HRPP/IRB Review Policy

• Risks to participants. Studies involving low risk to subjects are typically eligible to receive Exempt review which can be finalized by an HRPP regulatory expert, while minimal risk studies can be reviewed and approved by one or two IRB reviewers. However, greater-than-minimal-risk studies require more reviewers or a full-panel review.
• Complete information. Before starting an application,  please review the IRBManager Application Manual, Human Subject Research Training Videos, and IRBManager Help Library to ensure that you are submitting a complete application for IRB review. Create a new project and submit materials for review in IRBManager.  Incomplete submissions will not be assigned for CUNY UI-IRB review until all materials are complete.  Missing information or documentation will delay the review process.
• Attention to detail.  Creating a clear and detailed submission packet will greatly impact the reviewer’s ability to make a determination in a timely manner.  Information presented in more than one place, in the protocol and in the consent form for example, should be consistent.  Where there are inconsistencies, the reviewer often has to request clarification or further information to ensure that the regulatory requirements are being met.  Reviewers cannot make determinations based on assumptions, so clearly and consistently state your research plan throughout all your submission materials.

An exact HRPP/IRB approval timeline cannot be provided as it will vary from one submission to another. We recommend minimal risk studies be submitted at least three months prior to the planned start date of the research. Many protocols are not approved on the first review because there are typically reviewer questions or concerns about the content. Approval is dependent on meeting the regulatory criteria and the timely cooperation of the investigator(s) in responding to the HRPP/IRB’s requests for modifications. Approval turnaround times may also be affected by outside factors such as Export Control, Conflict of Interest,  Contracts/Agreements, CUNY permissions, or Federal/International regulations.

Approval times for studies that require full-board review by the CUNY UI-IRB may be affected by the timing of full board meetings. Full board meetings are scheduled twice a month. If your protocol materials are not received prior to the published board submission deadline, the review will be scheduled for the next scheduled meeting.

If your study may require full Board review, please take note of the CUNY UI-IRB meeting schedule and be advised that a complete submission would need to be received at least three weeks prior to the scheduled meeting date in order to be placed on the meeting agenda.  We recommend that studies that may require full IRB review be submitted at least six months prior to the planned start date of the research.

Most minimal risk research is not required to undergo continuing review. All protocols regardless of review type (exempt, expedited, or full) are required to undergo an annual check-in which will occur 364 days after last approval. Protocols approved without expiration dates (e.g., protocols determined exempt, exempt with limited IRB review, or expedited) must be revalidated annually by using the Annual Check-In Feature. PIs automatically receive an annual email after the protocol’s initial approval and/or the study’s approval anniversary date. The email contains a link for PIs to complete a short Annual Check-In Form. The Annual Check-In Form asks Researchers questions regarding the study’s current status and maintaining research compliance with IRB requirements. The form also gives Researchers the opportunity to verify their Research Team’s CITI certifications, upload annual reporting documentation, report compliance events, and close out the study if all human subject research activities have been completed. Failure to complete the Annual Check-In Process will result in administrative closure.

Once studies are completed (i.e. subjects are no longer being enrolled/private identifiable information is no longer being obtained) a final report must be submitted to the Research Compliance and Outreach Office. PIs and if applicable Faculty Advisors are responsible for ensuring that final reports are submitted in a timely manner.