Other Research Proposal Requests
Request for Participant Contact
The Executive Committee reviews requests for participant contact.
Executive Committee Considerations
- What is the expected burden to participants? Time and discomfort expectations.
- When will data be collected?
- Is follow-up needed? Specify length of time and events to be followed up on.
- Consent must be obtained from each subject in the ancillary study.
- Does the ancillary study interfere with or hamper participation in the main study?
- A copy of the signed ancillary study consent form for every individual participant is to be included in the FHS record. A file tracking all signed ancillary consent forms is to be maintained by the ancillary study and an electronic copy of that file is to be delivered to FHS.
- The FHS strongly urges that proposals include the use of Omni specimens and data in any study whenever the necessary covariates are available. Because of the smaller size of the Omni, the Executive committee will not require that power calculations be provided for the Omni.
Applications for Outside Funding
The Executive Committee reviews applications for outside funding. The ancillary study must provide the funds needed for successful completion of the study. The need for such support must be stressed in research grant applications. For FHS executive committee review: Submit application by the 3rd Monday of the month for review the same month. Submit 6 weeks before grant deadline to insure time for correspondence, clarifications and modifications.
Costs include, but are not limited to:
- Staffing for data collection and analyses
- Subject recruitment if outside of main exams
- FHS expense incurred by performing data manipulations
- On site rental of research exam, lab, and office space if required
- Personnel, equipment and supplies for the project
- Cost of notification of reportable results
Requests for Clinical Data
The Research Committee reviews requests for clinical data, including exam chart review and imaging data. A Framingham liaison and biostatistician need to be named on the application, and of particular importance is whether the proposal will require assistance from Framingham’s Data Management team and the extent of the burden.