Clinical Studies Resources



The following is a list of resources provided for Investigators and research personnel conducting clinical studies at Lurie Children's. For more information about each service, and the requirements for submissions, please click on the links and/or contact information provided. 

Educational Resources for Clinical Researchers

  • For more information about Human Subjects Research (HSR) and Good Clinical Practice (GCP) Education and Training requirements please visit the IRB Education page.

Research Safety Reviews

Research at Lurie Children's that includes one or more of the following procedures require written approval prior to the enrollment of participants. This written approval is required to be uploaded with the Initial Submission application in Cayuse IRB.

Radiation Safety Committee (RSC)

Studies which involve administration of radiopharmaceuticals or radioactive materials when the radioactive drug is experimental or is administered for research purposes only. If the research uses ionizing radiation without direct clinical indication, this also requires RSC approval.

Institutional Biosafety Committee (IBC)

Studies which involve administration of recombinant and/or synthetic nucleic acid molecules for research purposes.

​Research Support Services

Research at Lurie Children's often requires collaborations from multiple services, departments, or committees. Letters of support and/or reviews may be required prior to enrolling participants in research when using these support services. Please follow guidance provided by these support services for requesting their written support and/or review of your research protocols. 

Research Pharmacy

Studies which involve preparation, storage or dispensing of investigational medications or biologics will require written support.

Clinical Research Unit 

Studies requiring the use of CRU space and/or CRU personnel to support study visits will require written support. 

Medical Imaging Research Committee 

Studies which will include imaging such as x-rays, MRI/CT scans, etc. for research purposes, and/or deviation from the Medical Imaging standard of care imaging protocol, and/or research imaging that is not being billed to patient insurance will require written support.

Research Laboratory and Department of Pathology

Studies requiring the Research Laboratory to handle, process and ship samples to external entities, test any specimens, and/or will request and utilize samples from Pathology require written support.

Cardiopulmonary Lab

Studies that involve cardiology or pulmonary testing for research purposes require written support.

Infection Prevention and Control 

Written support is required when studies 1) utilize equipment/instrumentation (provided or purchased) that will be used on more than one patient including items that requires sterilization/disinfection before first time use, and/or 2) that involves the administration of a microorganism or a product that contains one or more microorganisms (i.e., bacteria, fungi, or virus; even if attenuated/non-replicable) to a participant.

Nursing Research Council 

Written support is required when studies focus primarily on the nursing profession, nursing care, or includes nurses (APN's or RN's) as the study population and the Principal Investigator or Sub-Investigator is an Advanced Practice Nurse (APN), Registered Nurse (RN) or Nursing Student 

Pediatric Intensive Care Unit (PICU)

Studies that will directly recruit from the PICU or utilize PICU services or staff for research purposes require written support. 

Ophthalmology

Written support is required when studies require eye exams and ophthalmologic services for research purposes.

Lurie Cancer Center Scientific Review Committee 

Oncology studies that have not been reviewed and approved by an NCI peer-review agency requires review by the Lurie Cancer Center Scientific Review Committee at Northwestern University. In addition, NCI peer-reviewed studies need to be submitted for administrative review only and Oncology study revisions (amendments) must also be re-submitted.

Research Conducted in Areas Outside of the Principal Investigator's Department/Division

  • ​If the study involves accessing another department's database it is necessary to obtain written support from that department. 
  • If study personnel will be actively recruiting (more than the placement of fliers, etc.) or consenting subjects from another department/division and personnel from that department/division are not listed as authorized study personnel in the Cayuse IRB submission, written support is required. 

Translations

For Original Consents (No prior translated consents)

  • Stamped (final, approved versions) of IRB consents 
  • IRB approval letter with expiration date and IRB number

For Amended Consents:

  • Stamped (final, approved versions) of IRB consents with tracked changes
  • Last version of Non-English translation/document
  • IRB approval letter with expiration date and IRB number

Clinical & Translational Research Program Services

The Clinical & Translational Research Program ​provides research support to investigators at Lurie Children's. Serivces include: