Lab Subcomittee Framingham Heart Study

The FHS Lab Subcomittee objectives are:

To oversee the collection, processing, distribution, and storage of biologic samples obtained from FHS participants; to oversee all laboratory analyses and quality control measures; to ensure accurate and timely reporting of laboratory results.
To evaluate proposals for research that request biologic specimens for non-DNA related analysis. The Committee will judge applications that have been properly submitted on a FHS Laboratory application form with an acknowledgement from prospective investigators that the policies and conditions specified by the FHS will be followed. Applications will be judged on their scientific merit and the availability of samples.

Committee Functions

The Framingham Heart Study (FHS) Laboratory Subcommittee constitutes two components: (1) an Operations component for policy-making and oversight and (2) a Research Review component that evaluates the scientific merit of all requests for biologic specimens from FHS for non-DNA/RNA analysis.

The Operations component of this committee enacts policies and has as its charge (a) the oversight of the collection, processing, distribution, and storage of biologic samples obtained from FHS participants; (b) the oversight of all laboratory analyses and quality control measures; and (c) the responsibility for ensuring that the data from laboratory analyses is reported in an timely manner.

The Research Review component of the Laboratory Committee has as its charge the evaluation of all proposals for research that request biologic specimens for non-DNA/RNA related analysis from FHS. This group judges applications that have been properly submitted on a Laboratory Specimens Research Project Application and with an acknowledgement from prospective investigators that the policies and conditions specified by the FHS will be followed. Applications are judged on their scientific merit and the availability of biologic material.

Committee Composition and Schedules

The Operations component consists of FHS-Boston University School of Medicine (FHS-BUSM) and FHS-National Heart, Lung, and Blood Institute (NHLBI) members. A representative of the NHLBI Project Office may also attend. The Operations component meets monthly with the chairperson being the director of the FHS laboratory.

The Review component consists of two FHS-BUSM members, one FHS-NHLBI member, three nonFHS, nonBUSM, or nonNHLBI members that have been appointed by the NHLBI, and a non-FHS-BUSM-NHLBI chairperson jointly selected by BUSM and the NHLBI. The Laboratory Review Committee meets quarterly with applications due on the 15th day of December, March, June, or September.

The Laboratory Review Committee meets by conference call. A representative of the NHLBI project office may attend the meeting as a non-voting member.

All policy recommendations by the Laboratory Operations committee and decisions by the Laboratory Review committee are forwarded to the FHS Executive Committee for final review.

Criteria for evaluating scientific merit include:

Appropriateness of measurement for a community-based cohort
Credentials and qualifications of laboratory performing analysis
Demonstrated reproducibility of measurement
Relevance to underlying themes of FHS research, with a priority for NHLBI-related research
If clinically actionable measurement (see item 5 below), appropriate plan outlined; sufficient resources available to refer lab values back to participants and/or their physicians
Availability of the biologic material that is requested
Agreement to return complete data sets in a timely fashion

The Operations Component of the FHS Laboratory Subcommittee will perform the following specific tasks:

Ensure that a current inventory of laboratory specimens is maintained and is regularly updated
Ensure that the large assortment of biologic specimens obtained from FHS participants at previous examinations is preserved in as optimum a condition as possible
Establish policies, guidelines, and an application form for investigators to obtain FHS specimens for laboratory measurements
Establish policies for and conduct regular quality control reviews of all analyses undertaken in the FHS core laboratory as well as by outside laboratories engaged in FHS research
Identify those laboratory measurements that are clinically actionable
- Identify analyte values which might have an adverse clinical consequence if unreported to participants in a timely manner
- Establish the level(s) of a measurement that will define an abnormal range likely to be of clinical significance
- Obtain reports of values at regularly recurring intervals from outside laboratories conducting FHS research if there is the possibility of detecting clinically relevant and reportable laboratory values
Ensure that an approved reporting system is in place prior to the initiation of any new labortory analyses that have the potential of detecting abnormalities of clinical significance (see point #5)

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