IRB review applications under Full Review will be reviewed with multiple reviewers depending on the complexity of the case. In complex cases, the entire board will deliberate on the application. For research projects approved under Full Review, an end of research final report is to be submitted to the IRB by the investigators. Studies that obtain data from vulnerable populations, use deception, or those that pose more than minimal risk to human subjects are usually subjected to Full Review. Applicants are reminded to ensure all documents and details of the protocol are submitted. Due to assessment by multiple reviewers, clarifications of your application’s protocol may be needed leading to decisions being deferred to the next review period. A minimal 15 working days is required for the decision by the IRB. However, when the decision is made, the IRB will seek to inform the applicant at the earliest possible date.
Your application for Full Review should contain:
*All attachments and supplementary materials containing identifying information of investigators should be submitted as .doc. Files. The IRB will attempt to remove or mask identifying information about the investigators to enable a double-blind process in the ethics review.
Providing information at this level of detail is necessary so that the Committee can make an informed decision about potential risks to participants. Insufficient information provided may result in clarifications needed or a deferred decision.