Collection of Biological and Environmental Samples and Clinical Data From Anonymous Adult Men and Women for Quality Control and Methods Development and Evaluation (ASCA)

Objective:

We propose a common protocol for use in non-invasive (i.e., minimal risk, not involving general anesthesia or sedation) collection of biological and environmental samples and clinical data from anonymous adult volunteers for methods testing and protocol development, quality control, methods development and evaluation. Individual collections conducted under this protocol will submit actual advertisements, forms and names of persons obtaining consent for IRB expedited review.

Study Population:

This protocol covers recruitment of healthy non-pregnant adults (men and women age 18+) and/or pregnant adult women (age 18+).

Design:

All clinical data and sample collection will be performed by clinical and research professionals as appropriate. Biological samples that may be collected include blood or plasma, breast milk, cerumen, exhaled breath, hair, mucosal and skin cells, nail clippings, saliva, semen, stool and urine. In some cases, lymphocytes will be isolated from blood and immortalized. Clinical data may be collected through non-invasive procedures routinely employed in research and clinical practice, and using medical devices approved for marketing (excluding procedures involving x-rays or microwaves). Clinical data collection may include anthropomorphic measurement, body composition assessment, detection of naturally occurring radioactivity, Doppler blood flow, exhaled breath, flexibility testing, moderate exercise, muscular strength testing, physical sensors, and sensory acuity testing where appropriate given the age, weight and health of the individual. Environmental samples may include dust, water, soil, air, vegetation, and other environmental samples that may be collected without damage to property. Compensation for clinical data and sample donation will depend on the time and effort involved in donation. Samples and clinical data may be collected during a one-time collection, or participants may be asked to provide samples and clinical data on several occasions over a specified period.

Outcome Measures:

The samples and clinical and response data will be used to determine if proposed research designs are feasible and if methods are sufficiently valid and precise to be used in epidemiologic studies. They will also be used for quality control purposes in study sample analysis projects. In epidemiologic studies involving the collection, storage and analysis of laboratory samples, it is essential to evaluate the performance of available assays and to assess the impact of storage and handling on the quality of samples

and laboratory analyses. It is also necessary to determine levels of specific biomarkers in the population to aid in study design as well as willingness of specific population groups to provide necessary samples and data. It is essential 1) to demonstrate that a method is sufficiently reproducible and stable over time such that differences in measurements among individuals in the population can be detected; 2) to evaluate measurement reliability by sending blinded control samples along with study samples to testing laboratories

for quality control purposes; 3) to test proposed laboratories or methods by using replicate samples in order to choose the laboratory or method with the greater precision; and 4) to assess how collection, handling, and storage procedures affect measured levels of specific analytes to allow informed decisions about whether to proceed with a specific analysis; 5) to determine levels and distributions of proposed biomarkers to assess study feasibility and determine appropriate study sample size; and 6) evaluate approaches to recruiting

participants for proposed studies with specific sample collection requirements. Under this protocol, methods may include analyses of genes and gene products, peptides, proteins, lipids, immunologic parameters, hormones, viability of cells, evaporation and dilution effects, chemical toxicants and their metabolites, metals, micronutrients and other analytes.