Research Proposal Review Procedures
Research Proposal Review Procedures
The Framingham Heart Study welcomes proposals from investigators (internal and external) seeking FHS data that is not already available through dbGaP or BioLINCC (see above) or seeking biological specimens.
Research Proposals will be reviewed by FHS Review Committees according to the following procedures:
Application Deadlines by Review Committee:
| For Review by: |
Application Deadlines (i.e. should be received by): |
| Executive Committee (EC) |
Six to eight weeks BEFORE your grant sponsor’s deadline |
| Biospecimen (DNA & Lab) Committee (LC) |
March 15, April 15, July 15, August 15, November 15, December 15, |
| Research Committee (RC) |
Any time (rolling review) |
Applications received past the requested receipt date may be subject to later review.
Review Committees Schedules:
- Executive Committee meets twice monthly, usually the 2nd and 4th Tuesday of the month
- Biospecimen Committee meets 6 times a year, usually 2 weeks after a submission deadline
- External Peer Review Committee meets on an adhoc basis
- Research Review Committee reviews are conducted on a rolling basis
Routing of applications:
| Proposals Involving: |
Will be reviewed by: |
| Application to a Sponsor for new funding |
Executive Committee |
| New Participant Contact |
Executive Committee |
| Third Party Involvement |
Executive Committee |
| Genetic Research Requesting |
| New DNA Specimens with data |
Biospecimen Committee |
Use of Extant DNA Specimens* with data
*DNA already in possession by the PI |
Biospecimen Committee |
| Genetic data (not from dbGaP) |
Research Committee |
| Biological specimens with data (other than DNA) |
Biospecimen Committee and Executive Committee |
| Research (not gene-based) Requesting |
| Previously collected clinical data |
Research Committee |
| Pedigree structure |
Research Committee |
| Biological specimens with data |
Biospecimen Committee and Executive Committee |
| Exam chart review |
Research Committee |
| Scan image data |
Research Committee |
Routing of applications requesting biospecimens for RNA extraction:
| Flow of FHS Reviews of RNA Applications |
Initial Routing of Applications is completed by the Ancillary Study Coordinator,
with EC Chairs’ consultation as needed |
| Source of RNA |
PLASMA |
PAX GENE TUBE |
| Consideration of Scientific Merit |
Review by Biospecimen Committee |
Review by Biospecimen Committee |
| Consideration of Specimen Conservation |
Review by Biospecimen Committee |
Review by Biospecimen Committee |
| Biospecimen Review Committee Decisions will be routinely reported to the Executive Committee, and reviewed under Committee Reports. Full EC reviews may be needed. |
Executive Committee Expedited Review (aka ‘Fast Track’):
Certain applications submitted through the Research Application will qualify for expedited review if they meet all of the following criteria:
- require no lab or other biospecimen;
- require no new participant burden;
- no involvement of a third-party;
- will use only preexisting de-identified data;
- falls within the existing informed consent;
- no distribution of PHI needed (either de-identified or to be analyzed at FHS); and
- seeking federal support (intramural or extramural) with no for-profit involvement.
Such applications may be reviewed by the FHS Executive Committee in an expedited fashion (e.g. by email), in lieu of review at the regularly scheduled bi-monthly FHS Executive Committee meetings.