The Framingham Heart Study
Research Application Overview
The Framingham Heart Study (FHS) is an epidemiologic study funded by the National Heart, Lung, and Blood Institute (NHLBI). Its core activity is to examine and follow the Original cohort, Offspring cohort, Third Generation cohort, and the Omni cohorts of the Study. A research proposal beyond the core aspects of the FHS contract include studies funded by NIH research awards (R01s), grants from academic institutions and private sources, or those performed at no additional cost. Research proposals may involve the collection of new data, either directly from participants or from previously collected samples, images, or other sources (e.g., medical records). They may also involve solely the use of existing data.
Philosophy
The FHS welcomes the interest and proposals of outside investigators. Collaboration is encouraged as it helps to maximize the scientific value of the wealth of epidemiologic data made possible by the participation of more than 15,000 individuals in the Framingham Heart Study. In order to facilitate access and ensure the optimal scientific outcome, the Heart Study requires the following application process.
Necessary Framingham Heart Study Review
Submission
A Research Application is provided which will request the necessary information for submission to each of the relevant review committees. Upon accessing the application, the investigator requests an account and is asked to provide certain preliminary information The Research Application Coordinator will review the request and e-mail an approved user name and password to the investigator. The investigator will then be able to "create an application" and submit it for review. Proposals involving new participant burden, seeking external funding and/or bio-samples require FHS Executive Committee approval. Proposals involving participant burden also require approval from the FHS Observational Studies Monitoring Board (OSMB). Proposals requesting bio-samples also require approval from the FHS Lab Sub-Committee prior to submission to the Executive Committee. Genetic research proposals requesting DNA require approval from the FHS DNA Committee. Studies involving data only (without new funding, participant burden, bio-samples or DNA) need be reviewed only by the FHS Research Committee. The Research Committee reviews but need not approve all ancillary study proposals. (Please see "Research Review Committees" for a complete list of committees).
Review criteria
Research proposals will be evaluated based on the following criteria:
  1. lack of interference with the main FHS objectives;
  2. highest scientific merit;
  3. smallest burden on FHS participants and on FHS resources;
  4. incorporation of the unique characteristics of the FHS cohort
Additionally, studies requesting biological samples will receive highest priority if:
  1. they do not use samples from those participants with the fewest samples available;
  2. they use thawed samples whenever possible;
  3. assays can be done on more than one sample type to allow selection of the most abundant type available (e.g. serum or EDTA plasma);
  4. they use the smallest sample volume possible; requests to minimize volumes will be examined by the FHS Laboratory Committee.
  5. an entire sample set is requested rather than a subset; subsets will be considered for proposals with ample justification
  6. they can be integrated with other studies to conserve sample or limit freeze-thaw cycles.
The Committees will consider the following in determining approval:
  1. acceptability to the participants; e.g. time, discomfort, privacy.
  2. lack of interference with other parts of the Heart Study and no risk of hampering continued participation in the main Study
  3. availability to the investigator of the resources to effectively complete the project:
    1. sufficient budget;
    2. staff with the requisite expertise to meet the objectives of the project;
  4. investigator's agreement to return the complete ancillary data set back to the Framingham Heart Study
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