All investigators and personnel engaged in human subject research (including exempt research) and all Institutional Review Board (IRB) members and IRB staff must be appropriately trained in the protection of human subjects. Good Clinical Practice training is required for all research personnel involved in the conduct, management and oversight of a clinical trial at Lurie Children's, additionally it may be required by sponsors or funding agencies. IRB approval will not be issued unless all research personnel are in compliance with the Human Subject Research Protection and Good Clinical Practice education requirements as applicable.
There are multiple options for fufilling these educational requirements.
Human Subject Research (HSR) Protection education is required for anyone engaged in human subject research at Lurie Children's prior to the start of study activity. Consistent with the NIH policy, this requirement applies to all human subjects' research, regardless of the risk level of the study, the institutional affiliation of the personnel, and/or the source of funding.
Continuing education in human subject research protection is required approximately every 3 years. Research personnel may choose from the following options to fufill the renewal of HSR Education:
Once an individual has completed the required education, a certificate or transcript is generated by the site, which is to be kept by the individual and the principal investigator of the study as documentation. A copy of this document along with a completed HSR Education Form must also be sent to
List of research personnel with current HSR Education Certification
For more information, please refer to the IRB Policy & Procedure Manual Section 6: Required Education or contact the Office of Research Integrity and Compliance (ORIC) at IRB@luriechildrens.org.
Good Clinical Practice (GCP) training is required for all research personnel involved in the conduct, management and oversight of a clinical trial at Lurie Children's, additionally it may be required by sponsors or funding agencies.
Consistent with the NIH policy, this requirement applies to studies meeting the NIH definition of a clinical trial, "a research study in which one of more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on biomedical or behavioral outcomes."
Continuing education in Good Clinical Practices is required every 3 years. Research personnel may choose from one of the above options to fufill the renewal of the GCP training requirement.
Once an individual has completed the required training, a certificate or transcript is generated by the site, which is to be kept by the individual and the Principal Investigator as documentation of course completion. A copy of this document must also be uploaded on the GCP Portal page. Upon receipt, research personnel will the be entered into the GCP database.