Resources for Industry Partners and Affiliates
Stanley Manne Children’s Research Institute is focused on improving child health, transforming pediatric medicine, and ensuring healthier futures through the relentless pursuit of knowledge. Research at Ann & Robert H. Lurie Children’s Hospital of Chicago is conducted through Manne Research Institute. In partnership with Northwestern University Feinberg School of Medicine, our scientists work in labs, clinics, at the patient bedside, and in the community to unravel the root causes of pediatric and adolescent disease, to understand childhood injury, and to find factors that precipitate health problems in childhood and over a lifetime.
The Office of Clinical and Community Trials (OCCT) acts as a liaison assisting sponsors and affiliates. Contact the OCCT at OCCT@luriechildrens.org to:
- Identify Principal Investigators (PI) with particular research expertise and interests.
- Obtain information about clinical research resources, research capabilities, and sponsored research administration.
- Streamline communications among sponsor, research administrators, PIs, and research personnel.
Ann & Robert H. Lurie Children’s Hospital of Chicago has fixed fees and patient care cost associated with participation in clinical research studies. These are considered non-negotiable and are subject to annual changes. Charges are only incurred when the specified service is required by the study. All research rates are adjusted each fiscal year, which runs September through August.
All research studies at Lurie Children’s involving human participants require prior approval from the Institutional Review Board (IRB). Lurie Children’s two IRBs, Panel #1 and Panel #2, are composed of a diverse selection of experts in the field of pediatric research.
- The Office of Research Integrity and Compliance has developed Informed Consent Form templates for use by the Lurie Children’s research community to enroll research participants. These templates include required language and format which cannot be changed.
- IRB Policies and Procedures Manual
- IRB meeting dates and the Federalwide Assurance (FWA)/IRB Registration (IORG)/IRB Roster
- Resources on use of a Single IRB
The Clinical Research Unit (CRU) at Ann & Robert H. Lurie Children's Hospital of Chicago is a 6,565-square-foot dedicated space for investigators to engage in clinical research within an optimal environment that offers a flexible infrastructure and highly trained staff, thereby assuring excellence in the conduct of clinical research.
This state-of-the-art facility on the 19th floor includes eight outpatient rooms and six private inpatient beds as well as consultation rooms. Experienced research nurses and medical assistants are on hand to assure the proficient implementation of research protocols in a child and family-friendly setting. The CRU is located adjacent to the Investigational Drug Service Pharmacy.
The CRU provides investigators with the specific clinical services required for their projects. Ongoing quality control programs and frequent communication with the research teams allow for the highest standard of patient care and data collection. Other facilities available to meet the needs of investigators include study coordinator touch down space, work areas for study auditors and monitors, and storage for study equipment and materials.
All clinical research at Ann & Robert H. Lurie Children’s Hospital of Chicago involving recombinant and synthetic nucleic acid molecules; cells, organisms, and viruses containing such molecules; and human gene transfer require prior approval from the Institutional Biosafety Committee (IBC).
The IBC is responsible for the review of all clinical research utilizing recombinant and synthetic nucleic acids in accordance with the NIH Guidelines for Research Involving Recombinant or Synthetic Acid Molecules (NIH Guidelines) and the Institutional Biosafety Program at Lurie Children’s.
The Investigational Drug Service (IDS) Pharmacy provides investigational drug management services with the primary goal of promoting patient safety for those participating in human clinical drug trials. The IDS Pharmacy assumes direct oversight responsibility for the storage, handling, preparation, dispensing, disposal, and coordination of all investigational drugs intended for human use. The IDS pharmacists are graduates of accredited Colleges of Pharmacy and are licensed to practice in the State of Illinois by the Board of Pharmacy. Certified pharmacy technicians work under the direct supervision of a pharmacist.
Ann & Robert H. Lurie Children’s Hospital of Chicago and Stanley Manne Children's Research Institute laboratory research services are managed and operate within the Department of Pathology and Laboratory Medicine. Processing, storage, and shipment of research samples are conducted within the CLIA-certified [by the College of American Pathologists (CAP)] clinical lab spaces by dedicated research personnel and other qualified and trained technicians and scientists. All laboratory personnel responsible for shipping samples are IATA-certified to package and ship biohazardous goods. Lurie Children’s CAP-accredited biorepository is also managed and operated within the department. Research and biorepository services are coordinated and supported by two clinical research professionals, a research technologist, and two pathology assistants.
Ann & Robert H. Lurie Children’s Hospital of Chicago Medical Imaging (Radiology) Department located in the main hospital supports safe pediatric imaging in a pediatric-friendly environment. The Medical Imaging Department and Medical Imaging Research Committee has made a broad set of resources available for clinical trial protocol review, study design consultation, imaging acquisition, and post-processing. Research is supported in the areas of magnetic resonance imaging (MRI), X-ray, X-ray computed tomography (CT), diagnostic ultrasound, positron emission tomography (PET/CT), dual-energy X-ray absorptiometry/bone desitometry (DEXA), interventional radiology, and nuclear medicine.