Study Background

In the recent years, there have been tremendous advances in the development of biological assays (proteomic, metabolomic, genomic, transcriptomic etc.,) that can be used to gain information about the pathways affecting human health and disease. This has fueled, in parallel, the need for readily accessible, well annotated biosamples, available in sufficient quantities, that can be utilized for such analyses. The use, utility and value of biorepositories has been well documented, since the first prospective research repository was established for the Framingham Heart Study (FHS). Appropriately stored and well-annotated samples can be invaluable to science, because not all research questions can be anticipated at the time of a sample’s collection. Emergent medical-scientific challenges (COVID-19 being an obvious, recent, and very relevant example) require rapid responses and valuable time can be gained by the use of pre-existing samples. This repository will allow us to collect and store commonly utilized human biological samples (whole blood, plasma, urine, and DNA) that can be used for future laboratory procedure development, assay development, and validation, analysis of analyte degradation over time, quality control testing and exploration of scientific hypotheses.

A number of studies are being proposed at NIEHS, which may perform ex vivo assays on human cells or measurements of cytokines, metabolites etc., in human samples. Many of these measurements and methods have been established in animal models or immortalized cell lines and have never been validated in human biospecimens. It is important to collect such samples from the population following procedures that mimic those in the study of interest. This protocol will meet this need by obtaining biological samples from adult participants and body measurements, in association with standardized medical information.

This protocol will help researchers address future, emerging environmental health hypotheses in a safe, controlled, and expedient fashion. Furthermore, scientists can get an accurate assessment of assay variability using replicate samples from the study population. Additionally, this protocol will help researchers determine the precision of an assay at exposure levels found in the study population The samples collected and provided will also help researchers with determining day to day variability of analytes of interest. For example, analytes that vary greatly from one day to the next are not suitable for an epidemiologic study when only a single sample is available. To test this, one needs to collect samples from the same individual on more than one day. These examples make clear the value of a biorepository such as the one this protocol would provide.

The objective of this repository is to build and utilize a prospectively and retrospectively (from protocol 10-E-0063 Sample Registry) collected pool of biological samples with which to develop and test specific laboratory assays, to maintain freezer and specimen handling quality control, to have blinded quality control specimens for testing labs, and to assess exposure variability over time. Up to 2,000 prospectively collected adult participants (age 18+).

Up to 8,500 previously collected future use stored biological samples (whole blood, plasma, urine, DNA), demographic, and medical history from protocol 10-E-0063 female and male participants who provided consent and agreed to having their specimens and data accessible and utilized for future use purposes.