Requests for Biological Specimens for Non-genetic Research
The FHS Laboratory Review Committee evaluates proposals requesting biological specimens for non-genetic research (requests for biological specimens for genetic studies are reviewed by the DNA Committee). Specimens are available from the Original Cohort, Offspring Cohort, NOS (New Offspring Spouses), Gen 3 Cohort and the two Omni Cohorts.
The Omni cohorts consist of men and women reporting African-American, Hispanic, Asian, Indian, Pacific Islander and Native American origins. Omni Cohort 2 included many individuals related to the participants of Omni Cohort 1 and also individuals unrelated to Omni Cohort 1 members. These samples were collected following the same laboratory protocols used for the concurrent Offspring and Third Generation examinations. Exam components also follow the same protocols, starting with the first exams of each Omni Cohort. The FHS strongly urges that proposals include the use of Omni specimens in any study whenever the necessary covariates are available. Exclusion of the Omni Cohort requires a specific scientific rationale.
Applications will be judged on their scientific merit and the availability of samples. Please direct questions regarding biological specimen availability to Dr. Sander Robins, Laboratory Director, at 508-935-3452. Applications are reviewed by the FHS Executive Committee after approval by the Laboratory Review Committee.Lab Review Committee Considerations
- Credentials and qualifications of laboratory performing analysis
- Suitability of analysis for a community-based cohort
- Demonstrated reproducibility of measurement
- Relevance to themes of FHS research, with a priority for NHLBI-related research
- If clinically actionable measurement, a plan to refer lab values back to FHS
- Availability of the biologic material that is requested
- A signed Data and Materials Distribution Agreement (DMDA) and IRB Approval
- Agreement to perform the approved assay directly from the tubes shipped from FHS
- Agreement to promptly provide all assay results to FHS such that:
- The investigator provide all results for all tests and duplicate results
- The investigator may not delete results considered to be unusual or "outliers"
- The investigator return results in the Excel spreadsheet that was initially provided with participant ID numbers and test date
- Agreement to return any residual specimens without delay
- Agreement to pay for the preparation of samples should it constitute an unusual burden
- Agreement to return resultant assay data to Patrice Sutherland, FHS Lab Manager.
- Agreement to communicate individual "notifiable" results to the Executive Committee. Investigators will be informed if a proposed assay may yield reportable results.
- Investigators further need to be aware that sample recipients are randomly requested to participate in a quality control program designed by the FHS.