The Children’s Healthcare of Atlanta Institutional Review Board (IRB) operates in compliance with hospital research policy (ies) and with the U.S. Code of Federal Regulations, Department of Health and Human Services (DHHS) Title 45 Part 46, entitled "Protection of Human Subjects", as well as the Food and Drug Administration (FDA) Title 21 Part 50 and Title 21 Part 56. The IRB reports to the Children’s Audit and Compliance Committee of the Board in conjunction with Children’s Administration. For more information regarding the IRB and its operations please see Institutional Review Board Standard Operating Procedures, Children’s Policy 1.16.
The IRB’s primary concerns in all its deliberations are to determine that:
- The rights and welfare of the subjects are protected adequately.
- The risks to subjects are outweighed by the potential benefits of the research.
- The selection of subjects is equitable.
- Informed consent will be obtained and documented.
The Children’s 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 (IRB Meeting Schedule).
The IRB Chair or Vice Chair or his/her designee will ultimately determine whether the research proposal meets the criteria necessary for full Board or expedited review.
A full Board review involves evaluation of the research proposal during a convened IRB meeting. Research activities presenting greater than minimal risk to subjects must be reviewed by the full Board. An expedited review involves evaluation of the research proposal by one or more IRB members with the appropriate knowledge and expertise. Research activities qualifying for expedited review must present no more than minimal risk to subjects and fall into one of the categories outlined in the Federal Register.
If a protocol is reviewed by the full Board, the IRB response will usually be sent to the study contact person and the Principal Investigator within 10 working days of the date of the IRB meeting. If a protocol is reviewed on an expedited basis, the IRB response will usually be sent to the study contact person and the Principal Investigator within 10 working days of the date of submission to the IRB office.
The Board may determine that certain research proposals are exempt from further IRB review. Only the IRB, not an investigator acting independently, may determine that a proposal is exempt.
If a research proposal involves Children's but is primarily conducted by an Emory faculty or staff member who is primarily using Emory property, facilities, or resources, in most cases Children's IRB will accept the Emory IRB's approval of the study without requiring a complete, separate Children's IRB review. For such studies, the IRB Authorization Agreement (IAA) must be submitted along with a complete copy of the Emory IRB application packet and Emory IRB approval notice, once available. The proposal will be administratively reviewed by the Clinical Research Department Director of Research and Research Integrity Officer. The response will be sent to the study contact person and Principal Investigator within 10 working days of the date of submission.
Note: Proposals that involve research activities primarily involving Children's faculty, staff, facilities, property, or other resources must receive a complete review by the Children's IRB. This includes research in which Children's medical records are the primary source of study data.
Research Participant Survey
If you have been a participant in a research study at Children’s Healthcare of Atlanta and you would like to provide comments and feedback, please complete our online Research Participant Survey. Each question in this survey is optional. You may choose to remain anonymous or provide your contact information at the end of this survey for follow-up purposes only. Your comments are important for improving research at Children’s.
You may also direct your comments to the IRB office through the following methods: