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Process

All research involving human subjects must be reviewed and approved before data collection can occur to assure that subjects are being treated ethically. Researchers cannot begin the study until they have received an approval letter from the IRB.

Types of review

Full-Committee Review
This type of review is carried out for studies that pose greater than minimal risk to subjects. The IRB meets regularly throughout the year. Researchers should refer to the meeting schedule for meeting dates and times. The deadline for submitting applications is at least 12 business days prior to the next scheduled IRB meeting. Principal investigators and co-investigators may be asked to attend the IRB meeting to answer any questions that the IRB has.

Expedited Review
Studies are reviewed by the IRB Chair or a qualified member of the IRB. This type of review is carried out for studies which involve minimal risk to subjects and fit into an expedited review category of research as defined by 45CFR46.

Exempt review
This type of review is used for studies that meet exemption categories as defined by 45CFR46. If the study is not found exempt, it will need to go through expedited or full-committee review.

For each of these review types, researchers will use Create a New Study in ERA. For further submission information, see these instructions.

Approval timelines

Researchers should submit applications via ERA to the Office of Research Integrity and Assurance when they are complete. IRB approval may take between 1 to 6 weeks so researchers are encouraged to plan accordingly. A particular protocol may take longer to process based upon issues such as complexity and completeness.

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