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An Institutional Review Board (IRB) is responsible for protecting the rights, safety, and welfare of people who take part in research. Under the Common Rule (45 CFR 46), an IRB may approve research only after it determines that specific criteria are met, such as minimizing risks to subjects and seeking and documenting informed consent appropriately.
The time that review takes also has consequences. Nonexempt research cannot begin until the IRB approves it, so turnaround affects when studies start. Part of that time can come from administrative steps, such as returning a submission to the investigator for missing documents, rather than from the review itself.
This article is for IRB administrators and compliance leads. It looks at where review time can be lost, how the Common Rule matches the level of review to the risk of a study, and which institutional practices can improve IRB review efficiency while the approval criteria that support human subjects protection stay the same. It also covers how to measure progress and where software can support the work. Regulatory references reflect 45 CFR 46 on the eCFR as of October 1, 2026.
Why IRB review efficiency is part of participant protection
Slow review carries its own risks for participants, most directly through amendments. Under 45 CFR 46.108(a)(3)(iii), investigators must follow the approved protocol until proposed changes are approved, except to eliminate an apparent immediate hazard to subjects. That rule protects participants, but it also means a revised consent form with new risk information or an added safety check cannot take effect while it waits in a queue.
Capacity is the second link. Time that staff and reviewers spend chasing a missing recruitment flyer or reconciling consent versions is time not spent on the questions only the board can answer. When administrative work crowds the calendar, higher-risk protocols can wait longer than should before they reach the board.
The approval criteria do not change when review moves faster. Under 45 CFR 46.111, an IRB may approve research only when it determines that :
- Risks to subjects are minimized and are reasonable in relation to anticipated benefits and the importance of the expected knowledge.
- Selection of subjects is equitable, with particular attention to people who may be vulnerable to coercion or undue influence.
- Informed consent will be sought and appropriately documented, or appropriately waived.
- When appropriate, the research plan provides for monitoring the data collected to ensure the safety of subjects.
- When appropriate, there are adequate provisions to protect privacy and maintain the confidentiality of data.
- Additional safeguards are in place when some or all subjects are likely to be vulnerable.
None of these criteria is a candidate for shortcuts. In this article, IRB review efficiency means reaching the point where reviewers can apply them sooner and apply them consistently, with no reduction in the review itself.
Where IRB review time is lost
Turnaround is usually reported as one number, which hides the stages where time accumulates. Breaking a protocol's path into stages, and asking who holds it at each point, shows which delays the office can control.
- Submission and pre-review: IRB staff check each submission for completeness before it goes to a reviewer. A missing consent document, an outdated recruitment script, or study personnel without current human subjects training sends the submission back to the investigator. Each return adds a full cycle before substantive review has started.
- Review path determination: Someone has to decide whether the study is exempt, eligible for expedited review, or needs the convened board. When the criteria for that decision are not written down, the same type of study can be routed differently from week to week, and borderline cases wait while staff seeks a second opinion.
- Reviewer assignment: A protocol may wait for a reviewer with the right scientific or community expertise. Under 45 CFR 46.107(d), a member with a conflicting interest cannot participate in the review except to provide requested information, so late disclosure of a conflict means reassignment and a restart.
- The meeting cycle: A protocol that misses the agenda deadline for a convened meeting waits for the next one. For a board that meets monthly, one missed deadline can add several weeks.
- Requested modifications: When a protocol comes back to the investigator for changes and the reviewer comments are vague, combine required changes with suggestions, or arrive in several separate messages, the study team needs more than one round to respond.
- Ancillary reviews: Studies that also need biosafety, radiation safety, conflict of interest, or departmental scientific review can stall when those reviews run one after another instead of side by side.
At any point in that path, the elapsed time sits with one of three parties: the IRB office, the reviewers, or the study team preparing a response. An office that does not track these separately may get blamed for delays it did not cause, while overlooking the ones it could actually fix.
Matching the level of review to the risk of each study
The Common Rule already builds proportionality into review. Minimal risk, defined in 45 CFR 46.102(j), means anticipated harm or discomfort is no greater than in daily life or during routine physical or psychological examinations. Research at that level can often be handled through exempt or expedited review, which keeps convened meeting time for studies that need group deliberation.
Three practical points follow from the table.
Expedited review applies the same approval standard: Expedited reviewers apply the 45 CFR 46.111 criteria. If a reviewer finds that a study on the expedited list involves more than minimal risk, the rationale must be documented (45 CFR 46.115(a)(8)), and the study goes to the convened board. The IRB must also keep all members informed of studies approved this way (45 CFR 46.110(c)).
Routing a study above its risk level has a cost: Minimal risk studies sent to the convened board by default consume agenda time, wait for a meeting date, and spread the board's attention across more items. Some institutions deliberately apply stricter routing than the regulations require. That is a legitimate choice when the institution knows what it costs in time.
Applicability is decided study by study: The table reflects the Common Rule. Research regulated by the Food and Drug Administration (FDA) also falls under 21 CFR 50 and 56, which still require continuing review at least once per year (21 CFR 56.109(f)) and permit, rather than require, reliance on another IRB (21 CFR 56.114). The Complete Guide to IRB Software for Research Institutions covers these differences in more detail.
How to speed up IRB review without compromising safety
The practices below are recommended institutional practices, not regulatory requirements. Each shortens a stage described earlier without changing what a reviewer must determine under 45 CFR 46.111. It is a practical answer to how to speed up IRB review without compromising safety: remove the delays around the review, and protect the time spent on the review itself.
Help investigators submit complete applications
Publish a short submission checklist for each common study type. Provide consent templates that already open with key information section required by 45 CFR 46.116(a)(5)(i) already added from a pre-reviewed and approved source. Where required by institutional or funding policy, confirm that listed study personnel have current human subjects protection training before the submission enters review.
Keep pre-review focused on completeness and routing. When staff raises substantive questions at intake, the protocol is effectively reviewed twice, and the investigator receives two sets of comments.
Write the routing criteria down
Turn the exemption and expedited review categories into a short decision aid that staff and reviewers share, and record the category relied on for each determination. Written criteria speed up clear cases, help newer staff decide confidently, and surface borderline cases early. They also give investigators consistent treatment for similar studies.
Assign reviewers by expertise, and surface conflicts early
Match protocols to reviewers whose expertise fits the study, and collect conflict of interest disclosures at assignment rather than at the meeting. Where the board lacks expertise, 45 CFR 46.107(e) allows the IRB to invite a nonvoting consultant. Arranging that at assignment avoids a deferral at the meeting.
Make requested modifications specific
Tie each reviewer comment to the section it concerns, separate required modifications from suggestions, and send the study team one consolidated set. Where the institution's written procedures allow the chair or a designee to verify responses to specific requested changes, define those conditions clearly so small corrections do not wait for the next convened meeting.
Plan the meeting calendar around the queue
Publish agenda deadlines well ahead and hold to them. Send complete materials early so meeting time goes to discussion rather than reading, and schedule reviews of higher-risk protocols earlier in the meeting while members are fresh. If meetings regularly overflow, check the routing criteria first.
Run ancillary reviews in parallel
When a study also needs biosafety, radiation safety, conflict of interest, or scientific review, start those reviews when the IRB submission arrives. Agree in advance which ones must be complete before IRB approval.
For federally supported cooperative research, 45 CFR 46.114(b) requires US institutions to rely on a single IRB, which removes duplicate local review when reliance is well managed. In such situations, relying institutions retain the responsibility for local requirements and compliance.
Keeping participant protection visible after approval
Oversight continues for the life of the study, and lighter post-approval obligations can make it easier to lose sight of a study.
Continuing review now varies by study: Under 45 CFR 46.109(f), continuing review is not required for research eligible for expedited review, research reviewed under limited IRB review, or research that has progressed to data analysis or follow-up clinical data, unless the IRB determines otherwise. Research approved by the convened board still requires it at least once per year. If the IRB requires continuing review where it is not otherwise needed, the rationale must be recorded (45 CFR 46.115(a)(3)). The office needs to know each study's obligation and next date, because a missed date means approval lapses.
Fewer renewals change the workload: Some institutions use a brief periodic status check for minimal risk studies that no longer need continuing review, so they still learn when a study closes or changes personnel. That is an institutional choice, not a federal requirement.
Amendments carry protective changes: Minor changes to approved research can go through expedited review (45 CFR 46.110(b)(1)(ii)), which keeps them off the convened agenda. Changes that are not minor still need convened review.
Reportable events need a clear path: 45 CFR 46.108(a)(4) requires written procedures for prompt reporting of unanticipated problems involving risks to subjects or others, serious or continuing noncompliance, and suspension or termination of approval. A defined intake route keeps these reports from waiting behind routine submissions.
Post-approval monitoring adds a direct view of practice: Post-approval monitoring (PAM) visits compare what happens at the study site with what the IRB approved, and often help educate study teams. PAM is an institutional practice rather than a Common Rule requirement. Where it exists, it shows whether human subjects' protection holds up after approval.
Measuring IRB review efficiency
A small set of measures, reported the same way each quarter, gives the human research protection program (HRPP) director something concrete to bring to the Institutional Official and research leadership.
Two cautions keep these measures honest. First, report speed alongside quality indicators such as lapses, reportable events, and monitoring findings, so that faster numbers are never achieved by thinner review. Second, avoid personal turnaround targets for individual reviewers. Pressure on the people applying the approval criteria is where speed and human subjects protection are most likely to conflict.
Used this way, the measures answer leadership's question about why approval takes as long as it does with evidence rather than impressions.
Where technology supports efficient IRB review
Many IRB offices already run a submission system, so the question is whether it supports the practices above. Software can check, route, version, remind, and report. It cannot assess risk, judge consent, or vote. The system supports the process; the principal investigator remains responsible for the protocol and the institution remains responsible for oversight.
How Key Solutions eProtocol supports this work
Key Solutions provides the eProtocol Human Subjects (IRB) module to support institutional IRB review and oversight. Several characteristics distinguish how it supports IRB review efficiency.
- Problems caught at submission: Smart forms guide investigators step by step, verify that required information is complete before submission, and flag potential issues early, so fewer submissions are returned at pre-review.
- Configuration owned by the institution: eProtocol deploys with a standard question set that the institution adapts to its own policies, including required questions, forms, and review workflows. Policy and routing changes do not have to wait on a vendor services request.
- Review activity kept together: Automated routing and notifications, version control, an audit trail of forms, comments, and meeting activity, and system-generated agendas and minutes keep each review traceable.
- Visibility for coordinators and leadership: Real-time status dashboards let investigators check progress without calling the office, and standard and ad hoc reports support turnaround tracking.
- Post-approval tracking: Renewals, amendments, and adverse events are tracked with the protocol, with automated reminders before approvals expire.
- Integrated across committees and research administration: The IRB module works alongside Animal Subjects (IACUC), Biosafety (IBC), Stem Cells (SCRO), Radiation Safety (RSC), Chemical Safety (CSC), and Controlled Substances (CS). Each committee keeps its own workflow, while investigators can reference a related protocol without re-entering study and personnel details. eProtocol also integrates with eCOI, eGrants, and institutional HR and finance systems through an open architecture.
Key Solutions brings 15+ years of focus on life sciences research and holds ISO 27001:2022 certification. More detail is on the IRB software page, and strengthening IRB protocol submissions with AI covers pre-submission checks in depth.
Faster review and stronger protection can move together
Improving turnaround starts with knowing where time accumulates in your own program. The practices in this article act on the administrative steps around the review, so the approval criteria that support human subjects protection stay the same while those steps get shorter.
To see how eProtocol supports IRB submission, routing, meetings, and post-approval tracking in your own environment, schedule a demo with us. If you are attending the PRIM&R Annual Conference (PRIMR26) in Denver, November 16 to 18, 2026, you can also meet the Key Solutions team at booth 306.
