Source: https://sphhrpp.commons.gc.cuny.edu/for-faculty/faculty-investigators/
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Faculty Investigators – HRPP | CUNY SPH
HRPP | CUNY SPH
A resource for human research protection
IDEATE Guidance
Doctoral and Masters Fieldwork
Home » For Faculty » Faculty Investigators
This page introduces SPH faculty investigators to the process of submitting an IRB application for HRPP/IRB review via IDEATE, CUNY’s IRB-submission software. The guidance is organized into four parts:
Part 1: Focuses on when HRPP/IRB review via IDEATE is needed (not all projects constitute Human Subjects Research as defined by the federal regulations).
Part 2: Addresses pre-IRB application submission steps and planning.
Part 3: Covers submitting an IRB application in IDEATE and the HRPP/IRB review cycle.
Part 4: Provides post-approval tips for maintaining an IRB-compliant protocol.
The SPH HRPP Office is available to assist you throughout this process. Please contact us with human subjects research-related questions and concerns.
Part 1: Determine if you need to submit an IRB application in IDEATE
Not all projects constitute Human Subjects Research (HSR). For a project to be considered HSR and thus require HRPP/IRB review in IDEATE, ALL the following criteria must be met:
The investigator is conducting research or clinical investigation;
The proposed research or clinical investigation involves human subjects; AND
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 (required for Doctoral and masters Fieldwork students; recommended for other researchers (e.g., faculty, staff, doctoral students working on dissertations) 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
Flowchart: Is the Proposed Project HSR?
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.
Part 2: Pre-IRB application submission steps and planning
Fulfill the human subjects training requirement. SPH faculty, staff, and students engaged in HSR must complete the online Human Subjects Curriculum CITI course.
Activate or update your IDEATE user profile. Refer to the IDEATE Guidance section for information on how to activate or update your IDEATE user profile.
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.
Review SPH HRPP IRB application development guidance.
Components of an Initial IRB application (Read me before developing a new protocol in IDEATE)
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)
Flowchart: HSR IRB Protocol Submission Process
Compile informed consent documents (if applicable). Review the CUNY Central Informed Consent Process and Documentation Policy and related informed consent document templates.
Obtain necessary data agreements (if applicable).
If a non-CUNY individual/organization will provide data to a CUNY researcher:
Establish a Restricted Data Use Agreement (RDUA) OR
Establish an Unrestricted Data Use Agreement (UDUA)
Please note: CUNY executes DUAs (Restricted or Unrestricted) when a research project does not have sponsor funding. Additionally, CUNY does not provide DUA templates. The holder of the data determines the terms and conditions of use of each unique dataset which they share with CUNY.
If a CUNY researcher will provide data to a non-CUNY individual/organization:
Establish a Data Transfer Agreement (DTA)
Review CUNY Central guidance on research with special populations (if applicable). Special populations in HSR include: children, pregnant women, students (including recruitment of CUNY students) and prisoners.
Obtain off-site recruitment permissions (if applicable). In order to recruit subjects at an off-site location (e.g., another CUNY campus, a clinic, a school), you will need to obtain letters of permission/cooperation from each site.
Each campus within the CUNY system grants different permissions and has different procedures for conducting research on their campuses and with their CUNY affiliates. Generally, campus-specific permission must be obtained after CUNY IRB approval has been received. See Guidance for Conducting Research at Other CUNY Campuses.
There are special guidelines from the NYC Department of Education (DOE) for research conducted at a NYC school site or in which information is gathered from its students or staff—permission letters must be uploaded to your IRB application!
Coordinate research collaborations involving an external institution or another CUNY campus (if applicable). Research involving external collaborations, including with another CUNY campus, will require additional planning and coordination. If your external colleagues are engaged in the research (clause #3), this may also involve IRB review at the other institution, or a process whereby one IRB relies upon the review of another IRB (i.e., establishing an IRB of record). Please review the CUNY Central Policy on Collaborative Research for further information. If you will be conducting an international research project, please refer to CUNY Central Guidance on Research in an International Setting.
Part 3: Submitting an IRB Protocol in IDEATE/HRPP/IRB review cycle
Submitting an IRB protocol in IDEATE. IDEATE is CUNY’s online IRB application system.
Before you begin a new application in IDEATE, carefully review Part 2 (above) as well as the FAQs.
When you are ready to create a new IRB application, go to the IDEATE Guidance section for a step-by-step guide, which includes helpful screenshots to orient you to the IDEATE system.
The HRPP/IRB Review Cycle. Once an IRB application is submitted via IDEATE, a multi-phase HRPP/IRB review process is conducted:
SPH HRPP Coordinator conducts a pre-review. Once a PI submits their IRB application, it is routed to the SPH Coordinator via IDEATE. 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 IDEATE. The PI will receive an automated email from IDEATE that the protocol has been returned, and the protocol will re-appear on the researcher’s To-Do list. 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.
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 IDEATE-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 IDEATE-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 IDEATE-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 IDEATE-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.
Part 4: Post-approval tips for maintaining an IRB-compliant protocol
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 faculty investigator. Communicate regularly with your 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 IDEATE prior to 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, which corresponded with a study’s assigned expiration date (see above). However, effective January 21, 2019, Continuing Review will no longer be required for:
Most studies that qualify for the expedited review process
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 IDEATE to close their study. For guidance on submitting a final report, see the IDEATE Guidance section.
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. For guidance on submitting amending an active protocol, see the IDEATE Guidance section.
Unanticipated Problems and Adverse Events. If an unanticipated problem or adverse event arises during a PI’s research, they 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 IDEATE) in accordance with CUNY Central policy and specified reporting timeframes. For guidance on reporting an unanticipated problem or adverse event, see the IDEATE Guidance section.
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.