What If Your Next IRB Submission Could Review Itself?

The Brutal Truth About IRB Review

You already know the drill.

You've spent months designing a study. Your protocol is thorough. Your consent form has been reviewed by three colleagues. You feel confident — maybe even optimistic — as you click "submit" to the IRB.

Then the email arrives. Modifications required.

Missing elements in your informed consent. An inconsistency between your protocol's risk description and the consent language. A data security provision that doesn't satisfy the latest regulatory guidance. Your recruitment materials use language that could be perceived as coercive. And your adverse event reporting plan doesn't align with the specific requirements your IRB has adopted.

For sponsors, every day a protocol sits in IRB review is a day your trial isn't enrolling. Delays cost money — sometimes hundreds of thousands of dollars per week at multi-site trials. And when a site gets a "modifications required" determination, the clock resets.

This is the world we've all been living in. Until now.

Meet Sunethics.ai

Sunethics.ai is not another IRB workflow portal. It's not a fancier way to route submissions through committees or track approval dates in a dashboard.

Sunethics.ai is a regulatory intelligence engine that actually reads your documents — every page, every paragraph, every clause — and scans them against the full body of federal regulations and your organization's own rules, in real time.

Think of it as a brilliant regulatory affairs expert who has memorized the entire Code of Federal Regulations, every OHRP guidance document, your IRB's standard operating procedures, and your site-specific policies — and who can review a 40-page protocol in under two minutes.

That's not a metaphor. That's what Sunethics.ai does.

How It Works

The experience is elegantly simple.

Upload your documents. Protocol, informed consent form, recruitment materials, investigator brochure — whatever you have. Sunethics.ai ingests PDFs, Word documents, and scanned files.

Select your compliance framework. Sunethics.ai comes loaded with the standard federal regulatory requirements — 45 CFR 46, 21 CFR 56, the Common Rule, FDA guidance documents. But here's where it gets powerful: organizations can layer on their own rules. Site-specific policies. SOPs. Sponsor requirements. The platform supports a three-tier rule cascade — federal standards, organizational policies, and site-level requirements — so every scan reflects the exact compliance landscape that applies to your study at your institution.

Hit scan. In real time, Sunethics.ai streams its findings as it works through your documents. You don't stare at a loading spinner for five minutes and hope for the best. You watch Sunethics.ai identify issues, cite the specific regulation or policy that applies, and explain exactly what needs to change — as it's happening.

Built for Everyone in the Compliance Process

For IRB Administrators

If you run an IRB office, you know that a huge portion of your reviewers' time is spent on preventable issues. Incomplete consent forms. Missing required elements. Inconsistencies between documents. These aren't complex ethical judgments — they're compliance gaps that could have been caught before the submission ever reached your desk.

Sunethics.ai doesn't replace your IRB. It arms your investigators with a tool so effective that by the time a protocol reaches your committee, the compliance fundamentals are already handled. Your reviewers can focus on what actually requires human judgment: the nuanced ethical questions, the risk-benefit calculus, the contextual decisions that no AI should be making.

And for administrators who want even more control, Sunethics.ai lets you define custom rules at the organizational and site level. If your IRB requires specific language in consent forms, specific adverse event reporting thresholds, or specific data security provisions beyond what the federal regulations mandate — you encode those rules once, and every investigator who scans against your institution automatically gets checked against them.

For Sponsors

The average time from protocol submission to IRB approval at academic medical centers can stretch weeks or even months, with the majority of first submissions requiring at least one round of revisions.

Now imagine handing your site investigators a tool that catches the vast majority of compliance issues before they submit. Imagine your CRAs spending less time chasing stipulation responses and more time on enrollment. Imagine a multi-site trial where every site is scanning against the same compliance rules, producing a level of consistency that's nearly impossible to achieve through training and SOPs alone.

For sponsors running adaptive trials, platform studies, or any protocol with frequent amendments, the value multiplies. Every amendment is another opportunity for compliance gaps to creep in. Sunethics.ai catches them before they slow you down.

For Researchers

Let's be honest — most researchers view IRB compliance the same way most people view filing taxes. It's necessary, it's important, and it's something you'd rather not spend your weekend on.

Sunethics.ai changes the emotional experience of IRB submission. Instead of anxiously wondering whether your consent form covers all the required elements, you know. Instead of guessing whether your data security plan satisfies your institution's policies, you've already scanned it and addressed the findings.

The platform doesn't generate your documents for you. It reviews what you've written and tells you exactly where the gaps are. You maintain full ownership of your research. Sunethics.ai just makes sure the regulatory foundation is rock solid.

For early-career researchers, it's like having a senior regulatory mentor available 24/7. For experienced investigators, it's like having a meticulous co-PI who never misses a detail.

The Technology Under the Hood

Sunethics.ai is built on a modern, purpose-designed architecture — not a chatbot bolted onto a document viewer.

Intelligent document parsing handles text-based PDFs and Word documents natively and can process scanned documents using advanced OCR. It doesn't just extract raw text — it understands document structure, identifying sections, headers, and the relationships between different parts of your submission.

Single-pass regulatory scanning loads the full applicable rule set — federal, organizational, and site-specific — and evaluates your documents in a single, comprehensive analysis. The result is thorough, fast, and cost-effective.

Real-time streaming results appear live as the scan progresses. There's no "processing… please wait" black box. You see Sunethics.ai working through your documents in real time, which means you can start addressing issues before the scan is even finished.

Three-tier rule cascade: standard federal regulations form the baseline. Organizations add their own policies on top. Individual sites add their specific requirements on top of that. This layered architecture means a single platform serves institutions of any size and complexity — from a single-site academic IRB to a multinational sponsor's global trial network.

Regulatory change monitoring: the regulatory landscape doesn't stand still, and neither does Sunethics.ai. The platform monitors the electronic Code of Federal Regulations for changes, so your rule sets stay current as regulations evolve.

What This Isn't

Sunethics.ai is not an IRB management system. It doesn't replace your submission portal, your committee scheduling, or your approval tracking. It integrates alongside those systems as a pre-submission quality layer — or as a tool that IRB reviewers themselves can use to accelerate their own review process.

Sunethics.ai does not make approval decisions. It identifies compliance gaps and provides specific, regulation-cited guidance on how to address them. The ethical judgment stays where it belongs: with your IRB, your reviewers, and your institution.

And Sunethics.ai is not a document generator. It doesn't write your protocol or your consent form. It reviews the work you've done and ensures it meets the standards that apply to your research. Your intellectual contribution remains entirely your own.