The Framingham Heart Study
Lab Specimens Responsibilities
Responsibilities Involved in Obtaining Laboratory Specimens
To receive non-DNA biologic specimens from the Framingham Heart Study (FHS) the investigator must complete a Laboratory Specimen Research Project Application. This is for blood or urine samples for a project that must ultimately be approved by the FHS Executive Committee.
We are increasingly concerned that certain kinds of research might yield results that may suggest a serious medical condition for a study participant. Depending on the kind of test and irrespective of the circumstances or the purpose of the testing (i.e., for research by a research laboratory), we believe it is incumbent upon the FHS to report certain of these findings to a participant's physician and/or the participant. This policy with respect to abnormal laboratory findings is consistent with reporting procedures for other testing (i.e., imaging procedures) currently on-going as part of a FHS examination. This reporting policy is also consistent with the recommendations of the FHS Ethics Advisory Board and is in concert with the policies of the Institutional Review Board of the Boston University Medical Center.
We will advise the investigator if the kind(s) of testing proposed may require that the FHS be notified of an abnormal finding that might require medical attention for a participant.
If approved to receive laboratory specimens, the investigator will need to comply with the following:
  1. Use these FHS specimens without re-labelling, re-aliquoting, or otherwise transfering the contents of these specimens to a non-FHS storage vehicle. The investigator is not to share any specimen obtained from FHS with other investigators.
  2. Once analysis is complete, the investigator must promptly provide all lab results to FHS in a specific format, requiring that:

    • the investigator return results using the same Excel spread sheet that was initially provided to you with participant ID numbers and test date (or by another approved format)
    • the investigator provide all results for all tests and duplicate results if duplicate testing was performed
    • the investigator does not delete results considered to be unusual, i.e., "outliers".
  3. After analyses are completed, any residual specimens must be returned without delay to the FHS laboratory for re-inventory and storage.
  4. The investigator explicitly acknowledge the participation of the FHS in this research with the statement (or a facsimile).

    "From the Framingham Heart Study of the National Heart Lung and Blood Institute of the National Institutes of Health and Boston University School of Medicine. This work was supported by the National Heart, Lung and Blood Institute's Framingham Heart Study (Contract No.N01-HC-25195)".
The investigator need be aware that, if obtaining the samples required constitutes an unusual burden for the FHS Lab (in selecting, sorting, aliquoting samples), the investigator will be charged for this laboratory service. The investigator further need to be aware that he/she may be requested to participate in a quality control program designed by the FHS during the course of analysis.
The data obtained should be returned to Patrice Sutherland, FHS Lab Manager. The FHS Data Management Department will then process the data as follows:
  • confirm that all test dates and ID's are valid;
  • check lab result ranges and statistical distributions; document, archive, and coordinate distribution of data to appropriate statisticians.
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