Program in Clinical Research, Clinical Support Services and Clinical Training

National Institute Of Environmental Health Sciences

Investigators

Linked publications, trials & patents

Abstract

The NIEHS Clinical Research Branch has continued to expand its scope of support for clinical and translational studies. The NIEHS Clinical Research Unit (CRU) has recorded over 11,000 patient encounters with over 95% patient satisfaction. Additional staff have been hired to support CRU functions. The NIEHS' CRU is tightly integrated into the Bethesda CC via the CRIS electronic health record system and the Clinical Trials Database, and collaborated with the NIEHS Environmental Autoimmunity Group in Bethesda. The CRU relies on the centralized IRB and extensively utilizes the Clinical Center laboratory for analysis of research patient samples. Studies are currently underway at the CRU, involving the fields of asthma, cancer, cardiovascular disease, immunology, inflammation, metabolic disease, neuroendocrinology, and pharmacokinetics. Prior research efforts were targeted to address the impact of COVID-19 pandemic and interactions with environmental exposures. Many studies take advantage of the Personalized Environment and Genes Study (PEGS), formerly known as the Environmental Polymorphisms Registry (EPR), a NIEHS-operated cohort encompassing almost 20,000 North Carolina residents, who have donated DNA and other biological specimens (urine, hair, house dust, etc) and have agreed to be called back for phenotypic studies. PEGS-related follow-up studies address issues of inflammation, DNA injury repair, endocrine receptor polymorphisms, endothelial function and lung disease. Furthermore, collaboration avenues with local universities as well as other governmental agencies are currently underway. The NIEHS Clinical Research Branch has established a comprehensive Human Research Protection Program thru the development of the Office of Human Research Compliance (OHRC). This office is responsible for managing and coordinating the pre-IRB clinical and scientific review of NIEHS clinical studies, supporting the day to day administrative operations of the IRB, Developing and maintaining electronic management systems and websites that support activities of the OHRC, Performing quality assurance/quality improvement audits of clinical sites, strengthening and enhancing the human research protection education and training program, working with scientific / clinical PIs and their staff to develop human research protocols, developing and implementing standard operational procedures, to ensure that NIEHS complies with DHHS, FDA, NIH guidelines and regulations.