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Principal Investigator: Janet Hall
Organization: NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES
Fiscal Year: 2023
Award: $5,332,395
Funding agency: National Institute of Environmental Health Sciences
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 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. Studies are currently underway at the CRU, involving the fields of asthma, cancer, cardiovascular disease, immunology, inflammation, metabolic disease, neuroendocrinology, and pharmacokinetics. In addition, new research efforts have been developed to address the impact of COVID-19 pandemic and interactions with environmental exposures. Many studies take advantage of the Environmental Polymorphisms Registry (EPR), a NIEHS-operated cohort encompassing over 15,000 North Carolina residents, who have donated DNA and have agreed to be called back for phenotypic studies. EPR-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.
This project involves research on human coronavirus, novel coronavirus, COVID-19, Severe Acute Respiratory Syndrome coronavirus disease, SARS coronavirus, SARS-coronavirus-2, SARS-cov-2, SARS-cov2, SARS-related coronavirus 2, Severe acute respiratory syndrome coronavirus 2, SARS-Associated Coronavirus, SARS-cov, or SARS-Related Coronavirus.
Terms: <2019 novel corona virus><2019 novel coronavirus><2019-nCoV><Address><Agreement><Area><Asthma><Autoimmune Status><Autoimmunity><Bronchial Asthma><COVID-19><COVID-19 pandemic affected><COVID-19 pandemic consequence><COVID-19 pandemic effects><COVID-19 pandemic impact><COVID-19 pandemic impacted><COVID-19 virus><COVID19><COVID19 virus><CV-19><CV19><Callback><Cancers><Cardiovascular Diseases><Centrifugation><Centrifugation Fractionation><Client satisfaction><Clinical><Clinical Protocols><Clinical Research><Clinical Study><Clinical Trials Database><CoV emergence><CoV-2><CoV2><Collaborations><Core Facility><DNA><DNA Damage><DNA Injury><Deoxyribonucleic Acid><Development><Drug Kinetics><EHR system><Education><Education and Training><Educational aspects><Educational workshop><Electronics><Endocrine><Endothelium><Enrollment><Environmental Exposure><Ethics><Follow-Up Studies><Followup Studies><Generations><Genetic Polymorphism><Goals><Guidelines><HCoV><Human><Human Rights><Human Subject Research><IRB><IRBs><Immunology><Individual><Inflammation><Institution><Institutional Review Boards><Investigation><Investigators><Lung diseases><Malignant Neoplasms><Malignant Tumor><Metabolic Diseases><Metabolic Disorder><Mission><Modern Man><Monitor><NIEHS><NIH><National Institute of Environmental Health Sciences><National Institutes of Health><Neuroendocrinology><North Carolina><Nursing Research><Participant><Patient Recruitments><Patient Satisfaction><Patients><Pharmacokinetics><Phenotype><Predisposition gene><Procedures><Protocol><Protocols documentation><Pulmonary Diseases><Pulmonary Disorder><R-Series Research Projects><R01 Mechanism><R01 Program><Receptor Protein><Registries><Regulation><Research><Research Design><Research Grants><Research Personnel><Research Project Grants><Research Projects><Research Specimen><Researchers><SARS><SARS Virus><SARS corona virus><SARS corona virus 2><SARS coronavirus><SARS coronavirus disease><SARS-Associated Coronavirus><SARS-CO-V2><SARS-COVID-2><SARS-CoV><SARS-CoV disease><SARS-CoV-1><SARS-CoV-2><SARS-CoV2><SARS-Related Coronavirus><SARS-associated corona virus 2><SARS-associated coronavirus 2><SARS-coronavirus-2><SARS-related corona virus 2><SARS-related coronavirus 2><SARSCoV2><Sampling><Scientist><Series><Services><Severe Acute Respiratory Coronavirus><Severe Acute Respiratory Coronavirus 2><Severe Acute Respiratory Distress Syndrome CoV 2><Severe Acute Respiratory Distress Syndrome Corona Virus 2><Severe Acute Respiratory Distress Syndrome Coronavirus 2><Severe Acute Respiratory Syndrome><Severe Acute Respiratory Syndrome CoV 2><Severe Acute Respiratory Syndrome CoV disease><Severe Acute Respiratory Syndrome Virus><Severe Acute Respiratory Syndrome corona virus><Severe Acute Respiratory Syndrome coronavirus><Severe Acute Respiratory Syndrome coronavirus disease><Severe Acute Respiratory Syndrome-associated coronavirus 2><Severe Acute Respiratory Syndrome-related coronavirus 2><Severe acute respiratory syndrome associated corona virus 2><Severe acute respiratory syndrome coronavirus 2><Severe acute respiratory syndrome related corona virus 2><Specimen><Structure><Study Type><Susceptibility Gene><System><Testing><Thesaurismosis><Training><Training Programs><Training and Education><Translational Research><Translational Science><United States National Institutes of Health><Universities><Workshop><Wuhan coronavirus><cardiovascular disorder><clinical research site><clinical site><clinical training><cohort><conference><convention><corona virus disease 2019><corona virus emergence><coronavirus disease 2019><coronavirus disease 2019 pandemic consequence><coronavirus disease 2019 pandemic impact><coronavirus disease 2019 virus><coronavirus disease-19><coronavirus disease-19 virus><coronavirus emergence><coronavirus infectious disease-19><developmental><disease of the lung><disorder of the lung><drug detection><drug testing><effects following the COVID-19 pandemic><electronic><electronic device><electronic health record system><emergent CoV><emergent corona virus><emergent coronavirus><emerging CoV><emerging corona virus><emerging coronavirus><enroll><ethical><hCoV19><human CoV><human corona virus><human coronavirus><improved><injury and repair><lung disorder><malignancy><metabolism disorder><nCoV><nCoV2><neoplasm/cancer><new CoV><new corona virus><new coronavirus><novel CoV><novel corona virus><novel coronavirus><operation><operations><participant recruitment><polymorphism><predisposing gene><programs><protocol development><quality assurance><receptor><severe acute respiratory syndrome-CoV><study design><summit><susceptibility allele><susceptibility locus><susceptibility variant><symposia><symposium><tenure process><tenure track><translation research><translational investigation><translational investigator><translational researcher><translational scientist><translational study><web site><website><welfare>