The Human Subjects Service Core provides a single point of contact for CRECE?s three research projects to obtain data, testing and biological samples from study subjects, and environmental samples linked to those human subjects. This Core builds on the experience and skills developed over the last decade by the UPR School of Public Health and the UPR Medical Sciences Campus in recruiting cohorts and performing follow up- studies of pregnant women and their infant. The Core will leverage PROTECT, an ongoing NIH-funded pregnancy cohort study in Puerto Rico (P42ES017198). PROTECT has formed and trained a team of nurses, physicians, support staff and graduate students, recruited 818 pregnant women to date, and plans to recruit another 1000, ultimately yielding a cohort of 1,200 mothers + live births needed for the funded study. The recruitment and follow-up efforts conducted by PROTECT end at birth, and there is no existing mechanism or support to follow-up on the mothers and infants postpartum, missing a unique opportunity to understand the impact of maternal exposure on children?s health. Building on this cohort, CRECE will follow a cohort of 600 infants to age four through a combination of observed, self-reported, and biological measures to analyze the effects of early life exposures (both specific stressors and mixture effects) on infant/child health and development. The CRECE Human Subjects Service Core will integrate with existing infrastructure to collect data and samples required for CRECE Projects. This infrastructure serves multiple projects in an efficient and timely fashion with specificity for each project?s needs. The Core will (1) maintain and enhance the infrastructure for recruitment and follow-up of 600 mother-infant pairs through age four from the study area in Puerto Rico, serving the research projects? longitudinal research needs, (2) conduct sequential interviews, abstract medical records, and conduct clinical measures (including measures of anogenital distance), neurobehavioral assessments by Non-Nutritive Suck measurement and the Battelle-Developmental Inventory, respiratory outcome measures, and collect air and water samples, and (3) process, archive, and distribute collected samples and data to project investigators. The Core will provide a single systematic process for collecting and sharing the required data and samples, avoiding duplication of effort and decreasing the number of contact times with study subjects. The Core will utilize a standardized system for of sample tracking and laboratory distribution, thus ensuring that samples are processed properly and that the chains of custody and sample integrity are maintained throughout collection, transport, processing, shipment, storage, and analysis. This translates into a more efficient use of time and available resources and reduced participant burden. The proposed Core will provide efficiency in data collection and sampling, as well as a high level of quality assurance in these processes, which is essential to the success of the Center?s three research projects.
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