Institutional Review Board

The Children’s Healthcare of Atlanta Institutional Review Board (IRB) is a committee created to help protect the rights and welfare of human subjects participating in research. The IRB operates in compliance with Children’s research policies, as well as with applicable federal and state laws and regulations, the U.S. Code, the Code of Federal Regulations (CFR), and regulations of the Department of Health and Human Services (DHHS) and the U.S. Food and Drug Administration (FDA). The IRB reports to the Children’s Audit and Compliance Committee of the Board in conjunction with the Children’s administration.

The IRB’s primary function is to determine whether:

• The rights and welfare of the subjects participating in research are protected adequately.
• The risks to subjects participating in research are outweighed by the potential benefits of the research.
• The selection of subjects participating in research is equitable.
• Informed consent is obtained and documented or waived, as appropriate.

All research activities involving human subjects are reviewed and approved by the IRB, unless the IRB can prospectively determine the research falls into a category of exemption established by federal regulation. The IRB meets monthly to review research proposals to be conducted at Children’s or otherwise involving Children’s faculty, staff, facilities or property. Children’s researchers must submit a complete application packet to the IRB office. Proposals requiring full board review will be scheduled for the earliest available meeting.

Read our Statement of Compliance and Registration

Federalwide Assurance (FWA), IRB and IORG registration numbers:

• Children’s FWA number: FWA00000644
• Children’s IRB registration number: IRB00001436
• Children’s IORG number: IORG0001045

To learn more about how the Children’s IRB is operating during COVID-19, visit the following websites and review the documents below:

• IRB FAQs
• Essential study visits
• National Institutes of Health (NIH) guidance
• U.S. Food and Drug Administration (FDA) guidance
• IRB-approved letter for participants

The eIRB is an electronic submission system for the Children’s IRB. If you have any questions regarding your submission or are unable to login, contact the IRB at irb@choa.org.

If you need to submit for a nonhuman subjects research determination, enter the project as if you are submitting a new study. Indicate this by putting “NHSR–” in front of the study title. In the protocol section, upload a brief description of the project.

• Access eIRB
• Initial submission and modification tip sheet
• Non-Human Subjects Research (NHSR) tip sheet
• Close-out tip sheet

Review the 2024 meeting dates for the Children’s IRB.

Every research submission requires basic information. Reference the Children’s IRB submission checklist to review our requirements. Below are common templates used for submissions.

• Full protocol template
• Retrospective chart review protocol template
• Children’s addendum for multi-site studies
• Informed consent and HIPAA authorization form
• Assent
• Verbal or online consent/assent
• External study staff

When a reliance agreement is required or requested, submit the study in eIRB and indicate that an outside IRB will provide review. The Children’s IRB will evaluate the study, including any potential conflicts of interest, before ceding review. For specific questions regarding reliance agreements, contact the IRB at irb@choa.org.

The Children’s IRB Office is located at:
Children’s Healthcare of Atlanta
1575 Northeast Expressway NE, Support II, Third Floor
Atlanta, GA 30329
Email: irb@choa.org