Student 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 of 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 researchers, such as faculty, staff, and doctoral students, who are uncertain if their proposed study involves HSR).
  • Please note that there are separate HRPP requirements for Fieldwork and Capstone students. If you are a Fieldwork student, please review requirements here. If you are a Capstone student, please review requirements here.
• 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. Identify a Faculty Advisor (FA). Doctoral and masters student investigators who wish to conduct HSR at the SPH must work with a FA (e.g., Masters’ Fieldwork Director, Doctoral Dissertation Chair). Per CUNY policy, either the student or the FA can serve as the project PI; however, if the student is the designated PI, the FA must be listed in the IRB application.
2. Fulfill the human subjects training requirement. SPH faculty, staff, and students engaged in HSR must complete the online Human Subjects Curriculum CITI course.
3. Activate or update your IRB Manager account. 
4. 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.
5. 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)
6. 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).
• Please note that student investigators must add their FA to their IRB application.

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). Researchers 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 student 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 student 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 student investigator via an IRB approval letter.

Once you have your IRB approval (congratulations!), be sure to review the following information so that you remain alert to your ongoing responsibilities as a SPH student investigator. Communicate regularly with your PI/research team throughout the implementation of the study. Contact the SPH HRPP at any time if you have questions or concerns.

• Approval Period. Under the Pre-2018 federal Common Rule (prior to January 21, 2019), expedited and full-board protocols were assigned either a three-year or a one-year approval period (exempt studies do not have an approval period or expiration date). To that end, the IRB approval letter you received from CUNY’S prior IRB management system, IDEATE, before 1/21/19 included an effective date and an expiration date. However, beginning January 21, 2019, IRB non-exempt applications will not be assigned an approval period.
• Study Renewal/Continuation. Pre-2018 federal regulations required that IRBs review continuing research until the time of study closure via submission of a Continuing Review (CR) application in IDEATE (CUNY’s previous submission platform), which corresponded with a study’s assigned expiration date (see above). However, effective January 21, 2019, Continuing Review is no longer be required for:
  • Most studies that qualify for the expedited review process
  • Studies (regardless of review path) that have completed subject intervention/interaction and in which activity is limited to either final analysis of identifiable data/biospecimens or involve accessing follow-up clinical data from procedures that subjects undergo as part of clinical care.
    2018 Common Rule: Continuing Review Transition Plan
    • For existing expedited studies approved on or before January 20, 2019, and for full board studies that no longer involve subject intervention/interaction, the CUNY HRPP/IRB will evaluate the need for continuing review at the time of the next Amendment or scheduled CR submission. Most studies will not require ongoing continuing review. Please note: In order to comply with Common Rule changes, PIs with active IRB protocols should submit an Amendment application at the time of their next CR submission, which will populate Common Rule-related CUNY IRB application revisions, thus allowing the PI to modify their protocol to comply with the new regulations.
    • For new studies approved via expedited review on or after January 21, 2019, the CUNY IRB expedited reviewer will determine the need for continuing review and set the “Continuing Review (CR) / No Continuing Review (No CR)” flag. Most studies will not require continuing review.
• Study Closure. It is the PI’s responsibility to submit a final report in IRB Manager to close their study.
• Amendments/Modifications. IRB amendment applications must be submitted to and approved by the CUNY IRB prior to implementation. This requirement pertains to all proposed modifications/changes to exempt and non-exempt currently approved protocols. Amendments include (but are not limited to): Requests to increase the approved total subject sample size; changes or additions to subject contact materials/consent documents; consent document translations; study personnel changes; changes in funding sources; study design modifications.
• Unanticipated Problems and Adverse Events. The student investigator should discuss any issue promptly with their FA. The student and FA should review CUNY Central Guidance on Unanticipated Problems and Adverse Events and determine if it triggers the need for a prompt report to the CUNY IRB. If so, review the CUNY Central flowchart on reporting unanticipated problems and adverse events and submit a written report (via IRB Manager) in accordance with CUNY Central policy and specified reporting timeframes.
• Protocol Deviations (includes noncompliances). Any deviation from an approved Non-Exempt protocol or Exempt protocol must be reported to the SPH HRPP promptly. Review CUNY Central Guidance the Disposition of Allegations of Non-Compliance. The SPH HRPP and CUNY Central HRPP will determine whether the incident was a serious or a minor noncompliance and assess whether any corrective actions or substantive changes are needed in order to protect the safety, welfare, and rights of subjects or others.