. The Cleveland Clinic BioRepository Steering Committee will provide a letter of support for approved projects.
  • A Cleveland Clinic collaborator must be included in proposals submitted by external investigators.
  • If competing requests have been received for the same BioRepository samples between investigators internal to Cleveland Clinic and external to Cleveland Clinic, then preference will be given to investigators internal to Cleveland Clinic.
  • In general, patient identifiers will not be provided to investigators. Under certain circumstances, however, patient identifiers will be provided with the approval of the Cleveland Clinic BioRepository Steering and Governance Committees.
  • Results will not be shared with patients or become a part of the medical record unless there is a clear clinical indication to do so. The Cleveland Clinic BioRepository Steering and Governance Committees will help determine if results should be considered medically significant information and will provide results to donors.
  • BioRepository samples/data are provided for specific uses, and any change in the scope of the project must be approved by the Cleveland Clinic BioRepository Steering Committee. Resources are not provided for future unspecified use.
  • A report describing the tests performed and the results obtained from experiments using BioRepository samples must be provided when the analysis is complete.
  • Publications using Cleveland Clinic BioRepository samples must include the acknowledgement, “The author(s) would like to thank the Cleveland Clinic BioRepository for their kind support and permission to use data and samples.” OR “This research has been conducted using the Cleveland Clinic BioRepository Resource.” When possible this should be linked to reference search tools such as PUBMED.
  • Researchers will have to pay for resources on a cost-recovery basis with a fixed charge for application review and a variable charge depending on the number of samples and/or data requested.
  • Access to samples that are limited and/or will be depleted will be carefully reviewed by the Cleveland Clinic BioRepository Steering Committee and will be prioritized against the quality and value of the proposed research project, consulting appropriate experts as required.
  • Re-contact of participants will be monitored and must be approved by the Cleveland Clinic BioRepository Governance and Steering Committees to ensure that participants are not over-burdened. Only Cleveland Clinic personnel can re-contact BioRepository participants.

Prioritization of Projects:

  • Quality
    • Scientific Excellence
    • Robust Methodology
    • Ethically Sound
      • Note: Requires requestors to specify research aims/protocol
  • Quantity
    • Number of subjects
    • Amount and type of sample requested
  • Value
    • Potential impact on public health
    • Potential to improve patient care
    • Alignment with institutional goals
  • Funding Status
    • Obtained or pending?
    • Public, private, both?