Institutional Review Board

Consultation Process

The Human Subjects Protection Program (HSPP) now offers a consultation program. This program provides researchers face-to-face and telephone consultations with HSPP staff for the purpose of providing education and guidance about the IRB review process for their research projects. Consultations take place prior to submission of IRB applications.

Consultations are required for the following types of studies:

  • Studies of first-time users (PIs) of Children's IRB
  • Coordinating Center studies where Children's will serve as the coordinating center for a multi-center study
  • Studies involving an investigational drug/device/biologic where the Children's investigator holds the Investigational New Drug (IND) or Investigational Device Exemption (IDE)
  • Genome-Wide Association Studies (GWAS) if it is the PI's first such study reviewed by Children's IRB
  • Banking/Repository studies if it is the PI's first such study reviewed by Children's IRB

Consultations are recommended for the following types of studies/questions:

  • Questions about "engagement" of other institutions/sites in research
  • Questions about whether certain groups qualify as "human subjects"
  • Questions about Certificates of Confidentiality
  • Questions about inclusion of Special Populations per federal regulations
  • Studies involving multiple institutions (consultation strongly recommended to avoid unnecessary work or dual IRB review)

Consultations are always available upon request for any type of study

See the Consultation Process Map (PDF).

To request a consultation, please send a completed Consultation Request Form via email to with the subject heading: CONSULTATION REQUEST.

Consultation Request Form (DOC): Complete this form to request a consultation with HSPP staff for your study prior to submission of application materials.