Faculty Investigators

Not all projects constitute Human Subjects Research (HSR). For a project to be considered HSR and thus require HRPP/IRB review in IRB Manager, ALL the following criteria must be met:

1. The investigator is conducting research or clinical investigation;
2. The proposed research or clinical investigation involves human subjects; AND
3. CUNY is engaged in the research or clinical investigation involving human subjects.

The HRPP Office can provide guidance if you are uncertain whether your proposed study meets these criteria.

• As a first step, complete the HSR Assessment Form (recommended for faculty and staff who are uncertain if their proposed study involves HSR).
• For further information on HSR, including definitions of terms, see:
  • CUNY Central Guidance on When CUNY HRPP or IRB Review is Required

HRPP Tip: Start the process early! If your project needs HRPP/IRB review, you should submit your IRB application at least six weeks in advance of when you plan to begin the research. We receive a high volume of applications, and most need adjustments before they may be considered review-ready. Please plan accordingly.

1. Fulfill the human subjects training requirement. SPH faculty, staff, and students engaged in HSR must complete the online Human Subjects Curriculum CITI course.
2. Activate or update your IRB Manager account.
3. Familiarize yourself with the types of IRB review and identify which you will seek in your IRB application. There are four types of IRB review: Exempt, Limited, Expedited, and Full-board (i.e., convened). The SPH HRPP Coordinator makes a final determination about which type of review is appropriate.
4. Review IRB Manager application development guidance here. 
   • Top Ten Tips to Avoid Delayed HRPP/IRB Protocol Review
   • Guidance on HRPP/IRB Review of Studies Involving Secondary Data Analysis (Read me if your study involves secondary data analysis)
5. Compile informed consent documents (if applicable). Review the CUNY Central Informed Consent Process and Documentation Policy and related informed consent document templates.

Submitting an IRB protocol in IRB Manager. IRB Manager is CUNY’s online IRB application system.

• Before you begin a new application in IRB Manager, carefully review Part 2 (above).

The HRPP/IRB Review Cycle. Once an IRB application is submitted via IRB Manager, a multi-phase HRPP/IRB review process is conducted:

1. SPH HRPP Coordinator conducts a pre-review.  Once a PI submits their IRB application, it is routed to the SPH Coordinator via IRB Manager. The HRPP Coordinator conducts a pre-review for accuracy and completeness. If modifications are required, the HRPP Coordinator will return the protocol to the PI with comments via IRB Manager. The PI will receive an automated email from IRB Manager that the protocol has been returned. This application revision and HRPP pre-review process continues until the HRPP Coordinator determines the protocol is sufficient. Pre-review of protocols are conducted on a rolling basis, and in the order received. 
2. HRPP Coordinator determines level of IRB review and initiates IRB review process. Following completion of the HRPP Coordinator’s pre-review, the Coordinator will make a determination about the level of IRB review required (i.e., exempt, limited, non-exempt expedited, or full-board).
   • Exempt review applications. The HRPP Coordinator processes all exempt IRB applications following completion of the pre-review process. The Coordinator will make a determination about the protocol and issue an IRB Manager-generated letter, notifying the PI of the outcome (i.e., exempt determination; not HSR as defined by the federal regulations; does not fit exempt criteria/submit non-exempt application). A PI may not initiate exempt research until and unless they have received a determination of exemption from the SPH HRPP Office.
   • Exempt with limited review applications.  The revised federal Common Rule, effective January 21, 2019, requires a new type of review called “limited IRB review” for certain exempt protocols. Limited IRB review allows certain research to be categorized as exempt, even when the identifiable information might be sensitive or potentially harmful if disclosed. Limited IRB protocols are reviewed by an Expedited CUNY IRB member; however, there is limited criteria for approval (i.e., whether appropriate privacy and confidentiality safeguards are in place). The IRB reviewer will conduct a protocol review (allow up to five business days) and make a determination (e.g., modifications required or approval). The HRPP Coordinator will then process the IRB reviewer’s decision and notify the PI of the outcome. If the IRB reviewer approves the protocol, the HRPP Coordinator will issue an IRB Manager-generated letter, notifying the PI that their study was approved. A PI may not initiate limited review research until and unless IRB approval has been obtained by the faculty investigator via a limited IRB approval letter.
   • Non-exempt expedited review applications. Following completion of the pre-review process, the Coordinator will send the protocol to an Expedited CUNY IRB reviewer. The IRB reviewer will conduct a protocol review (allow up to five business days) and make a determination (e.g., modifications required or approval). The HRPP Coordinator will then process the IRB reviewer’s decision and notify the PI of the outcome. If the IRB reviewer approves the protocol, the HRPP Coordinator will issue an IRB Manager-generated letter, notifying the PI that their study was approved. No research activities may be initiated until and unless IRB approval has been obtained by the faculty investigator via an IRB approval letter.
   • Full Board review applications. Following completion of the pre-review process, the Coordinator will submit the protocol for full-board review. Following the convened IRB meeting, the IRB will make a determination about the application (e.g., full approval, conditional approval, deferral to another convened meeting). The HRPP Coordinator will then process the IRB’s decision and notify the PI of the outcome. If the IRB approves the protocol, the HRPP Coordinator will issue an IRB Manager-generated letter, notifying the PI that their study was approved. No research activities may be initiated until and unless IRB approval has been obtained by the faculty investigator via an IRB approval letter.