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IRB Review Categories

There are three categories of IRB review. These categories are based on federal regulations and relate to the degree of risk to research participants.

If you have questions, please contact us.

Full IRB Review

Most studies conducted at Children's require full IRB review. The application is reviewed by a fully convened and duly constituted IRB.

Researchers are invited to attend the IRB meeting to present the project and answer questions. Attendance is optional.

To apply for full review, complete the IRB-ITHS Application.

Include all relevant attachments as described in the checklist at the back of the application and follow the application process instructions.

Children's IRB-ITHS Application is used both by the Institutional Review Board (IRB) and the Scientific Advisory Committee (SAC). SAC review is required when you are using the resources of the Pediatric Clinical Research Center at Children's.

Although both committees use the same application form, the committees have different members and the reviews of applications are conducted independently and at separate meetings.

Expedited Review

Certain types of studies that involve only minimal risk to research participants may qualify for expedited review.

The majority of research studies that qualify for expedited review involve the use of confidential records, data or specimens that exist (are on the shelf) at the time of IRB approval. These studies usually request the IRB to approve a waiver of consent and a waiver of HIPAA authorization.

If your research involves the use of existing and confidential data, records or specimens, use the IRB Expedited Review Application for Existing and Confidential Data, Records or Specimens.

A subcommittee of the IRB conducts the expedited review based on the written materials provided by the researcher. The review is usually completed within a few weeks.

All expedited review approvals done in subcommittee are reported to the full IRB.

Exempt Review

Federal regulations limit the categories of research that qualify for exemption. The IRB is responsible for determining that the research qualifies for exempt review.

Most research studies at Children's that qualify for exempt review involve the use of anonymous existing data or specimens.

Anonymous means the study information can never be linked to identifiers. Data that are coded and linked to name, medical record number, pathology number, Social Security number or other identifiers do not qualify for exempt review status.

A complete list of data that are considered identifiers can be found in the information sheet Federal Privacy Rules: HIPAA and Research (PDF).

For the list of categories that qualify for exempt review, read the Application for Exempt Review Status.

Submit two copies of the exempt review applications to the IRB office, one copy with original signature of the principal investigator.

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