About Us

Children’s Institutional Review Board (IRB) is a committee that helps protect the rights and welfare of human subjects in research. The board operates in compliance with hospital research policies and with the U.S. Code of Federal Regulations (CFR), Department of Health & Human Services (DHHS), and the Food and Drug Administration (FDA). The IRB reports to the Children’s Audit and Compliance Committee of the Board in conjunction with Children’s administration.

The IRB’s primary concerns 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 is obtained and documented or waived, as appropriate.

All research activities involving human subjects must be 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 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.

Read our Statement of Compliance and Registration

FWA and IRB Registration Numbers

  • The Children’s Federalwide Assurance number is FWA00000644
  • The Children's IRB registration number is IRB00001436
  • The Children's IORG number is IORG0001045

Information and resources

We offer a wide range of resources and information to assist researchers, including:

Contact us

Children’s Healthcare of Atlanta
Institutional Review Board Office, Third Floor
1687 Tullie Circle NE
Atlanta, GA 30329
Fax: 404-785-9470
IRB@choa.org

Types of Review

Federal guidelines determine the type of review that IRB must perform, including:

  • Evaluating the risks of the research project
  • Study procedures
  • Whether information is collected anonymously or confidentially
  • Other factors

Depending on the type of review, some protocols can only be reviewed at the IRB’s scheduled meetings. You should submit your research to the IRB in advance to allow adequate time for review and approval before they plan research procedures.

Review timeline

The following IRB review timelines are averages that are provided for applications that don’t require multiple changes during the review process. Changes will extend the processing time. Please review forms for completeness and accuracy before submitting to make the review process go more smoothly.

Nonhuman subjects research (NHSR)

Typically, IRB staff make NHSR determinations, which don’t require review by a member or board review. Timeline: Three to five days.

If you’re unsure if you’re conducting human subjects research or you’re certain you’re not conducting human subjects research but your sponsor or a publication requires certification, please complete the nonhuman subjects determination form and submit to the IRB for an official determination and letter. Err on the side of caution and consult the IRB if you’re uncertain whether the study is human subjects research.

Read more about how to determine if a study involves human subjects

Download the nonhuman subjects research determination form

Exempt research

The federal government has identified certain categories of research involving human subjects that qualify for exemption from federal regulations. At Children’s, only the IRB has authority to make a determination that a study is exempt from federal regulations and from IRB review and approval.

When the IRB notifies a principal investigator that a research project is exempt, it also notifies the PI that the research is approved for initiation or continuation. Exempt studies don’t require annual re-review. Timeline: Five to 10 days.

In order to qualify for exemption, a research study must fall entirely within one or more of the six categories for exemption, and it cannot place subjects at greater than minimal risk. If the research involves prisoners, it doesn’t qualify for exemption from federal regulations and IRB review.

  • What exemption means: Exemption from the requirements set forth in Regulations for the Protection of Human Subjects (Title 45 Part 46 of the Code of Federal Regulations), such as the requirement for a written informed consent document. 
  • What exemption doesn’t mean: The research activity is exempt from laws or that the research doesn’t need to conform to the canons of sound research ethics.
  • What you should do when considering changes to an exempt study that could make it nonexempt: Consult with the IRB whenever questions arise about whether planned changes to an exempt study might make that study nonexempt human subjects research. 

Read the HHS policy for protection of human research subjects

The Office for Human Research Protections (OHRP) provides more information about exempt review categories in its decision charts:

Expedited review

Under an expedited review procedure, the IRB chair—or one or more experienced reviewers designated by the chair from among the members of the IRB—reviews the research protocol. Timeline: One to two weeks.

Expedited review doesn’t require convening a meeting of the IRB. The term "expedited" is misleading—this type of review isn’t faster or less detailed, it just requires fewer reviewers for approval.

IRB reviewers may exercise all of the authorities of the IRB, except that they may not disapprove the research. A research activity may be disapproved only after review by the convened IRB.

In general, research may be considered for expedited review if it:

  • Involves no more than minimal risk
  • Doesn’t include intentional deception
  • Doesn’t use sensitive populations or topics
  • Includes appropriate consent procedures

Expedited review may also be used for amendments or modifications when minor changes have been made to a previously approved research project.

Studies that qualify for expedited review still require a full application form and an informed consent statement. As with all research, researchers must engage in practices that minimize risk, maximize benefit and ensure confidentiality.

The list of research categories that qualify for an expedited review process was updated in 1998, and Children’s or the IRB aren’t able to make changes to—or extrapolate from—this list. For example, an expedited review procedure can’t be used for the initial review of either research that involves minimal risk but doesn’t appear in the Federal Register’s categories of published research or research that involves greater than minimal risk.

Learn more about OHRP expedited review categories

Full board review

Human subjects research that isn’t classified as exempt or expedited requires review by the full IRB at a convened meeting, which takes place once a month. A full board meeting may be canceled or rescheduled for various reasons, such as insufficient number of applications requiring full board review, a Children’s holiday or the inability to secure a quorum.

Before a project can be sent for full board review, the project must pass the IRB staff screening that checks for completeness of forms, CITI certification, required materials, adherence to policies and regulations, and more.

All protocols submitted for full board review are assigned to one or more primary (or secondary) reviewers who will present the protocol to the full IRB for discussion. These reviewers will review the protocol, the proposed informed consent documents and any recruitment materials, including advertisements intended to be seen or heard by potential subjects. Timeline: Six to eight weeks.

Regulatory definitions

Research

A systematic investigation—including research development, testing and evaluation—designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that’s considered research for other purposes. [45 CFR 46.102(d)]

Research can also be defined as any experiment that involves a test article (any drug, biologic, medical device, food additive, color additive or electronic product) and one or more human subject. [21 CFR 50.3(c)]

Human subject

A living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information. [45 CFR 46.102(f)(1),(2)]

A human subject can also be defined as an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. [21 CFR 50.3(g)]

Intervention

Includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.

Interaction

Includes communication or interpersonal contact between the investigator and the subject.

Identifiable private information

Includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (for example, a medical record).

Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. [45 CFR 46.102(f)]

Frequently Asked Questions

How long will it take to get my approval?

The average time from submission to approval for full board studies is 56 days.

The average time from submission to approval for expedited studies is eight days. In order for your study to receive approval as quickly as possible, submit a complete application to the IRB, including all necessary documents, signature and CITI certifications. Your study won’t move forward without the required signatures and training. We recommend you consult with the IRB as you plan your project and complete your application.

How do I know if my study will be expedited or full board?

Federal guidelines determine what type of review is required. Guidelines include evaluating the risks of the research project, what is involved, whether information is collected anonymously or confidentially, and other factors. Some reviews can only be carried out at the IRB’s scheduled meetings. We encourage you to submit studies to the IRB in advance to allow enough time for review and approval.

Who can help me with IRB forms, protocol, consent, reportable events and other requirements?

IRB staff members are available to answer questions and help you complete IRB forms. IRB staff can be reached at IRB@choa.org or by phone at 404-785-7555.

Who needs to sign the initial submission form?

The initial submission form must be signed by the principal investigator and the division or area medical director. If there’s no division or area medical director or the PI holds that role, the PI’s supervisor can sign after he or she conducts a scientific review of this research application to assure that the PI and other study personnel have the knowledge, privileges and resources required to conduct the study.

The signature page must be faxed to 404-785-9470, scanned and sent as a PDF to irb@choa.org, or hand-delivered to the IRB office.

If my study involves researchers from Emory, should my study go to Emory or Children’s?

  • Studies that go to Emory: Collaborative research that’s conducted under the supervision of a PI who is employed by Emory, excluding CHOA research
  • Studies that go to Children’s: Collaborative research in which the research is limited to the review of Children's medical records or the research is conducted under the supervision of a PI who is solely employed by Children's, but involves the participation of other Emory-employed study personnel

How do I get CITI certification? Which courses do I need to take?

All study staff who may have contact with research subjects or identifiable data are required to have current CITI (Collaborative Institutional Training Initiative) certification, a Web-based training program in human research subjects protections. You must take either the biomedical course or the social/behavioral course—whichever is most appropriate for your type of research.

Learn about the CITI Program

What is protected health information (PHI)?

The Privacy Rule protects all “individually identifiable health information” held or transmitted by a covered entity or its business associate, in any form or media, whether electronic, paper or oral. The Privacy Rule calls this information “protected health information (PHI).”

Individually identifiable health information is information, including demographic data, that relates to:

  • The individual’s past, present or future physical or mental health or condition
  • The provision of healthcare to the individual
  • The past, present or future payment for the provision of healthcare to the individual and that identifies the individual or for which there is a reasonable basis to believe it can be used to identify the individual

Individually identifiable health information includes many common identifiers such as name, address, birth date and Social Security number.

What are the HIPAA identifiers?

  1. Names
  2. All geographical subdivisions smaller than a state, including street address, city, county, precinct, zip code and their equivalent geocodes, except for the initial three digits of a zip code, if according to the current publicly available data from the Bureau of the Census: (1) The geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000 people; and (2) The initial three digits of a zip code for all such geographic units containing 20,000 or fewer people is changed to 000.
  3. All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older
  4. Phone numbers
  5. Fax numbers
  6. Electronic mail addresses
  7. Social Security numbers
  8. Medical record numbers
  9. Health plan beneficiary numbers
  10. Account numbers
  11. Certificate/license numbers
  12. Vehicle identifiers and serial numbers, including license plate numbers
  13. Device identifiers and serial numbers
  14. Universal resource locators (URLs)
  15. Internet protocol (IP) address numbers
  16. Biometric identifiers, including finger and voice prints
  17. Full-face photographic images and any comparable images
  18. Any other unique identifying number, characteristic or code (this doesn’t mean the unique code assigned by the investigator to code the data)

Meeting Dates and Deadlines

You can email or fax your application to us:

Children’s IRB
Fax: 404-785-9470
IRB@choa.org

Institutional Review Board 2017 meeting dates