Introduction to the Clinical Research Unit
The Clinical Research Unit (CRU) at the National Institute of Environmental Health Sciences (NIEHS) operates as an essential cornerstone of translational research, quietly transforming scientific discoveries into meaningful health insights. This 14,000-square-foot outpatient facility provides comprehensive infrastructure including examination rooms, pulmonary function testing, advanced imaging capabilities, metabolic assessment tools, and sophisticated biobanking systems for sample preservation and analysis.
For NIEHS investigators, the CRU represents far more than just physical space—it provides the critical infrastructure needed to study human volunteers directly, ensuring that groundbreaking environmental health discoveries remain firmly grounded in robust clinical data and real-world applications.
“The CRU is where we bring science into contact with people,” explained Lawrence Kirschner, M.D., Ph.D., who assumed the role of medical director in 2024. “Our mission is to understand how the environment and our genes interact to affect health, and you can’t do that without studying real participants.”
Translational Research Hub at NIEHS
Comprehensive Research Capabilities
The CRU supports an impressive range of projects, spanning from pediatric protocols exploring early puberty and childhood obesity to adult studies examining immune responses, respiratory health, and diabetes risk factors. This versatility makes the facility uniquely positioned to address environmental health questions across the entire human lifespan.
Advanced Biobanking Infrastructure
Central to the CRU’s operational excellence is its extensive biobanking capability. The facility processes and meticulously stores biological samples from thousands of research participants, including blood, serum, white blood cells, urine, hair, fingernails, toenails, and nasal cells. For specialized investigations, researchers can collect cells or fluid from within the lungs through bronchoscopy procedures, perform skin biopsies for cell culture work, and even isolate menstrual fluid for endometrial cell studies.
Bridging Laboratory and Clinical Research
Collaborations with scientists conducting fundamental research drive much of this translational work. “A lab might find a gene variant in mice and wonder if it affects health in people,” said Kirschner. “Through the CRU, we can bring in volunteers, collect comprehensive data, and see if the same biological mechanisms apply in humans. That’s translational science in action.”
Leadership and Vision Under Dr. Kirschner
Distinguished Medical Background
When Dr. Kirschner joined NIEHS, he brought decades of experience as both an endocrinologist and clinical researcher. His impressive career includes work on numerous clinical trials that led to drug approvals for rare endocrine diseases and conditions, such as Cushing syndrome and acromegaly. Additionally, he has successfully operated a basic research laboratory studying the function of genes that cause inherited endocrine tumor syndromes.
Personal Research Focus
Dr. Kirschner investigates rare inherited tumor syndromes affecting the endocrine system, particularly pheochromocytoma and paraganglioma (PPGL). Approximately 40% of patients with PPGL carry a genetic mutation, yet only some develop the disease—a finding that underscores the critical importance of environmental factors.
“That tells us environment matters,” Kirschner emphasized. “It could be smoking, high-altitude exposure, or exercise patterns. Patients want to know what they can do to reduce their risk. Answering that requires the kind of gene-environment research NIEHS is uniquely designed to do.”
The Personalized Environment and Genes Study
Flagship Research Initiative
Dr. Kirschner serves as co-principal investigator of the CRU’s flagship effort, the Personalized Environment and Genes Study (PEGS). This ambitious long-term project has already enrolled more than 20,000 participants, building one of the institute’s most valuable resources for longitudinal environmental health research.
Innovative Research Methodology
PEGS integrates a comprehensive biobank of samples and survey data with geographic information systems (GIS) mapping, enabling researchers to analyze participants’ environmental exposures by ZIP code using high-density informatics. This sophisticated approach allows scientists to correlate specific environmental factors with health outcomes at an unprecedented level of detail.
Significant Research Findings
This innovative approach has already yielded important discoveries. Studies from the CRU demonstrate that living near concentrated agricultural feeding operations can negatively affect community health outcomes. Ongoing research examining environmental risk factors for diabetes could provide crucial insights for preventing what Kirschner describes as “an epidemic threatening public health.”
Diverse Research Portfolio and Active Studies
Current Active Research Projects
Beyond PEGS, the CRU currently conducts approximately eight to nine active primary studies, with additional sub-studies bringing the total to more than a dozen ongoing research projects. This diverse portfolio reflects the broad scope of environmental health concerns affecting communities today.
Pediatric Research Initiatives
For example, Natalie Shaw, M.D., who leads the Pediatric Endocrinology Group at NIEHS, is conducting groundbreaking research on early puberty in children and its potential environmental triggers. This work addresses growing concerns about earlier onset of puberty and its long-term health implications.
Pulmonary and Immune Research
Other investigators are exploring the complex intersection of environmental factors, immune system function, and lung health. The CRU also recently launched its first Investigational New Drug (IND) trial, examining a novel treatment approach for idiopathic pulmonary fibrosis, a devastating lung condition with limited treatment options.
Overcoming Challenges in Clinical Research
Building Public Trust
Dr. Kirschner openly acknowledges the challenges of leading clinical research in today’s environment. Recruiting participants, ensuring trust, and navigating increasingly complex data landscapes all require careful stewardship and transparent communication.
“One of the biggest issues is public trust,” he explained. “People sometimes assume researchers have hidden agendas or ulterior motives. But we’re here to ask important questions that can genuinely improve health outcomes. Rebuilding and maintaining that trust is absolutely critical to our mission.”
Leveraging Technological Advances
Despite these challenges, Dr. Kirschner sees unparalleled opportunities ahead. Revolutionary advances in genomic sequencing, data science, and wearable monitoring technologies allow NIEHS to explore environmental influences on health at a scale never before possible in human history.
“It’s an incredible time to be a scientist,” he noted with enthusiasm.
Future Directions and Opportunities
Under Dr. Kirschner’s leadership, the CRU continues to expand its role as the translational engine of NIEHS. With state-of-the-art facilities, a dedicated and skilled staff, and a growing portfolio of innovative studies, the unit continues to connect discoveries at the laboratory bench to real-world human health improvements.
The facility’s commitment to rigorous science, ethical research practices, and community engagement positions it to tackle the most pressing environmental health questions of our time. From understanding how air pollution affects respiratory development in children to identifying protective factors against environmentally-influenced cancers, the CRU stands at the forefront of translational environmental health research.
“What gets me up in the morning,” Dr. Kirschner reflected, “is the chance to think about things we don’t yet understand—questions that genuinely matter to patients and communities—and to figure out how to get those answers.”
