IRB Education

2018 Announcement

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 Protection

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.

Initial Training

Research personnel may choose from one of the following options:

  • NIH​ - Select the following course: Protecting Human Research Participants 
  • ACRP - Select the folowing course: Ethics and Human Subjects research. If you require login credentials, please send an email to GCP@luriechildrens.org
  • CITI Program​ - Select the following course: ​Biomedical Research
    Note: you will need a NU NetID to access this course in the CITI Program. For information on obtaining a NetID email IRB@luriechildrens.org.
  • Provide evidence of other comparable training. Note: this is subject to approval by the Office of Research Integrity and Compliance (ORIC)

Continuing Education

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:

  • Read a selection of 5 articles ​selected by the IRB
  • Complete one of the external courses listed above (NIH, ACRP or CITI Program)
  • Provide evidence of other comparable training. Note: this is subject to approval by the Office of Research Integrity and Compliance (ORIC)

Documentation & Database

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
IRB@luriechildrens.org.

HSR Education Form​

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

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."

Initial Training

Research personnel may choose from one of the following options:

  • NIH - Select the following course: Clinical Research Training
  • ACRP - Select one of the Good Clinical Practice Modules. Note: if you require login credentials, please send an email to GCP@luriechildrens.org.
  • CITI Program - GCP Modules. Note: you will need a NU NetID to access this course in the CITI Program. For information on obtaining a NetID email IRB@luriechildrens.org.
  • Society of Behavioral Medicine GCP Training. Note: Lurie Children's staff may also access this course in WeLearn by searching "NIH".
  • Industry sponsored GCP Training (meeting institutional requirements)
  • Clinical Research Coordinator (CRC) Basic Training offered by NUCATS
  • ​Provide evidence of other applicable certification, training or conference attendance (e.g., SOCRA, ACRP, PRIM&R, etc.)​

Continuing Education​

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.

Documentation & Database

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 be entered into the GCP database.

For more information please refer to the GCP Requirement Guide​ or contact GCP@luriechildrens.org​.