HRPP and IRB FAQ

An Institutional Review Board or IRB is a committee established to review and approve applications for research projects involving human subjects. The role of the IRB is to protect the rights and welfare of the human subjects involved in the research.

Under the Department of Health and Human Services (DHHS) regulations, human subject means a living individual about whom an investigator conducting research:

• obtains information or biospecimens through intervention or interaction with living individuals and uses, studies or analyzes the information or biospecimens; or
• obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

All submissions requiring IRB review are submitted in the electronic system, Cayuse IRB. More information on accessing Cayuse can be found here. 

Human subjects research (HSR) education is required for anyone engaged in human subject research at Lurie Children's prior to the start of study activity. Good Clinical Practice (GCP) education is required for all research personnel involved in the conduct, management and oversight of a clinical trial at Lurie Children's. More information about the accepted courses can be found here.

• Convened (Full Board) Review typically applies to non-exempt research involving greater than minimal risk to the participants. Other research may require convened review if the procedures do not fit within the expedited review categories outlined by the Office of Human Research Protections (OHRP) or involve a vulnerable population and sensitive data collection.
• Expedited Review typically applies to non-exempt research involving no greater than minimal risk as defined by OHRP and FDA. The research procedures must fit within the expedited review categories as outlined by OHRP.
• Exempt Review typically applies to research within specific categories defined by OHRP and is considered low risk. 

The time from approval to expiration. At time of review, the IRB may determine an approval period that is appropriate for the level of review required, study design, and subject population. The approval period may be less than annually for a high risk study, or up to 3 years for a minimal risk study. 

Any changes to a project that has received IRB approval or exemption must be reviewed and approved before the changes are implemented. 

A renewal should be submitted no later than 30 days prior to study expiration.

Informed consent is an ongoing process that starts when a study is proposed to a potential participant and continues until their participation is complete. Informed consent assures that research subjects will understand the nature of the research and can knowledgeably, and voluntarily, decide whether or not to participate. For more information on the types of informed consent, please review the IRB policy.

Written adolescent assent is required for children ages 12-17 and verbal assent is required for children under the age of 12. For more information on adolescent assent and when it may be waived, please review the IRB policy. 

To request access to Cayuse IRB, complete the Cayuse Access form and provide it to IRB@luriechildrens.org. Please note that access should only be requested for Lurie Children’s employees or collaborators conducting research at a Lurie Children’s site. 

The study expiration date can be found on the Study Details page. After logging into Cayuse IRB, a study can be opened by navigating to the Studies tab at the top of the page and clicking on any study. In addition, study expiration dates can be seen on the dashboard in the bottom middle tile titled Studies Expiring in 30, 60, or 90 days.

IRB determination letters for each submission are available on the Submission Details page. To locate a specific submission, open a study and click Submissions on the right to view a list of all submissions related to that study. Open a submission to navigate to the Submission Details page. Click the Letters tab to view or download any IRB letters.

Stamped consent forms are returned to a study team via a comment in Section 9. For any submission that provides new consents or updates existing consents, the newly approved forms will be attached in a comment in Section 9 of the corresponding application.

Single IRB is required when a multi-center non-exempt study is federally funded.

A reliance agreement (also called an IRB Authorization Agreement) is a document signed by two or more organizations engaged in human subjects research that permits one or more institutions to cede review to another IRB. The signed agreement permits a single IRB to review human subjects research activities for more than one site.

A study in which both Lurie Children’s and Northwestern University are engaged can be reviewed under the master reliance agreement. Please review this website for step by step instructions.