# Human Subjects and Sampling Core

> **NIH NIH P42** · NORTHEASTERN UNIVERSITY · 2021 · $365,022

## Abstract

PROJECT SUMMARY
Adverse pregnancy outcomes (APOs), such as preterm birth and low birth weight, are a major, costly health
problem[1, 2]. Compared to the United States overall, significantly higher rates of preterm birth exist in Puerto
Rico, where nearly 11.4% of all births in 2017 are preterm. Rates of low birth weight in Puerto Rico are likewise
much higher than the U.S. average. Evidence exists that exposure to Superfund chemicals contributes to
APOs. Established in 2010, the Puerto Rico Testsite for Exploring Contamination Threats Center (PROTECT)
uses a holistic system of research, training and stakeholder engagement to study transport, exposure, health
impact and remediation of contaminants. The focus in this submission is to study the impact of specific
mixtures of environmental contaminants on APOs. The set of mixtures selected for study are environmental
agents with potential for adverse health effect in the prenatal period and are consistently found in PROTECT
participants. The Human Subjects and Sampling Core (HSSC) provides a single point of contact to obtain data
and biological and environmental samples linked to human subjects. For this renewal, the HSSC will maintain
and enhance the infrastructure needed to recruit pregnant women from the northern karst region of Puerto
Rico to participate in the program’s longitudinal research (Aim 1). The HSSC will build on the experience of
partners from the University of Puerto Rico School of Public Health and the University of Georgia, who have
recruited cohorts of pregnant women for diverse studies over the last decade. In the current funding period,
HSSC formed and trained a team of nurses, physicians, support staff and graduate students that recruited and
retained 1457 pregnant women with over 1280 followed until they completed pregnancy (including 1210 live
births.) The intent of the proposed renewal is to recruit an additional 1000 participants, ultimately yielding a
cohort of over 2,000 complete births. In addition to recruiting, the HSSC will systematically collect and share
multiple sources of data. To acquire detailed information on potential predictors of APOs, the HSSC will
conduct sequential interviews with study subjects, abstract medical records, and collect biological and
environmental samples during pregnancy, delivery and postpartum (Aim 2). Because many of the projects
have the same data or sample needs, a single systematic process for collection and sharing data and samples
avoids duplication of effort and decreases the contact time with study subjects. This is a better use of time and
available resources and reduces participant burden. The HSSC will process, archive and distribute samples to
project investigators, and in collaboration with the Data Management and Analysis Core, maintain a repository
of samples with an integrated database (Aim 3).

## Key facts

- **NIH application ID:** 10128457
- **Project number:** 5P42ES017198-11
- **Recipient organization:** NORTHEASTERN UNIVERSITY
- **Principal Investigator:** Jose F Cordero
- **Activity code:** P42 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $365,022
- **Award type:** 5
- **Project period:** 2010-04-12 → —

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10128457

## Citation

> US National Institutes of Health, RePORTER application 10128457, Human Subjects and Sampling Core (5P42ES017198-11). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10128457. Licensed CC0.

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