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IRB - HUMAN PARTICIPANTS SUBMISSION REQUIREMENTS & REVIEW OVERVIEW

APPLICATION DEADLINE & SCHEDULE OF IRB MEETINGS

IRB submission deadlines are on a rolling basis. In the best case scenario, researchers should anticipate at least 2-4 weeks for an initial expedited review and 4-6 weeks for a full committee review. Most common reasons for delay pertain to incomplete documentation; poorly worded consent forms; and/or poor study design and overall scientific quality

DECISION TREE & EXAMPLES OF ACTIVITIES

Researchers may use Human Subject Regulations decision tree for assistance in determining if an activity requires IRB review.

EXEMPT REVIEW

These studies are exempted from IRB continuing review - not from initial review. The IRB determines whether the claim for exemption is appropriate and whether it will be granted. IRB Admin is responsible for making a determination of "exemption" from applicable regulations. Researchers must submit the Exemption Determination Form to IRD-IRB Admin and cannot self-determine exemption.

EXPEDITED REVIEW

Some research projects do no need review by the full IRB in order to protect the rights and welfare of the subjects. Research that presents no more than minimal risk can be reviewed under this category. The review can be conducted by the IRB chair, other IRB members designated, or a subcommittee of the IRB. Reviewer(s) are empowered to approve research qualifying for expedited review or to require modifications of a study to gain approval.

FULL COMMITTEE REVIEW

Protocols that involve more than minimal risk or do not meet the criteria for Exempt or Expedited. They are reviewed at a fully convened IRB meeting. At IRD-IRB, if a research protocol requires full IRB review, the submitted protocol undergoes a preliminary review by the administrative staff to ensure complete and adequate documentation. Following which, primary and secondary reviewers are assigned to do a detailed, thorough review of the study. Any queries or questions raised by the primary and secondary reviewer need to be addressed by the PI before it is ready to be reviewed by the full committee. This process makes the IRB review more efficient and useful for the PI.