An Institutional Review Board (IRB) is a committee, constituted per federally-defined membership requirements, tasked with reviewing human subject research to ensure subject rights, safety and welfare are protected. The University of Rochester’s IRB is referred to as the Research Subjects Review Board (RSRB).
This page summarizes the RSRB’s review process for basic, single-site submissions, and highlights best practices for facilitating IRB review.
Important notes before getting started
The RSRB is just one component of the University’s Human Research Protection Program (HRPP). The overarching aim of the HRPP is to ensure individuals involved in the conduct of human subject research understand and apply their obligation to protect the rights, dignity, welfare and privacy of research subjects.
The review process described below may be altered when the research involves multiple sites and is federally-funded or industry-sponsored. In this circumstance, the RSRB may elect to: 1) defer to another IRB for the review and approval of the research; or 2) conduct IRB review for all participating sites engaged in the research.
For additional information on this process, reference OHSP Policy 504: IRB Reliance and Collaborative Research and its corresponding Guidelines for When the University of Rochester Relies on a Non-University IRB and When the University of Rochester is the Reviewing IRB. More details are also available in the ‘Overview of Multi-Site Study Review’ section of the Click IRB: Overview and Basic Navigation Guide.
RSRB review is facilitated through an online platform called the Integrated Online Research Administration (IORA) system; the system includes a module for conducting IRB reviews, which is referred to as Click IRB.
Step-by-step instructions for navigating the Click IRB system and submitting research for RSRB review are available in the Click IRB Study Staff Manual. New users are strongly encouraged to follow the instructions available within the Click IRB manual for various submissions until they become comfortable using the system.
Following submission in the Click IRB system, proposals will undergo review as depicted in the image and drop-downs below.
All proposals are initially routed for departmental review and sign-off. Of note, some departments have their own procedures in place beyond the basic review conducted in Click IRB. As such, study team members are encouraged to contact their department reviewers early in the process to determine whether any additional procedures are required.
Following departmental approval, the submission will be assigned to any/all applicable ancillary committees (in accordance with OHSP Policy 503: Ancillary Committee Review) for review. Next steps are dependent on whether ancillary committee review is required and when their approval is required. Some committees block the RSRB review process–meaning, the committee must provide approval before the IRB Coordinator can initiate the review process. For others, committee review can happen in tandem with RSRB review, though approval is required prior to RSRB approval. Alternately, other ancillary committees can conduct their review and provide approval at any time, without dependence on the timing of RSRB review and approval.
The IRB Coordinator’s role is to shepherd the submission through the review process. Once a proposal is assigned to an IRB Coordinator, they will conduct an initial pre-review, ensuring adequate information is provided for the board to make the requisite determinations about the research and that the research satisfies regulatory and institutional requirements. Typically, IRB Coordinators initiate their review with the study protocol, ensuring that all of the necessary elements are adequately addressed in a consistent manner. From there, they will review all supporting documentation (e.g., recruitment materials and consent forms) to ensure they are complete, consistent with the contents of the study protocol and written at an appropriate reading level (as applicable).
Following IRB Coordinator review, where the submission moves in the process depends on several factors. If it is unclear what the research entails or how regulatory and institutional requirements will be met (e.g., information is missing, incomplete or inconsistent), the submission will likely be returned to the Investigator for changes (see additional information in the section below). On the other hand, if the submission is in relatively good shape, the proposal can be moved forward via one of three review pathways, as summarized in Appendix 1. Note, the review pathway is determined by IRB staff per the requirements set forth in federal regulations; Investigators and study staff cannot request a specific type of review.
The reviewing board or individual (based on the review pathway) will review the submission and make the requisite determinations, confirming whether: 1) the research meets exemption criteria or, for research undergoing expedited or convened board review, validate whether the criteria for IRB approval are met, as defined by the federal regulations; and 2) all applicable institutional policies have been met. In the event these criteria cannot be validated, based on the contents of the submission, the research will be returned for clarification/modification. Once the reviewing board/individual has made the necessary determinations, the submission will be returned to the IRB Coordinator for processing (submissions will either be returned for clarification/modification or processed for approval).
Although simplified for the purpose of this description, this process is complicated and involves multiple key players. Plan plenty of time for IRB review to be conducted; do not wait until the last minute if you have an anticipated start time for conducting the research. Turnaround times depend on multiple factors, including (but not limited to) submission quality, workload, and ancillary committee review requirements.
A workflow diagram is available in Click IRB to monitor where the submission is in the review process.
Study teams can identify where a proposal is in the review process via the study state and review workflow in the study workspace. When a submission is in Department Review, the study state will be noted as such.
Once the department has approved the proposal, both the study state and review workflow will update as follows:
Once an IRB Coordinator has been assigned to the proposal, their name will appear in the upper right corner of the study workspace. Contact information is available.
Submissions can be returned to the Investigator for clarification/modification at any point during the review process. When revisions are required, the PI, PI Proxy and Primary Contact (as designated in the Click IRB system) will receive an email notification alerting them to the request (with a written description of the request provided directly in Click IRB).
Obtaining IRB approval provides approval for only the study procedures described in the IRB approved protocol, as well as the provisions identified in the IRB submission form (including all approved supporting documentation uploaded within the submission form). Updates or revisions to these documents (including adding additional study personnel) cannot be implemented until IRB-approval has been obtained.
IRB approval is only granted for the period determined by the IRB. If an expiration date is assigned to the research, a continuing review (i.e., progress report) must be submitted and approved for the research to continue. If the approval lapses (expires), all research activities must be stopped until re-approval is obtained. To avoid lapses in approval, submit continuing reviews well in advance of expiration (30-60 days). For additional information, see the links/resources provided below.
Reference our Convened Board Guideline for full details
Reference our Expedited Review Guideline for full details
Reference our Exempt Status Determination Guideline for full details
Review our When Do I Need to get RSRB (IRB) Approval? page to learn when IRB approvals are needed.
When an IRB determines that a proposal is ‘not human research’, this means that the proposal does not involve ‘research’ and/or ‘human subjects’, as defined by federal regulation. This isn’t to say that aims of the project proposed are unimportant. Rather, the project just does not meet specific regulatory definitions and therefore review of the project falls out of IRB/RSRB scope (meaning, IRB/RSRB policies do not apply). If/when the aims or activities of the project evolve to include ‘research’ and ‘human subjects’ (as defined by federal regulation), the project would then be subject to IRB/RSRB policies, including IRB/RSRB review.
When an IRB determines that a proposal is ‘exempt’, this means the project: a) involves ‘research’ (as defined by federal regulation); b) involves ‘human subjects’ (as defined by federal regulation); and c) falls into a federally-defined exemption category. Once the IRB/RSRB confirms the research meets exemption criteria, further reporting to the IRB/RSRB in not required (provided there are no changes to the research, nor reports of new information).
For more information review the OHSP Guideline for Determining Human Subject Research; Institutional Review Board Scope; and IRB/RSRB Exemptions.
Exempt research involves very little risk and must fall into one or more federally-defined exemption categories.
The term ‘exempt’ does not mean that the research does not require IRB review. Rather, once it’s determined that the research falls into one of the exemption categories, it is exempt from further IRB reporting requirements provided there aren’t any revisions to the research.
Per institutional policy, the Research Subjects Review Board (RSRB) is responsible for making the determination of whether or not the research falls into one of the exemption categories; Investigators are not permitted to make this determination independently. For additional information reference our RSRB (IRB) Exemptions page.
Expedited research involves no more than minimal risk (meaning, the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and other themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychology examinations or tests) and must fall into one or more federally-defined expedited categories.
Whether a proposal’s review level is ‘exempt’ or ‘expedited’ affects the IRB review process. While both submissions are initially reviewed by an IRB coordinator, exempt submissions are confirmed by a secondary RSRB staff member (typically either a senior IRB coordinator or a director). Whereas expedited proposals, must be reviewed and approved by a board chair or the designated board member (i.e., the vice chair or another experienced board member). Based on this requirement, the term ‘expedited’ is not meant to reflect turnaround time; the term only reflects that the process does not require review by the convened board, which may only meet monthly or bi-monthly, depending on the board.
From the standpoint of the study team, whether the research falls into an exemption category or undergoes expedited review has very little effect on their IRB reporting requirements. In either case, following exempt confirmation or IRB approval, the study team is responsible for:
The primary difference is the requirement for continuing review (i.e., submission of a progress report), which the IRB may require for expedited research. Circumstances where the IRB may require continuing review include (but are not limited to):
When continuing review is required, the research will be assigned an expiration date (per federal regulations, this date cannot exceed a one-year approval period).
Reference our Submission Preparation FAQs for more information.
Reference our Deferred vs. Modifications page for more information.
As defined in OHSP Policy 501: Levels of RSRB Review, the approval date is the date the IRB decision was made to either approve or approve with modifications/stipulations the item under review (i.e., new study application, modification or continuing review). An effective date is the date IRB decision takes effect; it is the first possible date the research can be performed (or modification implemented) following notification from the IRB.
Depending on the determination the IRB makes, these dates may or may not be the same. When a submission is approved outright and no modifications/stipulations are required to secure approve, the approval and effective date will be the same. However, when modification/stipulations are required for approval, the effective date will be later; it will reflect the date the required modifications/stipulations were reviewed and accepted by the IRB.
Reference our Click IRB FAQs for more information.
The Research Subjects Review Board (RSRB) is frequently asked this question and the short and simple answer to this is everything!
Remember, IRB approval allows you to conduct the research as described in the approved IRB submission, including the approved version of the study protocol and all supporting documentation (i.e., the IRB submission form, consent forms, recruitment materials, study measures, etc.). Any modifications to those documents require the submission to, and re-review, by the Reviewing IRB. This review is required to ensure the research will continue to meet the criteria for IRB approval, given the proposed revisions.
This includes, but is not limited to, revisions regarding:
Instructions for submitting a modification to the RSRB are available in the Click IRB Study Staff Guide.
Federal regulations (45 CFR 46; 21 CFR 56) require continued IRB review of some types of minimal risk (expedited) research and all greater than minimal risk human subject research at least annually. In order to maintain IRB approval of the research, it is the responsibility of the Principal Investigator (PI) to ensure timely submission of a continuing review (also referred to as a progress report) prior to a study’s expiration date. Timely submission is necessary in order to provide the Reviewing IRB adequate time to review the submission and request clarifications, if necessary. Based on the required review level, board scheduling, and workload, Reviewing IRBs cannot guarantee timely renewal of research for continuing reviews submitted on, or just shortly prior to, study expiration. If IRB approval of the research lapses, all research activities, including recruitment, enrollment, interventions, interactions and data analysis on current subjects must cease until re-approval is provided. Lapses in IRB approval are considered non-compliance and multiple incidents of lapses in approval may be considered continuing non-compliance.
For research reviewed and approved by the RSRB, study expiration dates (or approval end dates) can be found in the upper left corner of the STUDY workspace in Click IRB. Note that this field is blank when continuing review of the research is not required.
As a courtesy, reminder e-mails concerning approaching expiration of RSRB-approved studies are sent to the PI, PI Proxy, and Primary Contact at 30 and 60 days prior to expiration. To help ensure timely review, as a general rule of thumb, the RSRB recommends submitting continuing reviews no later than 45 days prior to expiration.
‘Suspending’ a study means that the study, or a specific component of the study (e.g., enrollment, a specific study procedure, or intervention administration) is halted. Routinely, this occurs because of a safety or non-compliance incident and the study sponsor, Reviewing IRB, data and safety monitoring committee, or PI determines that the study should be stopped for a period of time in order to investigate the incident and determine the best path forward.
When the RSRB is the Reviewing IRB and the PI, study sponsor or data and safety monitoring committee determine that the study should be suspended, it should be reported via a Reportable New Information (RNI) submission form in Click IRB. Suspensions should not be requested through a request for study closure via continuing review, as this does not allow the study to be re-opened and modified to reverse the study suspension. Instructions for submitting a RNI to the RSRB are available in the Click IRB Study Staff Guide.
Note: If the Reviewing IRB decides that a study needs to be suspended for any reason, the IRB is required by federal regulation (45 CFR 46.108, 21 CFR 56.108) to report this determination to applicable institutional and regulatory authorities and the study sponsor.
Per OHSP Policy 502: Types of RSRB Submissions, when the RSRB is the Reviewing IRB, ‘a study is considered completed, and therefore may be closed with the RSRB, when:
Exceptions are as follows:
To close a study with the RSRB, submit a final continuing review as described in the Click IRB Study Staff Guide.